Guidelines for Plain Language and Good Design in Prescription Medication · 2018. 11. 8. · Good Medicine for Seniors:Guidelines for Plain Language and Good Design in Prescription

Guidelines for Plain Language and Good Design

in Prescription Medication

Canadian Public Health Association

National Literacy and Health Program

http://www.cpha.ca

http://www.nlhp.cpha.ca/

Good Medicine for Seniors:



ISBN: 1-894324-23-4

Copyright © 2002, Canadian Public Health Association. Permission granted for non-commercial reproduction only.

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This publication is also available on the Internet at the following addre s s :w w w . n l h p . c p h a . c a


The Canadian Public Health Association (CPHA) is a national, independent, not-for- p ro f i tvoluntary association re p resenting public health in Canada with links to the intern a t i o n a lpublic health community. CPHA’s mission is to constitute a special national re s o u rce inCanada that advocates for the improvement and maintenance of personal and communityhealth according to the public health principles of disease prevention, health pro m o t i o nand protection, and healthy public policy.


The National Literacy and Health Program (NLHP) is a partnership of 28 national healthassociations working together to raise awareness among Canadian health professionalsabout the links between literacy and health. The NLHP provides health professionalswith resources to help them serve people with low literacy skills more effectively. TheNLHP’s Plain Language Service offers plain language assessments, revisions andworkshops to the public, private and voluntary sectors.

http://www.cpha.ca

mailto:[email protected]

http://www.nlhp.cpha.ca





http://www.nlhp.cpha.ca

http://www.cpha.ca

Foreword and Acknowledgements

T he aging of the Canadian population has received much attention in recentyears, particularly as seniors are living much longer lives and the Baby Boomgeneration is approaching retirement. While the wisdom of age and good health

can make growing older a positive one, the reality is that older people often experienceillness, infirmity, isolation, loss and grief, deteriorating eyesight, and so on.

With aging often comes the need to take medication to manage chronic conditions,acute illness or trauma, and sometimes all of these. Managing a drug regimen can becomplex and sometimes potentially dangerous, particularly for those who have difficultyreading. The low literacy rates among Canadian seniors led the Canadian Public HealthAssociation (CPHA) to undertake this project to examine the issues and problemsrelated to low literacy and medication management, and come up with solutions.

These Guidelines should help those involved with providing patient information to useplain language and clear verbal communication – pharmaceutical manufacturers,physicians, pharmacists and other health care providers. The document was developedwith funding from the National Literacy Secretariat (Human Resources DevelopmentCanada) and Health Canada. The project was guided by a multi-stakeholder SteeringCommittee and benefited from the advice and input of the partners in CPHA’s NationalLiteracy and Health Program. I would like to thank all those involved.

Graphics were generously provided by Pharmasystems® Inc., and Literacy Volunteers ofA m e r i c a .

It is CPHA’s belief that patient information in plain language will help seniors maintaingood health and independence through the proper use of their medications.

Dianne Kinnon, Steering Committee Chair

Steering Committee members

Janet Cooper Canadian Pharmacists AssociationKaren Cuggy-Murphy Packaging Association of CanadaMicheline Ho Therapeutic Products Directorate, Health CanadaOwen Hughes College of Family Physicians of CanadaMyriam Jamault Canadian Nurses AssociationElisabeth Rode Canada’s Research-based Pharmaceutical CompaniesDorothy Silver Second Chance LearnersJulie Tam Canadian Drug Manufacturers AssociationRosalie Daly Todd Consumers’ Association of CanadaBarbara Wells National Association of Pharmacy Regulatory AuthoritiesMary Wyllie Nonprescription Drug Manufacturers Association of Canada

Table of Contents

Foreword and Acknowledgements

Introduction: About These Guidelines, and How to Use Them .............1

Chapter I Seniors, Literacy, and Patient Information .....................5

A Snapshot of Canadian Seniors.............................................................5

The Facts on Literacy in Canada.............................................................8

How do Patients Get Medication Information?....................................11

Regulation in Canada and Abroad........................................................13

Chapter II Plain Language and Good Design ...................................17

Introduction............................................................................................18

The Basics of Plain Language ...............................................................19

Compendium of Plain Language Terminology ....................................22

Clear Design, Layout, and Graphics.....................................................45

Testing for Readability...........................................................................49

The Physical Design of Packaging........................................................57

Chapter III Techniques for Enhancing Patient Compliance ..........63

Introduction............................................................................................63

Techniques for Involving the Patient ...................................................64

Triggers and Links..................................................................................67

Organizing and Packaging Medication.................................................72

Putting It All Together ...........................................................................74

Appendix Literacy Definitions and Levels Used inthe International Adult Literacy Survey ........................77

L ois took the medicine bottle out of her purse, hoping for

quick relief from her stress. What was it the doctor had

said? Lois tried to remember. Was it one pill three times a

day? Three pills once a day? When she tried to read the label, the

words didn’t seem to make sense.

The numbers on the label were

one and three, so she was pretty

sure that taking three pills a day

was okay. Since it was almost

supper time, she decided to take

all three right away. It would make

her feel better faster!

Lois woke up in the hospital several

hours later. Luckily, her husband had

called an ambulance when he couldn’t

wake her up. Lois had taken too much

medicine at one time because

she couldn’t remember what

the doctor had said, and couldn’t

read the medicine label.

Canadian Public Health Association. Easy Does It! Plain Language and Clear Verbal Communication. Ottawa, 1998......................

Patients need to understand theirmedication regimens and complyaccordingly to ensure they get the

greatest benefit from these drugs.

This document has been written to assistthose who develop and provideinformation for patients who useprescription medication. This includesmanufacturers of pharmaceuticalproducts and those whom they employto create information materials,physicians, pharmacists, and softwaremanufacturers who produce electronicinformation that is printed for patients atthe time a medication is dispensed. TheGuidelines will help in preparing writtenpatient information materials in plainlanguage and incorporating clear designfeatures. The heart of the publication isa Compendium of Plain LanguageTerminology for commonly usedinstructions to patients who are takingprescription medication (see Chapter II).

As we will learn in Chapter I, ad i s p roportionate number of Canadianseniors (defined herein as age 65 andolder) have literacy skills that fall belowthe level of everyday reading demands.Because seniors also consume most ofthe medications prescribed in Canada, itis essential that they be able tounderstand and follow the instructionsgiven to them verbally by care

p roviders as well as written patienti n f o rmation that comes from a variety ofs o u rc e s .

Written information can be provided ona medication package label or on apatient package insert in the case oforiginal package dispensing. However,the vast majority of prescription drugsin Canada are repackaged anddispensed by the pharmacist; in thiscase, written information appears on a label affixed to the re p a c k a g e dcontainer and frequently on ac o m p u t e r-generated information sheetp rovided at the time of dispensing.

Those who cannot understand verbal orwritten medication information due tolow literacy skills are at risk. Indeed,several Canadian research studies showthat roughly one-quarter of hospitaladmissions of seniors are related toproblems with medicationmismanagement. The resulting costs tothe health care system and to thepersonal well-being of older patients arestaggering.

This document encourages the use ofplain language so that most patientsunderstand the instructions on theirmedications. When preparing orrewriting text in plain language, aGrade 6 reading level is a generally

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INTRODUCTION: About These Guidelines and How to Use Them

accepted target to reach most people.H o w e v e r, there are segments of thepopulation who fall below this level in terms of reading compre h e n s i o nability, don’t understand either ofCanada’s official languages, or areblind. No amount of plain languagewill be of use to these people; thus,they will need assistance from otherssuch as family members or home careworkers, who will also benefit fro mplain language information.

Although this document is intendedprimarily for those who write patientinformation materials (i.e., manufacturersof pharmaceutical products and softwaremanufacturers of pharmacy-generatedpatient information), the Guidelines willbe of interest to other members of the“medication management team” whowork together to ensure good patientcare. In addition to manufacturers, teammembers include:

• health professionals involved inprescribing and administeringmedication;

• pharmacists;

• formal and informal caregivers whoadminister medications; and

• patients themselves.

Each member of the team has a role toplay in ensuring the safe and effectiveuse of medication, and collaboration is akey part of the process.

The text in this document is organizedinto three main chapters:

• Chapter I: background informationon seniors and literacy, as well asthe drug regulatory context;

• Chapter II: plain language and gooddesign in patient information, andthe Compendium of Plain LanguageTerminology; and

• Chapter III: techniques for enhancingcompliance.

In addition, an Appendix containsdefinitions of literacy from theInternational Adult Literacy Survey.

This document is part of a series ofpublications by the Canadian PublicHealth Association (CPHA) and itsNational Literacy and Health Program(NLHP). CPHA and the 27 nationalpartners in the NLHP focus on plainlanguage health information and clearverbal communication in healthprofessional practice. The program hasproduced the following materials, aimedprimarily at health professionals, whichprovide plain language and clear verbalcommunication tools and techniques.These materials are available fromCPHA’s Health Resources Centre.

• Easy Does It! is a training package forhealth care professionals, providinginformation, tips and techniques toimprove the way they communicatewith their patients. The packageincludes a manual, a training videoand a CD-ROM game called(plain•word)™.

• Working with Low-literacy Seniors is are s o u rce which focuses specifically on

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the senior segment of the population,giving practical strategies for healthp roviders serving these Canadians,and a bibliography of re s o u rc e s.

• Creating Plain Language Forms forSeniors is a guide for the public,private and not-for-profit sectors onthe design and plain-languagewording of forms intended to beused or completed by seniors.

Good Medicine for Seniors was developedunder the guidance of a SteeringCommittee of stakeholder re p re s e n t a t i v e sand with the advice and input ofindustry, seniors, pharmacists andregulatory bodies. These stakeholdersthen reviewed the Guidelines andassisted in the dissemination of thedocument. CPHA is grateful to the manyo rganizations and individuals whocontributed to the pro j e c t .

Good Medicine for Seniors: Guidelines for Plain Language and Good Design in Prescription Medication

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Prior to the Year itself, StatisticsCanada conducted its first majornational survey on the subject,

Literacy Skills Used in Daily Activities, andproduced an analytical report. In 1994,Statistics Canada and the Organisation forEconomic Co-operation and Development(OECD) carried out a joint study, theInternational Adult Literacy Survey (IALS).

Together with other pioneering studiesand demographic data, we now have arich source of data and analysis to help us understand the many aspects ofliteracy, including the particular needs andcharacteristics of older persons with lowliteracy levels. The following sectionpresents pertinent facts about Canada’saging population and IALS statistics toestablish a rationale for the use of plainlanguage in medication information forpatients.

A Snapshot of Canadian Seniors

Thanks to extensive research and analysis,particularly over the past two decades, wehave learned much about older Canadiansand the phenomena associated with theaging of the population as a whole. Thefollowing points highlight some of themore significant facts about Canada’sseniors.1

• Seniors are the fastest-growingsegment of the Canadian population.In 1998, there were 3.7 millionCanadians aged 65 and over (12.3% ofthe population). Projections indicatethat by the year 2031, this figure willalmost double to 21.7%. Seniors aged85 and older represent one in ten ofall seniors, up from one in twentyearlier in the 20th century.

• Women live longer than men inCanada, making up 57.4% of allseniors and 69.8% of seniors aged 85and over.

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CHAPTER I:Seniors, Literacy, and Patient Information

The United Nations designated 1990 as International Literacy Year,to draw attention to the scope and nature of literacy (and illiteracy)around the world as well as to examine its social, economic andpolitical implications. The Year generated considerable activity insome countries, including Canada.

1 So u rc e: Canada’s Seniors, pre p a red by Statistics Canada for

the Division of Aging and Seniors, Health Canada, 1999. For

the purposes of these figures, the age of 65 was used to

define “senior”.

…we now have a rich source of data and analysis to help

us understand the many aspects of literacy…

• The vast majority of seniors live athome. Of the 93% who do, 29% livealone (mostly women, who tend tooutlive their spouse); 7% live withmembers of their extended family(such as a daughter, son or sibling);and 2% live with non-relatives.Seniors living with a spouse orcommon-law partner account for58% of those living in privatehouseholds.

• Only 8% of seniors held a universitydegree in 1996, compared with 17%of Canadians aged between 25 and64. Six out of ten did not completehigh school, and 37% had less than agrade 9 education.

• In 1996, 4% of all people aged 65and over could not speak eitherofficial language, as opposed to 1%of those aged 15-64. This differencereflects, in part, the fact that manyseniors are immigrants.

• The average income for householdsheaded by a senior was just over$20,000 in 1997, compared with wellover $30,000 among those aged 35-54. Senior men had an averageincome of $26,150, while women inthis age range had an averageincome of $16,070. Of unattachedseniors, 45% were considered tohave low incomes.

• Seniors rely on others for help withhousework, shopping, etc. In 1996,84% received some form ofsupport, including 11.9% forpersonal care .

• Similarly, many seniors providedsupport to others (family andfriends): 35.3% helped by checkingup on others, 27.3% gave emotionalsupport, and 4.2% provided personalcare.

• Causes of death among seniors in1996 included 30% attributed to heartdisease, 26% from cancer, 11% fromrespiratory diseases, and 24% fromother diseases and conditions.

• Many seniors suffer from chronichealth conditions: in 1997, 42.4%lived with the pain of arthritis, while32.6% had high blood pressure.

• Also in 1997, one in four Canadianseniors living at home had a long-term disability. The proportion risessharply with age, with 45% of thoseaged 85 and over suffering from ahandicap.

• One-quarter of seniors experiencechronic pain, compared with only12% of those aged 25-54.

• In 1997, 84% of all seniors living athome took some form ofprescription or over-the-countermedication, with 56% using two ormore medications. Pain relieverswere taken by 62% of all seniors;33% took medication for high bloodpressure, 19% for other heartproblems. Other medicationsincluded stomach remedies (11%),diuretics (11%), and cough or coldmedication (10%).


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These figures reveal a segment of theCanadian population that is rapidlybecoming the largest age cohort in thiscountry. As the Baby Boom generation(those born between 1945 and 1965)ages, this diverse population will cometo dominate many aspects of Canadianlife – economic, social and political.Seniors are and will be a focal point inpolicy and programs affecting their lives,particularly in health care and, pertinentto this document, medication issues.Even though the Baby Boom generationmay be among the most educated inhistory, a significant portion of thispopulation – like those of generationsbefore it, and the ones that will follow it – has low literacy skills for enduringreasons such as poverty, rapidlychanging information andcommunication technologies, etc.

The fact that so many seniors takemedication – whether prescription, non-p rescription, natural health pro d u c t s ,herbal medicines, homeopathic medicines– cannot be overlooked by companiesserving this market. In Canada, $15 billiona year is spent on drugs; appro x i m a t e l y290 million prescriptions are written everyy e a r. Because more than half of seniorstake more than one medication – manytake more than ten a day – they mustunderstand their drug regimen in order toavoid negative interactions. TheGuidelines presented in this documentshould help those developing and/ordistributing pharmaceutical products andservices aimed at older Canadians top rovide them with the best possiblewritten information which will helpe n s u re that they take their medicationsafely and corre c t l y.

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What is a senior?

The arbitrary age of 65 is the most commonly used (and easily understood)definition of the beginning of one’s senior years. It has traditionally been the age ofeligibility for pension benefits, both public and private, and for other benefits such asgovernment drug plans and tax rebates.

In recent years, the over-65 population has been broken into three sub-categories:“young-old”, aged 65-74; “middle-old”, aged 75-84; and “old-old”, those aged 85 andover. Although some people find these distinctions offensive, the categories haveproven useful in research, statistical analysis, and policy and program development.

The increasing trend to early retirement has also led researchers to examine moreclosely the cohort aged 55-64. Those in this group are often referred to as “earlyretirees”, “pre-retirees” or “older workers”, depending on their status and theissue(s) under study.

These days, a healthy 78-year-old could have better health status and a moreactive lifestyle than someone 20 years younger. Both could be taking the samemedication. Which is the “senior”?

Many have dealt with the issue by using the term “older Canadians”.

The next section looks at the levels ofliteracy found among older Canadians,and discusses the implications forpatient information materials aboutprescription medication.

The Facts on Litera cy inCanada

As mentioned above, Canada has been aworld leader in the measurement ofliteracy. The International Adult LiteracySurvey, undertaken by Statistics Canadain partnership with the Organisation forEconomic Co-operation andDevelopment (OECD), assessed literacylevels in several countries in 1994 andpublished their findings the followingyear in a report entitled Literacy,Economy and Society.2

A major component of the study was the development of clear definitions ofliteracy as well as a methodology tomeasure effectively the literacy levelsamong the sample populations. TheIALS adopted the following basicdefinition of literacy: using printedand written information to function insociety, to achieve one’s goals, and todevelop one’s knowledge and potential.

Further refining this definition, IALSidentified three distinct types of literacy,defined as follows.

• Prose literacy: the knowledge andskills needed to understand and useinformation from texts includingeditorials, news stories, poems andfiction.

• Document literacy: the knowledgeand skills required to locate and useinformation contained in variousformats, including job applications,payroll forms, transportationschedules, maps, tables and graphics.

• Quantitative literacy: theknowledge and skills required toapply arithmetic operations, eitheralone or sequentially, to numbersembedded in printed materials, suchas balancing a chequebook, figuringout a tip, completing an order formor determining the amount of intereston a loan from an advertisement.

These three domains were then bro k e ndown into five levels in order tounderstand the broad and diversen a t u re of literacy and its meaning,extent and distribution. Level 1 wasidentified as the poorest and Level 5 thehighest; individuals in Level 5 weredefined as being capable of handlingmost everyday reading demands. (Thelevels are more fully described in theAppendix.) Testing took place in a face-to-face environment, where subjectsw e re asked to complete a series of taskssuch as reading a text and thenanswering questions about the content,filling in forms, finding pieces ofi n f o rmation, perf o rming arithmeticalcalculations, etc.

2 Statistics Canada and the Organisation for Economic

Co-operation and Development, Literacy, Economy and

S o c i e t y, 1995.

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It is worth noting that, even combining thenumbers for Levels 4 and 5, the oldest ageg roup perf o rmed significantly worse thandid the other age cohorts, with only 8.7%achieving a level where individuals couldhandle most everyday reading tasks. Thefact that 43.8% fell into the lowest category(Level 1) has serious implications forp roviding written information to this ageg roup and to those who are older (whoseskills are likely to be even poore r ) .

These low levels of literacy among olderCanadians prompt us to ask: Why? Whatfactors caused (or are causing) seniors inthis country to have trouble with printedm a t e r i a l s ?

Contributing Fa c t o r s

In addition to historical factors, such asthe Great Depression, World War II andgenerally lower education levels, othervariables contribute to low literacy. Whatbecomes of literacy skills over time? Likemany skills, they can become rustywithout regular use. For some, readingis simply not an enjoyable activity; forothers, it is an admission of inability.The resulting avoidance over the yearscan lead to loss of whatever skills theymay have had.

