CHAPTER I

PATIENT AT OUR FOCUS

More than 100 million Americans have been affected by medicinal mistakes or errors according to nation wide pool conducted by Louis Harris & Associates. The study was released on October 8th 1997 by the National Patient Safety Foundation (NPSF) and the American Association of Retired Persons (AARP) in partnership with National Consumers League. National Coordinating Council for Medication Errors Reporting and Prevention (NCCMERP) was formed to help reduce medication errors in health care delivery. A set of recommendations has been issued by NCCMERP for regulators and standard setters. “The key to success is to provide necessary medicinal information in the most efficient way, meeting expectations of consumers and health care providers, and doing so correctly, efficiently and timely recognizing the value that correct standardized information could play in doctor and pharmacist office, as well as patient home.” The recent advancement in information technologies provide an opportunity to pioneer a new, consumer oriented, innovative information system on pharmaceuticals called Labeling and Symbol System for Pharmaceutical (LSSP), a timely modern innovation concept in the era of consumerism. Pharmaceuticals are doing damage even when used properly, with Food and Drug Administration reporting 3400 deaths from adverse drug reactions (ADR) in 1994. The ADR meta analysis based on 39 studies ,estimates annual ADR related death in USA between 76 000 to 137 000 (with 95% confidence).In Canada, based on Health Canada ADR monitoring programming in 1996 and 1997 number of reported deaths was about 4000. Adopting proposed LSSP initiative should help professionals drug risk management, enhance corporate ethics by better accessing and sharing critical drug safety information between health care partners and if needed, help to develop timely, comprehensive action. This represents another way how ideas and modern technologies can save patients’ lives, improve public confidence in medicinals and help stakeholders in managing treatment process as a unit with patient at the focus.

CHAPTER II

THE GLOBAL GROWTH OF CONSUMERISM Experience gained with development of LSSP lead to design of unique public educational program through software plethora of drug related concepts on important issues of drug related information and information interactions within drug risk monitoring system. The system has been designed so that user can get the most out of treatment related issues. GLOBAL CONSUMER ORIENTED COMPUTER INTEGRATED DRUG RISK MANAGEMENT SYSTEM The convenience of computer as a communication tool is dramatically changing information landscape and the way in which data is managed in modern society. Wide dissemination of drug information increasingly requires medical practitioners and pharmacists to become sophisticated users of these new information’s tools, particularly if knowledge increases with logarithmic speed and patient is becoming increasingly more informed. As a consequence, appropriate curriculum is needed to focus on needs of both professionals and public. In the development of such program or curriculum, a number of hurdles need to be overcome. Proposed changes in public drug literacy and drug risk management require development of new skills to promote a fundamental shift in drug culture from current personally intrusive and potentially harmful to acquisition of a new, safer and user friendly. Public and practitioners visions are, that the medicinal information requirements must be tailored to the needs of users and that current focus on patient information are poor in term of patients-users. Contradictory, poorly conceived medicinal information is often alienating user, increase apprehension and inertia by involving the shift of focus from consulting partnership to authoritative statement with increasingly frustrated, passive patient. It is therefore critical to understand that the full extend of present proposal will require global shift in drug culture resources to implement the necessary changes including cooperation of professionals, pharmaceutical industry and regulatory agencies to help evaluate, develop, deliver and collectively improve and manage proposed new drug curriculum on every level.

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Finally, it is critical that added value must be forthcoming from the new patient - professional’s curriculum feedbacks, providing new scientific data base and propose new ideas how to enhance the patient standard of care. Access to harmonized important drug information worldwide, will bring patient and industry together making the world more human place to be. CONSUMERISM IN HEALTH CARE - A NEW EMERGING REALITY The upcoming fundamental changes in global health care industry market place brought about by new information technologies are changing landscape of professional-patient relationship and growing Pharmaceutical industry influence on healthcare delivery. The emerging consumer transformation from passive recipient into active participat requires new, consumer-oriented focus benefiting both, health care providers and consumers. EZON international survey with key health care individual and organization indicates that industry worldwide is beginning to listen. Ezon management believe that in the global market place opportunity exists for organization which can make a difference based on consumer drug information focus. In the past, patient being passive participant in drug management is becoming increasingly concerned and vocal. Public media, governments and consumers are challenging the treatment process, increasing demand on treatment choices and quality of care based on new tangible assessment-knowledge. The new consumer trend in society demands not only to provide the high quality of care, but also to process the information in such way that is becoming easy accessible, standardized and globally used. Pharmaceutical industry developed models with professional and consumer focused information and initiatives, for example educational pamphlets, focus groups, call free telephone assistance, etc. The hallmark of these initiatives is a fundamental lack of consumer-patient ability to make educated choices. For convenience, easy accessibility and capability to provide the same standard information to the patient requires new information format addressing adverse drug reaction monitoring that must meet new information standard criteria, - cultural diversity, transferability, availability, stability, and universality with readily accessible information world-wide (global system).

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THE GROWTH OF CONSUMERISM The summary of findings from KPMG in conjunction with Northwestern University

Institute for Healthcare Services in 1997 (32 key executives were interviewed at 70 health care organizations in USA)

Study hypothesis: “Individual consumer’s new performance in health care industry is increasingly influencing the policy, strategy, operation and investment decisions within segments of industry.” 32.3% indicated that consumers are asking more questions, wanted choices. 23.5% indicated that the interest is on developing focus on consumer’s satisfaction and consumer’s needs. 18.5% indicate that health care policy changes are indicative of consumer influence. 9.9% cited need for more services and information. However, one participant stated “Many of the efforts towards consumerism that are being played up in the press are superficial”. The most frequently cited reason (49%) was the importance in listening consumers and anticipating, understanding and responding to their needs. Several organizations noted difficulties in customizing such information to different market segments underscoring the improbability that a specific approach will “work” all target markets!

FOCUS A new consumer oriented drug information standard on pharmaceuticals could benefit patients, pharmaceutical industry and professional alike, providing that easily comprehensible, global literacy standard criteria will be met, braking the existing communication barriers. In addition, EZON research indicates that mature consumers demand more choice discretion in treatment process. The direct patient focus and participation in drug risk management will allow effective feedback mechanism disproportional for the low level of investment, improved public safety and enhancing confidence in treatment process. The lack of global legislative agreements and varied regulatory activity in today’s consumer-oriented society advocates establishment of the new, long term

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innovative industry, public, governments and professionals benefiting drug information standard.

