Pharmacy Law Flashcards
Food and Drug Administration (FDA)
Established in 1862, under US Department of Health and Human Services is the oldest consumer protection agency in the US federal government.
consists of chemists, physicians, veterinarians, lawyers, pharmacists and microbiologists
investigates the adulteration and misbranding of agricultural goods used for food and drugs
Harvey Wiley
Changed the direction of the FDA by establishing scientific authority. He researched the effects of chemical preservatives used in the production of foods and drugs.
His consumer safety focused research yielded the following:
exposing potential hazards in products and food
Paved the way for government regulations
In 1902,13 children and 9 babies died after they were injected with a tainted batch of tetanus diphtheria antitoxins
1906 Pure Food and Drug Act
One of the first laws enacted to stop the sale of inaccurately labeled drugs
All manufacturers were required to have truthful information on the label prior to selling
drugs had to meet the standards of strength, quality, and purity
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
Implemented restrictions regarding the importation, sale and distribution of opium, coca leaves and any derivative products
Individuals could no longer purchase opium without a prescription and therefore harder to get for nonmedical purposes
1938 Federal Food, Drug, and Cosmetic Act
Important concepts of this act were adulteration, misbranding, and providing the legal status for the FDA
all addictive substances were required to be labeled
“Warning: May be habit forming.”
Manufacturers had to prove to the FDA that a drug was safe for use before marketing it
In 1937, a Tennessee drug company advertised a sulfanilamide elixir for children
The solvent was untested and more than 100 people, mostly children, died
Its chemical makeup was similar to antifreeze
1951 Durham-Humphrey Amendment
Made the initial distinction between legend drugs and OTC medications that do not require a physician’s order
Required labeling “Caution: Federal law prohibits dispensing without a prescription”
1962 Kefauver-Harris Drug Amendment
Ensured safety and effective of all new medications in the US market
Manufacturers now had to prove safety and provide substantial evidence of effectiveness for the drug’s intended use
Had to include adequate and well controlled studies
Required drug related adverse events reported to the FDA
Prevented the sale of the sedative thalidomide
* Use in Europe found to cause severe birth defects (phocomelia - missing or deformed limbs), when administered during pregnancy. It was never approved for use in the US
Also known at the Controlled Substance Act
1970 Comprehensive Drug Abuse Prevention and Control Act
Formed the DEA to enforce the laws concerning controlled substances and their distribution and introduced a stair-step schedule of controlled substances
Came out of a growing concern of the use and abuse of amphetamines and barbiturates and other potentially addictive agents
Barbiturates - derived from barbituric acid; often used in the treatment of seizures and as sedative and hypnotic agents; depresses the central nervous system
1970 Poison Prevention Packaging Act
Requires manufacturers and pharmacies to place all mediations in containers with childproof caps or packing, including both over-the-counter and legend drugs
Includes OTC and prescription medications
Exceptions include physician requests for non-childproof caps for patients; certain legend medications, hospitalized patients or specific patient request
Its estimated 1.4 million childhood deaths are prevented annually due to childproof caps
1983 Orphan Drug Act
Encouraged drug companies to develop drugs for rare diseases by providing research assistance, grants and cost incentives to manufacturers.
Diseases like AIDS, cancer, and genetic diseases
Provided marketing exclusivity for orphan drugs for 7 years after FDA approval
1987 Prescription Drug Marketing Act
Helps to avoid counterfeit drugs and ingredients in the supply chain and also helps limit diversion of pharmaceutical samples and prescription drugs
The intent was to solidify the legal supply channel of prescription drugs from manufacturers to authorized distributors/wholesalers
Required chain of custody paperwork
1972 Drug Listing Act
Amends the Federal Food, Drug, and Cosmetic Act
Prevents unfair or deceptive packaging and labeling
Provides the FDA with an accurate list of all drugs manufactured, prepared, propagated, compounded or processed by a drug establishment
Introduces the practice of the National Drug Code (NDC)
1987 Omnibus Budget Reconciliation Act (OBRA ‘87)
1987 (original act) addressed the problems regarding quality healthcare for the elderly
Increasing number of elderly entering nursing homes, concerns over substandard care, high nursing personnel-to-patient ratio and unhealthy conditions rose
Set requirements for facilities participating Medicare and Medicaid programs
Addressed enforcement procedures; minimum standard of care was required
1990 Omnibus Budget Reconciliation Act (OBRA ‘90)
This act outlined specifics for pharmacies to participate in the Medicaid Drug Rebate program.
Pharmacist must offer a consult at time of purchase
Includes programs to alert pharmacists to possible drug interaction, precautions and other patient pertinent information
Three main provisions
Evaluation of therapy
Review of drug therapy
Drug Utilization Evaluation board review
Medicaid - federal and state operated insurance program that covers health care costs and Rx drugs for low income children, adults, elderly, and those with disability
Medicare - federal and state managed insurance program that covers health care costs and Rx drug for individuals older that 65, persons younger than 65 with long term disabilities, and individuals with end-stage renal disease
1996 Health Insurance Portability and Accountability Act (HIPAA)
Federal act for protecting patients; rights, establishing national standards for electronic health care communications, and ensure the security and privacy of health data
Established the principle of protected health information (PHI)
Protects all individually identifiable health information
Includes electronic, paper, verbal, or media sources
If electronic correspondence is used, all information transmitted must be encrypted
Confidentiality - keeping privilege information about a patient/customer from being disclosed without prior consent (information may cause patient embarrassment or harm)
Under federal law, patients have the right to privacy concerning their medication, treatment, or any aspect of their health care
Disclosure - pharmacy personnel can speak with other pertinent health care providers, insurance companies and the patient about coverage or medication