The changing nature of our society alsohas an impact on reading skills. A

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The following table shows the results of the IALS testing for Canada. The sample sizewas 4500 and included English, French and immigrant Canadians aged 16-65.

Literacy levels by age, Canada, 1994

A ge gro u p L evel 1 L evel 2 L evel 3 L evel 4/5 (aggregated)

% % % %

16-25 10.4 22.3 36.4 31.0

26-35 13.5 25.3 33.8 27.5

36-45 13.8 22.0 36.8 27.4

46-55 23.0 31.0 23.6 22.4

56-65 43.8 23.7 23.8 8.7

S o u rce: Statistics Canada, OECD

Legend

Level 1 – lowest

Level 5 – highest

reading level which may have beensatisfactory 40 years ago will not sufficein today’s technological, computerizedworld, when higher levels of educationin the general population have raisedthe norm. New vocabulary, newconcepts, new attitudes demandconstant upgrading of literacy skills tokeep pace with our culture. Literacy isrelative to time and society: it isdynamic, not static.

The normal physical changes that comewith aging can also have a bearing onolder people’s reading ability,particularly vision. As eyesight declines,it becomes more difficult to see smallprint or read from a distance. Highcontrast is needed to separate lettersfrom background, and some colours orcolour combinations can hamperreadability.

Many of these factors will be exploredmore fully in subsequent chapters.

The Health Impact of Lo wLiteracy on Seniors

Although advances in medicine, healthpromotion and technology haveimproved the health status of Canadiansdramatically, it is still a fundamentalreality of aging that disease and chronicconditions increase as people get older.As noted above, the incidence of heartdisease, cancer, arthritis and otherproblems are high in the olderpopulation. Those who have low literacyskills are more vulnerable in severalways.

Health information, by its very nature, iscomplex. In order to be accurate and

complete, written materials are oftenequally complex, using technical termsand a style of writing aimed more athigh-level readers, such as healthprofessionals, than at the general public.This makes the information inaccessibleto many, particularly those with lowliteracy skills.

The fact that seniors often experiencemultiple illnesses and/or conditions, andmay therefore be taking severalmedications, means that they are likelyto require information from severalsources about several medications. Asshown above (and in more detail in theAppendix), the capacity to make high-level inferences from several documentsis a Level 4 or 5 skill. If the language inthese information materials is already ata high reading level, the person withlow literacy skills will likely not be ableto understand or manage thecomplexities of a multi-medicationregimen.

The reality of medical conditions andcorresponding drug therapies is thatthey are complicated. However, it is notalways necessary for patients to receiveall of the information all of the time.Key facts – presented in clear languageand reinforced by physicians,pharmacists and caregivers – are oftensufficient to assist patients inunderstanding their medication. Whenthese “multiple interventions” are furtherreinforced by print materials written inplain language, patients with lowliteracy skills are much more likely to beable to understand their medical statusand take their medication properly.Seniors will enjoy a higher level ofhealth and well-being as a result.

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H ow Do Patients GetM e d i c ation Info rm at i o n ?

Where do people get information onmedication? The initial source is, ofcourse, the prescribing physician(or dentist). The time of issuing aprescription is the opportunity for the

physician to provide a verbalexplanation of the drug, its purpose,how to take it, precautions and sideeffects. If the physician has a copy ofthe patient package insert, it can bereviewed. A demonstration may also beuseful if there is a device involved, suchas an inhaler or a syringe. At this time,

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Seniors as Caregivers

Studies have shown that many seniors provide care to, or receive care from, familyand friends. It has been estimated that more than 90% of elder care in Canada isprovided informally; it ranges from personal care (including managing andadministering medication), to housework, transportation and emotional support.

Increasingly, seniors are growing older in their homes as community care replaceshospital and institutional care. However, seniors need more help and support in thehome, for example, when it comes time to take their medication, than they do in aninstitutional setting. If we want seniors to remain as independent as possible in asafe, supportive and healthy environment, it is important that medication instructionbe clear and practical and in plain language.

For those patients who, for whatever reason, no longer have the capacity tomanage their own medication at all, it is essential that informal caregivers they relyon be able to understand the medication therapy they are administering. Thus, it isnot only the patient but the caregiver as well who may require plain-languageinformation.

Seniors typically provide care for other seniors – spouses, siblings, friends, andeven aging parents. It is increasingly common for a young senior to be caring for a very elderly parent.

Seniors often find themselves caring for grown children who are ill or disabled orin some way needing care. The growing incidence of HIV/AIDS has also affectedmany seniors who may be caring for a family member stricken with the disease,and drug regimens for this condition are usually very complex. Understanding howand when to administer medications becomes a critical factor in maintaining thehealth of these patients, or caring for them during the process of dying. Plain-language information can make this task easier and safer, especially if the patientis in an isolated or rural area where supports – such as home care services oradditional informal caregivers – are limited.

the physician may also providesupplementary patient informationproduced by the manufacturer,brochures on the nature of the illness orcondition requiring the medication, andother appropriate materials. Althoughthe amount of counselling by physiciansvaries from one to the next, generallysome patient information is provided,either verbal or written (or both).

This information is later re i n f o rced bythe p h a rm a c i s t when the medication isdispensed. Pharmacists are now re q u i re dto provide a counselling service,especially the first time a prescription isfilled. At this time they ensure that thepatient understands what the physicianhas explained, and re i n f o rce the verbaland written information that he/she hasreceived. Pharmacists also may giveadditional written information about themedication to the patient as a computerprint-out. Hospital pharmacists fre q u e n t l yp rovide counselling and information asnecessary when a patient is discharg e df rom an institutional care setting.

Health personnel – such as nurses,therapists, dietitians, and social workers – may be involved insupporting the patient or an informalcaregiver in understanding andmanaging medication.

Many patients like to supplement theinformation received from care providersthrough their own research. Severalpublications are on the market whichlist thousands of drugs and provideinformation and instructions on theiruse. The level of writing in thesereferences is inconsistent, some beingfairly technical in nature and others

using a level of language moreaccessible to the average reader. Mostare produced in the United States, andmay not provide the Canadian brand ortrade name, which often is differentfrom the U.S. name. This can make itvery difficult to look up a particulardrug using the index.

Similar problems occur in druginformation available on the Internet.Some sites have an opening pageinviting the visitor to choose one of twoportals: one for physicians, pharmacistsand other professionals; the other forconsumers. The language andterminology is then provided at asuitable level. The professional sectionusually requires registration and apassword for access. A growing numberof physicians are using these sites.

A danger of Internet sites is that thedistinction between providinginformation versus marketing products isnot always evident. Some sites are in thebusiness of selling a wide range ofpharmaceutical products (dubbed“online drugstores”). Others are sitesmaintained by pharmaceuticalmanufacturers who use the opportunityof a visit to promote their products. Asystem known as Health on the Net( a b b reviated HON), in which companiesa g ree to abide by a set of establishedprinciples, is a helpful designationindicating that the information is not onlyaccurate but also unbiased. Consumersshould be aware of this and check for theHON logo on the opening website page.

Media stories – both print andelectronic – can also be a source ofinformation on medication. Whether in

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the form of a news story or an in-depthstory, article or documentary, this can bea useful source of information (assumingit is accurate) and is usually written inan accessible style for the averagereader or listener.

In Canada, p h a rm a c e u t i c a lm a n u f a c t u rers a re not permitted top romote products requiring a pre s c r i p t i o nt h rough the media except under strictHealth Canada guidelines. Some arg u ethat such media advertising, known asd i rect-to-consumer advertising (DTCA),can cause more visits to physicians,i n c rease the use of medication and re s u l tin higher costs for the health care systemand for public and private drug plans.Others claim that it is an importantmethod for patient education. DTCA isc u r rently permitted in the United States,and Canada’s proximity means a spill-overinto the Canadian media environment isimpossible to prevent. Health Canadacontinues to monitor the situation.

Reg u l ation in Canada andA b ro a d

Information provided with prescriptionmedications – both in Canada and inother countries – is strictly regulated.

Canadian Regulations

Pharmaceutical manufacturers,physicians, and pharmacists know thatmedications in Canada are controlled byHealth Canada, through its TherapeuticProducts Directorate (TPD) and NaturalHealth Products Directorate (NHPD).Drugs for human use which aresubmitted to TPD for approval arerequired to conform to the federal Food

and Drugs Act and the associatedRegulations. The Food and Drugs Act ispart of the Criminal Code of Canada ,and only infractions that can beconsidered of a criminal nature can beprohibited by the legislation.

Drug or pharmaceutical products inCanada are regulated under several legalstatutes administered by Health Canada’sHealth Products and Foods Branch. Themain statute – the Food and Drugs Actand Regulations – requires that allpharmaceutical products offered for salebe authorized by Health Canada prior tomarketing. As part of the evaluationprocess undertaken by Health Canada todetermine if a product meets therequirements of the legislation, thelabelling material proposed to be usedby the sponsor of the product is subjectto review.

A TPD guideline on labellingrequirements, produced in 1989, isavailable to manufacturers. Thisguideline, used in conjunction with theAct and Regulations, contains definitionsof terms and current interpretations oflabelling requirements. Theseinterpretations are based on legalprecedents and advisory opinionsestablished over a number of years.

The purpose of the Health Canadaguideline is to help manufacturersdevelop labelling material that fullyinforms the health professions and thegeneral public about the use ofparticular medicines. It applies to over-the-counter medicines as well asprescribed and parenteral drugs (thosetaken into the body otherwise than byway of the digestive tract).

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Definition of a Label

Under the legislation, the term“labelling” for a drug product isconsidered to be all-inclusive. Inaddition to the actual labels, it includesextensions of the labels such as packageinserts, product monographs,information on prescribing, and filecards whether included in the packagingor available on request.

When a submission or request forapproval of labelling materials is made,all such pertinent documents arerequired to be submitted.

Elements of a Label

Several elements of a label aremandatory, and the Health Canadaguideline lists these very specifically.They include such information as thep roper or common name of thep roduct, the Drug Identification Number(DIN), declaration of medicinali n g redients, and dosage form. Thisi n f o rmation is necessary for the healthp rofessional as well as the laboratoryanalyst to properly identify themedication, and to determine if thep roduct meets quality re q u i re m e n t s .Consumers are also served byconsistency in nomenclature as theymay need to recognize diff e re n c e sbetween products as well as similaritiesin situations where an ingredient mayneed to be avoided.

Wording of a Label

The Health Canada guideline makes aclear distinction between informationthat is directed to the professions andinstructions for use aimed at the public,i.e., the consumer. Although technicalterminology may be important forphysicians and pharmacists, theguideline recognizes that such jargonhas little meaning to the lay public. Itstates:

For example, the pharmacologicalclassification of a medicine as ananti-emetic would not be sufficienton an OTC [over-the-counter] label;an additional indication, such as“motion sickness”, would benecessary.3

Health Canada’s guideline does notspecify the actual wording of directionsfor use, warnings, etc., aimed at theconsumer of the medicine. Themanufacturer is required to providecertain required information, but mayphrase these elements in lay terms,provided the intent of each element ofthese directions is conveyed. Indeed,looking at the example above, the useof lay terms or plain language may benecessary, not optional, in order tosatisfy the requirement of the legislationto provide “adequate directions for use”.

3 Health Canada, Labelling of Drugs for Human Use, 1989,

p. 29.

14


The purpose of the CPHA guidelines in this document is to provide plain languageterminology for use by pharmaceutical manufacturers to meet this requirement.

International Regulations

During the research phase of thisproject, CPHA reviewed legislation andregulations on labelling and packagingof prescription medications in severalother countries.

European Union

In 1999, the European Commission (EC)adopted A Guideline on the Readabilityof the Label and Package Leaflet ofMedicinal Products for Human Use.Several directives require that label text“shall be easily legible, clearlycomprehensible and indelible”, and “bewritten in clear and understandableterms for the patient” (Council Directive92/27/EEC). As with the Health Canadaguideline, the EC document is for use bypharmaceutical manufacturers seekingapproval (termed “marketingauthorisation”).

The EC guideline draws a similardistinction between required wordingand elements which may be written inplain language. Similar to these CPHAguidelines, it provides suggested plainlanguage terminology, as well as designtips and a section on testing forreadability. Every effort has been madein the CPHA guidelines to achieveconsistency with the European guidelinein order to make product informationtransferable among countries, for the

benefit of both patients andmanufacturers who may producepharmaceuticals in several countries.

United States of America

The United States has also been movingin the direction of plain language inpatient information, particularly since therelease of a Presidential Memorandumon Plain Language in 1998 whichmandates federal employees to write orrewrite federal documents to make themeasy for the public to understand anduse. The U.S. Food and DrugAdministration (FDA) announced a newregulation for over-the-counter drugs inMarch 1999 requiring easy-to-understandlabelling on these products.

A public workshop held by the FDA inMarch 2000 on prescription druginformation for patients developedconsensus that comprehensibility andlegibility were key criteria. The agencyagreed to move in the direction of thisconsensus. The FDA is also evaluatingthe impact of a private-sector, industry-based action plan implemented in 1997,the goal of which is to provide patientswith better and easy-to-read informationabout prescription drugs. No regulationhas yet been adopted. An FDA directornoted at the workshop that “a century ormore of a professional model that didn’ttrust patients with information hascreated much inertia to overcome.”

15


The National Pharmaceutical Councilin the United States re c e n t l yreleased some sobering statistics:

• Nine of every ten outpatients arebelieved to be taking pre s c r i b e dmedications i m p roperly or not at all.

• An estimated three to five out ofevery ten prescriptions fail toproduce desired results becausethey are used improperly.1

Having established the link betweenliteracy and health earlier in thisdocument, it can safely be assumed thatthese disturbing figures are largely due topatients having difficulties understandingtheir medication information. With this inmind, Chapter II provides information onthe use of plain language and gooddesign in the preparation of medicationi n f o rmation and packaging.

The section begins with an overview ofplain language writing techniqueswhich are widely accepted by writersand editors who specialize in thedevelopment of written materials forreaders who may have low literacy skills.They are also used by literacypractitioners in preparing texts for theirstudents. These techniques can beadapted to virtually any subject matter,even when the content and concepts arecomplex. When used in the development

of patient information materials, thesebasic techniques can bring clarity to themanagement of what can sometimes bea difficult drug regimen. This is essential,for people with low literacy skills.

The second part of this chapter is aCompendium of Plain LanguageTerminology for use in patientinformation materials. The wordings areconsistent with similar terminologyapproved for use in Australia as well asthe countries forming the EuropeanUnion.

A third part contains advice on the useof clear design, layout and graphicsto help the reader make sense of theinformation. Also included are designideas to ensure that people with pooreyesight can make out the text.

A review of techniques to test thereadability of materials follows, withtools to analyze the text and methods oftesting a document with test subjects.

The chapter concludes with a look atthe physical design of packaging andhow it can help patients, such as seniorswho may have arthritis or otherproblems, manipulate the package safelyand effectively.

1 Facts of Life: Issue Briefings for Health Reporters. Pills

that aren’t taken can’t work. National Pharmaceutical

Council, 1997

17

CHAPTER II:Plain Language and Good Design

I n t ro d u c t i o n

As demonstrated in the previous chapter,using plain language and clear verbalcommunication is essential so that peoplewith low literacy skills understand how totake their medication properly. Failure tounderstand and follow medicationinstructions can have a direct effect on anindividual’s health and well-being. Plainlanguage and clear communication canenhance physician-patient andp h a rmacist-patient relationships whenmedication is prescribed and dispensed.

Seniors are at particular risk for thefollowing reasons:

• their higher use of medications;

• the vulnerabilities that can accompanytypical physical and cognitive changesrelated to aging, such as poor vision,confusion or forgetfulness; and

• lower literacy levels.

Other reasons may include the fact thatsome seniors:

• live alone and are unable/unwillingto self-medicate properly;

• don’t trust doctors and so don’t taketheir prescribed medications;

• are over-medicated (they may havemore than one physician prescribingmedication) and need an assessmentto determine if the number ofmedications can be reduced;

• accumulate their medication and saveit for a time when they feel they will

“ really need it”, or use medicationp rescribed for someone else;

• use over-the-counter (non-prescription) medications, herbalpreparations or other remedies butdon’t inform their doctors;

• may have trouble communicatingverbally (as well as in written form);and

• see doctors as authority figures andfind it difficult to ask questions.

Seniors from ethnocultural communitiesalso have particular reasons for being atrisk. These are outlined in Use andMisuse of Drugs by Seniors: A Cro s s -Cultural Educational Model, a publicationp roduced by the Canadian EthnoculturalCouncil in January 2000. Some of thefindings reveal that language issues aresignificant, and that many ethnic seniorsdo not go to the pharmacy themselvesand thereby do not receive counselling,or rely on someone else (usually a familymember) to convey the inform a t i o nreceived from the pharm a c i s t .

Individual responses to the agingprocess vary depending on severalvariables, such as physiology, genetics,socio-economic status, andenvironmental factors. Literacy levelsalso vary widely.

The resulting heterogeneity of olderpeople as a group adds to thechallenges of communicating importantinformation about managing amedication regimen. Clearly, olderpatients must be able to bothunderstand and carry out the required

18


steps to ensure they take the right doseof medication at the right time, in theright way.

Presenting written and verbal com-munications in an easy-to-understandstyle will do much to enable seniors totake charge of their care. This, in turn,will allow them to maintain theirautonomy, health and well-being.

An involved and informed patient ismore likely to adhere to prescribedmedication therapy. Indeed, lack ofcompliance may often be no more thanthe inability to read or to understandcomplex verbal instructions.

The Basics of Plain Language

Plain language is a way of org a n i z i n gand presenting information so that itmakes sense in terms of organization andflow and is easy to read for the intendedaudience. When writing for the generalpublic, material should be written at aGrade 6 level so that the greatest numberof people will get the message. Tools forassessing readability by grade level arep rovided later in this chapter.

To help clarify the writing task as youbegin, you should answer the followingquestions:

• Why are you writing this document?

• What do you want to say?

• Who is your audience?

• How will your reader use thedocument?

• How should you organize theinformation?

• How should you present theinformation?

Basic plain-language techniques will helpmake your writing clearer and easier tounderstand. The following are taken fro mCPHA’s Easy Does It!, a plain languageand clear verbal communication trainingmanual for health pro f e s s i o n a l s .1

Te c h n i q u e s

1. Use the active (rather than thepassive) voice.

Instead of:This medication is to be taken beforeevery meal.

Use:Take this medication before everymeal.

2. Use common words rather thantechnical jargon.

Instead of:Neuralgia which accompanies fracture sof the fibula indicates the advisabilityof administering an analgesic.

Use:Giving pain relievers to patients withbroken legs helps make them morecomfortable.

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Patients who don’t understand writtenor verbal instructions about theirmedications should ask their doctor,nurse, pharmacist or health careworker for more information.

1 Canadian Public Health Association. Easy Does It! Plain

Language and Clear Verbal Communication. Ottawa, 1998.

