The Poison Prevention Packaging Act (PPPA) was enacted in 1970 under the Consumer Product Safety Commission. It requires certain substances to be packaged in special child-resistant containers so children under age 5 can’t open them easily. Exceptions may be made for older adults and for people with certain conditions (such as arthritis of the hand) upon special request.

The Food and Drug Administration (FDA) was formed by the Pure Food and Drug Act of 1906, which prohibited misleading drug labeling and created consumer protections for drug safety. The Federal Food, Drug, and Cosmetic Act (FDCA) of 1938 required manufacturers to provide proof of safety and effectiveness and to include adequate label information.

The Durham-Humphrey Amendment was enacted in 1951 to distinguish between over-the-counter and prescription drugs. The Kefauver-Harris Amendment, enacted in 1962, was passed in response to the thalidomide tragedy. It strengthened the FDCA and gave more regulatory power to the FDA. Thalidomide was prescribed to treat pregnancy-induced vomiting; it was later found to cause severe developmental and limb defects in the growing fetus. The amendment required drug manufacturers to prove to the FDA that a drug is both safe and effective as a prerequisite for FDA approval.

HIPAA in relation to a pharmacy

HIPAA (the Health Insurance Portability and Accountability Act) is a federal law passed in 1996 that establishes national standards to protect medical records and other personal health information.

PHI (protected health information) is any individually identifiable health information. This can include a person’s name, date of birth, SSN, address, date of treatment, phone number, driver’s license number, email ID, full-face images, and health plan data (such as ID numbers).

PHI must be protected by law, and pharmacies are legally required to safeguard it and take steps to prevent security breaches. In a pharmacy, PHI is used during prescription processing, in patient profiles, for insurance processing and billing, and when storing and handling medical records.

The HIPAA Privacy Rule gives patients the right to obtain copies of their PHI upon request.

PHI (such as prescription labels and labeled prescription bottles) must be disposed of in opaque bags in a secure area and destroyed by shredding, pulverizing, or incineration.

Pharmacies are required to provide a notice of privacy practices in clear, concise language. This notice explains:

• How PHI is used and disclosed
• Patient rights
• The pharmacy’s legal obligation to protect PHI and prevent unauthorized access

The notice of privacy practices must be prominently displayed in the pharmacy and provided to new customers.

Pharmacies must maintain prescription records, including electronic prescriptions, for at least two years from the transaction date. Schedule II drug prescriptions must be filed separately.

Prescription forgery: Preventing and reporting prescription forgery is a legal requirement. The following constitute red flags on a prescription.

Indicators of prescription forgery:

• Unusual doses, directions or quantities
• Unusually legible handwriting
• Lack of standard abbreviations
• Use of multiple colors or varying handwriting
• Prescription seems to be tampered with or photocopied

Prescription monitoring programs: Prescription drug monitoring programs, commonly known as PDMPs or PMPs, are statewide electronic databases that track the use of controlled substances throughout a state. They are used to prevent drug abuse, misuse, and drug diversion; prevent overdose; identify individuals at risk of drug abuse; and facilitate continuity of care in pain management.

Omnibus budget reconciliation act (OBRA): The OBRA act of 1990 includes mandates regarding patient care that were originally intended for Medicaid beneficiaries but have now been applied to all patients. Under the act, it is mandatory for the pharmacist to counsel patients and conduct a drug utilization review. This helps prevent over- or under-utilization of a medication, incorrect dosing, drug duplication, drug abuse or misuse, contraindications, and drug allergies.

OBRA also mandates maintaining patient records by creating and updating a patient profile that includes the following information.

Components of a patient profile are as follows:

1. Patient’s full name
2. Address and telephone number
3. Date of birth or age
4. Gender
5. Drug profile
6. Pharmacist comments
7. Chronic conditions, allergies and drug reactions

ETASU: ETASU is an acronym for “elements to assure safe use.” It consists of requirements and activities designed to assure drug safety. ETASU are mandated under risk mitigation and drug safety programs like REMS.

Examples include requiring prescribers, pharmacies, and staff to complete certification or training before dispensing high-risk medications; allowing certain drugs to be administered or dispensed only in controlled settings (e.g., hospitals); requiring patients taking a particular drug to undergo laboratory testing or periodic health monitoring; or enrolling patients in a registry.

P, D, and U listed medications: Under RCRA law, P, D, and U listed medications are labeled as hazardous waste and must be disposed of according to regulations. The EPA defines a commercial chemical product (for P- and U-list purposes) as a chemical that is either 100 percent pure, technical commercial grade, or the sole active ingredient in a chemical formulation.

P listed medications are considered more toxic than U listed medications. The P-list identifies acute hazardous wastes, while the U-list identifies hazardous wastes from discarded commercial chemical products.

P listed medications are acutely hazardous and highly toxic. They can cause death or irreversible illness even at low doses. This includes the medications as well as devices (like syringes) used to dispense them. Examples include warfarin, epinephrine, nicotine, cyanide, nitroglycerine, arsenic trioxide, and phentermine.

There are more than 400 U listed drugs. Examples include cyclophosphamide, diethylstilbestrol, formaldehyde, lindane, chloroform, lead acetate, and selenium dioxide.

D listed medications are considered hazardous because they have one or more of the following characteristics: toxic, corrosive, ignitable, or reactive. Examples include solutions with >24% alcohol, flammable liquids, compressed gasses, strong acids and alkalis, benzene-containing products, etc.