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

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

2 Introduction Practice of pharmacy–governed by series of laws, regulations, and rules enforced by federal, state, local government; institutions and pharmacy managementPractice of pharmacy–governed by series of laws, regulations, and rules enforced by federal, state, local government; institutions and pharmacy management Technician–needs to understand these laws for passing the PTCB Certification Exam and for employmentTechnician–needs to understand these laws for passing the PTCB Certification Exam and for employment

3 Copyright © 2004 by Elsevier Inc. All rights reserved. Enacted to stop the sale of inaccurately labeled drugsEnacted to stop the sale of inaccurately labeled drugs Manufacturers were required to put truthful information on the label before selling the drugManufacturers were required to put truthful information on the label before selling the drug Manufacturers had to prove their drug’s effectivenessManufacturers had to prove their drug’s effectiveness 1906 Federal Food and Drug Act

4 Copyright © 2004 by Elsevier Inc. All rights reserved. 1914 Harrison Narcotic Act Enacted because of the excessive number of opium addicts in the United StatesEnacted because of the excessive number of opium addicts in the United States People could no longer obtain opium without a prescriptionPeople could no longer obtain opium without a prescription

5 Copyright © 2004 by Elsevier Inc. All rights reserved. 1938 Food, Drug, and Cosmetic Act Enacted because the earlier Food and Drug Act was not worded strictly enough and did not include cosmeticsEnacted because the earlier Food and Drug Act was not worded strictly enough and did not include cosmetics Required drug companies to include directions to the consumer regarding use and package inserts on drugsRequired drug companies to include directions to the consumer regarding use and package inserts on drugs All narcotics were required to be labeled “Warning: May be habit- forming”All narcotics were required to be labeled “Warning: May be habit- forming”

6 Copyright © 2004 by Elsevier Inc. All rights reserved. Defined the exact labeling for products and defined misbranding and adulteration as being illegalDefined the exact labeling for products and defined misbranding and adulteration as being illegal Proves the legal status for the Food and Drug Administration (FDA)Proves the legal status for the Food and Drug Administration (FDA) 1938 Food, Drug, and Cosmetic Act

7 Copyright © 2004 by Elsevier Inc. All rights reserved. 1951 Durham-Humphrey Amendment Required the labeling ”Caution: Federal law prohibits dispensing without a prescription”Required the labeling ”Caution: Federal law prohibits dispensing without a prescription” Made certain drugs require a doctor’s order and supervisionMade certain drugs require a doctor’s order and supervision Made the initial distinction between legend drugs (by prescription only) and over-the-counter (OTC) medicationsMade the initial distinction between legend drugs (by prescription only) and over-the-counter (OTC) medications

8 Copyright © 2004 by Elsevier Inc. All rights reserved. 1962 Kefauver-Harris Amendment Enacted in an attempt to ensure the safety and effectiveness of all new drugs on the marketEnacted in an attempt to ensure the safety and effectiveness of all new drugs on the market Burden put on manufacturing companies to have good manufacturing practices (GMP)Burden put on manufacturing companies to have good manufacturing practices (GMP) Prevented the sale of thalidomide in the United States because children were born with birth defects after usage in pregnancyPrevented the sale of thalidomide in the United States because children were born with birth defects after usage in pregnancy

9 Copyright © 2004 by Elsevier Inc. All rights reserved. 1970 Comprehensive Drug Abuse Prevention and Control Act The Drug Enforcement Agency (DEA) was formed to enforce the laws concerning narcotics and their distributionThe Drug Enforcement Agency (DEA) was formed to enforce the laws concerning narcotics and their distribution Created a stair-step schedule of controlled substancesCreated a stair-step schedule of controlled substances

10 Copyright © 2004 by Elsevier Inc. All rights reserved. Orphan Drug Act of 1983 Allowed drug companies to bypass the lengthy time requirements of testing a new drug and the cost that accompanied them to provide a medication to persons who had rare disease(s) (disease that affected 1 in every 200,000 people)Allowed drug companies to bypass the lengthy time requirements of testing a new drug and the cost that accompanied them to provide a medication to persons who had rare disease(s) (disease that affected 1 in every 200,000 people)