3. Use a positive tone whereverpossible.

Instead of:Do not fail to notify your familydoctor in case of illness.

Use:Notify your family doctor when youare sick.

Sometimes, however, a negative tonegives a clearer message.

Instead of:This medicine is suitable for childrenover 12 years of age.

Use:Do not give this medicine to childrenunder 12 years of age.

4. Write directly to your reader(using the “you” voice) to makeyour document more personal.

Instead of:Patients are asked to register at thereception desk before eachappointment.

Use:Please register at the reception deskbefore your appointment.

5. Use short words and shortsentences.

Instead of:Patients’ responsibilities for homeconvalescence will be enumerated bythe attending physician beforedeparture from the clinic.

Use:Speak with your doctor before youleave the clinic. He or she willexplain how to take good care ofyourself when you get home.

6. Write instructions in the orderthat you want them carried out.

Instead of:Before you leave the clinic, make anappointment for a follow-up visit atthe reception desk.

Use:Before you leave the clinic, make anappointment at the reception deskfor a follow-up visit.

7. List important points separatefrom the text.

Instead of:Feb. 7-8, 2002, Hotel Grand, Toronto,Better Breathing ’02, OntarioThoracic Society, 201-573 King St. E.,Toronto, ON M5A 4L3; tel. (416) 864-9911; fax (416) 864-9916

Use:Better Breathing ’02When: Feb. 7-8, 2002Where: Hotel Grand, Toronto,OntarioTel: (416) 864-9911Fax: (416) 864-9916For more information, contact:

Ontario Thoracic Society201-573 King St. E.Toronto, ON M5A 4L3

20


8. Don’t change verbs into nouns.

Instead of:All decisions pertaining to thepayment of medical claims whichexceed $500 are the prerogative ofyour insurance company.

Use:Your insurance company will decideif it will pay medical claims whichare more than $500.

9. List items in a parallel (the samegrammatical) form.

Instead of:Three healthy habits are:• Getting eight hours of sleep each

night.• You should eat three balanced

meals every day.• It is important to exercise

regularly.

Use:Three healthy habits are:• Getting eight hours of sleep each

night.• Eating three balanced meals every

d a y .• Exercising regularly.

General Stylistic Ti p s

• Don’t use long sentences (i.e., morethan 20 words) unless absolutelynecessary.

• Keep words that are three syllablesor longer to a minimum.

• Avoid run-on sentences andsubordinate clauses.

• Use punctuation – commas, periods,dashes, and bulleted points – sparingly.

• Introduce a group of bulleted ornumbered points with a colon.

• Place a period at the end of thegroup of bullet points.

• Begin a list of bulleted or numberedpoints with the uncommon andspecific case and end with thecommon or general case, unless thisis inappropriate for the product. Forexample:

Be sure to tell your doctor if you have:1. pulmonary tuberculosis2 . any allergies that affect your lungs3. any chronic lung condition.

• Use a minimum number of words inthe bulleted points and never morethan one sentence.

• Do not use more than nine itemswhere the bulleted points are simple,and no more than five when they arecomplex.

• Avoid abbreviations and acronyms ifpossible; however, when they arenecessary, always show theabbreviation or acronym at thebeginning of the text, immediatelyfollowing the first use of the fullword or phrase, as in this example:

The Canadian Public HealthAssociation (CPHA) is a national,not-for-profit organization…

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22


Compendium of PlainLanguage Te rm i n o l o g yfor Use in Prescription MedicationPatient Inform a t i o n

What’s in this Compendium

This Compendium contains:

• A brief background section outliningthe importance of plain language inpatient information;

• A framework for organizing patientinformation, typically for a patientpackage insert (PPI), also referred toas a “leaflet”, or other forms ofinformation such as a package labelor computer-generated leaflet. Notethat the wordings provided arederived from existing materials or areadapted from product monographs.It is essential that the accuracy ofinformation be maintained, but thatthe terminology be as clear andsimple as possible to ensure the usercan understand it.

• Plain language terminology for arange of prescription medications,among them:

• Pills, tablets, capsules, caplets andthe like;

• Syrups, suspensions and othersolutions that are swallowed orused as a rinse;

• Powders that are dissolved orotherwise prepared by the patientand swallowed or used as a rinse;

• Inhalers and sprays;

• D rops (for the eyes, ears or nose);

• Suppositories, vaginalmedications, etc.;

• Creams, lotions, gels, soakingsolutions, shampoos and soaps.

1 . B a ck gro u n d

Other sections of the Guidelines provideconsiderable detail on seniors, literacy,why and how to write in plain language,and issues related to patient compliance.This Compendium offers practical adviceon the organization of information aswell as wording which will ensure thatyour instructions are understandable bya maximum number of patients.

Not everyone wants to receive theinformation in a patient informationleaflet, or is going to read it. However,this information should be given to thepatient regardless, and it should bepresented in a way that the majority ofpatients can understand it easily.

Some health professionals andmanufacturers express the view that

It should be noted that parenteral drugsare not included in this Compendium;neither are potentially hazardous drugsor complex preparations (such as anAIDS ‘cocktail’). Medications such asthese require counselling fromphysicians and pharmacists and it is notthe purpose of these Guidelines toreplace such professional guidance andt r a i n i n g .

information that is written in plainlanguage is oversimplified for thepatient. Indeed, many healthprofessionals find that their clients orpatients want more information, ratherthan less. The guiding principle to keepin mind in this instance is that patientswho have moderate to high educationlevels have the skills and means toobtain additional information if theywant it.

In the case of patients with low literacyskills or vision problems, the label orpatient package insert may be their onlysource of information. In addition to notbeing able to read or comprehend well,many patients with low literacy skills donot have the skills or facilities to go tothe Internet for further information, or toconsult printed sources such as drugreference publications and otherdocuments.

Some are so embarrassed by theirinadequate reading skills that they willnot ask questions, for fear that theperson they are talking to mightdiscover this fact. They typically havelow self-esteem due to theircircumstances and/or do not have themotivation to seek out furtherinformation.

These are the patients who need materialwritten in plain language. Some will beable to read and understand it on theirown. Others will find someone to read itfor them.

Information that is accurate, completeand written in plain language benefits allof these people: those on medication,those caring for them (family members,

friends and neighbours, and low-skilledhome-care providers) and professionallytrained caregivers.

It is essential that writers and designersof patient information materialsunderstand these different audiencesand their behaviours, and take them intoaccount at all stages of development.

Some key points for presentingpatient information

• Pronunciation of drug names isdifficult for most people, regardlessof literacy level. Always include aneasy-to-understand phoneticpronunciation, for example:Nilandron – nigh-LAND-ron. Notethat the syllables are presented ascommon words, with the stressindicated by upper case. It is notnormally necessary to provide apronunciation for the generic nameof the drug.

• The information about the medicineshould be presented in a logicalsequence. For example, importantw a rnings and contraindications aboutwho should not take the medicineshould be placed near the beginningof the leaflet, in case the patient isnot able or willing to read the rest ofthe leaflet. At least he or she will beable to read that section and perh a p sd e t e rmine that this medicine is notsuitable to take. More information onlogical sequencing is presented inother parts of this Chapter; the nextsection shows an outline for a leafletthat will be easy for people tofollow.

23


• Avoid placing marketing messages inpatient information. Low-literacyreaders may not be able to tell thedifference between importantinformation and a sales pitch, resultingin confusion or misunderstanding. Apatient could be persuaded toconsume medication that isinappropriate and either exacerbate acondition or conflict with an existingmedication regime.

• Any graphics that are used in theleaflet should be clearly laid out. Thereshould not be too much detail andwriting in the graphics, but too littleinformation is also a problem. See thesection of this Chapter entitled ClearDesign, Layout and Graphics.

• People who have reading problemstake words (and letters) literally. Theyskip over words (or numbers orletters) they do not understand andthus often miss the context of theinformation. Therefore, they couldlook at a number and see it as a letter.This may lead to confusion, whichmay discourage the patient, who couldthen decide not to continue readingthe rest of the text.

• Generally speaking, people with lowliteracy skills cannot read tables, oftenused to present dosing information.This is especially true if there is a lotof information in the table. If it isnecessary to present a lot ofinformation, such as in the case of amedicine that has to be divided upinto different doses for infants,children, youth and adults, it is easierto present it in bullet points with the

age and/or the weight of the child atthe beginning of the bulleted point.

• People with low literacy skills oftenfind it easier to read numbers innumerical form than written out inwords, such as “18” instead of“eighteen”. However, care must betaken to choose a font that does notmake the number “1” appear as alower-case “L” or an upper-case “I”.

• Another area of difficulty for patientswith poor numeracy skills is the use ofmetric units of measurement. They,like many seniors who grew up withthe Fahrenheit standard fortemperature, do not know exactlywhat “store between 15-30 degreesCelsius” means. They also would haveproblems understanding that 5 ml isapproximately one teaspoon or that2.5 centimeters is about an inch.Provide Imperial equivalents.

• Other examples where numeracycould be a problem occur:

• When it is necessary to specify afraction of a pill. For example,“give 1/8 of a malarial prophylacticpill to a two-year old child”.Reading this fractionated numbercould be difficult for some peoplewith poor literacy skills, and forthose whose first language is notEnglish. Instead, suggest “For achild who is two years old, cut thepill into eight pieces and give onepiece to the child each day.”

• When describing the chances ofgetting a particular side effect. For


24

example, “5% of people who takethis medicine have this sideeffect.” In this case, it is better togive the chances as a proportionrather than as a percentage. “1out of 20 people who take thismedicine have this side effect.”Related to this issue are estimatesof efficacy, such as whencomparing several drug options.

• When a complicated word is usedwhen a simple term wouldsuffice. For example, instead of“This is an octagonal, crimsonpill..” use “This is an eight-sided,dark-red pill…”

• Finally, make the leaflet attractiveand inviting to read. Use as positivea tone as possible. Minimize thescare factor and patients will makethe effort to read and understandwhat you need to communicate tothem. Use design to focus thereader’s attention on the mostimportant information.

2 . A Stru c t u re for the Pat i e n tI n fo rm ation Leafl e t

The most logical way to orderinformation is to use the sequence ofactions and events that the patient willgo through when taking the medication.

Identifying information should alwaysappear at the beginning of the leaflet. Itshould be large enough for easyreference and contain important andrequired information about the drug:

• Brand name• Pronunciation of brand name

• Generic name and form• Manufacturer or supplier• Active and inactive ingredients• Dosage amount and quantity

contained in the package• Drug Information Number (DIN)• Physical description

A graphic element such as a simple linecan be used to separate this inform a t i o nf rom the instructional sections that follow.

The following main headingsdemonstrate ordering of information bysequential actions and can be presentedin two styles: simple headings andquestion-style headings. (The name ofthe medicine would replace the “XXX”.)

About this leafletWhat XXX is used forBefore you use XXX (includingwarnings)How to use XXXWhile you are using XXXSide effectsAfter using XXXWhat else to know about XXX

What is this leaflet for?What should I know before I use thismedicine?How do I use XXX?What should I know while I am takingXXX?What side effects are possible?What do I do after taking XXX?What else should I know about XXX?

The following sections provide briefexplanations of the content of eachheading in the structure and giveexamples.

25


Identifying information

Brand name. The brand or “trade”name should appear in a large, boldfont. Assuming the patient will keep theleaflet, this will permit easy retrievalfrom among other leaflets.

Pronunciation. This should be placedbeside or immediately beneath thebrand name, in brackets or preceded bythe word “Pronounced:”. It shouldappear in a similar or slightly smallerfont to prevent the reader from thinkingthis is another part of the brand name.Try to use recognizable words or verysimple phonetics, as in these examples:

Cardioquin – CAR-dee-oh-kwinElocon – ELL-oh-conNaphcon-A – NAFF-con, ayRynatan – RYE-nuh-tan

Note that the syllables are linked byhyphens or commas unless there areseparate words or an additional letter,such as the “A” in the third example.The stressed syllable is identified bycapital letters or could be bolded oritalicized.

This section should also contain adescription of the medicine. Thisinformation should be placed near thebeginning of the leaflet. It allows apatient who is taking several differentkinds of pills to be able to figure outwhich pill to take at which time. It canbe very confusing for a patient with lowliteracy skills to remember the namesand administration schedules for severaldifferent medicines. This description alsomakes if easier for a caregiver, orperhaps a relative who is called in at a

time of emergency, to identify theparticular medicines and to prepare a listof these medicines, if this is needed foranother doctor or for the hospital.

A description of a drug could includeany of the following details:

• colour• shape• size• form or consistency of medicine• markings or text on pill• smell• details about related devices, such as

inhaler

About this leaflet

This section should tell the patient thefollowing:

• Read all the information in thisleaflet, or ask someone to read it foryou or explain what it says. Be sureyou understand everything aboutyour medicine.

• If you are worried or unsure aboutany information in this leaflet, talk toyour doctor or pharmacist.

• Keep this leaflet in a safe placebecause you might need to read itagain, or a caregiver might need toread it.

• If you are taking several medications,keep all the leaflets in the sameplace. A file folder is handy for this.

• When you go to see a doctor or visita clinic or hospital, take this file withyou.

26


• This section should also feature thedate the leaflet was prepared (monthand year).

What this drug is used for

Explain in terms as simple as possiblehow the medication treats a certainillness. It may be necessary to usemedical or scientific words, such as“hypertension”, but these should alwaysbe paired with a plain-languageequivalent, in this case “high bloodpressure”.

For some medications, it may benecessary to explain that the drug helpsto control a condition but will not cure it.

Avoid long, complicated explanations ofthe way the drug works in the body.Keep in mind the distinction between“need to know” and “nice to know”. To omuch detail can confuse poor re a d e r sand lead to concerns that they don’tunderstand enough about the medicationand possibly result in non-compliance.

Before you use this drug

This section contains details aboutpeople who should not take thismedicine. It is sequenced early in thepatient information leaflet due to theimportance of the information. Patientswho have difficulties with reading oftenbecome frustrated and give up readingafter a short time. Therefore, it isimportant to place essential informationsuch as this first, and information that isnot so crucial later in the leaflet.

Include in this section some of the mostimportant standard warnings that the

patient should be aware of, such asinteractions with other medications,food or alcohol.

Make re f e rence to any special feature sof the package, if appropriate, such aswhether there is a tamper-evident sealor child-resistant closure (or not).

How to use this drug

In this section, the manufacturer wouldp rovide instructions, in simple language,which explain how to take the medicineor administer it to someone else, suchas a child. Dosage and timing detailswould appear here, with a reminder tofollow the instructions faithfully. Includei n f o rmation specific to the drug such as“take with food” or “do not lie down for45 minutes after taking this medicine”.

If the medication must be pre p a red bythe patient, such as dissolving a powderor mixing two or more ingre d i e n t s ,p rovide detailed instructions.

If a device is involved, such as asqueeze-bottle of eye drops, explain thesequence of steps to use it. Similarly,explain how to insert a suppository, howand where to apply a patch, how to usea cream, shampoo or mouth rinse, etc.

Wa rn patients that “more is notnecessarily better” to discourage themf rom taking extra doses. Note if thepatient is to take all the medicationp rovided in the prescription, such as inthe case of an antibiotic. Provide detailson length of tre a t m e n t .

Special warnings, such as “do notconsume grapefruit or grapefruit juice

27


while taking this medication” wouldappear here.

Specific or special instructions should beincluded that relate only to the medicineor class of medicine. These instructionsshould follow immediately after theinstructions about how to take themedicine.

While you are using this medicine

Important information and warnings notmentioned previously should appear inthis section, such as the effect of themedicine on the ability to drive vehiclesor to operate equipment. Include as wellinstructions on storage – temperature,moisture, etc. – and remind the patientto keep the medicine out of the reach ofchildren.

Special warnings, such as the effects onsensitivity to exposure to the sun, wouldbe placed here. Indicate that patientsshould not share their medications.

Explain here what to do and what notto do in the event that a dose is missed,and what to do if too much of themedication is taken.

Discuss the impact of the drug in termsof long term usage, length of time forthe effect to be felt, and the possibilityof addiction, if relevant. Advise patientsnot to stop taking the medicine if theystart to feel better.

Provide special warnings, such as whatto do if the patient suspects she ispregnant.

Always encourage the patient to consultwith a doctor or pharmacist on any

aspect of the drug treatment.Recommend that patients should informall doctors, dentists and pharmaciststreating them that they are taking thismedication.

Side effects

The side effects should be broken downinto four separate categories.

• Immediate and serious side effects,and what to do if these occur

• Common side effects• Rare side effects• Long term side effects

It is important not to scare patients intonon-compliance when describing sideeffects. Suggest ways of minimizing sideeffects, such as standing up more slowlyif dizziness occurs.

After using this drug

Describe what to do if symptoms persist orre t u rn once the course of treatment hasended. Provide special instructions on howto stop treatment, particularly if there maybe withdrawal or other adverse aff e c t s .

P rovide details of disposal, if appro p r i a t e ,of empty packages or medication that hasnot been used or has expire d .Recommend taking leftover medication toa pharmacy for proper disposal.

What else to know about this drug

Use this section to provide additional,non-critical information, or helpfuladvice on other things that can bedone to enhance the effect of themedication, such as dietary changes,

starting an exercise program, etc.

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3. Plain LanguageTerminology

The following is a list of common term s ,g rouped under the headings shown in thes t r u c t u re section above.

While the list not exhaustive, the terms aregood examples of the level of wording thatshould be used. As mentioned previously,very complex terms and instructions arebeyond the scope of this document.

Identifying information

Most of the information in this section isrequired and standardized. Here are someplain-language terms, phrases and sentencesthat would be useful in this section.

Quantity

This package contains (quantity, innumbers, except “1”) (product form). Notethat when the product cannot be countedindividually, the measurement units shouldbe included, with metric first followed byImperial in brackets.

• For example: This package contains 30pills.

• For example: This package contains oneinhaler.

• For example: This package contains 500ml (17 ounces) of liquid.

Package information

These pills are (or are not) in a child-resistant package. (note: Do not use theterm “child-proof”.)

Do not use this product if the package wasopened before you bought it. Take it backto the pharmacy. (This phrase explains thatthe package has a tamper-evident feature.)

Form

(Product name) is a (form).

• For example: Nyquil is a syrup.

• For example: Losec is a coated pill.

Description of product

This section goes into more detail todescribe the product.

This (product) is (light) (dark) (basiccolour). Avoid complicated or unfamiliarcolours, no matter how accurate they maybe.

• For example: This pill is light green.(Instead of “chartreuse”.)

• For example: This syrup is dark red.

It has a (shiny) (dull) coating.

The name of the (drug company) (drug) ismarked on the (product).

• For example: The name of the drug ismarked on the capsule.

• For example: The tablet has the letters“APA” stamped on it.

The pill has (number) sides.

This medicine smells like bananas.

