Pharmacy Law, Ethics, & Regulatory Agencies

Department of Health and Human Services

FDA is under the direction of the ___

FDA

Main function is to enforce guidelines for manufacturers to ensure safety and effectiveness of medications

Pure Food and Drug Act (1906)

Enacted to stop the sale of inaccurately labeled drugs. Manufacturers were required to: Provide truthful information on the label before a drug was sold, prove the drug's effectiveness

Harrison Narcotics Act (1914)

Enacted to curb recreational use of opium. No longer available without a prescription, records required for prescriptions, importation and distribution were restricted

Food, Drug, and Cosmetic Act (1938)

Enacted because the 1906 law was not worded strictly enough and did not include cosmetics. Required drug companies to include directions to the consumer regarding use of a drug, and also package inserts, all addictive substances had to be labeled: "Warning: May be habit forming"

Durham-Humphrey Amendment (1951)

Required label on prescription drugs: "Caution: Federal law prohibits dispensing without a prescription." Required a doctor's order and supervision for certain drugs, made the initial distinction between legend drugs and OTC medications

Kefauver-Harris Amendments (1962)

Enacted in an attempt to ensure the safety and effectiveness of all new drugs on the market. Burden put on manufacturers to ensure "good manufacturing practice" (GMP), prevented the sale of thalidomide in the United States.

Comprehensive Drug Abuse Prevention and Control Act (1970)

Established the Drug Enforcement Administration (DEA) to enforce the laws covering controlled substances and their distribution. Created stair-step categories of controlled substances (Schedules I- V)

DEA

The ___ issues physicians a ___ license number enabling them to write Rx for controlled substances

DEA

The ___ also issues licenses to pharmacies enabling them to order controlled substances from a wholesaler

Poison Prevention Packaging Act (1970)

Required all medications to be placed in containers with childproof caps or packaging. Exceptions include: Physician request for non-childproof cap, certain legend medications, emergency medications, patient or physician's request, and hospitalized patients or patient request

Drug Listing Act - National Drug Code (NDC) (1972)

A 10-digit number composed of 3 segments that is completely unique in identifying the label, product, and package size/type.

First segment of NDC

labeler code, assigned by the FDA. A labeler is any firm that manufactures (including re-packers or re-labelers), or distributes (under its own name) the drug

Second segment of NDC

product code, identifies a specific strength, dosage form, and formulation for a particular firm

Third segment of NDC

package code, identifies package sizes and types

NDC

The ___ will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1

Orphan Drug Act (1983)

Eased restrictions (and thus costs) for development of new drugs for those with a rare disease (affecting 1 in 200,000 people)

Prescription Drug Marketing Act (1987)

Helps prevent counterfeit drugs and ingredients from entering the supply chain, limits diversion of pharmaceutical samples and prescription drugs

Omnibus Budget Reconciliation Act (OBRA '90) (1990)

Enacted because of reimbursement regulations for people who are covered by Medicaid or Medicare. Requires pharmacists to counsel (at the time of purchase) all patients who receive new prescriptions; a patient can refuse counselling.

Drug Utilization Evaluation (DUE)

Also known as, Drug Utilization Review (DUR). Required review of healthcare provider prescribing, pharmacist dispensing, and patient use of medication for appropriateness. This can include, but not limited to, review of possible drug interactions, appropriateness of dosage and duration of therapy, and contraindications.

Evaluation of drug therapy, review of drug therapy, DUE board review

Three provisions of the Drug Utilization Evaluation (DUE)

Medicaid

State government insurance for the low income where patient may not pay any portion or have a shared-cost Medicaid (deductible); it may or may not include prescription benefits.

Health Insurance Portability and Accountability Act (HIPAA)

Deals with patient's right to continuance of health insurance even when changing employers; pharmacists and technicians have direct knowledge of a patient's medical information.

Patient Confidentiality

Prevents privileged information about a customer from being disclosed without his or her consent

Protected Health Information (PHI)

May be disclosed to public health authorities, entities subject to FDA regulation, those who have been exposed to a communicable disease, or employers regarding work-related illness/injury and safety to comply with OSHA

Drug Addiction Treatment Act (DATA 2000)

Physicians can prescribe controlled substances to persons suffering from opioid addiction; only for maintenance or detoxification treatments; the first letter in the DEA number begins with X

Medicare Modernization Act (2003)

Government insurance for seniors and for those with long-term disabilities under the age of 65, such as dialysis patients; pays for some medical devices such as walkers, breathing machines, some diabetic supplies, and bedside commodes

Combat Meth Act (2005)

Addresses all areas of the manufacture and sale of pseudoephedrine (an ingredient used to make methamphetamine); only a licensed pharmacist or technician may dispense, sell, or distribute this drug and is limited to 3.6 g per calendar day, 9g per 30 days from a retailer, 7.5 g per 30 days by mail order

Affordable Care Act (ACA) (2010)

Includes two important technician-related components, electronic health records (EHR) and medication therapy management (MTM)

Drug Quality and Security Act (2013)

FDA tracking system for bulk compounding supplies

FDA

Prevents illegal distribution and misuse of controlled substances; issues licenses and enforces the nation's drug laws

1-800-FDA-1088

Toll-free number for reporting any defect in OTC medications and any other drug problems

MedWatch

FDA program that allows consumers and health care professionals to report any discrepancies, drug errors and adverse reactions to medications

Class 1 Recall

Products that could cause serious harm or prove fatal

Class 2 Recall

Products found to cause a temporary health problem or pose a slight threat of serious harm

Class 3 Recall

Products that may have a minor defect or other condition that would not harm the patient

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; also affects mood and behavior

Opioids

Such as codeine and morphine, substances created from opium

Class 1 Drug

Strongest potential for abuse; no medicinal use in the United States (for example, LSD, heroin)

Class 2 Drug

Must be locked up because of high potential abuse.