11 Copyright © 2004 by Elsevier Inc. All rights reserved. 1987 Prescription Drug Marketing Act Controlled the use of drugs in animalsControlled the use of drugs in animals Required the labeling “Caution: Federal law restricts this drug to use by or in order of a licensed veterinarian”Required the labeling “Caution: Federal law restricts this drug to use by or in order of a licensed veterinarian”

12 Copyright © 2004 by Elsevier Inc. All rights reserved. 1990 Anabolic Steroids Control Act Helped stiffen regulation on the abuse problems of anabolic steroids and their misuse by athletesHelped stiffen regulation on the abuse problems of anabolic steroids and their misuse by athletes

13 Copyright © 2004 by Elsevier Inc. All rights reserved. 1990 Omnibus Budget Reconciliation Act (OBRA 90) Deals specifically with practicing pharmacistsDeals specifically with practicing pharmacists Enacted because of reimbursement regulations for people who are covered under Medicaid or Medicare InsuranceEnacted because of reimbursement regulations for people who are covered under Medicaid or Medicare Insurance States that a pharmacist must counsel (at the time of purchase) all patients who receive new prescriptionsStates that a pharmacist must counsel (at the time of purchase) all patients who receive new prescriptions

14 Copyright © 2004 by Elsevier Inc. All rights reserved. 1990 Omnibus Budget Reconciliation Act All patients must be given information on the drug that they are taking, its name, when to take it, how long to take it, and any side effects or possible interactionsAll patients must be given information on the drug that they are taking, its name, when to take it, how long to take it, and any side effects or possible interactions Many states adopted OBRA to apply to all new prescriptions. Federal law deals only with Medicare and MedicaidMany states adopted OBRA to apply to all new prescriptions. Federal law deals only with Medicare and Medicaid

15 Copyright © 2004 by Elsevier Inc. All rights reserved. Health Insurance Portability and Accountability Act of 1996 (HIPAA) Has been only partially implementedHas been only partially implemented Deals with patient’s right to continuance of health insurance even when changing employersDeals with patient’s right to continuance of health insurance even when changing employers Changes for pharmacy: Technician has direct knowledge of patient’s medical information on a daily basis –consent form to access this information will have to be signed by the patientChanges for pharmacy: Technician has direct knowledge of patient’s medical information on a daily basis –consent form to access this information will have to be signed by the patient

16 Copyright © 2004 by Elsevier Inc. All rights reserved. FDA/DEA Important with respect to pharmacyImportant with respect to pharmacy FDA was created under the department of Health and Human ServicesFDA was created under the department of Health and Human Services Main function–to enforce guidelines for manufacturers to ensure the safety and effectiveness of medicationsMain function–to enforce guidelines for manufacturers to ensure the safety and effectiveness of medications

17 Copyright © 2004 by Elsevier Inc. All rights reserved. FDA/DEA DEA–created under the Department of JusticeDEA–created under the Department of Justice Its function is to prevent the illegal distribution and misuse of narcoticsIts function is to prevent the illegal distribution and misuse of narcotics DEA–issues licenses to practitioners, pharmacies, and manufacturers of controlled substancesDEA–issues licenses to practitioners, pharmacies, and manufacturers of controlled substances

18 Copyright © 2004 by Elsevier Inc. All rights reserved. FDA Reporting Process and Adverse Reactions Toll free number (1-800-FDA-1088) for reporting any defect found in OTC medications and any other drug problemsToll free number (1-800-FDA-1088) for reporting any defect found in OTC medications and any other drug problems Any medication reaction that may cause disability, hospitalization, or death should be reportedAny medication reaction that may cause disability, hospitalization, or death should be reported Patient’s identity must be kept confidentialPatient’s identity must be kept confidential

19 Copyright © 2004 by Elsevier Inc. All rights reserved. MedWatch–program under the FDA that allows consumers and health care professionals to report any discrepancies in medication or adverse reactions to medicationsMedWatch–program under the FDA that allows consumers and health care professionals to report any discrepancies in medication or adverse reactions to medications FDA Reporting Process and Adverse Reactions