Here is a composite example:

Q. What does this medicine look like?

A. The medicine envelope may be orangeand white in colour, or yellow andwhite. When you tear the paperenvelope open, you will see tin foilinside the package. The medicine is apowder made up of large grains of fibrethat are brown, orange and white incolour. When you open the package,the medicine may smell a little likeoranges.

Q. What does the suppository look like?

A. The suppository is a long slim capsulemade of a waxy substance. It is creamywhite in colour. The medicine iscontained inside the waxy material ofthe suppository.

About this leaflet

This leaflet will give you answers to someof your questions about the medicine thatyour doctor has prescribed for you. If youare worried or concerned about any of theinformation in this leaflet, please contactyour doctor or pharmacist.

Be sure to:

29


• read and understand all of theinformation in this leaflet, or

• ask someone to read it for you andexplain what it means.

Please keep this leaflet in a safe place. Youmay need to read it again, or you can showit to someone who is helping you with yourmedications. It may be important to read itagain if your condition changes, or if yourdoctor prescribes another medicine for you.

If you are taking several medications, keepthe leaflets for all of them in the sameplace. A file folder is handy for this.

When you go to see a doctor or visit aclinic or hospital, take this file with you.

Direct Patient Information

The information in the following section ispresent in Question and Answer (Q&A)format. These phrases could also be re-organized into other formats whilemaintaining the plain language nature of thetext.

Patient information for several specificproduct types appears in this section, asexamples. Not every product or productcategory is represented. Demonstrating howthe plain language “style” can be adaptedvirtually any product is the purpose of thissection.

What this drug is used for

The following example relates to onespecific group of medicines and shows howa fairly complex drug and disease interactioncan be explained in plain language.

Q. What is an anti-inflammatory or non-steroidal anti-inflammatory drug(NSAID)?

A. An anti-inflammatory medicine is one thatreduces the pain and inflammation thatcomes with arthritis (pain in the joints).This anti-inflammatory medicine is one ofa group of medicines called Non-Stero i d a lAnti-Inflammatory Drugs. This means thatthey do not contain steroids. NSAIDsreduce the amount of the chemical inyour body that causes the inflammation

and pain in your joints. NSAIDs cannotc u re arthritis, but they can help to makeyour joints less painful as long as youcontinue to take the medication.

Before you take this drug

This section is also presented in Q&Aformat, but could easily be adapted to shortsentences and point-form lists. Include inthis section information about this package,such as whether it is child-resistant and/ortamper evident.

Q. Are there any reasons why I should notuse this medicine?

A. Do not use this hormone pill if youhave any of the following:

• You are pregnant, suspect you maybe pregnant, or are trying to becomepregnant;

• You have ever had cancer orproblems with your breasts or uterus(or womb);

• You have vaginal bleeding;

• You have blood clotting problems ora history of stroke;

• You have a history of migraineheadaches;

• You have severe liver disease.

Q. Is there anything I should talk to thedoctor about before taking this drug?

A. Talk with your doctor if you’ve had anyof the following:

• High blood pressure orhypertension;

• Heart or kidney disease;

• Asthma;

• Epilepsy or seizures;

• Migraine headaches;

• Sugar diabetes or high blood sugar;

• Depression; or

• Endometriosis.

Q. Are there any people who should nottake this medicine?

A. Yes, there are a few people who shouldnot take this drug:

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• Women who are pregnant, breast-feeding or planning to becomepregnant;

• People who are allergic tosulfonamides and pyrimethamine;

• People with kidney disease;

• People with liver disease;

• People with blood disease;

• People with porphyria or anemia;and

• Children under 2 months old.

Q. Who can use this medicine?

A. This medicine is meant for malesbetween the ages of 18 and 65 whowant to treat their baldness.

Q. Is there anybody who shouldn’t use thismedicine?

A. This medicine should not be used by: • Women;

• Those who are allergic to minoxidil(used to treat high blood pressure orhypertension), alcohol or propyleneglycol; or

• Those with heart problems or heartdisease.

Q. Is there anything I should discuss withmy doctor before taking this medicine?

A. Yes, before taking this medicine, talk toyour doctor if you have any of thefollowing conditions:

• You have had an allergic reaction toany ingredient in this medicine;

• You are pregnant, breast-feeding orthink you might be pregnant;

• You have serious kidney or liverdisease;

• You have unusual bleeding orvomiting;

• You are taking or have taken anyother medicine in the past; or

• You are taking any dietarysupplements such as vitamins orherbal remedies.

Q. Is there anything I should know beforemy child takes this medicine?

A. You should discuss with your doctorwhether your child has had any of thefollowing before using this medicine:

• Allergies;

• High blood pressure;

• Heart disorders;

• Thyroid disorders,

• Glaucoma (or high blood pressure inthe eye);

• Epilepsy or seizures;

• Agitation or nervousness;

• Tension or stress;

• Motor tics, twitches or uncontrollablemovements of muscles;

• A family history or diagnosis ofTourette’s syndrome (a diseasewhere the person cannot controltics, grunts, verbal outbursts,repetition of words, or imitatingothers);

• Depression or feeling very sad;

• Psychosis or mental disorders wherethe person does not know what isreal and what is imagined;

• Anxiety (a condition where theperson has many deep fears);

• Drug or alcohol abuse; or

• Other medical problems.

Q. Is there anything I should know before Itake this medicine?

A. There are a few things you should knowbefore taking this medicine:

• If you have diabetes or high bloodsugar, your dose of insulin or oralanti-diabetic agent may need to bealtered. You should monitor yourblood glucose level carefully.

• If you are taking an anticoagulant,such as coumadin or warfarin, tothin your blood, your dose mayneed to be changed. Check withyour doctor about this.

• You may lose some of your hairduring the first few months oftreatment but this is usuallytemporary.

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Q. Are there any medicines I shouldn’t takewhile taking this drug?

A. Yes, there are medicines that cannot betaken with this drug:

• sulfonamides (these are sulfur drugsprescribed for bacterial infections);

• pyrimethamine (these are medicinesgiven to prevent malaria); or

• trimethoprim (these are medicinesprescribed for bacterial infections).

Q. Who should not use this suppository forpain and fever?

A. You should talk to a doctor or apharmacist if you have any of thefollowing conditions:

• You are allergic to acetaminophen.

• You have been drinking more than 2alcoholic beverages a day for a longtime. This includes wine, beer orliquor.

• You have kidney disease.

• You have liver disease.

• You are taking other medicines thatcontain acetaminophen or salicylates.

How to use this drug

Q. How should I take this medicine?

A. The following are guidelines on how totake this drug but your doctor mayadjust it for you:

• Take this medicine exactly asordered.

• Take a single dose with supper or ahalf a dose at breakfast and half adose at supper.

• Do not take a double dose of thismedicine.

• Follow your doctor’s advice on dietand exercise.

• Do not change the dosage or stoptaking the medicine without tellingyour doctor.

• See your doctor regularly.

• Avoid large quantities of alcohol.

• Do not start taking any other

medicine without first seeing yourdoctor.

• Let your doctor know if you suffer asevere injury or infection.

• Let your doctor know about anydental surgery (or other surgery) thatyou are planning to have.

• Tell your dentist you are taking thismedicine.

Q. How should I take this tablet?

A. Follow this advice to take yourmedicine:

• Take this tablet with a small amountof water.

• The tablets must always beswallowed whole and never chewednor crushed.

• Do not take the tablet with food.

• Take it 1 hour before you eat onehour before or 2 hours after you eat.

• This will allow you to absorb asmuch of the medicine as possibleinto your body.

Q. How should I take this tablet?

A. Follow your doctor’s advice about takingthe tablet. Read the label on thepackage with care. Take the medicine inthe following way:

• The usual dose for children over 12is 20 mg 2 times a day.

• You should swallow the tablet wholewithout chewing it.

• Take it with a full glass of water.

• Take the tablet 2 hours after eatingfood, or one hour before eatingfood.

• Try to take the tablet at the sametime each day.

Q. How should I take this pill?

A. Follow your doctor’s advice about takingthe pill and read the instructionscarefully because they may change thenext time you get your prescriptionfilled. As well:

• Take the tablet with food or rightafter food.

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• If you forget to take a dose, you cantake it later in the day.

• Do not take more tablets in one daythan your doctor advised you totake.

Q. How often should I take it?

A. You should take the tablet 2 times aday, once in the morning and again theevening. It lasts for up to 12 hours.

Q. When should I take the pill for myasthma?

A. You should take the pill every day asyour doctor has prescribed it to controlthe symptoms of your asthma during theday and the night.

Q. What is a calendar pack?

A. A calendar pack is a convenient way toremember when to take your tablets.The pills are in a blister card with labelsshowing the days of the week, andthere are usually 2 slots for each day ofthe week. Take the pills as explainedbelow:

• Make sure you note down the dayof the week that you are starting totake the tablet.

• Find where on the pack it is labeled“start”, and punch out that pill andtake it.

• Take the next tablet about 12 hourslater.

• Find the label that shows that correcttime and day, and punch out thatpill.

• Keep following the system, andtaking a pill on the correct day andeither from the morning or theevening slot. This will help you toremember to take the tablet 2 timesa day.

• When you finish a card of pills, notedown the day and the time that youtook the last pill. Then take the nextpill from the new card of pills.

• Call your pharmacist for a refillbefore you use the last 4 tablets.

Q. What should I do if I miss a pill fromthe calendar pack?

A . If you miss a dose, take another tablet assoon as you remember it. If it is almosttime for the next dose of medicine:

• Take the tablet right away.

• Do not take a double dose of themedicine.

• Go on taking the medicine 2 times aday.

• Make a note of what day and timeyou missed the tablet as this will mixup the days and time shown on thecalendar packs.

Q. How do I take a suppository?

A. To use a suppository tablet follow thesesteps:

• If you have to empty your bowel (orhave a bowel movement), do that first.

• Wash your hand with soap andwater.

• Remove the plastic wrapper that isaround the suppository.

• Wet the outside of the suppositorylightly, with cool water so that it canslide in easily.

• Lie on your bed on your left or rightside. Your bottom leg should bestraight. Bend the leg, which is ontop, and bring your knee towardsyour chest.

• While keeping this position, insertthe narrow tip of the moistsuppository into your rectum, theopening where you push out yourbowel movements or stools. Useyour finger and push the suppositorytablet as high up into the rectum aspossible. This will make sure that itstays in place.

• Do not go to the bathroom rightafter inserting the suppository.

• Wash your hands again with soapand water.

Q. What is the correct dose of suppositoryto take?

A. The correct dose to take is onesuppository tablet every 4 to 6 hours, asneeded for pain and fever.

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Q. How often should I take thesuppository?

A. You can take a suppository up to sixtimes a day for pain and fever if youneed it.

Q. How should I mix the acne lotion?

A. To mix the acne lotion, follow thesesteps:

• Add the liquid in the bottle with thewhite cap to the powder in thebottle with the black cap.

• Shake the bottle until bothingredients are well mixed.

• The lotion will last for 21 days andshould be thrown out after it hasexpired.

• Mark down the day the lotion wasmixed so that you will know when21 days have passed and you canthrow out the expired lotion.

• A new bottle should be mixed afteryou have thrown out the old one.

Q. How should I use this acne lotion?

A. Follow your doctor’s instructions abouthow to use this acne lotion. To applythe lotion:

• Wash the infected area thoroughlywith water and mild soap. Pat it drywith a towel.

• Shake the bottle well beforeapplying the lotion to the area usinga cotton ball or a gauze pad.

• Apply it at night before going to bedand again in the morning.

• Wash the lotion off before goingabout your daily activities.

• Continue applying 2 times a day for4 days.

• After the 4th day, apply it once aday at night for the rest of yourtreatment.

• Continue applying the lotion for 3nights after the spots havedisappeared.

• The entire treatment should lastabout 4 to 6 weeks.

Q. How should I take these eye drops?

A. The eye drops comes in a white plasticbottle with a dropper tip. Follow theinstructions shown below:

• Wash your hands.

• Press your middle finger on theinside corner of your eye. Keep yourmiddle finger pressed on the insidecorner of your eye (while you put inthe drops) and for 1 to 2 minutesafter the drops have been put inyour eye.

• Tilt your head back and use yourindex finger (finger next to thumb)of the same hand to pull the lowerlid of the eye out to form a littlepouch or pocket.

• Drop the eye drops into the pouchor pocket and close your eye gently.

• Keep your eyes closed to allow thedrops to be absorbed. Do not blinkyour eyes.

• After you apply the eye drops, washyour hands again.

• Be careful to not touch the tip of theeyedropper to your eye, or anyother surface. This will keep the tipof the eyedropper free of germs, orsterile.

• Keep the bottle of eye drops closedtightly.

• If you are using the 2-ml sample,make sure that the bottle has notbeen used before you get it. Twistoff the cap.

• Do not reuse the sample bottle.Throw out the remainder.

• The eye drops also come in smallvials with enough medicine to applyone time to your eye.

• As this bottle does not contain anychemical to kill the germs, it isimportant to use it once and thenthrow out the rest of the bottle afteryou have used it.

Q. How do I know how much asthmainhaler medicine to take?

A. The label on your inhaler can / will tellyou how many puffs to take and how

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often to take them.

• If you do not understand thisinformation, you should consult yourdoctor or pharmacist.

• Do not take more than 8 puffs a dayand children should not take morethan 4 puffs a day.

• If you feel that this amount is nothelping or that your breathing isgetting worse, call your doctor.

Q. How long should one puff of asthmainhaler last?

A. One puff usually lasts 4 to 6 hours.

Q. Can I take other medicines along withthis asthma inhaler?

A. Yes, other asthma medicine that hasbeen prescribed by your doctor can betaken with this asthma inhaler.

Q. How should I take this stool softener orlaxative?

A. When you take this stool softener orlaxative, you should also drink morefluids. These could include water orjuice.

Q. What kind of package does the creamcome in?

A. The cream comes in packets containing250 mg each. There are 12 packets ineach box.

Q. How often should I use cream?

A. The cream should be applied to thewarts 3 times a week, waiting 1 daybetween treatments. For example, youcould apply it on Monday, Wednesdayand Friday, or Tuesday, Thursday andSaturday.

Q. How should I apply the cream?

A. The cream should be applied like this:

• Wash your hands before applyingthe cream.

• Open a new packet of cream andsqueeze some onto your finger.

• Apply a thin layer of cream to thewart area at night before going tobed.

• Rub the cream in until it can nolonger be seen.

• Do not use excessive amounts ofcream - just enough to cover thewart area. (Note that the actual areamay change during treatment.)

• Throw the packet away and washyour hands.

• The treated area should not bebandaged or covered, so that air canreach it.

• Do not bathe the area for the 6 to 10hours that the cream is on.

• When you awake in the morning (6to 10 hours later) remove the creamby washing the area with mild soapand water.

Q. How long will it take the cream towork?

A. After a few weeks, there should besome visible changes to your warts. Theaverage treatment takes anywhere from4 to 16 weeks. New warts may developduring the course of the treatmentbecause the cream is not a cure.

Q. How should I apply the gel?

A. Follow these guidelines to apply the gel:

• Apply the gel after washing (eitherat night or in the morning but at thesame time each day).

• Clean your hands before applyingthe gel.

• Remove the pump cover.

• When you open a new pump, presson the pump once or twice in orderto prime or start the pump. Discardthe gel that comes out during thefirst 1 or 2 times you press thepump.

• Press firmly on the pump once andcollect about 1.25 g of the gel inyour hand.

• Apply the gel to one arm coveringan area about 4 times the size ofyour hand.

• Apply the gel to the other arm.

• Other possible areas to apply the gelare the insides of the thighs or theabdomen.

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• Do not apply the gel to your breasts.

• Allow the gel to dry for 2 minutesbefore you cover the skin withclothing.

Q. How do I use this cream rinse?

A. Follow these steps to use this medicineproperly:

• Wash the hair with a conditioner-freeshampoo. Do not use a conditioner.Rinse with water and towel dry thehair thoroughly.

• Shake the medicine bottle well.

• Apply enough of the cream tothoroughly soak the hair and scalp(usually 1/2 to 1 bottle’s worth). Becareful to apply the cream behindthe ears and at the base of the neck.

• Leave the cream on the hair for 10minutes.

• Rinse off the cream using water.

• Towel dry hair and comb to removetangles.

• Remove the nits.

Q. How do I remove the nits?

A. Here are the steps to follow to removethe nits:

• Part hair into sections.

• Start as close to the scalp aspossible. Remove the nits using afine toothed nit comb or fingers.

• Be sure to comb to the end of thehair shaft to remove all the nits.

• The nit comb should be disinfectedby soaking in hot water after eachuse.

• Inspect entire head of hair well forany stray nits that might be hiding.

• Repeat this entire nit-removingprocess every day for 7 daysfollowing treatment.

Q. How many times should I apply thiscream?

A. Usually, one use of the cream is enoughbecause the active ingredients continueto kill nits for up to 10 days if you donot put any conditioner on your hair. If

you continue to see live lice and nitsafter the 7 days, use the cream again asdirected above.

Q. How do I use this drug?

A. Follow these steps to use this drugproperly:

• Wash your hair daily using a mildshampoo.

• Make sure your hair, scalp andhands are thoroughly dry beforeapplying this medicine.

• Apply 1 ml of the drug to your scalp2 times a day, twelve hours apart.For example, you could apply it at7:00 in the morning and again at7:00 in the evening.

• Spread the solution around to coverthe entire bald area. Avoid eyes, earsand other sensitive areas.

• Don’t use a blow dryer to make thesolution dry faster. This decreasesthe effectiveness of the medicine.

• Wash your hand after applying themedicine.

• Don’t use more than 2 ml a day,unless instructed by your doctor.

• Don’t use any other medicines onthe scalp, while using this drug.

Side Effects

This section provides examples of wordings for:

1. Immediate and serious side effects

2. Common side effects

3. Rare side effects

4. Long-term side effects

1. Immediate and serious side effects

Q. What should I do if I become pregnantwhile taking this acne pill?

A. If you become pregnant while taking it,contact your doctor immediately. Yourdoctor will discuss with you the chancesof your baby being deformed. Thedoctor will give you information, whichwill help you decide whether youshould continue with the pregnancy.

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Q. What are some of the serious sideeffects of the anti-inflammatory drug?

A. You should see your doctor as soon asyou can if you see or feel any of thefollowing:

• You may have bloody or black tarrystools or bowel movements;

• You may feel short of breath,wheeze or feel tightness in the chest;

• You may notice skin rash, swelling,hives or itching;

• You may have an upset stomach thatdoes not go away;

• Your skin or eyes may becomeyellow;

• You may feel tired, sick or do notfeel like eating;

• You may notice some changes inyour urine;

• You may notice that your feet orlower legs become swollen;

• You may notice that your visionbecomes blurred, or that you haveother problems with your eyes;

• You may feel confused, depressed ordizzy;

• You may have problems withhearing;

• You may have pain while peeing oremptying your bladder;

• You may have other side effects thatyou think may have been caused bythe drug.

