Chapter 2 Law and Ethics of Pharmacy Copyright © 2004 by Elsevier Inc. All rights reserved

Chapter 2Chapter 2

Law and Ethics of PharmacyLaw and Ethics of Pharmacy

Copyright © 2004 by Elsevier Inc. All rights reserved.


IntroductionIntroduction

• Practice of pharmacy–governed by Practice of pharmacy–governed by series of laws, regulations, and rules series of laws, regulations, and rules enforced by federal, state, local enforced by federal, state, local government; institutions and government; institutions and pharmacy managementpharmacy management

• Technician–needs to understand Technician–needs to understand these laws for passing the PTCB these laws for passing the PTCB Certification Exam and for Certification Exam and for employment employment


• Enacted to stop the sale of Enacted to stop the sale of inaccurately labeled drugsinaccurately labeled drugs

• Manufacturers were required to put Manufacturers were required to put truthful information on the label truthful information on the label before selling the drugbefore selling the drug

• Manufacturers had to prove their Manufacturers had to prove their drug’s effectivenessdrug’s effectiveness

1906 Federal Food and Drug Act 1906 Federal Food and Drug Act


1914 Harrison Narcotic Act1914 Harrison Narcotic Act

• Enacted because of the excessive Enacted because of the excessive number of opium addicts in the number of opium addicts in the United StatesUnited States

• People could no longer obtain People could no longer obtain opium without a prescriptionopium without a prescription


1938 Food, Drug, and 1938 Food, Drug, and Cosmetic ActCosmetic Act• Enacted because the earlier Food Enacted because the earlier Food

and Drug Act was not worded strictly and Drug Act was not worded strictly enough and did not include cosmeticsenough and did not include cosmetics

• Required drug companies to include Required drug companies to include directions to the consumer regarding directions to the consumer regarding use and package inserts on drugsuse and package inserts on drugs

• All narcotics were required to be All narcotics were required to be labeled “Warning: May be habit-labeled “Warning: May be habit-forming”forming”


• Defined the exact labeling for Defined the exact labeling for products and defined misbranding products and defined misbranding and adulteration as being illegaland adulteration as being illegal

• Proves the legal status for the Food Proves the legal status for the Food and Drug Administration (FDA)and Drug Administration (FDA)

1938 Food, Drug, and 1938 Food, Drug, and Cosmetic ActCosmetic Act


1951 Durham-Humphrey 1951 Durham-Humphrey Amendment Amendment • Required the labeling ”Caution: Required the labeling ”Caution:

Federal law prohibits dispensing Federal law prohibits dispensing without a prescription”without a prescription”

• Made certain drugs require a doctor’s Made certain drugs require a doctor’s order and supervisionorder and supervision

• Made the initial distinction between Made the initial distinction between legend drugs (by prescription only) legend drugs (by prescription only) and over-the-counter (OTC) and over-the-counter (OTC) medicationsmedications


1962 Kefauver-Harris 1962 Kefauver-Harris Amendment Amendment • Enacted in an attempt to ensure the Enacted in an attempt to ensure the

safety and effectiveness of all new safety and effectiveness of all new drugs on the marketdrugs on the market

• Burden put on manufacturing companies Burden put on manufacturing companies to have good manufacturing practices to have good manufacturing practices (GMP)(GMP)

• Prevented the sale of thalidomide in the Prevented the sale of thalidomide in the United States because children were born United States because children were born with birth defects after usage in pregnancywith birth defects after usage in pregnancy


1970 Comprehensive Drug Abuse 1970 Comprehensive Drug Abuse Prevention and Control ActPrevention and Control Act

• The Drug Enforcement Agency (DEA) The Drug Enforcement Agency (DEA) was formed to enforce the laws was formed to enforce the laws concerning narcotics and their concerning narcotics and their distributiondistribution

• Created a stair-step schedule of Created a stair-step schedule of controlled substancescontrolled substances


Orphan Drug Act of 1983Orphan Drug Act of 1983

• Allowed drug companies to bypass Allowed drug companies to bypass the lengthy time requirements of the lengthy time requirements of testing a new drug and the cost that testing a new drug and the cost that accompanied them to provide a accompanied them to provide a medication to persons who had rare medication to persons who had rare disease(s) (disease that affected 1 in disease(s) (disease that affected 1 in every 200,000 people)every 200,000 people)


