02: Pharmacy Law, Ethics, and Regulatory Agencies

Food and Drug Administration (FDA)

Agency within DHHS whose main function is to enforce manufacturing standards to ensure the safety and effectiveness of human and veterinary drugs, biological products, medical devices, the national food supply, cosmetics and radioactive products.

Adulteration

The mishandling of medication that can lead to contamination or impurity, falsification of contents, or loss of drug quality or potency. This may cause injury or illness to the consumer.

Misbranding

Labeling of a product that is false or misleading; label information must include directions for use; safe or unsafe dosages; manufacturer; quantity and weight.

Act

A statutory plan passed by Congress or any legislature that is a "bill" until it is enacted and becomes law.

Amendment

A change in the original act or law.

Pure Food and Drug Act of 1906 (Wiley Act)

One of the first laws enacted to stop the sale of inaccurately labeled drugs. Gave FDA power to prohibit the interstate transport of unlawful food and drugs. Drugs had to met the standards of strength, quality, and purity established by the USP and the NF. This act established standards that prohibit misbranding, adulteration and misleading labeling of any products before they are provided to consumers.

United States Pharmacopeia (USP)

An independent nonprofit organization that establishes documentation on product quality standards, drug quality and information, and health care information on medications, OTC products, dietary supplements and food ingredients to ensure that they have the appropriate, purity, quality and strength.

National Formulary (NF)

A publication of the USP that contains standards for medications, dosage forms, drug substances, excipients, medical devices, and dietary supplements.

Harrison Narcotics Act of 1914

Was enacted in parallel with international treaties to curb recreational use of opium. Individuals could no longer purchase opium without a prescription. This act required practitioner registration, documentation regarding dispensing and placed restrictions on the importation, sale and distribution of opium, coca leaves and any derivative products.

Federal Food, Drug and Cosmetic Act of 1938

This act was enacted because PFDA was not worded strictly enough and did not include cosmetics. This act granted legal status to FDA, and defined adulteration and misbranding as illegal. This act required package inserts and directions to the consumer regarding safe use. All addictive substances were required to be labeled "Warning: May be habit forming."

Durham-Humphrey Amendment of 1951

This law added more instructions for drug companies and made the initial distinction between legend drugs and OTC medications. It required the labeling "Caution: Federal law prohibits dispensing without a prescription."

Legend Drug

Drug that requires a prescription for dispensing; these drugs carry the warning: "Federal law prohibits the dispensing of this medication without a prescription." Pharmacy technicians are prohibited from receiving phone orders for prescription drugs. A pharmacist must translate any verbal orders into written form. Also if a patient wants a prescription transferred to another pharmacy, this transaction must be done between licensed pharmacists.

Over-the-Counter (OTC)

Describes medication that can be purchased without a prescription (i.e. nonprescription drugs or nonlegend medications).

Kefauver-Harris Amendments of 1962

This law ensures the safety and effectiveness of all new drugs on the U.S. market. It gave the FDA specific authority to approve a manufacturer's marketing application before a drug could be made available for commercial use. Manufacturers must conduct adequate, well-controlled clinical studies to prove that a drug is safe and effective before marketing. Drug-related adverse events must be reported to the FDA. Drug companies must ensure quality using GMP standards.

Controlled Substance Act of 1970

Under this act the DEA was formed to enforce the laws concerning controlled substances. A five-level stair-step schedule of controlled substances was introduced based on the drugs intended medical use and abuse potential.

Poison Prevention Packaging Act of 1970

This act requires childproof caps for all OTC and legend drugs with certain exceptions. Medication should not be able to be opened by at least 80% of children under the age of 5 and that at least 90% of adults should be able to open the medication within 5 minutes. Exemptions to this act include: physician or patient requests non-childproof caps; for hospitalized patients; or for certain legend medications. Nitroglycerin is the only medication that does not have a dosage limit for filling the prescription without a childproof cap. Other exceptions include oral contraceptives and various inhalers because of their unique design.