You should contact your doctor rightaway if you have any of these sideeffects

Q. What are some of the possible seriousshort-term effects of this medicine?

A. This medicine contains strong harsh ortoxic chemicals, which can cause seriousside effects in your body. Some of theseside effects are:

• Bone-marrow suppression. Bonemarrow produces red blood cells. Ifthis is suppressed or stopped, youwould have fewer red blood cellsand may feel more tired.

• Hypersensitivity reactions. You mayhave an allergic reaction such ashives or a rash to the medicine.

• Gastrointestinal toxicity. Due to thetoxic or strong chemical in themedicine, you may have abdominalcramps, diarrhea, flatulence or gas.

• Pulmonary toxicity. You may havecoughing or wheezing. The lungscould produce mucus as a result ofthe toxic side effect of the medicine.So you may find that you arecoughing up more mucus.

If you notice that you are experiencingany of these serious side effects, see yourdoctor right away.

Q. What are some of the warning signs ofthis medicine?

A. Contact your doctor immediately if youexperience:

• Skin rash (patches of red skin);

• Vasculitis (inflammation or swellingof the lining of small blood vessels).You may notice that the skinbecomes red, warm to touch orswollen. This could be a sign ofvasculitis.

• Bleeding;

• Fever;

• Persistent or continual cough.

If you notice any of these or otherunusual symptoms, see your doctor assoon as possible.

Q. What should I do if I have disturbingthoughts or unusual behaviour whiletaking this drug?

A. If you have any unusual or scarythoughts or if you find you are actingdifferently while taking this medicine,talk to your doctor immediately. Someof these behaviours may include:

• Aggression – becoming angry,arguing with others, interruptingconversations;

• Extroversion – talking to others morethan usual, talking continually;

• Confusion – forgetting where you

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are or what you were doing;

• Strange behaviour – any behaviourwhich is not normal for you;

• Restlessness – feeling as if you haveto be moving constantly, unable tosit still or concentrate;

• Hallucinations – seeing or hearingthings that aren’t real;

• Feeling like you are not yourself;

• Depression – feeling sad or unableto do your normal activities;

• Suicidal thinking – thinking aboutkilling yourself.

Report any of these symptoms to yourdoctor right away.

2. Common side effects

Q. What are the possible side effects of thissuppository?

A. In a few cases, you may be allergic ormore sensitive to acetaminophen. In thiscase, you may get a rash or hives. Youshould talk to your doctor about therash or hives.

Q. What are the possible side effects of thisasthma pill?

A. The possible side effects are:

• Headache or stomach indigestion. Ifyou have these, they will likely bemild and you can keep on using theasthma pill.

Q. What is happening? I’ve been taking thepill for acne and my acne is gettingworse!

A. For the first two weeks your acne mayseem to get worse. It will get better afterone or 2 months of treatments.

Q. What are some possible side effects oftaking this acne pill?

A. Possible side effects you may have are:

• You may feel that your lips, theinside of the nose, mouth and yourskin in general feel dry.

• You may have rashes on the face orbody.

• You may have flaking, itching and

peeling of the skin, especially on thepalms and soles.

• You may notice that you havebecome more sensitive to the sun.

• You may notice that your lips orgums swell, or that your gums ornose bleed.

• You may have aches or pains inyour joints.

• You may find that your skin is easilyinjured or bruised.

• You may feel more tired or fatigued.

• You may find that you are not ableto see well at night. You may alsofind that your eyes itch and water.This may cause problems for contactlens wearers.

• You may find that your hair isbecoming thinner.

If you have any of these symptoms andthey concern you, contact your doctorfor advice.

Q. What are the possible side effects ofusing acne lotion?

A. When you first begin to use this acnelotion, the following may occur:

• Your skin may become red.

• Your skin may feel warm.

Q. What are some of the possible sideeffects of using a decongestant?

A. Some side effects only occur if the dosegiven is too high. The side effects couldinclude:

• The person may become tooexcited, especially if he or she is achild.

• The person may feel drowsy.

Q. What are some of the possible sideeffects of taking eye drops after surgeryon my eyes?

A. Some of the side effects of taking eyedrops after surgery on your eyes are:

• Burning, redness, itching and/orswelling of the eyes. This could becaused by either the eye drops, orthe surgery, or by both.

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• Your vision may be blurred afterputting the drops in your eyes.

Q. What are the side effects from taking toomuch laxative medicine?

A. You may become dependent on thelaxative if you use it too much. Thismeans that, when you stop using it, it willbe difficult to have a bowel movement(or to expel stools from the bowel).

Q. What are the most common side effectsof the pain reliever?

A. The most common side effects arestomach problems. These could includeany of the following:

• Heartburn;

• Nausea;

• Vomiting;

• Stomach pain;

• Diarrhea; or

• Indigestion.

Q. What are the side effects of the cream?

A. Some of the effects in the treated areacan be:

• redness in the genital area;

• wearing away of the skin, in thearea where you have been applyingthe ointment;

• the skin may seem to come off inflakes; or

• the tissue may swell.

Inform your doctor if these side effectsare very severe. If you wear cottonunderwear, this may also help reduceany of these reactions to the cream.

Q. What are some of the most commonside effects of this pill?

A. Some of the side effects are:

• Having a headache;

• Finding it difficult to fall asleep;

• Feeling nervous;

• Feeling you are going to vomit;

• Having a dry mouth; or

• Feeling dizzy.

These side effects usually disappear aftera few days or if the doctor tells you to

reduce the dose. The side effects arealso lessened if you start off slowly andreach the maximum dosage after a fewdays.

Q. What are the most common side effectsof this pill?

A. Some of the side effects are:

• Feeling drowsy;

• Feeling dizzy;

• Feeling lightheaded;

• Having difficulty in coordinatingyour movements, such as walking,performing actions;

• After stopping this medicine youmay have anxiety and troublesleeping for a few days.

Q. What are some of the possible sideeffects of this medicine?

A. Some of the possible side effects are:

• The lining of the uterus may growtoo thick.

• You may have irregular menstrualperiods.

• You may feel nauseous.

• Your breasts may feel more tender,sore, or swollen.

• You may retain more fluid and findyour clothes or rings are tighter thanusual.

• You may feel depressed or moredepressed than before.

• If you suffer from migraineheadaches or other headaches, youmay find that they are worse.

• You may feel nervous.

• You may feel dizzy.

• You may feel tired.

• You may feel irritated.

• Your skin may feel irritated, sensitiveor tender.

• You may notice bleeding from thevagina.

Contact your doctor if any of these sideeffects become troublesome.

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Q. What are the most common side effectsof this drug?

A. The most common side effects of thisdrug are:

• upset stomach;

• nausea;

• headache; or

• your skin may become moresensitive to sunlight.

Q. What are the most common side effectsof this medicine?

A. The most common side effects include:

• itchiness;

• redness;

• swelling of the skin on the scalp;

• stinging/burning;

• numbness; or

• discomfort.

Q. What are the most common side effectsof this pill?

A. The most common side effects of thispill are:

• headaches;

• weakness;

• constipation, or being unable tohave a bowel movement easily;

• diarrhea; or

• abdominal pain.

Q. What are some of the most commonside effects of this medicine?

A. The most common side effects of thispill are:

• stomach discomfort;

• nausea, or feeling that you maythrow up or vomit;

• feeling that you are not hungry, orthat you do not want to eat;

• being unable to sleep.

These problems will go away with time.

Q. What if my side effects don’t clear upafter I stop taking the medicine?

A. If your side effects are still there after afew weeks, see your doctor right away.

Q. What are the side effects of the cream?

A. Some of the effects in the treated areacan be:

• Redness in the genital area;

• Wearing away of the skin, in thearea where you have been applyingthe ointment;

• The skin may seem to come off inflakes; or

• The tissue may swell.

Inform your doctor if these side effectsare very severe. If you wear cottonunderwear, this may also help reduceany of these reactions to the cream.

Q. What are some of the side effects of thisdrug?

A. Some of the common side effects are:

• aching muscles;

• muscle cramps;

• tiredness or weakness;

• fever; or

• blurred vision.

Let your doctor know as soon aspossible if you have any of thesesymptoms.

3. Rare side effects

Q. What are some of the rare or infrequentside effects of this medicine?

A. This is a list of the rare or infrequentside effects. If you have any of them,stop using this medicine and contactyour doctor as soon as possible.

• Feeling that your heart is beating ata rapid rate or irregular heart beat.

• Gaining weight (2.5 kg or more)quickly. This means weight gain thatis not due to a change you havemade in eating, or exercising.

• Having swelling or puffiness ofhands, face, ankles or stomach.

• Feeling dizzy or lightheaded, orfainting.

• Seeing objects in a blurred way.

• Having a severe pain in chest,shoulder, or arm.

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• If you already have pain in thechest, shoulder or arm, noticing thatthe pain is more severe or happensmore often.

• Having severe indigestion, or pain inthe stomach.

• Having severe discomfort or pain inlower chest or abdomen.

• Feeling nausea or vomiting; or

• Feeling that your scalp is veryirritated.

Q. What are the rare or infrequent sideeffects of this pill?

A. A few people who take this medicinemay find that their lips, face or tongueswell. If you experience any swelling inthese areas, stop taking the medicineand contact your doctor right away.

Q. What are the rare or infrequent sideeffects of this pill?

A. The rare or infrequent side effects ofthis pill are:

• You may feel short of breath.

• You may have a drop in your bloodpressure. If this happens, you mayfeel weak, unable to stand, feeldizzy or faint.

• You may notice small bumps orhives on your skin. The bumps orhives may be red or itchy.

If you see or feel any of thesesymptoms, stop taking the medicine andcontact your doctor right away.

Q. What are the rare or infrequent sideeffects of this medicine?

A. A few people who take this medicinemay have serious side effects which are:

• You suddenly get a high fever.

• Your heart starts beating quickly.

• You cannot breathe in a normalway.

• You may have chest pain.

• You may start sweating.

• You may vomit.

• You may see bruises on your body,but they are not due to a bump orfall.

• You may notice that your musclestwitch or that you have a tic.

• You may have a sore throat.

• You may feel confused or not knowwhat you are doing or where you are .

• You may hallucinate, or see or hearthings that aren’t real.

• You may have convulsions. Thismeans that your muscles twitch orjerk rapidly in a way that you can’tcontrol. You may becomeunconscious.

Contact your doctor immediately if youhave any of these symptoms.

Q. What are the possible side effects of thisasthma pill?

A. The possible rare side effects are:

• You may get a rash when using thepill.

• You may also get other symptoms ofallergic reaction to it, such as itching.

If these side effects become severe,contact your doctor.

Q. What are the possible side effects ofusing acne lotion?

A. You may feel more severe side effects:

• You may get a skin rash.

• Your skin may itch.

• Your skin may feel irritated ortender.

You should see a doctor if you areconcerned about any of the side effects.

Q. What are some of the possible sideeffects of taking this decongestant?

A. Some side effects only occur if the dosegiven is too high. At high doses, sideeffects may include:

• Feeling nervous or anxious;

• Feeling dizzy; or

• Being unable to sleep.

If you have any of these side effects andthey continue for more than 5 days, youshould see your doctor right away.

Q. What are some of the possible sideeffects of the asthma inhaler?

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A. Some of the side effects of the asthmainhaler include:

• Feeling palpitations, or irregularheart beats;

• Feeling that there is a pain in yourchest;

• Feeling that your heart is beatingrapidly;

• Feeling tremors in your muscles; or

• Feeling nervous.

Do not stop taking the drug because ofthis. Instead, keep taking the drug andconsult with your doctor. These sideeffects should stop after your bodyadjusts to the medicine.

Q. Are there any more serious side effectsfrom this asthma medicine?

A. In a few cases, the medicine may affectthe liver and you may feel some of thefollowing symptoms:

• You feel sick, or tired.

• You may feel like you have the flu.

• You may feel itchy.

• You may have a pain in the rightside of your stomach, just below theribs.

• You may get a yellow colour in yourskin or eyes. This is called jaundice.

If you have any of these signs andsymptoms, tell your doctor right away.

Q. What should I do if my symptomschange while taking this asthma inhaler?

A. You should contact your doctor rightaway if you notice the following:

• You are having more attacks ofwheezing.

• You are finding it difficult to catchyour breath.

• You have a tight feeling in the chest.

• You are using more of your fast-actingrelief medicine to treat your asthma.

• You wake up at night with tightnessin the chest, you cannot get yourbreath, or you are wheezing.

Q. Are there any symptoms that I shouldtell my doctor about while taking thistablet for acne?

A. Consult your doctor immediately if you:

• Have aches in your joints and havetrouble moving around;

• Feel depressed or sad;

• Have headaches, nausea, vomiting,vision problems, especially blurredvision;

• Have severe stomach pain, diarrhea,or bleeding from the rectum, theopening at the end of the bowel;

• Have dry and itchy eyes over a longperiod of time;

• Notice your skin is turning yellow,or if your urine has turned dark; or

• Have any other signs or symptomsthat you feel may be caused by theacne tablet.

Q. Are there any symptoms I should belooking for when I use the acne lotion?

A. If you notice any of the following signsor symptoms, you should see yourdoctor right away:

• sore throat;

• fever;

• fatigue; or

• mouth sores.

Q. What will this pill do to my memory?

A. This type of sleeping pill has beenknown to produce amnesia (memoryloss) of a few hours if you wake upbefore the drug has left your body. Forthis reason, this pill should not be takenwhile you are traveling.

Q. What are some of the rare or infrequentside effects of this drug?

A. Some of the rare or infrequent sideeffects are:

• Constipation – you may be unable tohave a bowel movement or passstools out of the bowel;

• Diarrhea;

• Gas;

• Stomach upset;

• Nausea or a feeling that you’re goingto vomit;

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• Pain in the abdomen;

• Headache;

• You may feel dizzy or lightheaded;

• You may notice one or more patchesof red skin.

Let your doctor know if you experienceany of these signs or side effects.


A. Severe depression is a rare side effect ofthis medicine. The severe depressionmay include the following symptoms:

• You may feel very sad.

• You may be unable to make anydecisions, or feel whatever you do isnot correct or acceptable.

• You may notice a change in yourappetite. This means that you maynot feel hungry or you may eat morethan usual.

• You may not be able to do yourusual activities or work.

• You may feel very tired and have noenergy.

Report this side effect to your doctor.


A. Some of the rare or infrequent sideeffects are:

• Kidney stones – you may feel painin the back below the waist or in thelower abdomen if you have kidneystones.

• Kidney disease or failure – you mayhave pain in the back below thewaist. You may also notice that yourlower legs and feet are swollen.

• Increased bleeding in hemophiliacs.

• Liver failure – you may feel pain inthe right side of your body.

• Rapid decrease in red blood cells –you may feel tired.

• Diabetes, or an increase in bloodsugar.

Q. What are some of the rare or infrequentside effects of this drug?

A. Some of the rare or infrequent, butsevere side effects are:

• Your tongue may feel sore, stingand/or swell.

• You may notice severe skin rasheson the body.

• You may feel itchy.

• You may have a fever.

• You may have a sore throat.

• Your skin may become pale.

• Your joints may ache.

• You may notice bruises that appearwithout any reason, such as after abump or a fall.

• You may see that your urine or peeis darker in colour than usual.

• You may notice that your skin or thewhite parts of the eyes are becomingyellow.

• You may get a severe bacterial orfungal infection.

Some of these symptoms may becaused by an allergic reaction. It isbest to see a doctor as soon aspossible if you have any of thesereactions.

4. Long-term side effects

Q. Are there any serious side effects that Imay get when I use acne lotion?

A. One of the ingredients in this acnelotion, chloramphenicol, may cause aserious blood disorder called aplasticanemia, if it is taken into the mouth orthe body. Aplastic anemia can make youvery sick or can cause death. It isimportant that you use the lotion verycarefully, and that you do not put thelotion near your mouth or your eyes.You should not use this lotion for a longtime.

Q. What are some of the possible seriouslong-term effects of this medicine?

A. Some of the long-term serious effects are :

• Infertility – if you have this side eff e c t ,you will be unable to have childre n .

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• Cancer.

If you notice any unusual symptoms, seeyour doctor right away. You shoulddiscuss the chances of your getting theseside effects with your doctor.

After using this drug

Q. What should I do with leftover pills?

A. If you do not need the pills any more,you should return them to thepharmacist. He or she will dispose ofthem safely.

Q. What should I do if the pills haveexpired?

A. If it is past the expiry date on your pills,return them to the pharmacist.

What You Should NOT Do:

Q. Can I throw leftover pills in the garbage?

A. Do not throw leftover pills in thegarbage. Return them to a pharmacistfor disposal.

Q. Can I flush leftover pills down the toilet?

A. Do not flush leftover pills down thetoilet. Return them to a pharmacist fordisposal.

Q. Can I still take my medicine if the expirydate on the package has passed?

A. If the expiry date on the package ofpills has passed, do not use the pills.Take the medicine to your pharmacistfor safe disposal.

C o n cl u s i o n

This section of the guidelines includedexamples of how the patient informationleaflet should be presented, a sampleleaflet structure, and examples of termsgrouped by the headings given in thepamphlet structure.

The above examples give the personpreparing patient information someideas about how to express complexmedical information in a simpler way.

These examples are not meant to beexhaustive — but to provide ideas abouthow to put the necessary informationinto plain language. Writers of patientinformation should consult the plainlanguage section of the guidelines forspecific advice on how to presentmaterial in plain language.

Overall, these examples provide helpfulinformation on what information toprovide to patient with low literacy skillsand, more importantly, how to provideit. Many patients with low literacy skills,but not all, will welcome the chance toread about their medicine in a way thatdoes not cause frustration. This will helppatient to take their medicine in aresponsible way, which in turn, will leadto better health. This is a goal that weall want to achieve.

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Clear Design, L ayo u t , a n dG rap h i c s

The following information is based onguidelines developed by theNonprescription Drug ManufacturersAssociation of Canada. Suggestionscontained in CPHA’s own publication,Creating Plain Language Forms forSeniors have also been integrated in thissection of the document.

Design and layout of text can go beyondm e rely creating an eye-pleasing document;it can also accomplish much in aiding thereader’s comprehension. For example,“chunking” information, i.e., breaking itinto small sections, will help re a d e r sdistinguish discrete ideas and re d u c ereading fatigue. Adding graphics or designelements such as lines or boxes can helpto re i n f o rce the text content and helpreaders follow the flow of the inform a t i o n .

All parties – drug manufacturers,designers, etc. – must be aware ofdesign issues and be involved in thedesign process to ensure that theprinciples and goals of plain languageare implemented visually.

The following layout and designrecommendations can help producepatient information materials thatsuccessfully convey the importantinformation about medication toconsumers at all literacy levels.