CURRENT EZON INITIATIVE LABELING AND SYMBOL SYSTEM FOR

PHARMACEUTICALS • First global data base with standardized information based on the principle of

“neutrality” • Establish primary global standard for consumer care oriented drug

information network • Establish secondary professionals (physicians, pharmacists) network

complementary to primary care network • Globalize and make system accessible on every commercial level • Adopt and use the LSSP system for post marketing drug surveillance in

community to enhance public safety. • Patient feedback will open new partnership with professionals and industry. • Professionals and industry can act on it.

ASSESSMENT OF COMMUNICATION SKILLS Several pilot patient professional studies show lack of competence as to how is the drug related information provided, collected, analyzed, recorded and processed. The information reliability and patient feedback, as well as professional communication skills are often difficult to define. The use of new curriculum must give a higher degree of patient story validity and reliability and minimize the risk of individual variations within the clinical setting encounter. CURRICULUM DEVELOPMENT The problem based approach to public drug curriculum The curriculum has been recognized as a response to frequent encounter of drug issues, wrong use, over use and misuse in clinical setting. The curriculum has several principles and commitments: • Principles: 1. Problem based 2. Patient centered 3. Integrated 4. Systematic

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5. Transferable • Commitments 1. Community and global oriented (internalization of curriculum) 2. Universal, crossing public industry and professional domains 3. Auto-motivated-promoting auto-learning New curriculum focuses on drug information to be easily accessible to patient as well as stressing the basic elements and promotion of basic drug risk management skill acquisition. A color coded pictograms are vertically integrated in label, leaflet or lecture centered drug profile allowing integration of both horizontal scientific and vertical patient information, since achieving scientific horizontal information is debatable if there is no vertical information. The short-term objective is to achieve implementation of collective problem solving attitude, including risk management, providing professionals and public with a universal, standard, simplified modem to handle drug risk management more objectively, collectivity, with patient as a bio-psycho-social entity in varied degree of intellectual and social development. Patient-bio-psycho-social entity at different stage of morbidity: • Acute • Sub acute • Chronic • Terminal Treatment short-term objective based on: • Symptoms analysis: macro analyses of the existing complains; • clinical symptoms, physical examination, laboratory investigation, referral to

specialist; • Integration in order of severity into working: diagnosis, differential diagnosis; • Institutionalize treatment-realistic therapeutic outcome with achievable goals. Curriculum treatment focus on adverse drug reactions, quality of life assessment, therapeutic outcome anticipation and achievable personal goals.

INTERVENTIONAL THERAPEUTIC SKILL

New curriculum guides patient in user friendly manner to commonly encountered adverse reactions and to uncommon therapeutic problems, rarely encountered, requiring high level of awareness.

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FAMILY DOCTOR ROLE AS A PATIENT EDUCATOR Potential achievements: • Knowledge related; • Trust related; • Problem solving related acquisition of mutual trust based on progressive

framework of problems contest; • Relevance and approaches build on critical thinking; • Mutual access to therapy units (pharmacist, physician, nurse, patient); Treatment can be simple or complex dynamic process requiring multiple therapeutic interactions, problem reassessment, treatment modifications where often there is no room for “learning” by doing. The key factors in treatment care can be defined as: factual knowledge, patient-professional interaction with proper communication, appropriate resources, ability to maintain the high level of drug risk / drug efficacy monitoring awareness to implement required changes in therapeutic intervention.

Drug cultural competence, humanization of doctors, community clinical settings

Medicine is life long learning. The problem starts where physician is both a coach and a teacher. Communication process often lacks clarity and is not problem centered. The shift, particularly in treatment process, must be the focus on community resources more than hospital setting. Cultural competence is widely implemented in medical schools; however, its practical application as an evaluation tool in drug risk management is ineffective. Learning how patient think, react, seeing patient perspective, ability to enter into dialog, being non-judgmental, playing appropriate role, setting limits to self reflection and exercising cultural awareness in health care settings are difficult tasks. New curriculum focus on patient access to quality information, give the patient opportunity of least resistant basic drug acquisition skills. Cultural drug skill competence program is an integral part of LSSP using appropriate teaching color-coding visual materials as an educational tool to develop basic community oriented drug risk management program. In view of impossibility to teach practitioners all basic knowledge on the thousands of drugs available, new approach design offers an effective friendly way of teaching patient basic rational in effective drug risk management participation.

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COMPUTER BASED LEARNING

Computer, with its capacity for managing information and link it, is the most powerful tool for processing medical knowledge and opens the new avenues to teaching-learning process. Drug risk management learning program is content specific with electronic drug curriculum data base, that is designed to help users to learn about particular drug profile using Labeling and Symbol System for Pharmaceuticals as an introduction package specifically designed as a broad public education course using cognitive process modeling. This helps support process of learning to develop basic knowledge and perceptions with change of attitude from negative or neutral to positive, helping to solve problems and develop more confident patient-professional relations with element of teaching activities. In order to transfer the computer base information into efficient tool for self-instructed learning, branching into the program are accessory helping questions making program more user friendly and suitable for self instructed and distance learning. By its interactive features, program allows better perception of complexities and dynamics within the treatment process. The simulator’s allows the demonstrations of treatment influence on different physiological systems and functions.

ADVERSE DRUG REACTION (ADR) MONITORING PROGRAM Assessment of common adverse drug reactions with program allowing multiple drug combination, adverse drug reactions assessment with verification based on existing adverse drug reaction profile, or new ADR monitoring design on hypothesis-generation, verification model, based on assessor computing “hidden agenda”. Computer does integration based on build in scoring system for body qualitative and quantitative scoring system, based on ratios of “known” Rx given versus “reported ADR”. At present, computer based LSSP should includes access proposal to: a) Patient oriented professional sessions; b) Pharmacist oriented professional sessions; c) Physician oriented professional sessions. Themes emerging in the future: • The relevance of life style in health promotion to desired therapeutic outcome • Standardized patient. This program introduces patient into real life situation examining dynamics and effect of treatments on patient physical and mental performances. Keeping up to date drug information, creation of the new, up to date data base, gathering input, evaluation of all inputs, and definition of drug profile will be

8

delegated to appropriate manufacturers, clinicians and review boards. Acquired data base should be provided to government regulatory agencies and to the industry. Accessing individual users comments could help evaluate the drug risk management quality in communities. Data collections, interpretation analysis and early dissemination of results are paramount in search for public safety as it relates to prescription drugs. Format and extent of hypothesis should be built on review of existing “field experience” literature, scientific journals with patient driven information. The life expectance of human beings has increased more in this century that in the span of the whole human history. As our patients are getting older, we are challenged to treat their specific ailments. The proposed program inquires proper approach to drug risk management in elderly. New public drug curriculum should meet minimal current and future demand. Changing spectrum, structure and education in society with aging population, migration, growing morbidity will require globalization of information wherever possible. Therefore, public drug curriculum system should enable the patient to acquire new drug literacy skills, so he will not relay upon official resources themselves with drug information often limited, often outdated, and sometimes inaccurate. In turn, professionals who cannot rely on complete up to date information often will acquire new quality information. In drug risk management, to become a patient consultant, able to recognize, monitor and direct patient care more appropriately, more efficiently, with less human and financial cost to society and patient, lives could be saved and improper medication use addressed in true sense of cooperative partnership of health care providers and public. We, therefore, need drug risk management curriculum to be an educational system that enables public and professionals to identify and solve drug risk management problems, which otherwise cannot be foreseen, or are foreseen, but nothing has been done about it. The new drug curriculum system should have the following quality attributes.