Drug Listing Act of 1972

Mandated the use of the NDC for both prescription and insulin drugs. A drug is not included in the NDC directory until the manufacturer has complied with all FDA requirements.

National Drug Code (NDC)

A 10-digit number that specifies three things about a prescription drug or an insulin product: 1) Labeler code identifies the drug company and is assigned by the FDA. 2) Product code identifies the specific strength, dosage form and formulation and is assigned by the drug company. 3)Package code identifies package types and sizes and is assigned by the drug company. If this number contains two asterisks at the end, this identifies the product is a nonformulated controlled substance in bulk or raw form.

Orphan Drug Act of 1983

This act encouraged drug companies to develop drugs for rare diseases that affected fewer than 200,000 people. Incentives include providing research grants, waiving lengthy testing requirements, and granting exclusive marketing rights for 7 years after FDA approval.

Prescription Drug Marketing Act of 1987

The intent of this act is to prevent counterfeit drugs and to limit diversion of pharmaceutical samples and prescription drugs. This is accomplished by solidifying the legal supply channel of prescription drugs from manufacturers to authorized distributors.

Omnibus Budget Reconciliation Act of 1990

This act changed reimbursement limits and outlines specifics for pharmacies to participate in the Medicaid Drug Rebate Program. Three important provisions include: 1) Evaluation of drug therapy - before a prescription is filled a pharmacist must offer to counsel all Medicaid patients who receive new prescriptions. 2) Long-term review of drug therapy - with educational outreach programs. 3) DUE board review - to improve care and reduce cost. Pharmacies must document and maintain records to track consultations and outcomes.

Medicaid

Federal and state operated insurance program that covers health care costs and prescription drugs for low-income children, adults, and elderly and those with disabilities.

Drug Utilization Evaluation (DUE)

A process that ensures that prescribed drugs are used appropriately. The main desired outcome is an increase in medication-related efficacy and safety. This process must include computer programs that alert the pharmacist to possible drug interactions. This process was mandated by OBRA '90.

Health Insurance Portability and Accountability Act of 1996

Federal act that protects patients rights, establishes national standards for electronic health care communication, and ensures the security and privacy of health data. This act established the principle of PHI and requires the sender of electronic PHI to use encryption.

Protected Health Information (PHI)

A term used to describe a patient's personal medical data. Under HIPAA, this information is prevented from being shared or distributed without permission. The Privacy Rule protects all individually identifiable data. Patient information must be communicated on a need-to-know basis only with a covered entity. However, the Privacy Rule permits certain persons identified by the patient to receive information that is directly relevant to the patient's care or the patient's payment for health care.

Drug Addiction Treatment Act of 2000

This act permits physicians to prescribe DEA approved controlled substances (C-III, C-IV or C-V) for maintenance or detoxification treatments of opioid addiction. Physicians must complete a training course and must be registered with the DEA to prescribe these agents. When the prescriber has met all conditions, the DEA issues a special number starting with an X, identifying the individual as a qualified prescriber. Patients must be in a treatment program that provides additional support services.

Methadone Maintenance Treatment (MMT)

This C-II drug is used to treat patients addicted to opiates. Patients are to receive specialized treatment while taking this medication. No more than 1 day's supply may be filled by a pharmacy, and the medication must be taken in a physicians office.

Medicare Modernization Act of 2003

The act, administered under the Medicare Advantage program, provides a drug discount card to beneficiaries with low incomes who require drug company assistance to obtain medications. Offsetting high drug costs should reduce preventable hospitalizations resulting from lack of medication treatment.

Medicare

Federal and state managed insurance program that covers health care costs and prescription drugs for individuals older than 65, persons younger than 65 with long-term disabilities, and individuals with end-stage renal disease.

