The Poison Prevention Packaging Act (PPPA) was enacted in 1970 under the Consumer Product Safety Commission. It requires certain substances to be in special child-resistant packaging so that children under the age of 5 cannot open the packaging easily. Exceptions can be made for the elderly and those with certain conditions, like arthritis of the hand, upon special request.
The Federal Drug Administration(FDA) was formed by enacting 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 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 enacted 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 the drug is both safe and effective as a prerequisite for FDA approval.
HIPAA, or 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 or protected health information is any individually identifiable health information which includes name, date of birth, SSN, address, date of treatment, phone numbers, driver’s license number, email id, full face images, health plan data like ID numbers etc. PHI must be protected by law and pharmacies are legally required to safeguard PHI and take steps to prevent security breaches. In a pharmacy setting, PHI is utilized while processing prescriptions, in patient profiles, insurance processing, billing and storing and handling medical records. The HIPAA Privacy Rule gives patients the right to obtain copies of their PHI on request. PHI such as prescription labels, labeled prescription bottles etc must be disposed of in opaque bags in a secure area and should be destroyed by shredding, pulverizing or by incineration. Pharmacies are required to provide a notice of privacy practices in clear and concise language, to their patients explaining how their PHI is used and disclosed, patient rights and the legal obligation of the pharmacy to protect patient PHI and prevent unauthorized access. The notice of privacy practices must be prominently displayed in the pharmacy and be provided for 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:
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 the Medicaid beneficiaries but has now been applied to all patients. Under the act, it is mandatory for the pharmacist to counsel patients and conduct a drug utilization review to prevent over or under utilization of a medication, incorrect dosing, prevent drug duplications, drug abuse or misuse, prevent drug contraindications and drug allergies. It also mandates to keep patient records by creating and updating a patient profile that includes the following information -
Components of a patient profile are as follows:
ETASU: ETASU is an acronym for “elements to assure safe use”. It consists of requirements and activities that aim to assure drug safety. ETASU are mandated under risk mitigation and drug safety programs like REMS. Examples include requiring prescribers, pharmacies and staff to undergo certification or training before dispensing high-risk medications, allowing certain drugs to be administered or dispensed in controlled settings only e.g., hospitals, requiring patients taking a particular drug to undergo laboratory testing, periodic health monitoring or enrolling in a registry.
P, D, and U listed medications: Under RCRA law, P, D, and U listed medications are labeled as hazardous waste and they have to be disposed of as per 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. It includes the medications as well as devices like syringes, that are 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 as 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.
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