1987 Prescription Drug 1987 Prescription Drug Marketing Act Marketing Act • Controlled the use of drugs in animalsControlled the use of drugs in animals

• Required the labeling “Caution: Federal Required the labeling “Caution: Federal law restricts this drug to use by or in law restricts this drug to use by or in order of a licensed veterinarian”order of a licensed veterinarian”


1990 Anabolic Steroids 1990 Anabolic Steroids Control ActControl Act• Helped stiffen regulation on the Helped stiffen regulation on the

abuse problems of anabolic steroids abuse problems of anabolic steroids and their misuse by athletesand their misuse by athletes


1990 Omnibus Budget 1990 Omnibus Budget Reconciliation Act (OBRA 90) Reconciliation Act (OBRA 90) • Deals specifically with practicing Deals specifically with practicing

pharmacistspharmacists

• Enacted because of reimbursement Enacted because of reimbursement regulations for people who are covered regulations for people who are covered under Medicaid or Medicare Insuranceunder Medicaid or Medicare Insurance

• States that a pharmacist must counsel States that a pharmacist must counsel (at the time of purchase) all patients (at the time of purchase) all patients who receive new prescriptionswho receive new prescriptions


1990 Omnibus Budget 1990 Omnibus Budget Reconciliation Act Reconciliation Act • All patients must be given information All patients must be given information

on the drug that they are taking, its on the drug that they are taking, its name, when to take it, how long to name, when to take it, how long to take it, and any side effects or take it, and any side effects or possible interactionspossible interactions

• Many states adopted OBRA to apply Many states adopted OBRA to apply to all new prescriptions. Federal law to all new prescriptions. Federal law deals only with Medicare and Medicaiddeals only with Medicare and Medicaid


Health Insurance Portability and Health Insurance Portability and Accountability Act of 1996 (HIPAA)Accountability Act of 1996 (HIPAA)

• Has been only partially implementedHas been only partially implemented

• Deals with patient’s right to continuance Deals with patient’s right to continuance of health insurance even when changing of health insurance even when changing employersemployers

• Changes for pharmacy: Technician Changes for pharmacy: Technician has direct knowledge of patient’s medical has direct knowledge of patient’s medical information on a daily basis –consent information on a daily basis –consent form to access this information will have form to access this information will have to be signed by the patientto be signed by the patient


FDA/DEAFDA/DEA

• Important with respect to pharmacyImportant with respect to pharmacy

• FDA was created under the department FDA was created under the department of Health and Human Servicesof Health and Human Services

• Main function–to enforce guidelines for Main function–to enforce guidelines for manufacturers to ensure the safety and manufacturers to ensure the safety and effectiveness of medicationseffectiveness of medications


FDA/DEAFDA/DEA

• DEA–created under the Department DEA–created under the Department of Justiceof Justice

• Its function is to prevent the illegal Its function is to prevent the illegal distribution and misuse of narcoticsdistribution and misuse of narcotics

• DEA–issues licenses to practitioners, DEA–issues licenses to practitioners, pharmacies, and manufacturers of pharmacies, and manufacturers of controlled substancescontrolled substances


FDA Reporting Process and FDA Reporting Process and Adverse ReactionsAdverse Reactions• Toll free number (1-800-FDA-1088) Toll free number (1-800-FDA-1088)

for reporting any defect found in OTC for reporting any defect found in OTC medications and any other drug problemsmedications and any other drug problems

• Any medication reaction that may cause Any medication reaction that may cause disability, hospitalization, disability, hospitalization, or death should be reportedor death should be reported

• Patient’s identity must be kept confidentialPatient’s identity must be kept confidential


• MedWatch–program under the FDA MedWatch–program under the FDA that allows consumers and health that allows consumers and health care professionals to report any care professionals to report any discrepancies in medication or discrepancies in medication or adverse reactions to medicationsadverse reactions to medications

FDA Reporting Process and FDA Reporting Process and Adverse ReactionsAdverse Reactions


Controlled SubstancesControlled Substances

• Commonly known as narcotics and are Commonly known as narcotics and are addictiveaddictive