Combat Methamphetamine Epidemic Act of 2005

This act changed the status of pseudoephedrine (PSE) from OTC to BTC. Only a licensed pharmacist or technician may dispense, sell or distribute PSE, which must be stored behind the counter or locked in a cabinet. The maximum amount sold may not exceed 3.6 g (31 to 123 tablets) in a calendar day or 9 g (92 to 367 tablets) per 30 days. By law the package size is not to exceed 3 grams. Purchaser's identification must be provided. The purchaser must be at least 16 years of age. Records of required documentation must be kept for 2 years.

Patient Protection and Affordable Care Act of 2010

This comprehensive health care reform makes preventive care more accessible and affordable. The law requires health insurance companies to cover all applicants with new minimum standards, including individuals with preexisting conditions. Components of this act include Electronic health record (EHR) and e-prescribing. Medication therapy management (MTM) and Medicare Part D. Accountable care organizations (ACOs).

Drug Quality and Security Act of 2013

This act has two separate acts: The Compounding Quality Act gives the FDA greater oversight of bulk pharmaceutical compounding by creating a new class of oursourcing facilities which sell to hospitals in bulk. This arrangement enhances the FDA's ability to track drugs through the distribution process. The Drug Supply Chain Security Act uses a national track-and-trace pedigree bar coding system by manufacturers. This system allows FDA to combat counterfeit prescription medication.

Med Watch Program

This program allows consumers and health care professionals to report adverse drug reactions to the FDA. Any medication reaction that may cause disability, hospitalization, or death should be reported along with other types of reactions that may not have been listed in the drug monograph.

Classes of Recalls

The FDA may request a recall of items that have been found to be defective or somehow tainted. Class 1: The highest level, deals with products that could cause serious harm or prove fatal. This includes life-saving drugs or food labels that do not list potential allergens. Class 2: Deals with products found to cause a temporary health problem or a slight threat of serious harm. This includes drugs that are dispensed at less than the labeled strength. Class 3: The lowest level, used for products that have a minor defect that would not harm the patient.

Drug Enforcement Administration (DEA)

Federal agency within the Justice Department. The function of this agency is to prevent illegal distribution and misuse of controlled substances. The agencies primary role is to enforce the nation's federal drug laws.

Controlled Substance

Drugs are assigned ratings by the U.S. Attorney General depending on addictive and abuse potential, and are regulated by the DEA. C-I drugs have no acceptable medical purpose with very high abuse potential. Pharmacies do not stock these drugs and physicians cannot prescribe them. C-II are medicinal drugs having high potential for abuse which may lead to severe dependence. Consequently these drugs must be kept in a locked storage area before filling. Most C-III drugs are combination narcotics (Tylenol/codeine). C-IV and C-V have low potential for abuse and limited dependence. Schedule C-V are exempt and may be kept OTC (the purchaser must be at least 18 years old).

Barbiturate

A drug derived from barbituric acid; these drugs acts as a CNS depressant and are often used in the treatment of seizures and as sedative and hypnotic agents.

Narcotic

A nonspecific term used to describe a drug that in moderate doses dulls the senses, relieves pain, and induces profound sleep but in excessive doses causes stupor, coma or convulsions and may lead to addiction. From the standpoint of U.S. law, opiates, opioids and cocaine (coca leaves) fall into this category.

DEA Form 224

This is the only form needed by the pharmacy to dispense controlled substances. It must be renewed every 3 years.

DEA Form 222

This form is needed to order (or transfer) C-II drugs. This form must be completed by the pharmacy, and signed by the pharmacist who signed Form 224. The pharmacy sends the top copy and the middle (DEA) copy to the distributor. The pharmacy retains the bottom copy. When the medication is shipped to the pharmacy, a final count of the drugs must be completed then the middle (DEA) copy is forwarded to the DEA to prove that the medication has been properly received. The pharmacist compares the pharmacy's (bottom) copy to the invoice and signs and dates both which are retained for 2 years.

