Chapter 2: Pharmacy Law, Ethics, and Regulatory Agencies

1906 Pure Food and Drug Act

One of the first laws enacted to stop the sale of inaccurately labeled drugs.

1914 Harrison Narcotic Act

Required practitioner registration, documentation regarding prescriptions and dispensing, and implementation of restrictions regarding the importation, sale, and distribution of opium, coca leaves, and any derivative products.

1938 Food, Drug and Cosmetic Act (FDC)

Important concepts of this act were adulteration, , misbranding, and providing legal status for the FDA

1951 Durham-Humphrey Amendment

This act distinguishes legend drugs(prescription) from the over the counter drugs (OTC). This act requires companies to label legend drugs "Caution: Federal law prohibits dispensing without a prescription", requires physician supervision for the purchase of legend drugs.

Also, over the counter drugs without medical supervision are required to have on the label: Product Name, Name and Address of manufacturer, Active ingredients, quantities of all other ingredients whether active or not

1962 Kefauver-Harris Amendment

All drugs made from 1938 forward must be proven save and effective. Also the FTC now handles drug advertisement. Stricter requirements for drug approval. Manufacturers must now register annually, be inspected ever 2 years, and report adverse effects of drugs.

1970 Comprehensive Drug Abuse Prevention and Control Act

Enacted to enforce the laws concerning controlled substances and their distribution.

Stair-step schedule of controlled substances introduced (I-V)

1970 Poison Prevention Packaging Act

This act required childproof packaging on most drugs dispensed in a pharmacy. Drugs that are exempt from this act are drugs used in emergency situations, such as dispensing nitroglycerin, or if a drug is packaged in such a small quantity it would not hurt a child under 5 years old.

*Exceptions:

(1) physician requests for non-childhood proof caps for their patients

(2) certain legend drugs

(3) hospitalized patients

(4) a specific request by the patient

1972 Drug Listing Act: National Drug Code (NDC)

Implemented under the authority of the FDS

Every drug has a unique 10-digit number divided into three segments

*Segment 1 - Labeler Code: Assigned by the FDA

*Segment 2 - Product Code: Identifies the specifics of the product

*Segment 3 - Package Code: Identifies the specifics of the package size and types

*2 and 3 are set by the drug company

1983 Orphan Drug Act

Provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases (1 in 200,000)

1987 Prescription Drug Marketing Act (PDMA)

Addressed issues related to the distribution and wholesale pedigree of human prescription drugs. To solidify the legal supply channel of prescription drugs from manufacturers to authorized distributors and wholesalers.

Helps to avoid counterfeit drugs and ingredients in the supply chain and limit diversion of pharmaceutical samples and prescription drugs.

1990 Anabolic Steroids Control Act (ASCA)

Amends the Controlled Substances Act to add anabolic steroids as a schedule III substance and define "anabolic steroid" as any drug or hormonal substance that promotes muscle growth in a manner pharmacological similar to testosterone

1990 Omnibus Budget Reconciliation Act (OBRA)

Pharmacists were required to participate in helping to provide medication to elderly and low-income individuals.

Medicare (over 65) and Medicaid

*(1) Evaluation of drug therapy

*(2) Review of drug therapy

*(3) DUE board review

*Pharmacies must now counsel all patients on medications that have been prescribed.

*A patient may refuse counseling

*all Medicaid patients who receive new prescription

1994 Dietary Supplement Health and Education Act

This act better defines the term dietary supplements; consumers must be informed of health-related benefits; manufacturers of these supplements are held to the same regulations; labels cannot mislead consumers and must include nutritional values.

1996 Health Insurance Portability and Accountability Act (HIPAA)

Federal Act for protecting patients' rights, establishing national standards for electronic health care communication, and ensuring the security and privacy of health data.

*electronic, paper, or oral

1997 FDA Modernization Act

Which act eliminated the requirement for the Legend statement, provided the labeling contained the words "Rx only."

2000 Drug Addiction Treatment Act (DATA)

Permits physicians to prescribe controlled substances

2003 Medicare Modernization Act

Provides a drug discount card to those with low incomes who require assistance from a pharmacy company to obtain medications

*provides assistance to people older than age 65

*provides assistance to people under 65 with disabilities and individuals with end-stage renal failure

2005 Combat Methamphetamine Epidemic Act

Addresses all areas related to manufacture of, enforcement of laws pertaining to, and sale of pseudoephedrine, which can be used to create methamphetamine.