• Narcotics are derived from opium or Narcotics are derived from opium or opium-like substancesopium-like substances

• Opium comes from the poppy seed Opium comes from the poppy seed plant and has analgesic effects and plant and has analgesic effects and also effects mood and behavioralso effects mood and behavior


Controlled SubstancesControlled Substances

• Opiates, such as codeine and Opiates, such as codeine and morphine, are substances created morphine, are substances created from opiumfrom opium

• Opioids are narcotics that are produced Opioids are narcotics that are produced synthetically in the laboratorysynthetically in the laboratory

• Each type of narcotic is assigned a rating Each type of narcotic is assigned a rating that depends on its addiction potentialthat depends on its addiction potential


Registration Required Registration Required for Maintaining Narcoticsfor Maintaining Narcotics• DEA–three main registration formsDEA–three main registration forms

• Form 224–needed by pharmacy to Form 224–needed by pharmacy to dispense controlled substancesdispense controlled substances

• Form 225–to manufacture or distribute Form 225–to manufacture or distribute controlled substancescontrolled substances

• Form 363–to run a narcotic treatment Form 363–to run a narcotic treatment program or compound narcoticsprogram or compound narcotics


Ordering Controlled SubstancesOrdering Controlled Substances

• Pharmacy obtains C-II substances Pharmacy obtains C-II substances from a distributorfrom a distributor

• Form 222 must be filled out by the Form 222 must be filled out by the receiving pharmacy in pen, typewriter, receiving pharmacy in pen, typewriter, or indelible pencilor indelible pencil

• Top copy and middle copy with carbon Top copy and middle copy with carbon paper are sent to the supplier or paper are sent to the supplier or manufacturermanufacturer



• Second Copy with carbon paper–Second Copy with carbon paper–returned to distributor or wholesalerreturned to distributor or wholesaler

• Third copy–sent by distributor or Third copy–sent by distributor or wholesaler to the DEA wholesaler to the DEA

• Errors–forms become invalid; cannot Errors–forms become invalid; cannot be erased or thrown awaybe erased or thrown away



• C-III, C-IV, C-V–ordered on normal C-III, C-IV, C-V–ordered on normal invoice forms but must be filed and invoice forms but must be filed and retained for DEA or BOP inspectionretained for DEA or BOP inspection

• Should be kept separate from other Should be kept separate from other nonscheduled drugsnonscheduled drugs

• Forms kept for 2 yearsForms kept for 2 years



• Receipt of controlled substances–Receipt of controlled substances–pharmacist compares copy of Form pharmacist compares copy of Form 222 to invoice222 to invoice

• Both copies signed for accuracyBoth copies signed for accuracy

• Documents stapled together and Documents stapled together and retained for 7 yearsretained for 7 years


Record KeepingRecord Keeping

Three Methods of Filing Controlled Substances and Three Methods of Filing Controlled Substances and Legend DrugsLegend Drugs

SystemSystem Drawer 1Drawer 1 Drawer IIDrawer II Drawer IIIDrawer III11 C-IIC-II C-IIIC-III All other All other

separate separate through C-V through C-V prescriptionsprescriptions

22 C-IIC-II C-III–C-V* and C-III–C-V* and separate separate all legend drugsall legend drugs

33 C-IIC-II All otherAll otherthrough C-V*through C-V* prescriptionsprescriptions

*If any C-III, C-IV, or C-V controlled drugs are kept with non-controlled drugs (System 2) or mixed with C-II drugs (System 3), they *If any C-III, C-IV, or C-V controlled drugs are kept with non-controlled drugs (System 2) or mixed with C-II drugs (System 3), they must be stamped with a red “C” for easy identification. All records must be kept on site for no less than 2 years. Many states, must be stamped with a red “C” for easy identification. All records must be kept on site for no less than 2 years. Many states, however, have longer requirements for keeping records; remember the strictest law is the one that must be followed. When taking however, have longer requirements for keeping records; remember the strictest law is the one that must be followed. When taking inventory it is necessary to have exact counts of C-II controlled substances at all times. The final count can only be inventoried by inventory it is necessary to have exact counts of C-II controlled substances at all times. The final count can only be inventoried by a licensed pharmacist. a licensed pharmacist.


