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36 Cards in this Set

  • Front
  • Back
no drug completely safe

may interact with another drug or condition the patient has

may prevent patient from getting effective help
Why is the requirement that drugs be effective so important?
There was a backlog of drugs approved 1938-1962
What made enforcement of the new law so difficult? (Kefauver-Harris Drug Amendment 62')
Prescription Drugs
7100 drugs approved

3000 still on market

16000 claims made for these 3000 drugs

For every drug on market, five were unapproved (15000 more)

me too drugs
combinations of approved ingredients
me too drugs
chemically SAME ACTIVE INGREDIENTS "inert" substance may differ
Over the counter
100,000 to 500,000 on market

Only about 200 active ingredients used
drug companies change labels often

deals with symptoms not traceable to specific disease
What is the PROBLEM with O.T.C.?
1. define 25 categories of drugs
2. List acceptable active ingredients and certain combinations
3. List acceptable dosage ranges, indications for use, and directions
What is the SOLUTION for O.T.C. drugs?
1970 - Drug Abuse Prevention and Control Act
What is the name of the act that has to do with Narcotics laws and drug control?
1970 - Drug Abuse Prevention and Control Act
Name the Act:

Applies to all dependence causing drugs obtainable only by prescription ("Controlled Substances Act")
1970 - Drug Abuse Prevention and Control Act
A very comprehensive law

research into and prevention of drug abuse

treatment and rehabilation of drug abusers

strengthen law enforcement authority

improve regulation of manufacture and distribution

controlled drugs prescribed only by licensed physician, dentist, veterinarian.
federal permission
What must licensed physicians, dentists, and veterinarians apply for to prescribed controlled drugs?
Department of Justice
After applying for federal permission, physicians are given a registration number which must appear on each ___________. They must be renewed each _____ by __________ ___ ________.
Drug Enforcement Administration
Who keeps the records of prescriptions written for 2 years?
Some states allow nurses to prescribe SOME medications under a _________ supervision. CA currently has nurse practicioners/physician's assistants able to do this.
Schedule of ____________ drugs I-V
Which of th I to V controlled drugs is the most stringent with regulations?
Which of th I to V controlled drugs is the least stringent with regulations?
Attorney General
Placing of drugs into thses categories (I to V), can be changed by __________ ________ which is __________ action.
medical usefulness
potential abuse
Based upon what, How are the controlled drugs categorized?
Schedule I
use forbidden except for research

What schedule?
Schedule I
What schedule?

All drugs begin here whether destined to become over the counter products, or prescription only, or a "controlled" medication.
Schedule I
What schedule?

drugs remain here if no therapeutic use even with medical supervision (too high potential for abuse)
schedule I
What schedule?

hallucinogens (LSD)
marijuana (less than 1 oz is misdemenor - 100 fine)
schedule I
researchers must apply to FDA for clearance to use or obtain "investingational new drug exemption" (IND)
schedules II-IV
What schedule?

can be ordered with a perscription; physician must renew registration number yearly with Drug Enforcement Administration (DEA)in Department of Justice records kept for two years
Schedules II-IV
DEA sets quotas for amount manufactured and distributed through pharmacies and health care agencies. Has responsibility of monitoring distribution and sales of all controlled substances and can request records at any time from physician's, pharmacists, and manufacturers. States help monitor compliance with this data collection and supply records requested.

What schedule?
Schedule V
What schedule?

DEA monitors distribution and sale

will include signature drugs (no prescription necessary)

amount or concentration of narcotic controlled (i.e. codeine in cough syrup)

Pharmacy keeps record of purchaser, address, date, etc. for years.
Schedule V drugs are synonymous with OTC drugs.

Some states, not including CA, allow schedule V drugs to be dispensed without a prescription.

California law doesn't permit Schedule V drugs to be dispensed without a prescription. Even though federal law allows "signature" drugs, the more strict state law applies in this state.

tamper resistant security prescription
Law no longer requires triplicate forms for schedule ___ drugs. As of Jan. 06, _____________ (state) is requiring that prescriptions be written on "_________ __________ __________ _____________" forms or "security paper" that includes each physician's liscense numbers and business address.
The word "void" appears acroos the prescription from a hidden watermark.
What happens when a prescription is copied or faxed?
schedules II to V
What schedules are required to be written on "security paper" for controlled substances?
The state
Who is electronically collecting and compiling data on both schedule II and III drugs and placing them in a database in the public domain that will provide info on physicians and the prescriptions they write?
Although individual patient data is not publically accessible, once yearly, __________ may request information on their patients as to schedule II and III prescriptions filled.
Federal DEA
The system, "security paper", meets the _________ _____ requirement to follow controlled substances from site of manufacture through physicians and pharmacies to the patients.