Goal

Curriculum

Means Outcome

The goal is to improve drug risk management in society using Labeling and Symbol System for pharmaceuticals as a curriculum with Pharmaglyphs and

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color-coding as a means and professional patient partnership interaction as an outcome.

INFORMATION PROCESS This can be summarized as follow: • involve critical thinking • gives public an understanding of basic mechanisms in drug risk management, • provide creativity and open mindedness to both professionals and public, • Focus responsibility on management away from individual professional to

working team, • Builds public capacity for collaboration with professionals, • Provides foundation to the new inter-professional, patient-professional

centered communications, • Global drug risk management standard will enhanced concept of humanity, • Establish scientific approach to drug surveillance in community in those

connected with pharmaceutical industry. There are number of new uses for drug curriculum in society. The most important will be an enhanced ability of professionals to learn from patients and provide information to the net. The process of drug human evaluation is limited how the study is designed, how the data are collected, analyzed, and what type of patients is included. There is no “standardized” patient and therapeutic outcome. That often remains an open-ended question.

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CHAPTER III

SOCIOPHARMACOLOGY

“If the diseases are caused by environment, human beings are a part of, drug as a part of the environment must contribute to public morbidity. Historically, the drug hazard is a constant threat to individual patient and society.” The prohibitive cost of curative medicine, high prevalence of chronic “incurable” diseases in an aging population, Medicare under fire by economists and politicians are headlines familiar to all of us. The practicing physicians should, however, be equally concerned with the issue of medication misuse and drug hazards in society. It seems that the society became too trusting in therapeuticals and do not have time to evaluate a drug’s consequences on the individual, or the effect they have on society. The first necessary step to correct our over-confidence is to recognize the basic principles of drug behavior in society in its broader philosophical context. In other words, we must look beyond therapeutical efficacy, and consider the harm a drug can cause in society, and how such harm affects the public’s attitude toward drug use in general. “What are the philosophical considerations, methodology and practical approaches to the problem of drug ethics in society, and what are the fundamental principles of drug risk management in modern society?” “How should we understand the principle of “minimal drug information”, and how should we approach dialogue with patients on drug risk management strategies, should the passivity of the patient be preserved?” “Do the professionals see the need to improve inter- professional cooperation in drug risk management for benefit of the patients, and how should this be done?” “How do professionals protect society against another “Thalidomide” disaster?” “Did the doctrine of learned “intermediary” rob professionals of a valuable resource-patient, whose participation in drug risk management was undesirable?” “What should be done by professionals to restore the fading public confidence in treatment based on scientific principles?” The post-World War II’s success of the pharmaceutical industry also gives rise to some disturbing ethical complications. In 1961 the Thalidomide disaster

1 focused

international attention on the harm and devastation the medicine can cause. This disaster led governments to impose a much stricter quality drug control, but these controls have failed in the long run to be fully effective. The latest example was the drug Halcion, which can cause cognitive impairment in elderly patients

2.

In the last two decades, the public witnessed many other drug-induced disasters

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with Practolol3, Clioquinol

4, Metamizol

5, Triazolam

2, Benoxaprofen

6, and

Zomepirac7 standing as a testimony of the failure of science to foresee and

prevent these tragedies. Since neither industry nor government can guarantee the total drug safety, emphasis must be placed on education and professional competence to protect the public from drug exposure risks. Ideally, the acceptance of drugs by society should be based on many interactions, and decisions by different and often opposing forces in society, but in reality this is not so. To day, the drug market introduction is basically a process of gradual adaptation by different strata’s of society. The harmony of the social fabric might be under strain with innocent victims being either the drug, e.g., Prozac, a valuable antidepressant getting bad publicity in the U.S. media in 1990, not based on scientific facts, or public, as was the case with Thalidomide

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and, more recently, Halcion2.

Sociopharmacology is an emerging new science based on interdisciplinary research involving pharmacy, epidemiology, social medicine and sociology seeking to find answers to some of these questions. As a science of social behavior, the Sociopharmacology should seek to discover cause and effect that arise from drug attitudes among different social groups, study the process of drug integration into society, and study interaction amongst pharmaceutical industries (e.g., advertisement), and public, focusing attention on public behavioral changes under the influence of drugs. As applied science, it must develop the professional scope of enquiries, scientific methods, and be a force likely to influence human conduct in the future. As a true science, it will use exact scientific methods to analyze drug hazards in society and its public tolerance and acceptance level. One of the fundamental requirements of Sociopharmacology must be to define the natural laws characterizing principles of drug ethics in society. As the field and scientific scope of Socipharmacology will expand, the professionals and industry will utilize its expertise, until it will become a valuable resource of the society as a whole. Sociopharmacology, if it would exist, should take responsibility to alert various “drug stake holders” of any serious deficiencies in the way services are provided from the human and technical standpoint. Sociopharmacology must subject the treatment process to critical scrutiny, and draw attention to discrepancies between professional and public interest, aided in its work by social values. Ultimately, sociopharmacology must incorporate the public into the healing process through active participation in drug risk management. The Diethylstilboestrol (DES) story illustrates how strict adherence to professional prudence and social ethics could prevent drug-induced catastrophes. In the U.S.A. DES was approved by the Food and Drug Administration in 1938 (after much controversy) for four indications (menopause, senile vaginitis, juvenile Gonococcal vaginitis, and lactation supression

8. The drug was never

intended to be used by healthy pregnant mothers to have “healthier babies”. The “fifth indication” was introduced to the medical community by Harvard based

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researches with enthusiastic acceptance. One famous Bostonian physician said: “As a former Bostonian, I would be entirely lacking in civic loyalty if I had not used DES in my private practice”

9. In 1971 association between maternal

exposure to DES and clear cell adenocarcinoma in DES daughters forced the Food and Drug Administration to ban DES use during pregnancy. Total number of DES daughters is estimated between 500,000 to 2,000,000 in the United States alone

10.

