Pharmacy laws Flashcards
1
Q
1906 Pure Food and Drug Act
A
- 1st federal law regulating drugs
2. Enacted to stop the sale of inaccurately labeled drugs.
2
Q
1914 Harrison Narcotic Act
A
- Enacted because of the excessive number of opium addicts in the United States.
- People could no longer obtain opium without a prescription.
3
Q
1938 Food, Drug, and Cosmetic Act
A
- Enacted because of the 1906 Pure Food and Drug Act was not worded strictly enough and did not include cosmetics.
- Basis for pharmacy law today.
- All narcotics were required to be labeled “ Warning: May be habit- forming”.
- Required adequate directions for use ( package inserts)
- Definite the exact labeling for products and defined misbranding and adulteration as being illegal.
4
Q
1951 Durham-Humphrey Amendment
A
- Made the initial distinction between legend drugs (by prescription only) and non prescription (over-the-counter medications).
- Requires legend drugs be labeled “Caution: Federal law prohibits dispensing without a prescription”.
- Must be prescription by a licensed practitioner.
5
Q
1962 Kefauver-Harris Amendment
A
- Enacted in an attempt to ensure the safety and effectiveness of all new drugs on the market (both legend and OTC).
- Burden put on manufacturing companies to have good manufacturing practices (GMP)
- Prevented the sale of thalidomide in the United States because children were born with birth defects after use in pregnancy.
6
Q
1970 Comprehensive Drug Abuse Prevention and Control Act.
A
- The Drug Enforcement Agency (DEA) was formed to enforce the laws concerning narcotics and their distribution.
- Created controlled substance I-V
- Closed system allowing distribution of controlled substances to only those registered with DEA.
Established strict record keeping guidelines.
7
Q
1970 Poison Prevention Packaging Act (PPPA)
A
- Enacted to reduce accidental poisoning in children.
- Requires most OTC and legend drugs be packaged in child-resistant container.
- Exceptions to child resistant containers.
- Upon specific request of physician or written consent of elderly patient.
- Institutionalized patients.
- Certain emergency’ medication (sublingual nitroglycerin tablets)
8
Q
Occupational Safety and Health Act of 1970 (OSHA)
A
- Ensure a safe and healthful workplace for all employees .
- Requires a reporting system for job-related injuries and illness.
- Attempts to reduce hazards in the workplace and conduct audits to ensure compliance with the Act.
- Established universal precautions.
- Addresses air contaminants, flammable, combustible liquids, eye and skin protection, and hazard communications standards.
- OSHA requires use of Safety Data Sheets (SDSs), which are to be provided by the seller of a particular product to the purchaser.
9
Q
1972 Drug Listening Act: National Drug Code
A
- Implemented under the authority of the FDA
2. Every drug has a unique 10-digit number divided in to three segments.
10
Q
Orphan Drug Act of 1983
A
- Allowed drug companies to bypass the lengthy time requirements of testing a new drug and the cost that accompanied them to provide a medication to persons who had rare diseases.
- Also covers diseases that affect >200,000 if it could be proved that the cost of developing and testing the drug could not be recorded by the eventual sales.
11
Q
1987 Prescription Drug Marketing Act
A
- Maintain legal supply channel from mfg. to distributors and wholesalers.
- Prohibits sale or distribution of samples to anyone other than who can prescribe them.
- Controlled the use of drugs in animals.
- Required the labeling “Caution: Federal law restricts this drug to use by or in order of a licensed veterinarian”.
12
Q
1990 Omnibus Budget Reconcilaiation Act (OBRA 90)
A
- Set limitations on Medicare and Medicaid reimbursement for medications.
- All medication prescribed would be reviewed for appropriateness
- States that a pharmacist must counsel (at the time of purchase) all patients who receive new prescriptions.
- All patients must be given information on the drug that they taking, its name, when to take it, how long to take it, and any side effects or possible interactions.
- Act created need for pharmacy technicians .
13
Q
Resource Conservation and Recovery Act (RCRA)
A
- General guidelines for the waste management program envisionsed by Congress.
- Hazardous waste- waste with properties that make it dangerous or potientially harmful to human health of environment.
14
Q
Health INsurance Portability and Accountablity Act of 1996 (HIPAA)
A
- Deals with patients right to continuance of health insurance even when changing employers.
- Confidentially: Technician has direct knowledge of patients medical info on a daily basis, so patients sign a consent form to grant access to this information.
THIS INCLUDES:
-Any info created or received by the pharmacy
-any info relating to patients health
-Info that may identify a patient.
15
Q
200 Drug Addiction Treatment Act
A
- Permits physicians to prescribe controlled substances in schedules C-III, C-IV, C-V to individuals suffering from opioid addiction for the purpose of maintenance or detoxification treatments.
16
Q
2003 Medicare Prescription and Moderization Act
A
- Medicare is a government- managed insure program that provides assistance to people older than age 65.
- Younger than 65 with disabilities and individuals with end-stage renal failure.
17
Q
Isotretinoin Saftey and Risk Manangemetn Act of 2004
A
- Regulates use of Accutane.
- Powerful medication used to treat acne. - Can cause severe birth defects and adverse psychiatric effects (depression/suicide)
18
Q
2004 Anabolic Steroid Control Act
A
- Placed anabolic steroids on Schedule III
- Harsher penalties for the abuse of anabolic steroids and their misuse by athletes.
- Amended in 2004 (stricter).
19
Q
2005 COmbact Meth Act
A
- Bill addresses all areas of maufacturing, law enforcement, and sale of ephedrine and pseudoephedrine, which is used as an ingredient in the preparation of methamphetmine.
- Strict guildlines: only a licensed pharmacist or technincian may dispense, sell, or distribute.
- Daily sales limit of 3.6 grams/ 9 g per 30 days.
20
Q
Biologics Price Competiton and Innovation (BPCI) ACt of 2009
A
- Created an abbreviated pathway for approval of biological products demonstrated to be bio similar to or interchangeable with an FDA-licensed reference biological product,
- Lower cost and provides patient acces to crucial biological therapies that they need.
- Permits the FDA to approve a bio similar product with a designation that is interchangeable with the FDA-licensed reference biological.
21
Q
Drug Supply Chain Security Act
A
- Outlines critical steps to build an electronic , interoperable system to identify and trace certain prescription drugs as they distributed in the US.
22
Q
2010 Patient Protection and Affordable Care Act
A
- Makes preventive care more accessible and affordable for many Americans.
- Requires insurance companies to cover all applicants with the minimum standards, including individuals with pre existing conditions.
- Components of the ACA involve pharmacy professionals such as
- EHR
- MTM
- ACO
- The Home Demonstration Project.
23
Q
2013 Drug Quality and Security Act
A
- Gives FDA greater oversight of bulk pharmaceutical compounding and enhances the agency’s ability to track drugs through the distribution process.
- Compromises two separate act
-the Compounding Quality Act
—Creates a new class of compounding manufacturers that voluntarily register with the FDA as an “Outstanding facility”
-the Drug Supply Chain Security Act
—Requires the FDA to create and implement a national tracking system to be used by manufacturers.