Ratings of Scheduled Ratings of Scheduled (Controlled) Substances(Controlled) Substances• Letter “C,” meaning controlled substances, Letter “C,” meaning controlled substances,

is used in addition to Roman numerals to is used in addition to Roman numerals to indicate the addictiveness or abuse potential indicate the addictiveness or abuse potential

of narcoticsof narcotics

• Five levels based on potential Five levels based on potential for abusefor abuse

• C-I–strongest potential for abuse; no C-I–strongest potential for abuse; no medicinal use in the USA–LSD, Heroinmedicinal use in the USA–LSD, Heroin


Ratings of Schedules Ratings of Schedules (Controlled) Substances(Controlled) Substances• C-II, C-III, C-IV, C-V–all medicinal narcotic C-II, C-III, C-IV, C-V–all medicinal narcotic

drugsdrugs

• C-V–kept OTC in some states because of C-V–kept OTC in some states because of low potential abuselow potential abuse

• C-II–must be locked up because of high C-II–must be locked up because of high potential abusepotential abuse

• Attorney General decides which schedule Attorney General decides which schedule to place a drug underto place a drug under

• Refer to Table 2.2Refer to Table 2.2


Refilling Controlled SubstancesRefilling Controlled Substances

• Strict guidelinesStrict guidelines

• C-II or C-IV–can be refilled a maximum C-II or C-IV–can be refilled a maximum of 5 times or within 6 months from the of 5 times or within 6 months from the original order, whichever comes firstoriginal order, whichever comes first

• Record must be kept with pharmacist’s Record must be kept with pharmacist’s initials and date it was dispensedinitials and date it was dispensed


Monographs/Package InsertsMonographs/Package Inserts

• Contained in the Contained in the Physicians’ Desk Physicians’ Desk Reference (PDR)Reference (PDR) in doctor’s office and in doctor’s office and Facts and ComparisonsFacts and Comparisons in pharmacy in pharmacy

• Contains the following: Adverse Contains the following: Adverse reactions, Clinical pharmacology, reactions, Clinical pharmacology, Contraindications, Description, Contraindications, Description, Dosage, Drug abuse and dependence, Dosage, Drug abuse and dependence, How supplied, Indications and usage, How supplied, Indications and usage, Precautions, and WarningsPrecautions, and Warnings


Prescription RegulationsPrescription Regulations

• Who can prescribe? FDA and DEA Who can prescribe? FDA and DEA have no authority in determining have no authority in determining prescribersprescribers

• Prescribers are licensed by their Prescribers are licensed by their governing bodiesgoverning bodies

• Standard practitioners in all 50 states Standard practitioners in all 50 states are: physicians, surgeons, doctors of are: physicians, surgeons, doctors of osteopathy, dentists, podiatrists, osteopathy, dentists, podiatrists, veterinarians, and optometristsveterinarians, and optometrists


Who Can Receive a Prescription?Who Can Receive a Prescription?

• Pharmacy Technicians–takes in Pharmacy Technicians–takes in prescriptions, interprets them, and prescriptions, interprets them, and fills themfills them

• Technicians cannot take phone ordersTechnicians cannot take phone orders

• Pharmacists–give the final check, take Pharmacists–give the final check, take verbal telephone orders, and transfer verbal telephone orders, and transfer prescriptions to another pharmacyprescriptions to another pharmacy


Receiving Prescriptions for Receiving Prescriptions for Controlled DrugsControlled Drugs• Pharmacists can receive an oral Pharmacists can receive an oral

prescription for a controlled drug prescription for a controlled drug over the phone by reducing it to over the phone by reducing it to written formwritten form

• C-II has strict guidelines–refer to C-II has strict guidelines–refer to guidelines on page 21guidelines on page 21


Prescription LabelPrescription Label

• The information on a prescription The information on a prescription label differs from a prescription orderlabel differs from a prescription order

• Two necessary components: pharmacy Two necessary components: pharmacy information and patient informationinformation and patient information

• Refer to list on page 21Refer to list on page 21

• Special labeling–sometimes required Special labeling–sometimes required because of possibility of teratogenicity because of possibility of teratogenicity on an unborn fetuson an unborn fetus