The scientific achievements become worthless if they are not acceptable to society because of ethical and moral concerns. Scientific and ethical considerations are often opposing forces in everyday decision making, and nowhere is this more apparent than in the field of medicine. Modern medicine, a construct of both science and philosophy, is judged by society according to ethical values that are constantly changed. The Thalidomide disaster illustrates that pseudoscience has no place in modern treatment. The part of Sociopharmacology in our society is challenging, complementing physician effort to minimize and reduce adverse drug reactions and medication misuse in society.

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REFERENCES: (1) LENZ, W.: (1966) Malformations Caused by Drugs in Pregnancy. AM. J. DIS.

Children. 112, 99-106. (2) DUKES, M.N.G.: (1980) The Vander Kroef Syndrome in Side Effects of Drug

Manual (Ed. M.N.G. Dukes), Vol. 7, 104-125, Experta Medica, Amsterdam. (3) FELIX, R.H., and DAHI, M.C.G.: (1974) Cutaneous and Ocular Reactions to

Practolol. Br. Med. J. 4, 321-324. (4) KONO, R.: (1975) Introductory Review of Sub acute Myeloopticoneuropathy

(SMON) and Its Studies Done by the SMON Research Commision. Jap. J. Med. SCI.Biol. 28 (Suppl.) 1-21.

(5) PRESCOT, L.F. (1980) Anti-inflammatory Analgesics and Drug Used in Rheumatoid Artritis and Gout. In Side-effects of Drugs Annual (Ed. M.N.G. Dukes) Vol.4, 63-73. Experta Medica, Amsterdam.

(6) DEL FAVERO, A.: (1983) Anti-inflammatory Analgesics and Drugs Used in Rheumatoid Arthritis and Gout. In Side-effects of Drugs Annual (Ed. M.N.G. Dukes). Vol. 7, 104-125. Experta Madica, Amsterdam.

(7) PAULUS, H.E.: (1983) FDA Arthritis Advisory Committee Meeting. Arthritis Rheumatism. 26, 1288-1289.

(8) BELL, SUSANE E.: (1986) A New Model of Medical Technology Development, A Case Study of DES, In J. Roth and S. Ruzek. Eds. Research in The Sociology of Health Care, Vol., 4, Greenwich, Conn.: J.A.I. Press; pp 1-32.

(9) DICKMANN, W.J., M.E. DAVIS, L.M. RYNKIEWICZ AND R.E. POTTINGER(1953) Does the Administration of Diethyl-Stilboestrol During Pregnancy Have Therapeutic Value? Americ. Journal of Obstetrics and Gynecology. 65:592-601.

(10) APFEL, Roberta J., and Susan M. FISHER: (1984) To Do No Harm: DES and Dilemas of Modern Medicine. Newhaven: Yale University Press.

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THEORETICAL FOUNDATION FOR DRUG ETHICS IN SOCIETY

General Principles of Biological Individuality, Therapeutic Uncertainty and Re-normalization of Homeostasis

-The General Principle of Biological Individuality emphasizes the individual uniqueness of drug response based on inter-individual difference in pharmaco-geneticic makeup. -The General Principle of Therapeutic Uncertainty explains the conflict between the desire to cure and the ever present drug potential to cause harm. -The General Principle of Re-normalization of Homeostasis demonstrates the drug potential to cause irreversible change in the homeostasis, potentially leading to iathrogenic disease. Staggering changes are taking place within our society; the age of communication has eroded paternalism in medicine. The individual in society is increasingly vocal, influenced both by the easy accessibility of information and the spirit of liberalism born with the French Revolution. Every medical practitioner has a professional responsibility to maintain an interest in evaluating drug safety and efficacy. The task requires precise and detailed responsibility to maintain an interest in evaluating drug safety and efficacy. This requires a precise and detailed understanding of the drug safety profile including toxicity and adverse drug reactions. But the practitioner’s skill and familiarity with drugs will still fail to minimize the inherent risk to the patient from therapeutic effects. For monitoring and preventing unintendent consequences of drug use, the fundamental mechanism is the practitioner’s problem awareness and the patient’s ability to provide the practitioner with an accurate personal history.

Pharmacogenetics as a General Principle of Biological Individuality

Medical Science becomes an art at the precise moment when a doctor prescribes drugs to the patient. Each administration of a drug is a new experiment, an experiment whose results vary according to biological individuality. Each patient is unique (except identical twins): his drug response can never be exactly replicated. Although science provides a huge resource of information on drugs, there is a great deal still to be known. And yet, we seem to behave at times as though our

15

knowledge is complete. In order to treat the patient properly, we must acknowledge the principle of biological individuality-the infinitely variable phylogenetic expression of the “scavenger genes” that alter and ultimately dispose of ingested drugs. It is a remarkably dynamic system which is constantly undergoing changes. As a result, drug administration can not only cause bizarre reactions, but also has the potential to cause a different therapeutic outcome in other segments of the population-e.g., among newborn, adolescent, adult, or elderly patients. Everyday practice confronts medical practitioners with repeated examples of changes in therapeutic response, changes caused by drug incompatibilities that modify the microcosmal enzyme process responsible for drug biotransformations. The general principle of biological individuality emphasizes the individual uniqueness of drug response. Regardless of how much we know about drug effects on living matter, it is still the patient’s pharmacogenetic makeup that determines therapeutic outcome.

The General Principle of Therapeutic Uncertainty

The General Principle of Therapeutic Uncertainty leads us to recognize the inability of science to explain certain phenomena-for example, “bizarre” adverse drug reactions, or cases of therapeutic inefficiency. The treatment success can fail for no apparent reason. To deny this fact is, at least in ethical terms, to adhere to a treatment approach that would be clearly undesirable for the patient! There has been a recent trend towards prescribing additional medication to prevent drug-side effects-for example, using cyto-protective drugs to avoid the effects on non-steroidal anti-inflammatory drugs on the gastrointestinal tract. Considering the variability in individual make-up (adoptive mechanisms, the mosaic of known and unknown diseases, polypharmacy, personal lifestyle, genetic destiny, etc.), the physician must be painfully aware that medicine may at times cause harm. If we recognize the general principle of therapeutic uncertainty, continuous drug therapy monitoring acquires a new significance. Patient participation (and the clinician’s reliance on the patient’s subjective symptoms) becomes an imperative consideration in drug risk management. In practical terms, the general principle of therapeutic uncertainty address the conflict between the singular purpose of drug administration-to heal or cure-and the potential of drugs to cause harm. Therefore, treatment must not be viewed as static, but as dynamic process which requires constant readjustment and change to ensure optimal results.