Class 5 Drug

Kept OTC in some states because of low potential abuse and is considered an exempt controlled substance

Tamper-Proof Prescriptions

New scripts have up to eight different tamper proof security marks on them; prevents forgery and fraud

DEA Form 224

Needed by pharmacy to dispense controlled substances

DEA Form 225

To manufacture or distribute controlled substances

DEA Form 363

To run a narcotic treatment program or compound narcotics

DEA Form 222

Used for the purchasing and returning of outdated CII drugs (three part copies to it) and there are ten lines on each order form; only one item may be entered per line

DEA Form 41

Returns to reverse distributor damaged, outdated or unwanted controlled substances

3, 5

Drugs rated Class ___ through ___ can be refilled a maximum of five times or within 6 months of the original order, whichever comes first

2

Pharmacies must physically count Schedule ___ drugs every two years

Controlled Substance Act

Requires pharmacies to purchase class-Il controlled substances with DEA form 222 (Triplicate)

Copy 1 and 2

sent to the supplier

Copy 1

(original; brown) retained by the supplier

Copy 2

(first carbon copy; green) is forwarded to the DEA

Copy 3

(second carbon copy; blue) stays with the Pharmacist (the purchaser)

DEA Form 222

Must be filled out in pen, typewriter, or indelible pencil and can be signed by the pharmacist who signed Form 224 (registration of new pharmacy) or the person who has been the legally designated Power of Attorney by that pharmacist

Bottom, 2

For controlled substances, the pharmacy retains ___ copy; invoices and forms must be kept onsite (in-store) and made readily available for inspection for ___ years.

3, 5

For drugs class ___ to ___, they are ordered on normal invoice forms but must be filed and retained for DEA or board of pharmacy (BOP) inspection

3

Federal law allows the choice of one of ___ different prescription-filing methods

Perpetual Inventory

Pharmacist must validate all counts done by a technician

Reverse Distributor

All controlled substances that are unwanted, unusable, or outdated that are returned to the distributor

Drug Diversion

intentional misuse of a drug intended for medical purposes or recreational use of a prescription or a scheduled drug

Class 2-5 Drugs

Its original fill is written, oral, or fax

Emergency Class 2 Drugs

Its original fill is a verbal order only in emergency situations

Class 2 Drugs

It has no refills

Class 3-4 Drugs

It can be refilled 5 times within 6 months

Class 5 Drugs

It has no restrictions on refills

Class 3-5 Drugs

Must have remainder dispensed within 6 months if it is partially filled

Class 2 Drugs

Must have remainder dispensed within 72 hours if it is partially filled

Class 3-5 Drugs

Drugs may be transferred only once

Class 2-5 Controlled Substances

May be mailed as long as contents are not identified on packaging

Monographs/Package Inserts

Contained in the Physicians' Desk Reference (PDR) in doctor's office and Facts and Comparisons in pharmacy; includes description, clinical pharmacology, indications and usage, contraindications, warnings, precautions, etc.

MedGuides

Printouts required for certain medications

Category X

Pregnancy category not to be used during pregnancy highest degree of teratogenicity

Category A

Pregnancy category with no evidence of harm based on studies

Categories B-D

Pregnancy categories with various levels of risk

Pharmacy Technicians

Take in prescriptions, interpret them, and fill them; cannot take phone orders

Pharmacists

Give the final check, take verbal telephone orders, and transfer prescriptions to another pharmacy

Prescription Labels

Include name, address, and phone number of the pharmacy; name of prescriber and date prescription was filled; prescription number and cautions

DEA

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

2, prescriber, 7

First ___ characters will be the letter: A, B, F, G, M, or X followed by the first letter of the ___'s last name Next ___ digits are composed of numbers added together

P, R

If the first character begins with the identifier ___ or ___ they are typically one of the following… manufacturer, distributor, researcher, analytical lab, importer, exporter, reverse distributor, or a narcotic treatment program.

1, 3, 5

To verify the DEA #, first add the ___st, ___rd, and ___th digits together = Sum1

2, 4, 6, 2

To verify the DEA #, secondly add the ___nd, ___th, and ___th digits together then multiply the sum by ___ = Sum2

Sum1, Sum2

To verify the DEA #, thirdly add ___ and ___ together = Sum3

Sum3, 7

To verify the DEA #, fourthly the last digit of ___ should match the ___th digit of the given DEA#

Programs for opioid maintenance

Methadone maintenance treatment (MMT), Suboxone and Subutex

Risk management programs for prescription drugs

iPledge Program

E-Pharmacies

National Association of Boards of Pharmacies (NABP) verifies these sites but does not regulate them; potential for illegally ordered drugs

Material safety data sheet (MSDS)

A U.S. government-managed entity that oversees safety in the workplace

Safety Data Sheet (SDS)

Must be available for all chemicals; includes information on storage requirements, handling, and what to do in case of a spill or contact with the eyes.

The Joint Commission

Mission is to improve the safety and quality of care via accreditation of healthcare organizations

Morals

A person's beliefs concerning right and wrong

Ethics

A set of values used in a profession