DEA Form 41

This form grants authorization to destroy damaged, outdated, or unwanted controlled substances. Retail pharmacies can request this form from the DEA only once a year. Hospitals may request a blanket destruction permission form. The disposal must be witnessed by a physician, pharmacist, RN or police officer who sign the form and forward it to the DEA.

Refilling Controlled Substances

C-II drugs may not be refilled, however physicians may write up to three separate C-II prescriptions at one time for multiple drugs, to be filled sequentially over 90 days. The date of each subsequent prescription must be written on the order, and the prescription cannot be filled before that date. C-III to C-V drugs can be refilled a maximum of 5 times or within 6 months from the original order, whichever comes first (i.e. unfilled prescriptions expire after 6 months).

Board of Pharmacy (BOP)

State organization that regulates the practice of pharmacy within the state.

Filing Prescriptions

The pharmacy is required by law to maintain the actual hard copy of all original prescriptions. The controlled substance act provided two options for filing prescriptions. Option 1 (three separate files): 1) C-II. 2) C-III, C-IV and C-V. 3) All non-controlled drugs dispensed. Option 2 (two separate files): 1) C-II. 2) all other drugs dispensed. If this method is used, a prescription for C-III, C-IV or C-V must be made readily retrievable by use of a red "C" stamp in the lower right hand corner. Note in both options C-II prescriptions are filed separately.

Controlled Substance Inventory

The pharmacy maintains a perpetual inventory of controlled substances; the technician must have exact counts of C-II substances at all times. The final count can be inventoried only by a licensed pharmacist. All records must be kept for 2 years and the DEA requires an inventory to be taken every 2 years. All discrepancies must be explained.

Emergency Filling of C-II Drugs

Although a C-II order may be called or faxed, the written signed prescription must be presented before it is actually dispensed. However in an emergency the C-II order may be dispensed but the physician has 7 days to produce the written signed prescription to the pharmacist.

Partial Filling of Controlled Drugs

Controlled drugs may be partially filled if the pharmacist does not have enough in stock. For C-II the remaining amount must be dispensed within 72 hours of the first fill. If this is not possible the pharmacist must notify the physician because no further quantity may be supplied after 3 days. For C-III, C-IV and C-V the remaining amount must be dispensed within 6 months.

Transferring of Controlled Drug Prescriptions

C-II prescriptions are not transferable because they can only be filled once (i.e. no refills). C-III, C-IV and C-V prescriptions may be transferred to another pharmacy one time only.

Monograph

Comprehensive information on a medication's actions within that class of drugs. Also lists generic and trade names, ingredients, dosages, side effects, adverse effects, how the patient should take the medication, and foods or other drugs (OTC medications, herbals) to avoid while taking the medication.

Physicians Desk Reference (PDR)

A reference book that compiles select manufacturer-provided package inserts and prescribing information useful for health professionals.

Drug Diversion

The intentional misuse of a drug intended for medical purposes; the DEA usually defines this as the recreational use of a prescription or a scheduled drug. It can also refer to the channeling of the prescription drug supply away from legal distribution and to the illegal street market.

Boxed Warning or

Black Box 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. This warning lists monitoring recommendations like blood tests that should be taken while using the medication. It also lists medications that cannot be taken at the same time. This is the strongest warning the FDA can give. Their outlined appearance on the drug label is to draw attention to the content.

MedGuides and Patient Package Inserts

These handouts are distributed by the pharmacy with each prescription. They contain FDA approved information that can help patients avoid serious adverse events (boxed warnings) as well as directions that are essential to the products effectiveness. The FDA requires certain drugs include specific information because of the possibility of adverse effects from the medication (REMS); interactions between food & drugs; and teratogenicity to an unborn fetus.

Pregnancy Category

FDA mandated labeling describing five levels that indicate the potential of a drug to cause fetal defects; the levels are based on the ratio of risks to benefits.

A: Clinical trials show no risk.