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The Therapeutic Principle of Re-normalization of Homeostasis

The administration of drugs to a patient results in a change of homeostasis. These changes may, at times, continue indefinitely-even after medication use is discontinued. The process of re-normalization, therefore, may be definite or infinite. For example: The same group of patients using non-steroidal anti-inflammatory drugs was advised to report any health problems experienced during a two weekwash-out period after discontinuing usage. This study was a low intensity monitoring study which led to the conclusion that a two week wash-out period precipitated significant change in homeostasis which resulted in increased morbidity among subjects, with one patient developing discoid lupus. A review of the seriously ill patients who died after the intensive treatment program provides evidence that a majority of the deaths occurred after a drug change in their medication profile. A drug, therefore, might have an influence on public health not only during its use but even after discontinuation. This phenomenon is well-known in drug compliance categories, where patient morbidity and mortality are inversely related to drug compliance (E. Novak, British Columbia Medical Journal 1991; 32:499-500. Many medical practitioners treat patients, mostly geriatric, who are on Beta-Blockers and are non-compliant, and who come into the office with problems of increased blood pressure or unstable angina because of a failure to adhere to to proper medical usage. There is, however, ethically speaking, a much more important aspect of the general principle of re-normalization of homeostasis that I would like to address: society may be exposed unknowingly to drugs which may have long-lasting adverse effects on both mental and physical public health.

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CHAPTER IV

LEGAL VIEWS ON PATIENT DRUG INFORMATION

“Informed consent” remains the firmly established practice and applies to decisions regarding “major medical treatment”. The definition of informed consent does not include “routine diagnosis and treatment”, such as the prescribing of medication and its ultimate administration. The exclusions comprise some procedures that were not viewed as warranting the legal formality of informed consent, some that were deemed too controversial and some for which new laws were being considered. In responding to drug information one must consider three questions:

1. Treatment is a judgmental process where benefits of it (measured by maintenance or improvement of patient health) are balanced by the risk inherent in probable and possible adverse drug reactions on patient mental or physical health.

2. The practitioner must determine whether the patient can “adequately

understand and appreciate” the nature and consequences of medical treatment including the benefits and / or risks.

3. The patient must understand that by accepting the information, he or

she voluntarily agrees to comply with given advice and must be held responsible for failure to do so in the event that harm is done as a result of neglect to follow instructions.

Increasingly negative decisions against stakeholders, physicians, pharmacists as well as manufacturers are based upon inadequate essential information being provided (e.g. precautions and warnings) to patients. It is to the advantage of the “stakeholders” to give careful consideration to “scientific partnership” with the patient, instead of the rather loose relationship that currently exists where communication may not be totally adequate. This “ideal model value” proposal should represent ethical response of the health care providers based on maximum objectivity in an ever changing world. It is a response both to social pressure and interpretation of analysis of existing

18

inadequacies working critically and open-mindedly to more dynamic informative ways. J. Pelican in the best of tradition of humanities said: “By including the dead [traditional view] in the circle of discourse, we enrich the quality of conversation”. So we are always active in harmony with tradition relating to it, or ignoring it. The World Health Organization, which has a leading role in many drug policies implemented worldwide, agreed at the 1985 Conference in Nairobi on a broad concept “Promoting National Drug Policies and Rational Prescribing” but have no publication for the general public related to education in the field of drugs. In 1980 the International Organization of Consumer Unions sponsored work on the minimum information that consumer needs on medication and about the drug information’s needs of the patient. At the legislative level in the United States the most recent course to regulate the Labeling of Pharmaceuticals occurred between 1975 and 1980. The Federal Food and Drug administration devised a program on the patient package inserts. The program required that each patient is given an information leaflet about the medication dispensed to him. The program was finalized by the FDA in 1980 but later abandoned in favor of relying on the industry to design a new method of informing the patient. More recently (1989 National Council on Patient Information and Education in the United States) devoted the Seventh Annual Conference almost exclusively to patient drug information and education. It is note worthy that the conference was attended by only three physicians. In Canada supplementary information on medication sheets (SIMs) or patient advisory leaflets (PALS) were developed by commercial organization called Pharmasave System Inc. in response to effort by Consumer Association of Canada (1977 Annual Meeting). No physician participated in this valuable project. The Advisory Committee on Patient Information which met in Ottawa (1988) and was sponsored by Pharmaceutical Manufacturers Association of Canada; not one seat was reserved for a member of the Canadian Physicians community.

Drug misuse a Growing Global Epidemic

The Urgent Need for Partnership The results of patient’s noncompliance with the prescribed drug instructions are far-reaching. Omissions, errors, over-medication and exchanged medications lead to human suffering, and sometimes to tragical and unnecessary death. In a significant percentage of the cases noncompliance is due to the lack of both general and specific selective drug information available to the patient. This fact had been recognized for a long time and attempts had been made to deal with it both at the industry level and at the legislative level. The declaration of World Health Organization says: “The health of my patient will be my first consideration, I will not use medical technology contrary to the laws

19

of humanity”. There is a growing global need to rectify growing issue of medicinal misuse. The American Medical Association stated: “A physician should practice a method of healing founded on scientific principles”. Rather than legislate and enforce, the FDA decided that the pharmaceutical industry deserves a chance to show that it would be able to devise an effective way of informing the patient about the drug he / she is taking. In reviewing a few representative cases, it is important to note that the courts had ruled on a number of occasions that the manufacturer has a common-law duty not only to warn and to inform the prescribing physician, but also the end-user, i.e. the patient (see e.g. References 11,13,14). The widely accepted practice, that in order to avoid liability under the defect of warning, the warning has to be conveyed to the ultimate user, seems therefore to hold true also for the pharmaceutical industry. “THEREFORE, NOT ONLY THE PRESCRIBING PHYSICIAN AND THE DISPENSING PHARMACIST, BUT ALSO THE MANUFACTURER OF THE DRUG CAN BE HELD LIABLE IN COURT DUE TO THE LACK OF LABEL WARNING”. Furthermore, Restatement (second) of Torts, paragraph 388 (1965) provides: CHATTEL KNOWN TO BE DANGEROUS FOR INTENDED USE One who supplies directly or through a third person a chattel for another to use is subject to liability to those whom the supplier should expect to use the chattel in the manner for which and by a person for whose use it is supplied, if the supplier: • knows or has reason to know that the chattel is or is likely to be dangerous

for the use for which it is supplied, and • has no reason to believe that those for whose use the chattel is supplied will

realize its dangerous condition, and • fails to exercise reasonable care to inform them of its dangerous condition or

of the facts which make it likely to be dangerous. (Journal of Legal Medicine, Vol. 7, No. 3, 1986, p.284)

