pharmacy law

Question 1

One of the first laws to stop the sale of inaccurately labeled drugs, requiring manufacturers to provide truthful information on the label before a drug was sold + prove the drug’s effectiveness w/ scientific studies

Answer 1

1906 - PURE FOOD AND DRUG ACT

Question 2

Law enacted to curb recreational use of opium – no longer available without prescription (documentation is needed/required), importation and distribution was restricted

Answer 2

1914 - HARRISON NARCOTICS ACT

Question 3

Law enacted because the 1906 law (Pure Food and Drug Act) did not include cosmetics.
- required drug companies to include directions to consumers regarding the usage of drugs, and also package inserts
- all addictive substances had to be labeled “WARNING: MAY BE HABIT FORMING”
- defined misbranding (false or exaggerated claims on labels) and adulteration (inclusion of impurities/harmful ingredients that could cause result in injury/death for consumers

Answer 3

1938 - FOOD, DRUG, AND COSMETIC ACT

Question 4

Made the distinction between legend drugs and OTC medications
- Required a doctor’s order & supervision for drugs
- Required label: “Caution: Federal law prohibits dispensing without prescription”

Answer 4

1951 - DURHAM-HUMPHREY AMENDMENT

Question 5

Law that required manufacturers to prove the safety of a drug and to provide substantial evidence of its effectiveness for its intended purpose (rules for clinical drug trials in order to provide evidence of scientific study)
- Burden put on manufacturers to ensure “good manufacturing practice” (BMP)
* PREVENTED the sale of thalidomide after mothers used drug during pregnancy that caused birth defects in children

Answer 5

1962 - KEFAUVER-HARRIS AMENDMENT

Question 6

Established the Drug Enforcement Administration (DEA) to enforce the laws covering controlled substances & distribution.
- The FDA created the schedule system to identify controlled drugs by their potential for abuse. [stair-step categories for controlled substances I-V]

Answer 6

1970 - COMPREHENSIVE DRUG ABUSE PREVENTION & CONTROL ACT (CONTROLLED SUBSTANCES ACT)

Question 7

Requires ALL medications to be placed in containers w/ childproof caps or packaging (includes both OTC and legend drugs)
- Exceptions:
* Physician or patient request for non-childproof cap
* Certain legend medications (nitroglycerin sublingual tablets)
* Hospitalized patients

Answer 7

1970 - POISON PREVENTION ACT

Question 8

Established special numbering system created to identify a medication as a unique product.

** the FDA assigns the first 5 numbers for the manufacturer/labeler
** drug manufacturer assigns the remaining numbers
** when missing a #, always put a zero in front of the set of numbers

Answer 8

1972 - DRUG LISTING ACT: NATIONAL DRUG CODE (NDC)

Question 9

• Eased restrictions and costs for development of new drugs for those w/ rare disease (affecting 1 in 200,000 people)
• Was designed to allow companies w/ medications intended for special/smaller populations to reach market earlier than normal for approval.
• Prior to this act, there was no incentive to spend millions of dollars for developing medications.

Answer 9

1983 - ORPHAN DRUG ACT

Question 10

Federal law that applies ONLY to prescriptions for patients w/Medicare or Medicaid (deals with reimbursement procedures for Medicare & Medicaid)

• requires pharmacists to counsel (at the time of purchase) Medicaid patients who receive new prescriptions AKA DRUG UTILIZATION EVALUATION (DUE)

Answer 10

1990 - OMNIBUS BUDGET RECONCILIATION ACT (OBRA ‘90)

Question 11

Privacy rules meant to protect patient’s protected health information (PHI)
- Changes were made throughout medical facilities to limit access to patient information

Answer 11

1996 - HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPPA)

Question 12

Addresses ALL areas of the manufacture & sale of pseudoephedrine

STRICT guidelines:
- Only a licensed pharmacist or technician may dispense, sell, or distribute this drug
- BTC (BEHIND THE COUNTER) drug in which:
* no more than 3.6g in a calendary day
* no more than 7.5g per 30 days via mail order
* DOCUMENTATION is required + needed to be kept on file for 2 years

Answer 12

2005 - COMBAT METH ACT

Question 13

Gives the FDA greater oversight of bulk pharmaceutical compounding & tracking through the distribution process

Answer 13

2013 - DRUG QUALITY AND SECURITY ACT

Question 14

Mission is to improve the safety and quality of care via accreditation of health care organizations
- Areas of concern:
How look alike, sound-like drugs are identified
Surveys all aspects of hospitals, including their pharmacies

Answer 14

THE JOINT COMMISSION (changed from JCAHO TO TJC IN 2007)

Question 15

Safety data sheet (sds) must be available for all chemicals

• Includes information on:
  Storage requirements, handling, and what to do in case of a spill or contact w eyes

Answer 15

Occupational Safety and Health Administration (OSHA)