20 Copyright © 2004 by Elsevier Inc. All rights reserved. Controlled Substances Commonly known as narcotics and are addictiveCommonly known as narcotics and are addictive Narcotics are derived from opium or opium-like substancesNarcotics are derived from opium or opium-like substances Opium comes from the poppy seed plant and has analgesic effects and also effects mood and behaviorOpium comes from the poppy seed plant and has analgesic effects and also effects mood and behavior

21 Copyright © 2004 by Elsevier Inc. All rights reserved. Controlled Substances Opiates, such as codeine and morphine, are substances created from opiumOpiates, such as codeine and morphine, are substances created from opium Opioids are narcotics that are produced synthetically in the laboratoryOpioids are narcotics that are produced synthetically in the laboratory Each type of narcotic is assigned a rating that depends on its addiction potentialEach type of narcotic is assigned a rating that depends on its addiction potential

22 Copyright © 2004 by Elsevier Inc. All rights reserved. Registration Required for Maintaining Narcotics DEA–three main registration formsDEA–three main registration forms Form 224–needed by pharmacy to dispense controlled substancesForm 224–needed by pharmacy to dispense controlled substances Form 225–to manufacture or distribute controlled substancesForm 225–to manufacture or distribute controlled substances Form 363–to run a narcotic treatment program or compound narcoticsForm 363–to run a narcotic treatment program or compound narcotics

23 Copyright © 2004 by Elsevier Inc. All rights reserved. Ordering Controlled Substances Pharmacy obtains C-II substances from a distributorPharmacy obtains C-II substances from a distributor Form 222 must be filled out by the receiving pharmacy in pen, typewriter, or indelible pencilForm 222 must be filled out by the receiving pharmacy in pen, typewriter, or indelible pencil Top copy and middle copy with carbon paper are sent to the supplier or manufacturerTop copy and middle copy with carbon paper are sent to the supplier or manufacturer

24 Copyright © 2004 by Elsevier Inc. All rights reserved. Ordering Controlled Substances Second Copy with carbon paper– returned to distributor or wholesalerSecond Copy with carbon paper– returned to distributor or wholesaler Third copy–sent by distributor or wholesaler to the DEAThird copy–sent by distributor or wholesaler to the DEA Errors–forms become invalid; cannot be erased or thrown awayErrors–forms become invalid; cannot be erased or thrown away

25 Copyright © 2004 by Elsevier Inc. All rights reserved. Ordering Controlled Substances C-III, C-IV, C-V–ordered on normal invoice forms but must be filed and retained for DEA or BOP inspectionC-III, C-IV, C-V–ordered on normal invoice forms but must be filed and retained for DEA or BOP inspection Should be kept separate from other nonscheduled drugsShould be kept separate from other nonscheduled drugs Forms kept for 2 yearsForms kept for 2 years

26 Copyright © 2004 by Elsevier Inc. All rights reserved. Ordering Controlled Substances Receipt of controlled substances– pharmacist compares copy of Form 222 to invoiceReceipt of controlled substances– pharmacist compares copy of Form 222 to invoice Both copies signed for accuracyBoth copies signed for accuracy Documents stapled together and retained for 7 yearsDocuments stapled together and retained for 7 years

27 Copyright © 2004 by Elsevier Inc. All rights reserved. Record Keeping Three Methods of Filing Controlled Substances and Legend Drugs SystemDrawer 1Drawer IIDrawer III 1C-IIC-IIIAll other separate through C-V prescriptions 2C-IIC-III–C-V* and separate all legend drugs 3C-IIAll other through C-V* prescriptions *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, 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 a licensed pharmacist.