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STUDIES SHOW THE IMPORTANCE OF THE ADEQUATE AND UNDERSTANDABLE INFORMATION TO BE SUPPLIED TO THE PATIENT

WITH THE MEDICATION

It had been shown that both the quantity and the quality of the information provided to the patient at the time of dispensing is inadequate (10). The lack of knowledge in most of the patients is not due to the lack of time they devote to perusing the information provided. Research had already shown that adequate information can be communicated within a brief period of time, if only effective means are used (8). Therefore the current practice of a few verbal instructions combined with a warning label (in some cases only) and with a brief description of how to take the medication is obviously not effective. The noncompliance of patients with the drug regimen prescribed for them by their physician reported by some investigators to occur in as much as 50% of patients followed in some studies, has been attributed to the inadequate information provided (12)(7). Davis reported an overall 30-35% noncompliance with medications (6). Blackwell noted that 25-50% of outpatients do not comply with medication instructions (4). He subsequently categorized patient noncompliance with drug treatment into five types:

a) errors of omission b) taking the medicine for the wrong reasons c) mistakes in timing d) taking additional medicine not prescribed by physician e) mistaken identity

Even if results of many of noncompliance studies suffer from methodological imperfections the noncompliance is indeed widespread. Many of the factors related to noncompliance with drug regime are within the control of health care professionals. For example, the compliance enhancing strategies could include simple written instruction on dose, common side effects, and therapeutic goals with willingness to change the drugs to avoid side effects (9). Based on the above informations, Ezon management believes that the PharmaSense Drug Risk Management Tool Kit implementation into the global domain could result in a significant decreased patient noncompliance and improved drug risk management in community.

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References 1. 44

th Fed. Reg., 40, 016, 1976 (the Proposed Rule).

2. 45

th Fed. Reg., 60, 754, 1980 (the Final Rule).

3. 47

th Fed. Reg., 39, 147, 1982.

4. Blackwell, B. (1973). “Drug Therapy: Patient Compliance, “New England

Journal of Medicine, 289:249. 5. Blackwell, B. (1976). “Treatment Adherence”, British Journal of Psychiatry,

129:513. 6. Davis, M.S. (1966). “Variations in Patients ‘Compliance with Doctors’ Orders”,

Journal of Medicinal Education, 41:1037. 7. Malay. (1966). “The Effects of Instruction and Labeling on the Number of

Medication Errors Made by the Patients at Home,” 2Am.J.Hosp. Pharmacy, 283.

8. Morris, Barkdoll, & Savvier. (1984). “A Survey of Patient’s Sources of

Prescription Drug Information, “Am. J. Public Health, 1:1161. 9. McDonald, Merry et al. (1985). “Compliance with Hypertension and Treatment:

Strategies for Improving Patient Care”, Postgraduate Medicine, 72 (8): 10. McGurie. (1976). “Some Internal Physiological Factors Influencing Consumer

Choice”, 2J. Consumer Research 302. 11. Rodgers vs. Ortho Pharmaceutical Corp., 609 F. Dsupp. 867. E.D. Michigan,

1985. 12. Sackett, D., & Hay, J. (1976). “The Magnitude of Compliance and

Noncompliance”. In Compliance with Therapeutic Regimes, 9-25. (D. Sackett & J. Hay NES eds.1976).

13. Steffens vs. G.D. Searle Co., 602 F Supp. 369. E.D. Michigan, 1985. 14. Wells, & Mahafer vs. Ortho Co., 615 F Supp. 262. N.D.

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CHAPTER V

DRUG RISK MANAGEMENT PARADIGM IN SOCIETY

There are growing ethical, moral and legal reasons why a modern society requires a harmonized global family and community-oriented concept of basic drug risk awareness skill and national long-term drug risk surveillance policy. At the national scale, goverments are demanding improved drug risk management, consumer associations advocate drug risk management partnership and the licentiate is increasingly being blamed for lack of leadership. The message for stakeholders is unequivocal there is a growing public demand for a new drug risk management paradigm in society. The role of the health care providers, pharmacist and physician has to be redefined to become an expert advisers working as a team. The limitations of drugs clinical trials to provide an unbiased drug information is currently being augmented by fragmented and ineffective public drug risk management educational system and fragmented ineffective post-marketing drug safety surveillance national policies. The consequences are visible in failing public trust on treatment based on solid scientific foundation damaging the credibility of licentiate and undermining confidence in therapeutic process. Public safety demands an introduction of a new instructive drug risk awareness system standard based on solid scientific foundation. The system must take into consideration that the patient is not only the recipient of information, but also a potential source of valuable database. A new drug risk management in society must take into consideration “drug personality” with its purpose time and mode of administration, precaution, warnings, incompatibilities and possible adverse drug reactions, recognizing the patient’s authority and his individual rights to be informed. No drugs information limitation must be imposed on the professional / patient contractual relationship in any society; on the contrary, the partnership is an example of the consumer contractual law extension with licentiate being responsible for expert drug risk management strategies in patient care where the patient becomes an equal partner. What are than those public strategies and policies for public education which allowing the patient to adhere to instruction, minimizing his fear, insecurity and mistrust and motivate the patient to actively participate in drug risk management? We must suppose that should such a strategy exist the reward would be immense with public confidence helping professional’s ability to deal with the issue of drug safety in society more efficiently.