DEA VerificationDEA Verification

• All prescribers must be registered with All prescribers must be registered with the DEA to write prescriptions for the DEA to write prescriptions for controlled substancescontrolled substances

• Prescribers are given a nine character Prescribers are given a nine character identification code, which is different identification code, which is different for each prescriberfor each prescriber


DEA VerificationDEA Verification

• First two characters are letters–A or B First two characters are letters–A or B followed by first letter of prescriber’s followed by first letter of prescriber’s last namelast name

• Next seven digits are composed of Next seven digits are composed of numbers added togethernumbers added together

• Refer to Box 2.3 for DEA Verification Refer to Box 2.3 for DEA Verification ProcessProcess


Childproof CapsChildproof Caps

• The Poison Prevention Act addresses The Poison Prevention Act addresses the issue of accidental poisoning of the issue of accidental poisoning of childrenchildren

• Childproof caps were createdChildproof caps were created

• Adults–can require no childproof Adults–can require no childproof caps by requesting itcaps by requesting it

• Pharmacy–keeps information on Pharmacy–keeps information on patient’s record and may require patient’s record and may require a signed release forma signed release form


Mailing Prescription DrugsMailing Prescription Drugs

• Online and mail-order pharmacies Online and mail-order pharmacies provide an option to patients to provide an option to patients to receive their prescription via the mailreceive their prescription via the mail

• U.S. Postal Service will not allow U.S. Postal Service will not allow narcotics to be sent by mail unless narcotics to be sent by mail unless it’s a veteran through the Veterans’ it’s a veteran through the Veterans’ AdministrationAdministration


Mailing Prescription DrugsMailing Prescription Drugs

• For mailed prescriptions–envelope For mailed prescriptions–envelope must be unmarked as to contentsmust be unmarked as to contents

• Pharmacy must be registered with Pharmacy must be registered with the DEAthe DEA

• Manufacturer to patient–must be sent Manufacturer to patient–must be sent registered mail with a return receiptregistered mail with a return receipt


Recalled DrugsRecalled Drugs

• Manufacturers must recall items that Manufacturers must recall items that have been found to be either defective have been found to be either defective or somehow taintedor somehow tainted

• Three classes of recallsThree classes of recalls

• Refer to list on page 23 for levels Refer to list on page 23 for levels of recallof recall


Records and Labeling Records and Labeling RequirementsRequirements• Repackaging–done from bulk to unit Repackaging–done from bulk to unit

dose by techniciansdose by technicians

• Following information is needed on Following information is needed on each label: Drug name, strength, each label: Drug name, strength, dosage form, manufacturer, lot dosage form, manufacturer, lot number, and expiration datenumber, and expiration date


State LawsState Laws

• Each state has their own set of laws Each state has their own set of laws that must be followed by all employees that must be followed by all employees in the pharmacyin the pharmacy

• States have laws that differ from States have laws that differ from federal lawfederal law

• The strictest law is the one you followThe strictest law is the one you follow


LiabilitiesLiabilities

• Tort–causing injury to a person Tort–causing injury to a person intentionally or because of negligenceintentionally or because of negligence

• Negligence–an action taken without Negligence–an action taken without the forethought that should have the forethought that should have been taken by a reasonable person; been taken by a reasonable person; a mistakea mistake


LiabilitiesLiabilities

• Intentional mistake–penalty ranges Intentional mistake–penalty ranges from criminal charges to awarding from criminal charges to awarding of damagesof damages

• Negligent mistake–affect employment Negligent mistake–affect employment and can result in punitive damagesand can result in punitive damages

• Be aware of rights and responsibilitiesBe aware of rights and responsibilities

• Refer to list on page 25Refer to list on page 25


Morals Versus EthicsMorals Versus Ethicsin the Workplacein the Workplace• The pharmacy technician has a clear The pharmacy technician has a clear

responsibility to the patient on many responsibility to the patient on many levelslevels

• Ethics are morals in the workplace Ethics are morals in the workplace and in the public domainand in the public domain

• Work ethics will guide your behaviorWork ethics will guide your behavior

• Working within pharmacy guidelines Working within pharmacy guidelines will ensure that patients are getting will ensure that patients are getting the best service possiblethe best service possible