Medication Development, Regulation, and Resources

Flashcards about Medication Development, Regulation, and Resources.

World Health Organization (WHO)

The coordinating authority on public health for the United Nations which provides technical assistance on pharmaceuticals and promotes research.

Federal Laws

Federal regulation intended to protect consumers from harmful, impure, untested, and unsafe medication.

Pure Food and Drug Act of 1906

Set standards for quality and proper labeling of medications.

Food, Drug and Cosmetic Act of 1938

Requires animal testing and approval based on effectiveness on animals to market medications.

The Dunham-Humphrey Amendments to the Food, Drug and cosmetic Act of 1952

Required physician’s order to dispense certain medication and established over the counter (OTC) category of meds.

Controlled Substance Act of 1970

Designated certain drugs as controlled substances and established classifications known as schedules for drugs that have potential for abuse.

Schedule 1 Drugs

Schedule of drugs with no current legal medical use and a high potential for abuse.

Schedule II Drugs

Schedule of drugs with a high potential for abuse but accepted legal medical use.

Schedule III Drugs

Schedule of drugs with a low to moderate potential for physical dependence and accepted legal medical use.

Schedule IV Drugs

Schedule of drugs with a low potential for dependence and low risk for abuse with accepted legal medical use.

Schedule V Drugs

Schedule of drugs with a limited potential for dependence and low risk for abuse with accepted legal medical use and over-the-counter availability.

Schedule VI Drugs

Schedule of drugs that are legal without a prescription.

Drug Enforcement Administration (DEA)

Established under the Department of Justice for enforcement of the Controlled Substances Act.

Occupational Safety and Health Administration (OSHA)

Under the US Dept of Labor with the mission to ensure the safety and health of American workers by setting and enforcing standards.

Centers for Disease Control and Prevention (CDC)

Under the US Department of Health and Human Services, it is the leading federal agency for protecting health and safety of people and for providing credible information to enhance health decisions.

State Practice Acts

State laws that govern the ordering, dispensing, and administration of medications.

The Joint Commission

Evaluates and accredits health care organizations in the US and publishes National Patient Safety Goals (NPSGs).

Food and Drug Administration (FDA)

Within the Department of Health and Human Services, it inspects all drug manufacturing facilities, reviews new drug applications, and investigates and removes unsafe drugs from the market.

Center for Drug Evaluation and Research (CDER)

Regulates the pharmaceutical industry, ensures basic standards are followed, and evaluates all new drugs before sold and drugs on the market.

Pharmacogenetics

Study of genetic factors in predicting a drug's action and how it could vary from its intended response.

Pharmacogenomics

Study of all genes and genetic technology that determine medication behavior.

Generic name

Name assigned to a drug during development.

Trade name

Name given by the manufacturer once FDA approval is granted.

United States Pharmacopeia and National Formulary (USP-NF)

Assigns official name to a drug.

Brand or proprietary name

The manufacturer’s name for the medication.

Generic name on medication label

Located directly below the brand name in lowercase letters and is given by the USP.

Medication Label

Contains manufacturer’s name, dosage strength, form, supply dosage, total volume, and administration route.

Medication References

Physician’s Desk Reference (PDR), United States Pharmacopeia and National Formulary (USP-NF), American Hospital Formulary Service Drug information.

Occupational Exposure to Bloodborne Pathogens Standard (1991 revised 2001)

Healthcare workers at higher risk for contracting hepatitis B, hepatitis C, HIV, each employer must have a plan to ensure immediate and confidential postexposure treatment and follow up procedures in accordance with current CDC guidelines

1995 Emergency Needlestick Information

Recommends prophylactic medication treatment asap needlestick or sharps injury (within 2 hours of exposure) and Postexposure prophylaxis (PEP) antiretroviral drugs

Components of a medication order

Medication order must include patient full name, date and time of order, name of medication, dosage, route of administration, time and frequency of administration, provider signature, any special instructions.

Aseptic Technique

Aseptic technique minimizes contamination, medication and equipment remain sterile, hand hygiene is performed, gloves are used, invasive procedures must be done using sterile gloves and equipment.

General principles for preparing injectable medications

Use strict aseptic technique, consider using a filter needle when withdrawing medication from a glass ampule, use a new sterile syringe and needle for each aspiration, do not leave prepared syringes unattended, clearly and accurately label syringes.

Information on a medication label

Name of medication, strength of medication, total dose, route of administration, expiration date and time, initials of preparing nurse.

Rights of Medication Administration

Check each medication against the medication order, check medication label 3 times before administering, after retrieving from drawer, when removing from container, before administration.