28 Copyright © 2004 by Elsevier Inc. All rights reserved. Ratings of Scheduled (Controlled) Substances Letter “C,” meaning controlled substances, is used in addition to Roman numerals to indicate the addictiveness or abuse potential of narcoticsLetter “C,” meaning controlled substances, is used in addition to Roman numerals to indicate the addictiveness or abuse potential of narcotics Five levels based on potential for abuseFive levels based on potential for abuse C-I–strongest potential for abuse; no medicinal use in the USA–LSD, HeroinC-I–strongest potential for abuse; no medicinal use in the USA–LSD, Heroin

29 Copyright © 2004 by Elsevier Inc. All rights reserved. Ratings of Schedules (Controlled) Substances C-II, C-III, C-IV, C-V–all medicinal narcotic drugsC-II, C-III, C-IV, C-V–all medicinal narcotic drugs C-V–kept OTC in some states because of low potential abuseC-V–kept OTC in some states because of low potential abuse C-II–must be locked up because of high potential abuseC-II–must be locked up because of high potential abuse Attorney General decides which schedule to place a drug underAttorney General decides which schedule to place a drug under Refer to Table 2.2Refer to Table 2.2

30 Copyright © 2004 by Elsevier Inc. All rights reserved. Refilling Controlled Substances Strict guidelinesStrict guidelines C-II or C-IV–can be refilled a maximum of 5 times or within 6 months from the original order, whichever comes firstC-II or C-IV–can be refilled a maximum of 5 times or within 6 months from the original order, whichever comes first Record must be kept with pharmacist’s initials and date it was dispensedRecord must be kept with pharmacist’s initials and date it was dispensed

31 Copyright © 2004 by Elsevier Inc. All rights reserved. Monographs/Package Inserts Contained in the Physicians’ Desk Reference (PDR) in doctor’s office and Facts and Comparisons in pharmacyContained in the Physicians’ Desk Reference (PDR) in doctor’s office and Facts and Comparisons in pharmacy Contains the following: Adverse reactions, Clinical pharmacology, Contraindications, Description, Dosage, Drug abuse and dependence, How supplied, Indications and usage, Precautions, and WarningsContains the following: Adverse reactions, Clinical pharmacology, Contraindications, Description, Dosage, Drug abuse and dependence, How supplied, Indications and usage, Precautions, and Warnings

32 Copyright © 2004 by Elsevier Inc. All rights reserved. Prescription Regulations Who can prescribe? FDA and DEA have no authority in determining prescribersWho can prescribe? FDA and DEA have no authority in determining prescribers Prescribers are licensed by their governing bodiesPrescribers are licensed by their governing bodies Standard practitioners in all 50 states are: physicians, surgeons, doctors of osteopathy, dentists, podiatrists, veterinarians, and optometristsStandard practitioners in all 50 states are: physicians, surgeons, doctors of osteopathy, dentists, podiatrists, veterinarians, and optometrists

33 Copyright © 2004 by Elsevier Inc. All rights reserved. Who Can Receive a Prescription? Pharmacy Technicians–takes in prescriptions, interprets them, and fills themPharmacy Technicians–takes in prescriptions, interprets them, and fills them Technicians cannot take phone ordersTechnicians cannot take phone orders Pharmacists–give the final check, take verbal telephone orders, and transfer prescriptions to another pharmacyPharmacists–give the final check, take verbal telephone orders, and transfer prescriptions to another pharmacy

34 Copyright © 2004 by Elsevier Inc. All rights reserved. Receiving Prescriptions for Controlled Drugs Pharmacists can receive an oral prescription for a controlled drug over the phone by reducing it to written formPharmacists can receive an oral prescription for a controlled drug over the phone by reducing it to written form C-II has strict guidelines–refer to guidelines on page 21C-II has strict guidelines–refer to guidelines on page 21

35 Copyright © 2004 by Elsevier Inc. All rights reserved. Prescription Label The information on a prescription label differs from a prescription orderThe information on a prescription label differs from a prescription order Two necessary components: pharmacy information and patient informationTwo necessary components: pharmacy information and patient information Refer to list on page 21Refer to list on page 21 Special labeling–sometimes required because of possibility of teratogenicity on an unborn fetusSpecial labeling–sometimes required because of possibility of teratogenicity on an unborn fetus

36 Copyright © 2004 by Elsevier Inc. All rights reserved. DEA Verification All prescribers must be registered with the DEA to write prescriptions for controlled substancesAll prescribers must be registered with the DEA to write prescriptions for controlled substances Prescribers are given a nine character identification code, which is different for each prescriberPrescribers are given a nine character identification code, which is different for each prescriber

