Chapter 2 Law and Ethics of Pharmacy Copyright

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

Introduction • Practice 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 employment Copyright © 2004 by Elsevier Inc. All rights reserved.

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

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

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

1951 Durham-Humphrey Amendment • Required the labeling ”Caution: Federal law prohibits dispensing without a prescription” • Made certain drugs require a doctor’s order and supervision • Made the initial distinction between legend drugs (by prescription only) and over-the-counter (OTC) medications 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 market • 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 pregnancy 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 distribution • Created a stair-step schedule of controlled substances 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) Copyright © 2004 by Elsevier Inc. All rights reserved.

1987 Prescription Drug Marketing Act • Controlled 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” 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 athletes Copyright © 2004 by Elsevier Inc. All rights reserved.

1990 Omnibus Budget Reconciliation Act (OBRA 90) • Deals specifically with practicing pharmacists • Enacted 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 prescriptions 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 interactions • Many states adopted OBRA to apply to all new prescriptions. Federal law deals only with Medicare and Medicaid Copyright © 2004 by Elsevier Inc. All rights reserved.

Health Insurance Portability and Accountability Act of 1996 (HIPAA) • Has been only partially implemented • Deals 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 patient Copyright © 2004 by Elsevier Inc. All rights reserved.

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

FDA/DEA • DEA–created under the Department of Justice • Its function is to prevent the illegal distribution and misuse of narcotics • DEA–issues licenses to practitioners, pharmacies, and manufacturers of controlled substances 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 problems • Any medication reaction that may cause disability, hospitalization, or death should be reported • Patient’s identity must be kept confidential Copyright © 2004 by Elsevier Inc. All rights reserved.

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

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

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

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

Ordering Controlled Substances • Pharmacy obtains C-II substances from a distributor • Form 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 manufacturer Copyright © 2004 by Elsevier Inc. All rights reserved.

Ordering Controlled Substances • Second Copy with carbon paper– returned to distributor or wholesaler • Third copy–sent by distributor or wholesaler to the DEA • Errors–forms become invalid; cannot be erased or thrown away 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 inspection • Should be kept separate from other nonscheduled drugs • Forms kept for 2 years Copyright © 2004 by Elsevier Inc. All rights reserved.

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

Record Keeping Three Methods of Filing Controlled Substances and Legend Drugs System Drawer 1 1 C-III separate Drawer II All other through C-V Drawer III prescriptions 2 C-III–C-V* and separate all legend drugs 3 C-II All 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. 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 narcotics • Five levels based on potential for abuse • C-I–strongest potential for abuse; no medicinal use in the USA–LSD, Heroin Copyright © 2004 by Elsevier Inc. All rights reserved.

Ratings of Schedules (Controlled) Substances • C-II, C-IV, C-V–all medicinal narcotic drugs • C-V–kept OTC in some states because of low potential abuse • C-II–must be locked up because of high potential abuse • Attorney General decides which schedule to place a drug under • Refer to Table 2. 2 Copyright © 2004 by Elsevier Inc. All rights reserved.

Refilling Controlled Substances • Strict guidelines • C-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 dispensed 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 pharmacy • Contains the following: Adverse reactions, Clinical pharmacology, Contraindications, Description, Dosage, Drug abuse and dependence, How supplied, Indications and usage, Precautions, and Warnings Copyright © 2004 by Elsevier Inc. All rights reserved.

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

Who Can Receive a Prescription? • Pharmacy Technicians–takes in prescriptions, interprets them, and fills them • Technicians cannot take phone orders • Pharmacists–give the final check, take verbal telephone orders, and transfer prescriptions to another pharmacy 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 form • C-II has strict guidelines–refer to guidelines on page 21 Copyright © 2004 by Elsevier Inc. All rights reserved.

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

DEA Verification • All 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 prescriber 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 name • Next seven digits are composed of numbers added together • Refer to Box 2. 3 for DEA Verification Process Copyright © 2004 by Elsevier Inc. All rights reserved.

Childproof Caps • The Poison Prevention Act addresses the issue of accidental poisoning of children • Childproof caps were created • Adults–can require no childproof caps by requesting it • Pharmacy–keeps information on patient’s record and may require a signed release form 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 mail • U. S. Postal Service will not allow narcotics to be sent by mail unless it’s a veteran through the Veterans’ Administration Copyright © 2004 by Elsevier Inc. All rights reserved.

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

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

Records and Labeling Requirements • Repackaging–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 date 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 pharmacy • States have laws that differ from federal law • The strictest law is the one you follow Copyright © 2004 by Elsevier Inc. All rights reserved.

Liabilities • Tort–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 mistake Copyright © 2004 by Elsevier Inc. All rights reserved.

Liabilities • Intentional mistake–penalty ranges from criminal charges to awarding of damages • Negligent mistake–affect employment and can result in punitive damages • Be aware of rights and responsibilities • Refer to list on page 25 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 levels • Ethics are morals in the workplace and in the public domain • Work ethics will guide your behavior • Working within pharmacy guidelines will ensure that patients are getting the best service possible Copyright © 2004 by Elsevier Inc. All rights reserved.