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Human semantic reactions The human response to words is highly individual. For us practicing physician’s everyday reality has taught us that explaining by words usually requires more explaining and more words. The misunderstanding and memory failure of what was said is common and the ill patient is often not quite receptive to counseling. The elderly patient’s memory is often failing and he cannot retain given information. Another difficulty is to transfer scientific information on the level comprehensible to the patient. The required simplicity is difficult to accomplish and in the process the message might be misunderstood. Behavior sciences teach us that our conduct is based on “instructive thinking” and our reaction patterns can be highly predictable. Based on individual memories, experience and education the reaction pattern can also be quite unpredictable as a result of reasoning deductively from what initially appeared self evident. When we talk to the patient we have specific information in mind. The information provided to the patient is inherently biased because it is provided on generalization based on limited clinical trials and is usually not predictable with any certainty unless you want to express it in the terms of scientific probabilities. When we say to patients “this pill can cause slowing of your heart, it may not be unusual to have the heartbeat below 72 per minute and this is good for your heart”, patient may understand this information in many ways depending on his individual general semantic reactions: a), “my neighbor had a pacemaker implanted because of a slow heart rate; b), TV serial showed a man collapsed on the street because of a slow heart rate and was resuscitated by paramedics; c) medication will make me weak; d) medication may slow my heart and I can die.” Not a very good strategy how to improve medication compliance. Whether we liked it or not, the patient reaction on therapeuticals can be highly individual and emotional – a case of “general semantic reaction”. I am sure we all have our “communication failure” experiences where we needed more words to explain what we meant e.g. provide the patient with specific semantic information. When we compare the responses that patient makes to counseling, we may discover among them prejudice, foolishness, loss of trust and confidence so if we care, we have to revise our thought that patient counseling alone will pay a dividend in better drug risk management. The meaning of what we said, therefore, is not in the words, but in specific semantic reaction of the patient e.g. how it will modify his behavior pattern. Futhermore, you would agree that if we would counsel the patient that “this drug will constipate and make you dizzy”, the patient will be poorly motivated to adhere to instructions or to take the medication at all. The concept of patient drug risk management counseling is not based on scientific foundation, but represents rather an ethical convenience in the area of medicinal safety what in today societies constitute an immense ethical problem.

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Semiotics in society The meaning of the symbols (glyphs) in society are characterized by observing and learning how people react to it and by the social mechanism of common acceptance and loyalty. The symbols both motivate, create the awareness and instruct us to identify the message by a simple powerful way. The reason is that the symbols exist independently of the personality. In today’s society the symbols are powerful communicators for the multitude of vast range of sciences (e.g. traffic signs, computer software) and they recognize neither international boundaries, nor language or educational skill barriers, they are indeed a growing modern global information concept. They are here to identify problems in the community and to guide. Besides the global universality, the visual symbol has the advantage of quantitative limitation and longer lasting physiological “visual memory” important for the elderly. Human semantics habits to symbols are also different. • The symbols are instructive giving limitation freedom of thoughts. • They introduce new concept to society “the problem awareness” with logical

and meaningful associations. • Basic idea of the visual symbol cannot be found in symbols alone but in

specific semantic reactions (not general semantic reactions) based on instructive programming by society.

Labeling and Symbol System for Pharmaceuticals The “labeling and symbol system” of patient oriented drug information is based on the concept of the drug personality, standard flow of information and color coding, taking into consideration some of the socially agreed on concept of semiotics (shape, expression of abstract meanings etc.). a) Instructive Labeling: Drug Identification Symbols The system of visual symbols is based on modified therapeutic drug classifications. The capital letter and number under the target organ tell the patient that he is not unnecessarily exposed to the same drugs under the different brand names. This information is essential because on the given market place are several generic drugs choices available to consumer. The next set of symbols is for usage and mode of administration instructions followed by a set of symbols for precautions instructing the patient how to modify his lifestyle to participate in drug risk management safely and efficiently. Such symbols would advise the patient to avoid alcohol, exercise proper cautiousness while driving, how to adhere to instructions, how to discontinue his

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medication etc. The set of warning symbols conveys to the patient some essential “Do-not” information about the drugs they are taking. Serious health hazard causing accidents, injuries and potential deaths are often associated with patient ignoring precautions and warnings. The symbol for warning instruct the patient that the medication is not for infant or children and should not be used when breast feeding or if pregnant and can be habit forming, cause drowsiness or has the potential for substance abuse. The last part of the instructive labeling are drug incompatibilities. The senior citizen consumes today on the average about four over-the-counter medications annually. It is important for him to recognize whether his medication is compatible with prescribed drugs. This can be accomplished quite easily by proper labeling strategies which will provide this essential information in the standard red color coded format (I.D.Code) properly placed on the label. The target organ (Indication), dosage, mode of administration, precaution, warnings, drug incompatibilities, all are presented to the patient as an instructive system of visual symbols designed to assure the patient’s safety before he takes his medication. This system incorporates an important element in behavior sciences -predictable patient response to instructive labeling. Auxiliary Patient Leaflet Information on Drug Risk Management The physician knows that side effects are common with some drugs and less common with others. They can be variably predictable on a person to person basis. They can be either transient or permanent and their management often requires special skill and knowledge e.g. knowledge and experience of clinical pharmacologist. The interplay of many factors of the individual patient, for example, genetic destiny,life style,the mosaic of patient illness, presence or absence of other drugs can all influence drugs safety and efficacy. Adverse reactions are often not predictable on a patient to patient basis. The adverse reaction experienced by patient during the treatment often results either in non-compliance or in medicinal spiraling, where other drugs are added to control side effects which may have not been be recognized as a result of the drug-patient interaction , but rather as a complain related to initial concept of illness. The concept of any drug risk management today must imply close patient physician collaboration necessary to implement proper therapeutic strategies and focus on the paramount importance of the patients’ ability to participate in this conceptual framework. To provide a meaningful scientific information and to use the patient as a resource we must find a way how to create a better public awareness of the medication potential side effects as well as motivate the patient to reason deductively from what appears to be self evident. The auxiliary Insert leaflet will provide the patient in an orderly manner with clinical trials Adverse Medecinal Events results where symbols-pharmaglyphs guide the patient

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to use his own resource to develop basic essential drug risk awareness skills and learn to participate with professionals as a partner in day to day drug risk management. Summary Medication misuse is an immense health problem with 70 million Americans classified as illiterate. The lack of verbal instruction, poor memory retention on the part of the patient and poor labeling practices continue to be a major, social and public health problem extracting an increasingly unacceptable toll in human suffering and economical cost to society. With consumer drug risk awareness increasing, global community needs a family oriented basic drug risk literacy concept. The public drug education is essential for the consumer ability to adhere to medication instruction and participate as a partner in drug risk management. The onus is to learn the basic skills in proper drug risk management and self-medication and have reasonable expectations from prescribed medication and confidence in the professionals.