37 Copyright © 2004 by Elsevier Inc. All rights reserved. DEA Verification First two characters are letters–A or B followed by first letter of prescriber’s last nameFirst two characters are letters–A or B followed by first letter of prescriber’s last name Next seven digits are composed of numbers added togetherNext seven digits are composed of numbers added together Refer to Box 2.3 for DEA Verification ProcessRefer to Box 2.3 for DEA Verification Process

38 Copyright © 2004 by Elsevier Inc. All rights reserved. Childproof Caps The Poison Prevention Act addresses the issue of accidental poisoning of childrenThe Poison Prevention Act addresses the issue of accidental poisoning of children Childproof caps were createdChildproof caps were created Adults–can require no childproof caps by requesting itAdults–can require no childproof caps by requesting it Pharmacy–keeps information on patient’s record and may require a signed release formPharmacy–keeps information on patient’s record and may require a signed release form

39 Copyright © 2004 by Elsevier Inc. All rights reserved. Mailing Prescription Drugs Online and mail-order pharmacies provide an option to patients to receive their prescription via the mailOnline and mail-order pharmacies provide an option to patients to receive their prescription via the mail U.S. Postal Service will not allow narcotics to be sent by mail unless it’s a veteran through the Veterans’ AdministrationU.S. Postal Service will not allow narcotics to be sent by mail unless it’s a veteran through the Veterans’ Administration

40 Copyright © 2004 by Elsevier Inc. All rights reserved. Mailing Prescription Drugs For mailed prescriptions–envelope must be unmarked as to contentsFor mailed prescriptions–envelope must be unmarked as to contents Pharmacy must be registered with the DEAPharmacy must be registered with the DEA Manufacturer to patient–must be sent registered mail with a return receiptManufacturer to patient–must be sent registered mail with a return receipt

41 Copyright © 2004 by Elsevier Inc. All rights reserved. Recalled Drugs Manufacturers must recall items that have been found to be either defective or somehow taintedManufacturers must recall items that have been found to be either defective or somehow tainted Three classes of recallsThree classes of recalls Refer to list on page 23 for levels of recallRefer to list on page 23 for levels of recall

42 Copyright © 2004 by Elsevier Inc. All rights reserved. Records and Labeling Requirements Repackaging–done from bulk to unit dose by techniciansRepackaging–done from bulk to unit dose by technicians Following information is needed on each label: Drug name, strength, dosage form, manufacturer, lot number, and expiration dateFollowing information is needed on each label: Drug name, strength, dosage form, manufacturer, lot number, and expiration date

43 Copyright © 2004 by Elsevier Inc. All rights reserved. State Laws Each state has their own set of laws that must be followed by all employees in the pharmacyEach state has their own set of laws that must be followed by all employees in the pharmacy States have laws that differ from federal lawStates have laws that differ from federal law The strictest law is the one you followThe strictest law is the one you follow

44 Copyright © 2004 by Elsevier Inc. All rights reserved. Liabilities Tort–causing injury to a person intentionally or because of negligenceTort–causing injury to a person intentionally or because of negligence Negligence–an action taken without the forethought that should have been taken by a reasonable person; a mistakeNegligence–an action taken without the forethought that should have been taken by a reasonable person; a mistake

45 Copyright © 2004 by Elsevier Inc. All rights reserved. Liabilities Intentional mistake–penalty ranges from criminal charges to awarding of damagesIntentional mistake–penalty ranges from criminal charges to awarding of damages Negligent mistake–affect employment and can result in punitive damagesNegligent mistake–affect employment and 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

46 Copyright © 2004 by Elsevier Inc. All rights reserved. Morals Versus Ethics in the Workplace The pharmacy technician has a clear responsibility to the patient on many levelsThe pharmacy technician has a clear responsibility to the patient on many levels Ethics are morals in the workplace and in the public domainEthics are morals in the workplace and in the public domain Work ethics will guide your behaviorWork ethics will guide your behavior Working within pharmacy guidelines will ensure that patients are getting the best service possibleWorking within pharmacy guidelines will ensure that patients are getting the best service possible


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