B: Animal studies show no risk no clinical trials exist.

C: Animal studies show risk no clinical trials exist.

D: Clinical trials show risk potential benefits warrant use.

X: Clinical trials show risk that outweigh benefits.

Risk Evaluation and Mitigation Strategy (REMS)

Certain drugs are placed in a restricted status for use. For these drugs the FDA requires manufactures to establish a special program to ensure that the benefits of a drug outweigh its risks. Restricted drugs have different levels of restrictions based on evaluation of risks to benefits. For example the FDA regulates isotretinoin under the iPledge program because it causes severe birth defects. This agent requires a MedGuide with boxed warning and there are restricted distribution guidelines that must be followed before a patient can receive a prescription.

Prescribing Authority

The FDA and DEA have no authority in determining prescribers. Each state has its own state board which regulates prescriber authorization. The scope of practice is determined by the person's degree. For example physicians (MD, DO) have unlimited, independent prescribing authority in every state. Other providers (DDS, Doctor of podiatry & DVM) have independent prescribing authority limited to their scope of practice in every state. Chiropractors have no prescribing authority in any state. Individuals who can prescribe controlled drugs must be registered with DEA Form 224. In some states pharmacists are granted prescribing privileges under a collaborative drug therapy management agreement.

DEA Number

All prescribers of controlled substances must be registered with the DEA. They are each issued a unique 9 character identification code. The first two characters are letters. The first letter is an A, B, F, M or X followed by the first letter of the prescribers last name. Prescribers who are qualified to order medications to treat opioid addiction are assigned an X. The letter M is assigned to midlevel practitioners (nurse practitioners and physician assistants). The next 7 digits are composed of numbers that form an equation which can be verified.

AJ1234892

1+3+8=12

2(2+4+9)=30

12+30=42

If the last digit from the total (2) matches the last digit in the DEA set (2) the number is valid.

Occupational Safety and Health Administration (OSHA)

The purpose of this Federal agency is to make the workplace safe for employees. This includes ensuring that the policies and procedures of the pharmacy are safe. This agency requires SDS availability for every potentially dangerous chemical used in the pharmacy.

Safety Data Sheet (SDS or MSDS)

A document providing chemical product information. It includes the product name, composition, hazards, toxicology and other information about the proper steps to take with spills, accidental exposure, handling and storage of the product. By law all chemicals used in the pharmacy must have this document on file in a binder.

Negligence

A legal concept that describes an action taken without the forethought that would have been taken by a reasonable person of similar competency; a mistake was made. Pharmacy technicians can be held accountable for their actions. Not understanding the specifics of a new rule or regulation and not seeking further guidance are unacceptable excuses because understanding is a fundamental competency of all pharmacy technicians.

Tort

An act that causes harm or injury to a person either intentionally or because of negligence. A negligent mistake can affect a person's ability to continue to work as a pharmacy technician and may result in punitive damages. An intentional mistake could result in imprisonment.

The Joint Commission (TJC)

An independent, nonprofit organization that accredits hospitals and other health care organizations in the U.S. Accreditation is required to be eligible for Medicare and Medicaid payments. Organizations must be surveyed at least every 3 years.

Ethics

The values and morals used within a profession. These are a set of standards that should be followed by anyone working in a field. One important standard is a clear responsibility to the patient. Patients have the right to receive goods that have been handled properly and are in good condition. Patients trust that their information will be treated as confidential. Pharmacy technicians must follow the pharmacy's policies to ensure that patients receive the best service possible. Pharmacy technicians have a responsibility to make informed decisions based on their specialized training.

Morals

A person's beliefs about what is right or wrong in human behavior. Ethics require professional behavior of a technician regardless of a patient's beliefs. When you accept the responsibility of serving the public, you accept work ethics that guide your behavior, even if they conflict with your beliefs about what is right or wrong. Respect is a key component of professional behavior in the pharmacy.