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Chapter 1. OBJECTIVES  see p-2 of text book KEY TERMS / CONCEPTS  controlled substances  Drug Enforcement Administration (DEA)  drug standards  Food.

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Presentation on theme: "Chapter 1. OBJECTIVES  see p-2 of text book KEY TERMS / CONCEPTS  controlled substances  Drug Enforcement Administration (DEA)  drug standards  Food."— Presentation transcript:

1 Chapter 1

2 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

3 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 4. All drugs produced in the US are made in federally approved labs… 5. All herbal medicines and dietary supplements are safe…


6 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)

7 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

8  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)

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

10 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

11  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


13  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


15 Controlled Substances

16  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

17 Know this chart… (p7 texbook) Schedule Number Abuse Potential Legal 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,

18 another example…

19 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

20 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

21 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

22 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

23 Health Care Practitioners and the Law general 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

24  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

25  establish a working rapport with pharmacists – excellent informational resource  maintain professional rapport with pharmaceutical representatives (offices and clinics) – informational resource

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