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CHAPTER VI

THE CONCEPT OF THE DRUG PERSONALITY A competent adult undeniably has the right to make decisions, and such a decision must be based on unbiased information. A crucial element for ethical patient care is empathy, the ability of the health care provider to understand the individual patient point of view. The science of drug risk management requires individual drug risk assessment, e.g., taking into consideration the patient’s historical individuality. The essential treatment component must be patient feedback based on accessibility and a sound understanding of basic drug hazards. The drug risk awareness concept should help the patient to define the drug effect on his “life project” and help him to formulate strategies to restore balance to his life. An important part of any educational concept is the emphasis on consumer behavior modification. Behavior modification is a social concep whose principle could be applied to maximize the adherence to medication instruction. It begins with problem awareness, education, acquisition of positive knowledge and lifestyle changes, with new cultures maintained permanently. The adherence to medication instructions cannot be enhanced without focusing on the benefits gained from the awareness of medication hazard through public education. Today's failing public confidence in drugs reflects our inability to motivate the consumer to become an integral and essential part of the treatment process. The communication between the manufacturers and the patient must incorporate new operational strategies to create better public drug risk awareness in terms the patient can understand. The consumer currently does not have the necessary skills required to participate in drug risk management because society does not have any conceptual framework how to provide broader drug risk awareness in the community. There are, however, many criteria by which the drugs can be classified to increase consumer drug safety awareness. Ezon has divided drugs into five categories with five stars for ideal drug and one star for a restricted drug (Table I.)

Table 1

Ideal drugs xxxxx

Safe drugs xxxx

Satisfactory drugsxxx

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Restricted drugs xx

Drugs under developmentx

The classification is based on the drug safety criteria. All drugs have in common fundamental elementary properties, but the proportions of those properties vary. Indeed, the each drug posses a unique personality. Ideal Drug: The Ideal drug would not be toxic and would require no educational skill for human consumption, except adherence to instruction to assure proper usage. This group of the drugs would be ideal as over-the-counter medication. Safe Drug: The safe drug implies that the patient must be aware of the potential to cause side effects which can adversely affect his health or lifestyle. The patient also should be aware of the fact that the usage of the other drugs might be restricted due to drug incompatibilities. Drug Incompatibility means that taking an additional prescription or over-the-counter drug can result in adverse drug reactions or a new toxicity, danger to life, or can make the drug less efficient. Most of the drugs on today's market belong to the safe categories. The consumer must be aware, not only of the "side effects" and drug incompatibilities, but also to precautions and warnings.Ignoring precautions or warnings, could expose the user, public or fetus (during the pregnancy) to serious hazard because of drug use related confusion, memory, judgment and personal skills impairement. The consumer must be informed to comply with given instructions. Satisfactory Drugs: What was said in the previous drug category also is valid for satisfactory drugs. In addition, however, this drug has the potential of being habit forming in metabolic terms. The time requirements for this drug phenomenon are varied from drug to drug and also from person to person. Patient should be aware of this drug potential and discuss the proper drug risk management, including gradual discontinuation of the drug with physician. The adherence to given instruction is essential and it should be clearly understood.

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Restricted Drug: The next drug category caries all of the health hazards ascribed to the previous drug categories, but it has the potential for abuse and dependancy. Drug abuse and drug dependency might become a difficult management issue and are clearly not desirable. Therefore, the use should be closely monitored by physician and pharmacist. From my experience, drug addiction potential is likely inherited, increase with history of alcoholism, indiscriminate drug use (pill poppers) and history of previous substance abuse. Exposure to drug abuse can starts at a relatively early age, 12 to 15 years, with devastating consequences. Educational Posters could be used by patients, parents and teachers to educate the children about substance abuse and the “button” could be worn by those children who underwent proper drug education counselling and could be obtained free of charge from the Company. Every patient-parent must be advised to use this simple educational material to counsel their children at the age of 10 or 11 about the problem of drug addiction and its devastating consequences. Drug Safety Means Being Informed: To avoid unnecessary drug hazard there are certain basic policies the consumer must adhere to. Firstly: establish good relations with your physician and pharmacist and do not change doctors or pharmacists indiscriminately. There are no magic cures , learn to trust your professionals. Before you take any over a counter medication you should discuss with your pharmacist or physician the reason, provide the curent list of medications being taken, inform whether you are planning pregnancy, whether you are breast feeding, operate a vehicle or participate in any activities posing a potential public hazard should you fail in your duty. Check the medication Label to make sure that it is the right medication, and that you use it properly. Be informed about drug risk on the quality of your lifestyle. Follow drug instructions. Be aware of the drug adverse effects and communicate your concern to your physician and pharmacist. Understand that the knowledge of the drugs give you confidence to take medication as prescribed. Habit forming drugs and restricted drug while beneficial for many seriously ill patient, might interfere with your lifestyle (decision making, memory impairment, lack of motivation in problem solving, etc.) and you must understand the risk and circumstances where the regular use of such a drug would not be recommended. If you are taking prescription drugs, consult your physician regularly.

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CHAPTER VII

SOCIOPHARMACOLOGY

PRACTICAL CONSIDERATION AND EXPERIMENTAL APPROACH

The informed consent remains the firmly established practice in the field of Medicine and applies to any decision regarding "Major Medical Treatment". However, informed consent is not usually required for "Routine Diagnosis and Treatment" such as the prescribing and administration of medicine. The institution of any treatment process must considers three points. 1. Treatment is a judgmental process whose benefit (measured by maintenance or improvement of the patient's health) are balance against the risk of possible adverse effects on the patient's mental or physical health. 2. The practitioner must determine whether the patient can adequately understand and appreciate the nature and the consequences of the medical treatment, including the benefit and risk. 3. The patient must understand that by accepting the treatment, he or she voluntarily agrees to comply with medicinal advice and share responsibility for harm that might be done as a result of neglect to follow the instructions. It is therefore to the practitioner's advantage to establish a scientific partnership with a patient. Increasingly, negative courts decisions against professionals as well as manufacturers are based upon inadequacy of the essential information being provided to the patient. The patient to day does not have at his disposal the necessary skills and resources required to participate as a knowledgeable partner in day to day drug risk management, because the society does not have any basic conceptual framework how to provide public with broad educational drug risk literacy concept. Today, patient, unless he is a professional, posess limited skills as to how to participate in drug risk management or how to provide an accurate information to professionals. Few professionals have the time and ability to extract, collect, evaluate, interpret and analyze the patient information and act on it in the best interest of the patient-user.

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Consequences of the limited patient participation in drug risk management The current focus to provide the patient with limited verbal information or providing the with insert instructions does not take into consideration 30% of the illiterate population. The infomation provided is often not simple enough to be understood and might be difficult to comprehend in its multiplicity. The patient, furthermore, doesn’t think “drugs” but think “illness” and so does the physician which leads to misrepresentation of the symptoms caused by the drugs for those caused by illness, unnecessary prescriptions of more and more medication e.g., medications spiraling. The concept of current drug information has a number of ethical inadequacies needed to be adressed, primarily that is not adequately community and consumer centered.

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