White Space

White space is the blank space betweenand around text and graphics. Thereader needs white space in order to re s tthe eyes and stay oriented in the text.

To keep your text from lookingcrowded, incorporate some white space:

• in margins and between paragraphs;

• between words and letters;

• between lines; and

• at the end of lines.

A page that incorporates white spacenot only “feels” more spacious, butoffers an opportunity for writing inspecial notes or reminders.

Type (font) Size, Style, andLe a d i n g

When designing a package label orinsert, choose a type (font) size t h a tis sufficiently large to allow easyreading. For side panels on drugpackaging, use the largest point sizepossible while respecting re g u l a t o r yre q u i rements and packagingconstraints. Type size is extre m e l yimportant for low-literacy seniors whomay have poor eyesight compoundingtheir poor reading skills.

Most readers identify words and lettersby shape. The most shapely type stylesare called “serif types”, serifs being theshort lines extending from the mainstrokes of a letter, such as the “feet” onthe letter “A”. Serif type (such as TimesRoman) is appropriate for the bodycopy of a package insert in a type sizeof 10 points or more.

At small type sizes less than 10 points, itis best to use a “sans serif” type (withoutserifs). These type styles (such as


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Helvetica, Univers or Arial) are lessornamented and will stay crisper in thesizes needed for packaging panels. Theyappear larger than a serif type.

Following are examples of serif and sansserif type styles, both in 12-point size:

This is an example of a seriftype style (Times).

This is an example of a sansserif type style (Arial).

Leading is the white space betweenlines of print, which is related to fontsize as a percentage (usually 10% abovethe type and 10% below.

When text type is very small, designers need to

compensate by adjusting the leading so that the

space between lines increases by another few

percentage points.

Type Alignment

Use left-justified text alignment, withragged right edges as used in thisdocument.

This prevents the forced gaps between words created by fully j u s t i f i e d text, and reduces the need for hyphenation.

H y p h e n a t i o n is not recom-mended. Breaking a word inter-rupts the reader’s concentration and the flow of meaning; some readers may have trouble con-necting the two parts of the word to understand it.

Centre-justified text creates a problemfor less-skilled readers because they

tend to lose the flow of text. Their eyeshave to jump different distances for eachline. There is no rhythm to reading cen-tered text, leaving readers frustrated and

lost in the text.

Line Le n g t h

Readability research is divided on thequestion of the ideal line length, whichis usually measured in number ofcharacters per line (including spaces andpunctuation). Some say 39 characters isthe maximum; others recommend 60 to65; and others prefer 52 (the equivalentof two alphabets).

Note that too shorta line length can be tiring to the eyes. Readersare unable to make efficient use of their peripheral vision and the normal pattern of eye movements is disrupted.

Text on a long side panel should bebroken into two columns to preventexcessive line lengths.

H e a d i n g s

Headings are visual markers that leadthe reader quickly to key information.They also serve to break text into logicalchunks. Headings should be used toseparate the key information.

Leave more space above a heading thanbelow it to separate it from thep receding information and to link it withthe text which follows. Never break a


46

column immediately below a heading, asthis separates the text from its identifier.

Sans serif type fonts make good headings,because their straight lines lead thereader’s eye down into the text thatfollows. Always put headings in bold face.

E m p h a s i s

Bold is the best way to emphasize textin drug packaging, provided it is notused in continuous text, where it cancreate after-images for the reader. Avoidextensive use of italics, underlining,ALL UPPER CASE, reverse (white or lighttype on a solid, dark background) and

types. These can increasereading strain when used in small typesizes or for long sections of text.

Colour and Contrast

Colour alone should never be used tocue the reader to important information.Use it in combination with bold face,graphics or symbols.

High contrast – dark lettering on a lightsurface – is best for readability. Avoidcolour-saturated backgrounds and greyor coloured screens which reducecontrast and cause eyestrain, especiallywith small type sizes. Designers sensitiveto these issues recommend that abackground screen should be no morethan 65% of the solid colour used forthe text, for example, 100% black textagainst a 65% or less screenbackground. Some readers find anythingover 40% contrast is difficult to decipher.

Colours have their own inherent colourdensity, which must be taken into

account. For example, solid pale blueagainst a 50% green screen would bedifficult to read. Solid black on solid redis widely used, but is notoriously poorin contrast. Colour blindness can also bea factor when two colours are used.

Brightness and high contrast helpreadability; glossy or reflecting surf a c e sdo not, because the glare interf e res withreading, particularly for older eyes thathave trouble adjusting to extremes oflight. The weight of the paper stockused on an insert should also figureinto this equation (opacity), as textprinted on both sides of a thin sheetcan show through and make re a d i n gd i ff i c u l t .

La y o u t

The organization of text begins with thewriter, but continues with the designerand layout artist. As noted, chunkinginformation can help the reader focuson logical sections of text andunderstand that each paragraph, whichmay or may not have a heading, dealswith a single subject.

Ordering the text in a familiar re a d i n gp a t t e rn on the page is important as well.For example, newspaper-style columnsa re familiar to most readers. A hairline toseparate columns can be a helpful device.

Using a box to emphasize text iseffective if there is sufficient white spaceavailable to set off the box from the textaround it. Several boxes on a side panel,however, may reduce the impact andproduce crowding and clutter; in suchcases, hairline separators may be abetter alternative.


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Numbers placed at the beginning ofmajor sections of text can be used tohelp guide poorer readers through adocument. Format them in a large, boldfont to make the roadmap easier tofollow. However, avoid using numbers inlists, such as adverse reactions to amedication which are equally common,as some readers may think they are listedin priority. If they are, say so; otherwise,use bullets instead of numbers to re d u c ethe reader’s impression of ranking.

Graphics and Illustrations

Whether you use simple line drawings,full-colour illustrations or photographs,graphics should always serve to helpyour audience understand the text.There is good reason for their use.

Visual presentations have beenshown to be 43 percent morepersuasive than unaidedp resentations. The re s e a rch on visualsand graphics shows that the memorysystems in the brain favour visualstorage, so that when a message isvisualized we remember it better thanif we just read or hear it.2

Visuals have a number of advantagesover words. They can be:

• identified more accurately when seenat a glance;

• understood by people with lowliteracy skills;

• used to represent information incondensed form (thereby reducingthe amount of written material); and

• designed to be multidimensional,incorporating colour, shape and sizeas well as combinations of these.

Graphics should not interrupt thereader’s journey through the text, but,rather, facilitate it. Placement ofillustrations should follow a logical flowjust as the written content should. Forexample, a column of drawings placedbeside a column of text they illustrate isan arrangement that would be intuitiveand transparent to the reader. The samecan be applied to horizontal rows.

As with text, noted above, it is useful tonumber clearly the frames of a step-by-step illustration – such as how to use aninhaler or nasal spray – to lead readersproperly through the procedure. Thisavoids confusing readers who may notknow whether to follow the steps acrossor down in, say, a four-step process setup as a two-by-two grid.

Visuals can have problems that preventor diminish their value and effectiveness.Here are some common problemsassociated with visuals:

• too small;

• too complex, or totallyincomprehensible;

• illegible, badly drawn or coloured,poor contrast;

• too much information; and

• missing information.


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2 Cecilia C. Doak, Leonard G. Doak, and Jane H. Root, Te a c h i n g

Patients with Low Literacy Skills, 2nd edition, Philadelphia, PA.

J.B. Lippincott Company, 1996.

Graphics work best when theydemonstrate actions. This is sometimesdifficult in a static drawing, but lessonscan be learned from the art ofcartoonists and action photographers.Actions also need to be divided intounderstandable steps. Focus in on theessential actions; and avoid unnecessaryclutter in illustrations.

One of the most familiar examples ofthe use of visuals with medication is thesmall rectangular strip (with roundedcorners) affixed to pill vials by thepharmacist. These consist of a shortmessage, written in plain language (e.g.,TAKE WITH FOOD!) and a simplesymbol such as the following examples.

Other examples of visuals to reinforcepatient information are shown inChapter III.

Testing for Re a d ab i l i t y

Canadian pharmaceutical manufacturersprovide patient information onprescription medications, either requiredunder the regulations or supplied at themanufacturer’s discretion. Typicalexamples are:

• the label on the container of themedicine and/or the packageenclosing the container;

• the patient package insert or leaflet;

• supplementary information distributedby physicians and/or pharmacists; and

• the patient information section of theproduct monograph.

To reach the maximum audience, a Grade 6 reading level is thecommonly accepted standard.

How can a manufacturer be sure thatpatient information is communicatingimportant messages effectively? Thereare two main techniques for testing thereadability of written materials, andthese should form an integral part of thedevelopment of the materials and guidethe writing, revision, design and layoutprior to final approval and production.

The two techniques can be usedsimultaneously or at different stages inthe development process. They are:

Standardized readability assessmenttools. These tests involve analyzing thetext using formulas and calculations tocome up with an indicator, usually gradelevel, to measure the readability of the


49

These labels contain a simple message reinforced byan illustration. They are easiest to read whenaffixed vertically.

information. They are applied directly tothe text and do not involve readers.

Focus testing. This process involves the use of test subjects who, eitherindividually or in a group, are pre s e n t e dwith the materials and invited to re s p o n dto a series of interview questions tod e t e rmine whether they understood thei n f o rmation presented. Test subjects maybe re p resentative of specific user gro u p sor selected at random.

Examples and descriptions of severalcommonly used tests are presented below.

S t a n d a rdized ReadabilityAssessment To o l s

The literature reports approximately 40 readability tests, most of which arebased on the idea that big words andlong sentences are harder to understandthan simple terms and shorter sentences.They typically involve selecting sectionsof the test document, counting longwords and long sentences, andp e rf o rming a calculation to yield areading level. Some are available ascomputer programs to analyze texte l e c t ronically, but many of these can beu n reliable. For example, a program thatcounts sentences by using the period as amarker would count “Mr.” as a sentence.

Although these tests are quick and easyto perf o rm, they lack sophistication. Forexample, they do not take into accountwords that may be short but are used inan unusual context, or complexconceptual structures or assumptions thatlie behind an apparently simple text. Aswell, grade level is not consistent fro mone educational jurisdiction to another;nor does it take into account linguistic

and cultural diff e rences common toethnic sub-groups. (Note: Readabilityf o rmulas are available for severallanguages other than English or Fre n c h . )

P resented here are three summaryexamples of readability assessment toolsthat do not re q u i re the use of test subjects.

The Fry Readability Graph

This graph is an interpretive devicewhich takes the scores from word andsentence counts and yields a grade levelfor readability. Developed by EdwardFry, it is among the most commonlyused assessment tools and is widelyavailable on the internet.

To perform the test, follow these steps:

1. Select one or more 100-wordpassages from the text, dependingon the total length of the document.

2. Count the number of sentences ineach passage.

3. Count the number of syllables ineach passage.

4. If you are using more than onepassage, calculate the average foreach figure.

5. Place the scores on the graph below:

• find the number of sentences onthe left-hand axis;

• find the number of syllables acro s sthe top and bottom of the graph;

• follow each line across or downto a point of intersection.


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6. The point of intersection falls withinan area that establishes anapproximate grade level for the test.

The S.M.O.G. (Simple Measure ofGobbledygook) Readability Test

Like the Fry readability formula, this testcan help establish the grade level of adocument by applying a simplecalculation to the number of polysyllabic(words with three or more syllables)words in the text. Developed by G.H.McLaughlin in 1969, the test is widelyused.

If the text has 30 or more sentences:

1 . Select 30 sentences within thedocument: 10 consecutive sentences atthe beginning, 10 in the middle, and

another 10 near the end of the text.Do not include titles and headings.

2. Mark all polysyllabic words in the30-sentence sample.

3. Count the total number ofpolysyllabic words.

4. Find the squared number that isclosest to this total and calculate itssquare root. For example, if the totalnumber of polysyllabic words is 29,the nearest squared number is 25.The square root of 25 is 5.

5. Add a constant of three to the squareroot. This gives you the reading levela person must have to understandthe text. In the example given above,the reading level would be Grade 8(square root of 25 + constant of 3).

Edward Fry’s Readability GraphAverage number of syllables per 100 words

Short words Long words

51

College

If the text has fewer than 30 sentences:

1. Count all polysyllabic words in thetext.

2. Count the number of sentences inthe text.

3. Find the average number ofpolysyllabic words per sentence:

average = Total # of polysyllabicwords divided by...

Total # of sentences

4. Subtract the total number ofsentences from 30 and multiply theremainder by the average number ofpolysyllabic words per sentence.

5. Add this figure to the total numberof polysyllabic words.

6. Find the square root (as described instep 4 in the previous set of steps fortext with 30 or more sentences) andadd the constant of 3. This gives youthe reading level a person must haveto understand the text.

Additional guidelines for using theS.M.O.G.:

• Hyphenated words are consideredone word.

• Numbers in numeric form should bepronounced to determine if they arepolysyllabic. (Example: 337 has 8syllables.)

• Proper nouns, if polysyllabic, alsoshould be counted.

• Abbreviations should be read asunabbreviated to determine if theyare polysyllabic. (Example: ON, forOntario, has four syllables.)

• Include all repetitions of the sameword, no matter how often it is used.

• The grade level is accurate to +/- 1.5grades.

Suitability Assessment of Materials(SAM)

This tool was developed by C.C. Doak,L.G. Doak and J.H. Root, and iscontained in their seminal publication,Teaching Patients with Low LiteracySkills3. This book is essential reading foranyone involved in the developmentand/or assessment of patient informationmaterials.

The SAM is unique among readabilitytests because it consists of six areas tobe assessed, with subsections withineach. As with the previous example,sections of the text are selectedaccording to the length of the documentand evaluated against the criteria listedon the score sheet.

Once this assessment is complete, thef i g u res are totalled and a perc e n t a g ecalculated based on a 44-point perf e c ts c o re. A score over 70% indicates superiormaterial; 40-69% is adequate; and 0-39%means the material is not suitable.

It is worth noting that the SAM can beapplied, with minor changes, to audio andvideo materials as well as printed text.


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3 I b i d . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .


53

Assessing Suitability of Materials: SAM Scoring Sheet

2 points for superior rating 1 point for adequate rating0 points for not suitable rating NA if the factor does not apply to this material

Factor to be Rated Score Comments

1. Content

a) Purpose is evident ————— ———————————b) Content about behaviors ————— ———————————c) Scope is limited ————— ———————————d) Summary or review included ————— ———————————

2. Literacy Demand ————— ———————————(a) Reading grade level ————— ———————————(b) Writing style, active voice ————— ———————————(c) Vocabulary uses common words ————— ———————————(d) Context is given first ————— ———————————(e) Learning aids via “road signs” ————— ———————————

3. Graphics(a) Cover graphic shows purpose ————— ———————————(b) Type of graphics ————— ———————————(c) Relevance of illustrations ————— ———————————(d) List, tables, etc. explained ————— ———————————(e) Captions used for graphics ————— ———————————

4. Layout and Typography(a) Layout factors ————— ———————————(b) Typography ————— ———————————(c) Subheads (“chunking”) used ————— ———————————

5. Learning Stimulation, Motivation

(a) Interaction used ————— ———————————(b) Behaviors are modeled and specific ————— ———————————(c) Motivation—self-efficacy ————— ———————————

6. Cultural Appropriateness

(a) Match in logic, language, experience ————— ———————————(b) Cultural image and examples ————— ———————————

Total SAM score: ______________________

Total possible score: ____________________ Percent score : ______________%

Focus Te s t i n g

The use of test subjects to reviewinformation materials in various stagesof development can be a useful, if notalways reliable, technique for assessingreadability. As noted, test subjects maybe drawn from a specific target group(or several groups) or selectedrandomly, depending on the nature ofthe medication and user profiles.

Consumers respond to writteninformation in ways that may beunpredictable. Choosing test subjectswho come from a range of backgroundsand circumstances will help demonstratehow various users of the product reactto the patient information materials.

There are conflicting views on thedesign of the focus testing exercise,primarily related to the use of groupversus individual interviews. It could bewise to use a combination of bothoptions in designing a focus test.

Group interviews: This option can havethe advantage of a dynamic exchange ofviewpoints, information and advice.However, even with a skilled facilitator,some participants may emerge as“leaders” and shape the opinions ofthose who may be shy or reluctant toparticipate fully in the group, thusskewing the discussion and the results.

Individual interviews: This method reliesvery heavily on the design of theinterview and the technique of theperson conducting it, but the value ofpersonal contact and a non-competitiveenvironment can add to the quality ofthe input.

Two examples of focus testing usingsubjects are the Cloze Procedure andDiagnostic Testing, both of which canbe used in a group test or withindividual interviews.

Cloze Procedure

Cloze pro c e d u re, developed in theearly 1950s by a psychologist, is atechnique in which words are deletedf rom a passage according to a word-count formula, such as every fifthword, or various other criteria. Inschools or reading programs, thepassage is presented to students who,as they read, insert words to completeand construct meaning from the text.This pro c e d u re can be used as adiagnostic reading assessmenttechnique, or to help assess thereadability of text for readers withvarying levels of literacy.

❍ Purpose

The purpose of using Cloze pro c e d u reas a teaching tool is usually tod e t e rmine which cueing systems aree ffectively used by readers to constructmeaning from print. It is also used to assess the extent of re a d e r s ’vocabularies and knowledge of asubject, and to encourage students tothink critically and analytically abouttext and content.

As a test for readability, the procedurereveals whether the text is conceptuallysound, follows a logical sequence, usesproperly constructed sentences, andcontains or implies vocabulary that isunderstandable to the test subjects.


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❍ Procedure

The person(s) running the procedureshould clearly explain Cloze to the testsubjects, and should administer inadvance a sample exercise, preparedusing the following methods, to ensurethey are familiar with the procedure.Then, following the same procedure,they should administer the text that is tobe tested.

1. Select a self-contained passage of alength appropriate for the grade orreading level of the test subjectsbeing assessed.

2. Leave the first and last sentencesintact as well as all punctuation inthe text.

3. Carefully select the words foromission using a word-countformula, such as every fifth word orother criteria. To assess subjects’abilities to use semantic cues, deletecontent words which carry meaning,such as nouns, main verbs, adjectivesand adverbs. To assess their use ofsyntactic cues, delete someconjunctions, prepositions andauxiliary words.

4. When preparing the final draft of thetest passage, make all blanks ofequal length to avoid includingvisual clues about the lengths ofomitted words.

5. Have the subjects read the entire testpassage before they fill in the blanks.

6. Encourage subjects to fill in all of theblanks if possible.

7. Although there should be no timelimit for this exercise, the timenecessary for completion should benoted.

8. Suggest that subjects reread theircompleted passage.

❍ Scoring the Procedure andInterpreting the Results

There are two ways of scoring theseprocedures.

• Exact replacement. Only those wordsthat are exactly the same as thedeleted words are scored as correct.If exact replacement is necessary, ascore of 40% or less indicates thereader is unable to read the passageeffectively or has reached afrustration level. A higher scoreindicates that the material isappropriate for both guided andindependent reading experiences.

