Drug Standards and Drug Regulations and Pharmacy Standards

Pharmakon

Drug

Poien

to make

Pharmacopeia

to make drugs

1580

drug standards book in Bergamo, Italy

Lititz Pharmacopeia

• 1st American pharmacopeia

• 32-page booklet: 84 internal & 16 external drugs & preparations

Lyman Spalding

Father of the United States of Pharmacopeia

1820

US Pharmacopeia established by physicians

1830

Pharmacists became involved

USP

under continuous revision

National Formulary

Published in 1888 by APhA

1975 USP

Purchased the National Formulary

2005

USP Pharmacist’s Pharmacopeia published

The Federal Food, Drug, and Cosmetic Act of 1938

• FDA created to enforce this

• Enforce standards (strength, purity, & quality) for the pharmaceutical industry

• “New drug”

• “Safety”

• “Grandfathered drugs”

• Prohibits the distribution & use of any new drug or drug product w/o the prior filling of a new-drug application and approval of the FDA

Sulfanilamide

• An Elixir with a solvent diethylene glycol which is a highly toxic agent used in antifreeze solution

• Diethylene glycol poisoning

Durham-Humphrey Amendment of 1952

• Prescription Drug Amendment

• Separated drugs into two categories:

• Legend(Prescription drugs)& Over the Counter (OTC)

• Caution: Federal Law Prohibits Dispensing Without Prescription

• Refill authorization

Kefauver-Harris Amendments of 1962

• Institute higher safety measures for drugs approved by FDA.

• Manufacturers become responsible for GMP (prove safety and effectiveness of drugs in clinical trials ) before FDA grants permission for marketing and distribution.

• Established definitive procedures for new drug applications (NDA) and investigational drugs.

Thalidomide

• Before: OTC drug which is used as a sedative & tranquilizer

• ADR: Phocomelia – an arrested development of the limbs of the affected newborn

• Now: Tx fever & painful skin lesions associated with erythema nodosum leprosum in px w/ leprosy

Schedule I

High risk of abuse, no accepted medical use

Schedule II

High risk of abuse, accepted medical use with severe restrictions.

Schedule III

Moderate risk of abuse, accepted medical use. 5 refills in 6 months

Schedule IV

Low risk of abuse, accepted medical use. 5 refills in 6 months

Schedule V

Lowest risk of abuse, commonly available as over-the-counter medicines. Many Refills

Category A

Controlled human studies have demonstrated no fetal risk.

Category B

Animal studies indicate no fetal risk, but no human studies or adverse effects in animals, but not in well controlled human studies.

Category C

No adequate human or animal studies, or adverse fetal effects in animals studies, but no available human data.

Category D

Evidence of fetal risk, but benefits outweigh risks.

Category X

Evidence of fetal risk, Risks outweigh any benefits.

Teratogens

• Radiation

• Infections

• Maternal and metabolic imbalance

• Drugs and environmental chemicals

Black Box Warning

• There is adverse reaction so serious in proportion to the potential benefit  of using the drug

• Risk of serious adverse reaction can be prevented in severity by careful use of the drug

• FDA has approved the drug with restrictions to prescribing/distribution to ensure its safe use.

Orphan Drug Act of 1983

• Special program to speed up the approval process for new medications intended to help people with urgent needs.

• Help develop and market treatments for rare diseases

• Grants, special tax credits, protocol assistance  are incentives for researchers.

• Manufacturer gets exclusive marketing rights for seven years if drug is approved.

Prescription Drug Marketing Act of 1987

Goal is to reduce the risk of repackaged, mislabeled and adulterated substances entering the marketplace.

Prescription Drug User Free Act of 1992

• To accept user fees from drug and biologic companies in return for committing to review new drug and biologic applications within certain time frames.

• More rapid application review process and speedier approval of new drug products.

Drug Price Competition and Patent Term Restoration Act of 1984

• Approved new drugs can be filed through ANDA (Abbreviated new drug application) and extensive animal and human studies no longer required (NDA)

FDA Modernization Act of 2007

• Detailed organizational structure and personnel

• Protect the public health against risks associated with production, distribution and sale

• Responsible for enforcing additional pieces of legislation

Poison Prevention Packaging Act of 1970

• Created to reduce accidental Poisonings.

• Included are child resistant closures on prescription and OTC drugs intended for oral use and provision of package inserts

• Few exemptions to the act include cardiac  medications and single dose sizes.

• Originally with FDA but now with Consumer Product Safety Commission.

Biologics Price Competition and Innovation Act (BPCI Act of 2009)

It was enacted to create an abbreviated approval pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved reference product.

Drug Quality and Security Act (DQSA) of 2013

The was enacted to enhance the safety and security of the drug supply chain in the United States.

Class I

Reasonable probability of serious adverse health consequences or death

Class II

May cause temporary or medically reversible consequences

Class III

Not likely to cause adverse health consequences

Abbott’s MitraClip Cardiac Device

This device was recalled due to serious safety concerns.

Apple Cinnamon Fruit Puree Pouches

These were found to contain elevated levels of lead and chromium.

Various Dairy Products

Wegmans issued a recall due to potential contamination.

Omnibus Budget Reconciliation Act of 1990

• Required states to develop programs to improve the quality of pharmaceutical care.

• Requires pharmacist to perform Drug Utilization Review (DUR). As a re patients

• Counseling about prescribed and OTC medications, Warnings about potential allergy interactions, Techniques for self monitoring drug therapy

Patient Self Determination Act of 1990

Requires hospitals to inform patients about their rights and their ability to create an advance directive.

Living Will

This document provides very specific instructions about the type of care a patient chooses in particular circumstances

Durable Power of Attorney

This allows a patient to choose a representative to make decisions on the patients behalf should the patient become incapacitated.

Blanket Consent

• A form that allows a physician to do what he or she thinks is necessary for a patient. Signed at the first meeting between a healthcare provider and a patient.

• Details are written as to how it was discussed and explained and questions asked by the patient.