*Customer requirements: photo id and sign a log book

*The maximum amount sold may not exceed:

- 3.6 g in a calendar day

- 9 g per 30 days retail

- 7.5 g per 30 days via mail order

*Documentation may be done electrically or via a bound log book

*Pseudoephedrine storage: Behind the country or locked in a cabinet

*Records of all information must be kept for at least 2 years

*Documentation required:

- Drug name, strength, amount

- Date/Time of sale

- Customer's name, address, and signature

2010 Patient Protection and Affordable Care Act

Makes preventative care more accessible and affordable for many Americans

2013 Drug Quality and Security Act

Gives FDA greater oversight of bulk pharmaceutical compounding and enhances the agency's ability to track drugs through the distribution process.

Schedule I

Drugs are illegal and not approved for medical use because of their high potential for abuse or dependence

Schedule II

Drugs have a high potential abuse, potentially leading to severe psychological or physical dependence

(Vicodin, Methamphetamine, Methadone, Dilaudid (hydromorphone), OxyContin (Oxycodone), Fentanyl, Adderall, Ritalin, Percocet)

Schedule III

Drugs have moderate to low potential for physical or psychological dependence or abuse

(Tylenol with Codeine, Ketamine, Anabolic steroids, Testosterone)

Schedule IV

Drugs have a low potential of dependence or abuse

(Xanax, Soma, Valium, Ativan,Talwin, Ambien, Tramadol, Restoril)

Schedule V

Drugs have the lowest potential for abuse or dependence

(Robitussin AC, Lyrica, Phenergan AC)

Pregnancy Category A

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

(Levothyroxine, Folic Acid, Liothyronine)

Pregnancy Category B

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

(Metformin, Hyrdochlorothoazide, Cyclobenzaprine, Amoxicillin, Pantoprazole)

Pregnancy Category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

(Tramadol, Gabapentin, Amlodiphine, Trazodone)

Pregnancy Category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

(Lisinopril, Alprazolam, Losartan, Clonazepam, Lorazepam)

Pregnancy Category X

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

(Atorvastatin, Simvastatin, Warfarin, Methotrexate, Finasteride)

DEA 41 (return drugs)

registrats inventory of contolled substance drugs surrendreed, used to return drugs to the DEA or other acceptable recipient

DEA 82 (form of inspection)

notice of inspection of controlled premises, used to inform a registrant that an inspection will be made

DEA 104 (close a pharmacy)

voluntary surrender of controlled substance privileges, used to surrender permit to teh DEA on a voluntary basis. mostcommonly used to close a pharmacy

DEA 106 (lost or stolen)

Used to report lost or stolen controlled substances.

DEA 222

order form for sched I and II drugs - used to order from another registrant. retail and hospital pharmacies would rarely order CI. nany sale or transfer of CII drugs between registrants (wholesaler to retail pharmacy or hospital) uses this form

DEA 222a

Used to obtain DEA form 222 from the DEA

DEA 224

new app for regisration under controlled substances act of 1970. Form used by retail pharmacies hospitals, clinics, practitionsers and teaching institutions to be licensed to obtain and or ispense controlled substances

DEA 225

new app for registration under controlled substances act of 1970. form used by manufacturers, wholesalers, distributors, importers, exporters, most research activities to obtain and use controlled substances

DEA 226

app for re-registration of controlled substances privilieged by retail pharmacies, hospitals, clinics, practitioners, and teachgin institutions to obtain or dispense controlled meds

DEA 363

registration for narcotic tax programs - used to obtain approval to operate a narcotic tx program using controlled substance agents

Drug Utilization Evaluation (DUE)

A process that ensures that prescribed drugs are used appropriately. The main desired outcome of an DUE program is an increase in medication-related efficacy and safety.

Boxed Warning

Drug warning that is placed in the prescribing information or package insert of the product and indicates a significant risk of potentially dangerous side effects.

*The strongest warning the FDA can give

*Common in the pharmacy profession to call these warnings "Black Box Warnings"

*The warning is often enclosed in black outlined box to draw attention to the content

Drug Diversion

The intentional misuse of a drug intended for medical purposes;

The recreational use of a prescription or scheduled drug; illegal

Protected Health Information (PHI)

A term used to describe a patient's personal health data. Under HIPAA, this information is protected from being shared or distributed without permission.

Risk Evaluation and Mitigation Strategies (REMS)

Ensures that the benefits of a drug or biological product outweigh its risks.