• Synonymous replacement. Words arescored as correct if they are the sameas the deleted words or if they aresynonyms or words which preservethe meaning of the sentence inwhich the blank occurs. If theprocedure is scored using thismethod, a score of 70% or lowerindicates that the material isinappropriate and frustrating for thereader.

Scores and completion times can thenbe used to determine the suitability ofreading material for the individualand/or group of test subjects.


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Diagnostic Testing

Diagnostic testing, as developed by theCommunications Research Institute ofAustralia, helps assess a document byobserving and analyzing subjects’behaviour in using the document. Itconsists of:

• asking users to carry out the tasksthey might carry out when using theinformation in a normal, non-testenvironment;

• observing and recording in detailwhat they do;

• recording anything they say, eitherabout the particular tasks they areundertaking or about the documentin general; and

• probing to find out whether they canappropriately interpret and use theinformation they have read.

❍ The Testing Process

The Communications Research Institute ofAustralia (CRIA), in its publication Wr i t i n gabout Medicines for People,4 re c o m m e n d sthat the testing be carried out by theperson who wrote the document, to allowfor firsthand observation of the testsubjects’ response to the information. Thiscan help considerably when the testing isiterative, i.e., perf o rmed at several stagesof the document’s development. As anadded benefit, the knowledge gained bythe writer through this process is easilyt r a n s f e r red to the writing of newd o c u m e n t s .

Test subjects may be selected from thepopulations at risk – those people whoare likely to have problems using themedicine – or, in the case of rare orcomplex ailments, from actual suffererswho would be more likely to have thepatient knowledge to assess thedocument effectively. CRIA’s process isbased on individual interviews.

The document should be tested in thelayout and on the same paper stock as itwill be presented to consumers. Thiswill ensure a genuine response. As well,different ways of presenting theinformation can be tested, provided youavoid giving both options to the samesubjects, as the information gleanedfrom the first document may assist themin interpreting the second.

❍ Developing Test Questions

Because the aim of this process is tod e t e rmine how consumers go about usingthe document, test questions should bedeveloped by first considering whatspecific patient actions are re q u i red. Forexample, if you are probing about how tos t o re the medication, the subject may haveto first locate information from severalparts of the document; then interpret thesec o r rectly; and explain each step orrelevant information in a compre h e n s i v eway that demonstrates that the documenthas succeeded (or not) as intended.Questions should be open-ended (such as:“What would you do if you took toomuch of this medication?”) and not simplycall for a “yes or no” answer.

CRIA suggests that about 15 keyquestions is a good number, so as not tot i re the subjects. Many participants will


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4 Communications Research Institute of Australia. Sless, David

and Wiseman, Rob. Writing about Medicines for people .

2nd ed. 1997

start to noticeably tire after about 30-35minutes. Questions should be clear andto the point, avoiding a formal style ortechnical jargon. Do not answer thequestion in the question itself (such as:“ Would you rather see the dosagei n f o rmation in a table format?”). Startwith easy, general questions andp roceed logically through the document.Do not be afraid to conclude withgeneral questions so that participants canraise points not triggered already (suchas: “How can we improve this leaflet?”).

The questions should be tested inadvance and modified if they are noteliciting an adequate response.

❍ Conducting the Test

Conduct test sessions in a relaxed andinformal manner to put participants atease. Offer refreshments to break theice. Remind subjects that they aremaking an important contribution to thesuccess of the document and that thepurpose of the test is to assess thedocument, not them.

Following the test session, makethorough notes. It may help to tape-record sessions, provided participantsagree. Summarize the results todetermine their implications forchanging the document or to identifysections that were particularly successful.

If diagnostic testing is part of an iterativeprocess, in which the document istested, modified and re-tested, recruitnew participants for each round oftesting. A test subject who is alreadyfamiliar with the document will useprior knowledge during the second

round, which will give a false indicationof the success of the revised version.

The Importance of Te s t i n g

Any or all of the methods above can beused as part of the development of patienti n f o rmation materials; some are morep o w e rful than others. When pre p a r i n gi n f o rmation about medication that oftenhas a considerable impact on a patient’shealth and well-being, particular attentionshould be devoted to the capacity ofpotential users to understand and act onthe instructions. If the document is nottested, it may fail to convey importanti n f o rmation in a usable way.

The Physical Design ofPa ck ag i n g

I n t r o d u c t i o n

In the world of medications, thephysical design of packaging is notm e rely a matter of aesthetics; rather,it is important for conveying criticali n f o rmation to consumers andc o n f o rming to government andindustry regulations. In addition, thepackage needs to accomplish thef o l l o w i n g :

• ensure the stability, sterility, safetransport and proper storage of themedication;

• meet the needs of pharmacists indispensing the medication;

• meet environmental standardsconcerning the amount of packaging;and


57

• provide optimum usability to theconsumer, particularly:

• opening the package;

• using the medicationappropriately and safely;

• closing the package;

• storing the package appropriatelyand safely;

• disposing the package after use.

This section focuses on physical design asit pertains to prescription medications but,according to the Nonprescription DrugM a n u f a c t u rers Association of Canada,o v e r-the-counter medications typicallyfollow similar guidelines for packaging.

This document has demonstrated thatseniors have special needs when itcomes to medication packaging thatshould be taken into considerationduring the design process. For example,a number of seniors have problems witharthritis, strength and shakiness; these allhave implications for the manualdexterity required to handle and opencertain types of packaging. Visiondifficulties should be considered whenselecting type size and font style used inpackage labelling. Finally, seniors withpoor hearing can have problems whenthe doctor or pharmacist is explainingthe package’s directions for themedication and how to take it.

Package design can help compensate fordiminished capacities. A good examplewas a new container for a well-knownover-the-counter analgesic featuring acap which:

• was large enough to be grippedcomfortably;

• had knurled edges to improve grip;

• required only a quarter turn to openand re-secure; and

• was not child-resistant, but wascoloured bright red.

For consumers with arthritic hands, whoare typical users of this product, thenew design was a success. However, thenew package was not child-resistant;some users had difficulty removing thetamper-evident plastic; and the productwas more expensive in this form ofpackaging. Nevertheless, the exampleshows how package design can besensitive to the needs of consumers.

Packaging can also enhance compliance,reduce errors, and improve the qualityof life and health for consumers. Ofcourse, there are trade-offs in terms ofthe cost to produce such packaging aswell as the effect on the environment.Other sections of this document providedetail on issues such as layout, designand compliance.

Prescription medications are typicallydispensed in one of two ways: in theoriginal package provided by themanufacturer; or in a package providedby the pharmacist, such as pill vials orbottles for liquids.

Original Package Dispensing

Manufacturers of prescription medicationdesign and print their individual-usepackaging (or purchase it from apackaging manufacturer), fill it with


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medication, and distribute it topharmacists. “Original packagedispensing” (OPD), as it is known,constitutes about 10-25% of allprescription medication in Canada, theremainder being repackaged at thepharmacy.

When a medication is intended for OPD,the manufacturer often prepares a“patient package insert” (PPI) or leafletcontaining detailed information aboutthe medication. This paper insert isusually included in the package which isdesigned for individual use.

Compliance packaging, often in the formof the blister pack, is an OPD optiondesigned to increase the correct takingof the medication by prompting theconsumer in various ways. These typesof packaging are discussed in moredetail in Chapter III of this document.

Despite these important advantages toOPD, there are also drawbacks:

• The dispensing pharmacist is re q u i re dto put a label on the package withcertain elements which are re g u l a t e dby provincial pharmacy authorities.This label may (and often does)o b s c u re a portion of the inform a t i o non the original package. Somem a n u f a c t u rers have met this challengeby designing a package with a blankspace for the pharmacist’s label so thatvaluable information is not covere d .

• The size of the package mayp reclude the provision of adequatei n f o rmation. For example, a smalland irregularly shaped container ofe y e d rops is often too small for thelabel which may be wrapped

completely around the container,obscuring all information provided bythe manufacture r. The pharmacy labelmay even overlap itself, covering upimportant information (such as theexpiration date). In addition, the fontmay be too small to be read easilyand the container itself may bed i fficult to handle (the manipulabilityfactor) by seniors and others. Theobvious solution to this problem is topackage the small container in al a rger box, to accommodate thep h a rmacist’s label and also permit theinclusion of a PPI. However, therea re trade-offs, including incre a s e dpackaging material finding its wayinto the environment and highercosts for the manufacture r.

How a package opens and closes canalso be important. Pharmaceutical andpackaging manufacturers workedtogether to develop child-resistantclosures (CRCs) to make it difficult forchildren to open a package containingmedication and possibly ingest thecontents. Although some patientsrequest non-CRC packaging, it isimportant not to lose sight of theimportance of child safety. Patients whoremove child-resistant caps to makeaccess easier should ensure child safetyby keeping medications out of the reachof visiting grandchildren, for example.

Tamper-evident packaging wasdeveloped following the well-publicizedtampering of some over-the-countermedications. If such packaging has beenopened (or possibly tampered with)prior to purchase, it is physically evidentand easy to see. These measures offerdegrees of security; however, they havenegative implications for ease of use,


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especially for seniors who may findtamper-evident seals difficult to open.

Manufacturers have developed severalsolutions:

• visible perforations in the seal whichcan be separated to remove it, eitherby pulling on the perforated sectionwith a fingernail or by twisting thecap to snap the perforation;

• a cardboard box to contain themedication which is glued shut,preferably with one side perforatedfor easy opening by the consumer;

• inner bottle seals which are lightlyglued and are easy to remove; and

• inner bottle seals that requirestronger adhesion due to the natureof the contents (e.g. liquids) buthave a tab or ring for easy removal(grocery-product manufacturers andpackagers have been innovators inthis field).

Other issues p resent problems andsolutions. As noted, manufacturers muste n s u re the integrity, stability (from thedeleterious effects of heat, light andm o i s t u re) and sterility of the pro d u c t .These re q u i rements are primeconsiderations in the design process for anew package. Meeting these re q u i re m e n t scan make it difficult for some consumersto manipulate the package.

Another problem arises whenmanufacturers want a similar “look” totheir lines of medications. However,when packaging has such ahomogeneous look, there is a distinctpossibility that a pharmacist caninadvertently choose the wrong (and

potentially very harmful) product orstrength. Manufacturers must ensure thattheir products are clearly marked andeasily distinguishable.

Drug manufacturers must face all ofthese issues and more when designingand producing original package designfor their products. Related issues arefound with repackaged drugs.

Repackaging

As mentioned above, manufacturersproduce original package designs fortheir products (for individual use).However, the vast majority of drugs (anestimated 75-90% in Canada) aredelivered in bulk form and are thenrepackaged into smaller containers bythe pharmacist for the individualconsumer.

Most repackaged medications,particularly tablets, capsules, etc., aredispensed in vials supplied by thepharmacist. This is most commonamong products which come in largebulk containers and are then countedout to fill each prescription.

If a patient package insert is availablefor such products, the pharmacist mayprovide it to patients at the time ofdispensing, although this option isproblematic in practical terms, as manypharmacies lack storage space for suchmaterial or are simply too busy toprovide it. Often, a computer-generatedpatient information sheet is provided atthe time of dispensing.

Seniors and others receiving medicationin vials from their pharmacist can re q u e s ta closure that is not child-resistant but is

easier to open (e.g., a “flip-cap”). This


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request is then usually stored on thepatient’s file for future re f e re n c e .Unfortunately, not all patients who needthis option are aware of it. Education onthis point is re q u i red to ensure thatseniors who prefer this type of packagingcan take advantage of it. Otherwise, it hasbeen reported that patients leave the CRCpackage open or transfer the contents toa n o t h e r, easier-to-open container, losingthe important label information andpossibly causing deterioration of thep roduct. Some seniors report injuringthemselves using a tool such as a kitchenknife or screwdriver to open a CRCpackage. Although flip-caps are generallyeasier to handle, some seniors may wishto request CRC packaging, to ensure thatc h i l d ren don’t get into the medicationwhen they come to visit.

Most vials or caps are manufactured inultraviolet light-resistant colours tomaintain the integrity and stability of thecontents. These coloured vials may makeit difficult for seniors and others withpoor sight to see the size and shape ofthe drugs inside. Seniors often identifypills by shape and/or colour withoutopening the container or reading thelabel. Coloured vials which distort theshape and colour of the pills can beespecially problematic for those with lowliteracy and/or vision problems who mayhave trouble reading the labels. Onesolution would be to standardize thecolour of vials but use a colour that leastdistorts the contents. In addition, thesec o l o u red vials have associated costs.

As described earlier in this chapter,pharmacists often use small stick-onlabels (affixed to the vial) to highlightimportant information for consumers.For example, the “TAKE WITH FOOD”label is a common one familiar to

many people. The labels may consist ofwords only or may be words plus asimple illustration. These become anintegral part of the package whenapplied, as the simple graphics help toreinforce instructions.

Some pharmacists are repackagingmedications in their own blister packs.These provide a convenient and easy-to-handle way of storing medications andinclude compliance mechanisms. Youcan find more on this form of packagingin Chapter III.

Conclusion

This chapter has reviewed the following:

• p l a i n - l a n g u a g e writing techniques;

• proposals for the presentation ofpatient information and medicationlabelling (the Compendium of PlainLanguage Terminology);

• the design and layout of information,the reinforcement provided by goodgraphics and illustration;

• the need for adequately testing theinformation; and

• the physical design of the packageand/or container.

These elements are complex inthemselves, and need to interact in a waythat ensures good understanding bypatients of how to properly take theirmedicine. Manufacturers who aresensitive to the special needs of Canadianseniors and those with low literacy skillscan make a significant contribution totheir safety, health, and well-being.


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I n t ro d u c t i o n

T o get the most benefit from adrug, the patient has to take themedication as prescribed by the

doctor – in the correct amount, at theproper times, and for the completeduration. Compliance (i.e., correctlyfollowing the instructions for use) notonly helps improve the individual’shealth, it saves money for both thepatient and society through savings tothe health care system. This chapteroutlines techniques that can involve allmembers of the medication managementteam – manufacturers, physicians,pharmacists, health personnel, informalcaregivers and patients.

The importance of medicationcompliance, especially among low-literacy seniors, may not be fullyappreciated by practitioners and thepublic. For the professional audience,this topic should be included inconferences, seminars, workshops andjournals. Some health associations haveundertaken programs and advertisingcampaigns that focus on educating targetgroups (such as doctors, nurses andpharmacists) about medicationcompliance issues. For example, theCanadian Pharmacists Association hasdeveloped a set of materials called

Just Checking offering pharmacistsguidance in counselling their clientele;and Canada’s Research-BasedPharmaceutical Companies (Rx&D) has aKnowledge is the Best Medicine kit forcommunity workshops.

Links among industry, non-governmentalorganizations and government areneeded to develop and spread the word.Literacy associations, consumer groups,community associations and caregivergroups should all be partners in the goalof medication compliance. In particular,educating their constituencies can be oftremendous value.

It is also widely recognized thatindividuals have a responsibility for theirown health care. The patient isresponsible for following the advice andd i rections given by the health carep r a c t i t i o n e r. Patients who are seniorstypically want to retain theirindependence and autonomy. Carryingan updated medication record booklet(such as that provided in the K n o w l e d g eis the Best Medicine kit) to visits to healthc a re professionals is one way to do that.The booklet can be filled in to include acomplete list of prescription medications,o v e r-the-counter drugs, altern a t i v emedicines, herbal preparations, vitamins,etc., being taken by the patient.

CHAPTER III:Techniques for Enhancing Patient Compliance

Senior citizens who are patients may notadhere to medication regimens for avariety of reasons:

• low literacy;

• isolation;

• cognitive impairment;

• general forgetfulness;

• diminishing physical abilities, chronicdiseases, etc.;

• lack of feeling in control of theirlives which leads them to give up;and

• lack of social supports which canlead to poor personal care andhygiene.

Identifying the relevant reasons forindividual patients is important in orderto determine the most appropriate andeffective techniques to overcome them.Clearly written plain languageinformation materials can help tocompensate for low literacy levels.Home care and other services can helpreduce isolation and allow familymembers and friends to spend qualitytime with the patient and avoid burnout.Educational and counselling strategiesand memory aids can compensate forforgetfulness. Physical compliance“tools”, including innovative packaging,

can influence behaviour. An appropriate,supportive emotional framework set bygood physician-patient and pharmacist-patient communication can gain patienttrust, nurture a positive attitude, andmotivate the patient to adhere to amedication regimen.

No one strategy will result in patientstaking their medication properly. Acombination of techniques, counsellingand innovative packaging – tailored tothe individual’s unique needs – isneeded to improve compliance. Just asbehaviour and people are dynamic,ongoing monitoring and flexibility areessential to ensure that changing needsare met. This can mean researching,being aware of, and taking advantage ofnew strategies and devices as they aredeveloped and become available.

Techniques for Involvingthe Patient

Whenever possible, patients should beinvolved in setting up the drug regimenso they have a sense of control andresponsibility for their medication-takingand well-being. Both the physician andthe pharmacist play an active role incounselling patients and explaining thepurpose of the medication, how to takeit, precautions and possible side effects.The patient information materialsprovided by the manufacturer can be akey element in this process. Everyoneinvolved must view the patient as an


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Using compliance-enhancing interventions, strategies and tools empowers seniors,enabling them to manage their care. This empowerment can improve quality of life,and the therapeutic gains from compliance can contribute to their well-being.

active participant unless illness hascaused an incapacity to self-manage adrug regimen.

Personal Communication andE d u c a t i o n

All members of the medicationmanagement team have a role to play incommunication and education.

Drug manufacturers operate at thebeginning of the process and can set thestage for doctors, pharmacists andpatients. By realizing that low literacymay be one of the factors in patientprofiles, manufacturers can work withhealth professionals to ensure clarity intheir education material. The patientpackage insert – which is put directlyinto the medication box or container –offers an important opportunity to reachlow-literacy patients. Drug manufacturerscan help to increase the correct takingof medication by ensuring that theinformation and instructions are writtenin plain language, are easy to read, andin a readable font size. One idea forincreasing compliance is the use ofgraphics (in addition to words) toconvey information. Another is to add adaily or weekly calendar (see examplesbelow) to the patient package insert; thepharmacist can explain to the patienthow to use it as a reminder device andto record the taking of medication.

Product sponsors cannot be expected toprepare packaging/labelling material thatwill meet the needs of all segments ofthe population, no matter how small thissegment may be. For example, only thetwo official languages are required ondrug products directly accessible to the

public (one official language onprescription medication), and Brailleprint is not mandatory. Patients orconsumers who may not be able to reador understand medication instructionsare advised to seek assistance.

Doctors who prescribe medications areat the next stage of the process. Givingsimple and clear information verbally,especially to seniors who may have lowliteracy, is essential. One method forincreasing patients’ recall of theinformation is to organize what is to besaid into an “agenda” and following alogical sequence.

