Chapter 1

Consumer Safety and

Drug Regulations

OBJECTIVES see p-2 of text book

KEY TERMS / CONCEPTS controlled substances Drug Enforcement Administration (DEA) drug standards Food and Drug Administration (FDA) orphan drugs

What are the facts? (true / false)

1. Only nurses can give medication to patients…

2. Only doctors can write prescriptions….

3. Prescriptions are required for narcotics only…

4. All drugs produced in the US are made in federally approved labs…

5. All herbal medicines and dietary supplements are safe…

DRUG LAWS

drug standards (federally approved requirements) – ensures that all drugs with the same drug name must be uniform in strength, quality and purity

Pure Food and Drug Act (1906) required all drugs marketed (US) to meet minimal standards of strength, purity and quality drug preparations containing dangerous ingredients have a labeled container indicating the ingredient established two references of officially approved drugs (USP/NF)

Federal Food, Drug and Cosmetic Act (1938 – amended 1951 / 1962)

established the Food and Drug Administration (FDA) under the Department of Health and Human Services to enforce the provisions of the act

all labels must be accurate and include a listing of all active and inactive ingredients all new products must be approved by the FDA before public release “warning” labels must be present certain drugs must be labeled with a legend (inscription) – “Caution – federal law prohibits dispensing without a prescription”(legend drugs)

designates which drugs do not need a prescription prescription and nonprescription drugs must be shown to be effective and safe

Controlled Substances Act (1970)

established the Drug Enforcement Administration (DEA) as a bureau of the Department of Justice to enforce the provisions of the act

tighter controls on drugs being abused by society (substances that needed to be controlled) – depressants, stimulants, psychedelics, narcotics, and anabolic steroids

isolated the abused and addicting drugs into five levels (schedules) according to their medical value, harmfulness and potential for abuse / addiction (C-I, C-II, C-III, C-IV, C-V) demanded security of controlled substances – anyone who dispenses, receives, sells or destroys controlled substances must use DEA forms indicating current inventory for every controlled substance transaction

set limitations on the use of prescriptions – guidelines for the 5 schedules of controlled substances demanded manufacturers and prescribers of controlled substances register with the DEA and obtain a registration number – indicated on the prescription

Controlled Substances

the five schedules of controlled substances are arranged with the most potentially dangerous at level I and the least dangerous at level V the lower the level, the more strict are the restrictions schedule I drugs are illegal in the US and not approved for medical use drugs are frequently added, deleted or moved from one schedule to another

Know this chart… (p7 texbook)Schedule Number

Abuse PotentialLegal Limitations

Examples of Substances

C! - High abuse potential- Not approved for medical use in US

Heroin, LSD, mescaline, ecstasy

CII - High abuse potential / severe dependence- Written prescription only (no verbal)- NO refills without NEW prescription- May be faxed – original prescription for pick up- Emergency verbal prescription only – written prescription within 7d

Morphine, codeine, methadone, Percocet, Tylox, Dilaudid, Ritalin, cocaine, Oxycontin, Demerol (meperidine)

CIII - May lead to limited dependence- Written, faxed or verbal prescription by physician ony- May be refilled 5x / 6mo

Codein and Hydrocodone with aspirin / Tylenol, anabolic steroids

CIV - Lower abuse potential than above schedules- Prescription may be written by health care

practitioner but must be signed by physician- May be faxed or verbal prescription by health care

practitioner- May be refilled 5x / 6mo

Valium, Ativan, Xanax, phenobarbital, Librium, Darvocet, Restoril, Ambien

CV - Low abuse potential- Primarily cough suppressants (codeine) and

antidiarrheal

Promethazine with codeine, Lomotil,

another example…

uspharmacist.com

Orphan Drug Act (1983)

gives pharmaceutical companies financial incentives to develop medications for diseases that affect only a small number of people encourages the development of orphan drugs – low profitability

Omnibus Budget Reconciliation Act (1990)OBRA

mandates that all over the counter (OTC) drugs a patient is taking must be documented in the medical record mandates that pharmacists provide drug use review and patient counseling before dispensing prescriptions to patients

FDA and DEA

Food and Drug Administration (FDA) concerned with general safety standards in the production of drugs, foods and cosmetics

testing of proposed new drugs manufacture facility inspections review new drug applications investigate and remove unsafe drugs from

the market (benefits no longer outweigh risks) ensure proper labeling of foods, cosmetics

and drugs

Drug Enforcement Administration (DEA) concerned with controlled substances only enforces laws against drug activity – illegal drug use, dealing and manufacturing monitors need for changing schedules of abused drugs

Health Care Practitioners and the Lawgeneral guidelines keep a current drug reference book keep controlled substances securely locked (double locked)

place drugs in a locked safety box place lock box in a locked cabinet

conceal and secure prescription pads keep accurate records of controlled substances received, dispensed or destroyed(keep for two years) – properly destroy expired drugs and old records keep up to date with current news / activities of FDA / DEA – monitor DEA registration renewal date

establish a working rapport with pharmacists – excellent informational resource

maintain professional rapport with pharmaceutical representatives (offices and clinics) – informational resource