Such a conversation begins by telling apatient what the agenda contains: ‘I’mgoing to tell you’:

1. What I think is wrong with you.

2. What tests we need to carry out tobe sure.

3. What I think will happen to you.

4. What treatment you will need.

5. What you can do to help yourself.1

Developing a good rapport with thepatient is the foundation of goodcommunication and relationship-building. The patient must feel safe,accepted, valued and respected.Nurturing trust and confidence requiresdeveloping an open, empathetic, caring,non-judgemental demeanour.


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1 Cecilia C. Doak, Leonard G. Doak and Jane H. Root, Te a c h i n g

Patients with Low Literacy Skills, 2nd edition, Philadelphia, PA :

J.B. Lippincott Company, 1995, p. 163.

Doctors need to tell patients in a veryclear manner what they need to do, andhow and when to do it. Seniors need tohear and understand why it is importantto take medications, in the doseprescribed and at stated times, for themedicines to work properly.Practitioners need to explain possibleunwanted side-effects, and what patientsshould do if side effects occur.

Pharmacists are playing an increasinglyimportant role in patient care,particularly with mandatory patientcounselling. By realizing that seniorsmay have low literacy skills, pharmacistsunderstand the importance ofdemonstrating and verbally reinforcinginstructions given by the doctor. Intoday’s world, patients are relying moreon pharmacists for information andadvice. As a result, pharmacists have theopportunity and the obligation to speakwith patients and give them verbaladvice and written materials that canincrease compliance. Pharmacists canplay a coordinating role for patients whodeal with different medication regimens;this is needed because the patientpackage insert is product-specific.

Formal and informal caregiverscontinue to care for patient needs inmany ways, especially with shorterhospital stays. Because the care is givenin a home setting, the patient tends tobe comfortable with formal caregiverssuch as home care workers and privateor non-profit services. Informal caregiven by family members and friends isalso very trusted. All of these caregiverscan convey instructions to and from thepatients and the doctor and pharmacist.They may also remind patients when it

is time to take their medication. (Note:certain caregivers, such as some homecare workers, are not permitted toadminister medication or fill medicationorganizing boxes.)

Educational Support Groups

These groups – often organized byhealth associations, hospitals andcommunity groups – are a useful toolfor patients with special conditions suchas heart disease, asthma or diabetes.Information is conveyed verbally byguest speakers who can providevaluable ongoing learning while groupmembers can share practical informationtips. Patients with low literacy can thusget information verbally in a supportiveenvironment.

Regular Patient Contact andMonitoring

Health care practitioners need to doongoing review and reinforcement withthe patient to explain the purpose of thetherapy and the instructions for use.Similarly, periodic reassessment of thepatient’s cognitive and physical abilitieswill help to ensure that the materialsand tools are at an appropriate level.Modifications such as larger print labelsor additional memory cues may berequired as the individual ages. Ongoingmonitoring allows for adjustments inscheduling and compliance tools tomeet the patient’s changing needs.Services such as home care as well asfamily and friends can be involved inthis process.

At the same time, seniors need to beable to access health care professionals


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on a timely basis in order to makeinformed decisions or to clarifymedication use. Such access cancontribute significantly to reducing themisuse of medication by seniors.

Written Patient Information

Doctors and pharmacists should reviewpatient information with the patient. This can be supplemented withdemonstrations (as appropriate) andplain language materials such aspamphlets and information sheets.

Patients must understand the materials;if low-literacy patients cannot read andunderstand them, they may not take themedication properly. Chapter II, whichdiscusses plain language and clearcommunication, gives advice on how toprepare these documents. Pamphletsserve as a reference for the patient toreview and reinforce counselling fromthe physician and pharmacist. Mostpeople find it reassuring to havesomething to refer to when questions orconcerns arise and to take personalcharge by knowing all they can abouttheir medication.

Tr i gge rs and Links

One of the most effective ways toi m p rove compliance among low-literacyseniors is to tailor the regimen to thepatient in ways that do not necessarilyrely on written materials. Identifyingpatient routines, such as mealtimes, thatcoincide with dosing intervals can behelpful, acting as a trigger to re i n f o rc ea d h e rence. The schedule has to bepractical for the senior and fit in with hisor her life.

The health care practitioner shoulddiscuss the patient’s daily routine andfind something to “hang” takingmedications on. For example, if a certainmedication should be taken in them o rning and that’s the usual time towalk the dog, the patient can mentallylink the two activities to remember totake the medication.

Depending on the individual and thedosage frequency, patients often findmorning and bedtime routines as well asmeal times to be helpful reminder aids.Routines may vary on weekends andholidays, and patients must be informedof tolerable time limits and what to do ifthey miss a dose.

It is useful to advise patients to keeptheir medication in a handy, highlyvisible area such as on the kitchen table,by the television, at a routine work orrecreational station, or right at the frontof the refrigerator. However, safety

Some seniors have poor eatinghabits and tend to skip meals or eatat inconsistent times. This can causeproblems when taking a medicationis expected to be triggered by amealtime; it can also cause problemswith absorption, etc., if themedication needs to be taken withf o o d .

As well, irregular sleeping patternsare common among older persons,and it may be unrealistic to hope fora routine bedtime and wake-up timeas a trigger.


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precautions must be taken to preventaccidental ingestion by children orothers and ensure that the medicine willnot deteriorate.

Demonstration and Practice

Special medical devices such as inhalersmust be demonstrated, and the patientneeds the opportunity to practise thetechnique with the pharmacist or otherpractitioners. Clearly written instructionsand simple illustrations will reinforce thedemonstrations.

Audiotapes and Videotapes

Educational reinforcement usingaudiotapes and videotapes has beenproven effective in some clinicalsettings, and may be adapted toreinforce compliance at home. For low-literacy seniors, the visual and auditoryreinforcement can be particularlyeffective. Health care practitionersshould carefully screen patients toensure that this technique is suitable.

Telephone Reminders

It is helpful to have someone who can“remind” the patient to take theirmedications. This can be done by phoneor in person by a caregiver (volunteer orpaid) or family member. Recordedmedication messages can beprogrammed if it is not feasible to havea personal call. A family member orother familiar voice should record themessage. A call tracking system shouldbe used to follow-up and reportunanswered calls. Paging services canalso be used for this purpose.

Electronic Cues and Memory Aids

A basic alarm clock or programmablewatch with an alarm function canprovide the patient with an audio cue totake their medication at the right time.For patients with hearing impairments,visual cues can be provided by devicessuch as a programmable flashing light ora vibrating bracelet.

More sophisticated devices are on themarket using technology to provide cuesand reminders. Although the cost ofthese devices is high now, the price will

Did you hear the one about…

An elderly woman, recentlydiagnosed as diabetic, took aclass in an out-patient clinic tolearn how to self-inject herinsulin. The nurse providedsample syringes and an orangeto each participant and taught thetechniques step by step.

Several days later the womanarrived at emergency. At home,she had taken her insulinsyringe, injected an orange andeaten the orange.

This is not really a funny story,but it does illustrate the necessityof clear verbal communication. Inthis case, the nurse should haveasked each participant to repeatthe steps back, and the errorcould then have been detectedand corrected.


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continue to drop as the cost oftechnology decreases. These productsare options for people who are on theirown or very busy and need a regular,external cue that does not requirepersonal contact.

Some of these reminder devices alsorecord and monitor the taking of themedication. However, they all need tobe programmed which may be difficultfor low-literacy seniors. In these cases,patients may need someone else, suchas a paid or volunteer caregiver, to teachthem how to program the device or toactually program it for them.

The cutting edge of reminder devicescomes in the form of technology whichdispenses drugs to patients in blister cardsintegrated with inexpensive micro c h i ptechnology. The cards are programmed to“beep” at dosing intervals, monitoring andrecording the times the drug was actuallytaken so the information can bedownloaded for assessment by thep h a rmacist and physician. This allowsearly detection of problems and mayindicate the use of other, perhaps moresuccessful, interventions.

Calendar Tracking andScheduling Charts

Tracking medication administration on a calendar or diary can be a helpfulreinforcement to people on either


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This product combines (a) a custom blister packmade up by the pharmacist with (b) microchiptechnology to create a reminder and recordingdevice.

Daily schedule

Drug Name Directions 7 a.m. 12:00 noon 5:00 p.m. 10:00 p.m.

& Strength breakfast lunch supper bedtime

Drug A

Drug B

Drug C

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Weekly Schedule

Day Drug Name Time Time Time Time Time Time& Strength

Mon.

Tue.

Wed.

Thurs.

Fri.

Sat.

Sun.


Reminder sheet for medications that the patient marks and takes home. (Source: This information is takenf rom: Do You Understand? developed by the Hospital Aw a reness Committees of LVA Nassau County and LVAR o c h e s t e r, NY, Inc.© 1 9 8 9 . )


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simple or complex drug regimens.Personalized schedules must be tailoredto reflect the patient’s needs and lifestyleto support the regimen.

A medication calendar or chart,identifying the time and dose requiredin a grid, allows the patient to simplycross off doses as taken. This can bevery useful in both reminding andrecording, especially for low-literacyseniors who rely on the visual aspects ofa chart. Caregivers can easily review thechart to detect and remedy problemsearly. Two samples are shown here.

Other Visual Aids

Pharmacists and others can use variousvisual aids to enhance compliance inindividuals who have low literacy skills.For example, the pharmacist can sitdown with a patient and use thepictorial representation of a clock toillustrate how, when and how muchmedication should be taken. The patientcan draw in the hands at scheduleddosage administration times andpictorially depict the dosage form (andquantity).

Visual devices can be useful by:

• helping the patient to concentrate onthe main message;

• reducing the amount to be read;

• providing visual cues and interaction;and

• providing motivation.

Counter caps that fit on pre s c r i p t i o nbottles are available. These have built-in counters that “count down” thenumber of pills/capsules so thatpatients can keep track of how muchmedication they have taken. This visualindication is useful for low-literacys e n i o r s .

A scratch-off label, similar to a“scratch and win” or lottery card, canhelp patients keep track of medication.In this system, the patient scratches offthe appropriate scheduled dose whenthe dose is taken. Although the visualn a t u re of the system is useful for low-literacy seniors, this system re q u i res ad e g ree of manual dexterity.

Suitable features for poor readersare:• Clear line drawing of commonly

used medicines• Patient can point to the

medicine being taken

F i g u re displays and communicates inform a t i o nhelpful in a medical history. (Source: Thisi n f o rmation is taken from: Do You Understand?developed by the Hospital Aw a reness Committeesof LVA Nassau County and LVA Rochester, NY, I n c .© 1 9 8 9 . )


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O rganizing and Pa ck ag i n gM e d i c at i o n

Pre-packaged containers organize andpackage medication to enhancecompliance. These containers allowseparation and identification of eachdose to facilitate patient handling andaccurate self-medication. Threeexamples of such container packagingare:

• medication organizers;

• blister or bubble packaging; and

• original package dispensing.

Medication organizers, which arecommonly available in pharmacies, arere-usable plastic containers that organizedoses of medication. The most widelyused is known as the DOSETT®. Theboxes are divided into sections fordifferent times throughout the day(usually morning, afternoon, eveningand bedtime). Medication organizerscome in different sizes, and can hold aday’s or a week’s worth of medication.The patient’s medications are placed ineach compartment according to whenthey are to be taken. This provides avisual reminder to patients to take (or thatthey have taken) their medications. As

well, if a patient sees pills in the org a n i z e rbox at a point in the day after themedication should have been taken, thiscan provide a visual reminder to checkm o re often to ensure that medications aretaken at the proper time. Patients can fillthe organizers themselves, or a home carep rovider or pharmacist can do it.

Blister or bubble packing ofmedication in-store is sometimes doneby pharmacists for individual patients.Blister packs help organize the doses of medication in the same way ascommercial organizers do. Blister packsare sealed on cards with clear plasticbubbles that hold the doses for eachscheduled administration, and the cardcan be custom-printed at the pharmacy.When it’s time to take the dose, thepatient pushes the medication outthrough the back of the card. Thebubbles are usually divided into fourcolumns labelled morning, noon,evening and night, with a different rowfor each day of the week. More thanone card may be required to fit allmedications. Some medications, such ascreams and drops, are not suitable forthis type of packaging.

Original package dispensing is oneof the two ways that medications aretypically dispensed in Canada; the

Vial dispensing: In this traditional dispensing method, medications are packagedin bulk and delivered to the pharmacist in this form. The pharmacist then fillsindividual prescriptions by putting the necessary quantity in a plastic vial or othercontainer and labels it for the patient. This method is cost-effective but provides noreminder mechanism as part of the package. In Canada, between 75-90% ofmedications are dispensed in vials.


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This organizer holds a week’s worth of medication,with four compartments for each day. Labels are inEnglish, French and Braille. The DOSETT® isavailable in two sizes and comes with an optionallocking device.

This customized, disposable and inexpensive blister pack is made up by the pharmacist. There is space at thetop for the pharmacist’s label, and on the back a place to describe each medication’s colour, shape, etc. This isespecially useful when several diff e rent people are involved in administering the medication.

The advantage of this organizer is that each day’ssection can be removed, a handy option when thepatient will not be at home when the medication isto be taken.

other method is the vial dispensingmethod (see sidebar). As discussed in more detail in Chapter II, themedication arrives at the pharmacyalready pre-packaged for patients,frequently in the form of blisterpackaging as discussed above. Patientsusually receive complete productinformation and instructions. The unit-dose, blister type packaging itselfprovides a visual cue and allows thepatient or caregiver to see if a requireddose has been taken. Original packagedispensing, which is more costly thanvial dispensing, is still relatively rare inCanada. The drugs available this waytend to be the newer, costliertherapeutic agents or where themanufacturer wishes to distinguish theproduct from earlier generations.Concerns about patients’ ease of use of this type of packaging were reflectedin a 1993 survey carried out by thePackaging Association of Canada. TheNational Survey on PackagingExperiences found that 40% ofrespondents over age 75 found itinconvenient or difficult to open someforms of blister packaging .

Putting It All Toge t h e r

Strategies and devices are useful tools for:

• giving senior patients the appropriateinformation, expressed and/orwritten in plain language;

• motivating them to take theirmedications properly; and

• providing “simple tools” to helpthem monitor and facilitatemedication-taking.

However, used alone, none of thesestrategies and tools is the magic bullet.The complexity of compliance requires amulti-faceted approach that integratescounselling, instructional materials andinnovative packaging with acombination of tools and techniques tohelp the individual by organizing,providing cues, and tracking theappropriate taking of medication. Thesephysical and cognitive techniquesrequire collaboration and partnershipbetween the drug manufacturer,practitioner, pharmacist, patient andcaregiver to ensure success.


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P rose Litera cy

Level 1

Most of the tasks at this level require the reader to locate one piece ofinformation in the text that is identical or synonymous to the information given inthe directive. If a plausible incorrect answer is present in the text, it tends not tobe near the correct information.

Level 2

Tasks at this level tend to re q u i re the reader to locate one or more pieces ofi n f o rmation in the text, but several distractors may be present, or low-leveli n f e rences may be re q u i red. Tasks at this level also begin to ask readers to integratetwo or more pieces of information, or to compare and contrast inform a t i o n .

Level 3

Tasks at this level tend to direct readers to search texts to match information thatrequire low-level inferences or that meet specified conditions. Sometimes thereader is required to identify several pieces of information that are located indifferent sentences or paragraphs rather than in a single sentence. Readers mayalso be asked to integrate or to compare and contrast information acrossparagraphs or sections of text.

Level 4

These tasks require readers to perform multiple-feature matching or to provideseveral responses where the requested information must be identified throughtext-based inferences. Tasks at this level may also require the reader to integrateor contrast pieces of information, sometimes presented in relatively lengthy texts.Typically, these texts contain more distracting information and the informationthat is requested is more abstract.

Level 5

Some tasks at this level require the reader to search for information in dense textthat contains a number of plausible distractors. Some require readers to makehigh-level inferences or use specialized knowledge.

APPENDIX Literacy Definitions and Levels Used in the

International Adult Literacy Survey


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Document Litera cy

Level 1

Most of the tasks at this level re q u i re the reader to locate a piece of inform a t i o nbased on a literal match. Distracting information, if present, is typically locatedaway from the correct answer. Some tasks may direct the reader to enterpersonal information onto a form.

Level 2

Document tasks at this level are a bit more varied. While some still require thereader to match on a single feature, more distracting information may be presentor the match may require a low-level inference. Some tasks at this level mayrequire the reader to enter information onto a form or to cycle throughinformation in a document.

Level 3

Tasks at this level appear to be most varied. Some require the reader to makeliteral or synonymous matches, but usually the matches require the reader to takeconditional information into account or to match on multiple features ofinformation. Some tasks at this level require the reader to integrate informationfrom one or more displays of information. Other tasks ask the reader to cyclethrough a document to provide multiple responses.

Level 4

Tasks at this level, like those in the previous levels, ask the reader to match onmultiple features of information, to cycle through documents, and to integrateinformation; frequently however, these tasks require the reader to make higherorder inferences to arrive at the correct answer. Sometimes, conditionalinformation is present in the document, which must be taken into account by thereader.

Level 5

Tasks at this level require the reader to search through complex displays ofinformation that contain multiple distractors, to make high-level inferences,process conditional information, or use specialized knowledge.


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Q u a n t i t at ive Litera cy

Level 1

Although no quantitative tasks used in the IALS fall below the score value of 225,experience suggests that such tasks would require the reader to perform a single,relatively simple operation (usually addition) for which either the numbers arealready entered onto the given document and the operation is stipulated, or thenumbers are provided and the operation does not require the reader to borrow.

Level 2

Tasks in this level typically require readers to perform a single arithmeticoperation (frequently addition or subtraction) using numbers that are easilylocated in the text or document. The operation to be performed may be easilyinferred from the wording of the question or the format of the material (forexample, a bank deposit form or an order form).

Level 3

Tasks found in this level typically require the reader to perform a singleoperation. However, the operations become more varied – some multiplicationand division tasks are found in this level. Sometimes two or more numbers areneeded to solve the problem and the numbers are frequently embedded in morecomplex displays. While semantic relation terms such as “how many” or“calculate the difference” are often used, some of the tasks require the reader tomake higher order inferences to determine the appropriate operation.

Level 4

With one exception, the tasks at this level require the reader to perform a singlearithmetic operation where typically either the quantities or the operation are noteasily determined. That is, for most of the tasks at this level, the question ordirective does not provide a semantic relation term such as “how many” or“calculate the difference” to help the reader.

Level 5

These tasks require readers to perform multiple operations sequentially, and theymust dis-embed the features of the problem from the material provided or relyon background knowledge to determine the quantities or operations needed.

Documents

Guidelines for Plain Language and Good Design in Prescription Medication · 2018. 11. 8. · Good Medicine for Seniors:Guidelines for Plain Language and Good Design in Prescription