1. Drug Approval and Regulation
John Paul Joson MSN CNS
Drug Approval and Regulation
Way of grouping/organizing drug information.

2. Objectives Role of the F.D.A. Phases of Approval
Controlled Substances, Drug Schedules, and Teratogenic Risks

3. F.D.A. U.S. Food and Drug Administration 1997 Black Box Warnings
Drugs with “special problems”
Adverse Effects aka Undesirable

4. Black Box Warning

5. Phases of Approval 1. Preclinical investigation
3. Review of the New Drug Application
4. Post marketing surveillance

6. Preclinical Investigation
Laboratory research
Animal studies/ studies on human cells
Prediction
Inconclusive

7. Clinical Investigation
Longest part of drug approval process
Good let’s go!!!!
Show’s promise but precautions slow down.
Safe for humans

8. New Drug Application Review
Drug’s name is finalized
FDA review = 6 months
All good go to Post marketing surveillance

9. Post marketing Surveillance
Survey for harmful drug effects
FDA can withdraw med

10. Prototype approach to drug classification
“Prototype” drug is one drug from a class of drugs that is well understood and serves as model
Predicts the action and adverse effects of other drugs in that class
in that pharmacologic class to be compared to
Familiarize selves with a prototype drug, know the therapeutic and pharmacologic actions to assist in understanding another drug in same class.
Example: Beta blockers pg. 315

11. U.S. controlled substances act of 1970
Drugs placed into 5 schedules
Under law, hospitals/pharmacies must maintain complete records of all controlled substances purchased and sold
Drug Enforcement Administration (DEA) –regulates Controlled Substance Act
Comprehensive Drug Abuse Prevention and Control Act –restricts use of drugs with significant potential for abuse
MD, NP, PA those with prescriptive authorities receive a DEA # license to prescribe meds.
Example in nurses have access to narcotics –must always have a count of how much, witness….

12. Controlled substance
Drugs frequently abused or have a high potential for addiction or dependence
Addiction –overwhelming feeling that drives repeated drug use
Dependence –physical or psychological need for substance
Restricted for use in medical necessity
Physical dependence = withdrawal
Psychological dependence = intense desire to use
Some drugs are frequently abused or have a high potential for addiction.

13. Scheduled drugs Drugs that have a significant potential for abuse
Placed in 5 categories called “schedules”
Classified according to potential for abuse
According to the law, drugs have a significant potential for abuse.

14. U.S. Drug schedules Drug Schedule Abuse Potential Examples I Highest
Physical Dependency
Psychologic Dependency
Examples
Therapeutic use I
Highest
High
Heroin, LSD, MJ
Limited or none II
Morphine, PCP, Cocaine
Used therapeutically with prescription
III
Moderate
Steroids, Vicodin, T#3 IV
Lower
Darvon/
Darvocet, Valium V
Lowest
OTC cough meds w/ codeine
Used therapeutically without prescription
Pg. 15
Schedule I drugs have highest potential for abuse. Restricted for use in situations of medical necessity.
Schedule V –quantities of the controlled drug so low, possibility of dependence extremely remote.
Can you think of examples that are or can be highly abused, but not placed on regulations or schedules?
HEROIN 1970’s (euphoria, alert): Under the chemical name diamorphine, diacetylmorphine is prescribed as a strong analgesic in the United Kingdom, where it is given via subcutaneous, intramuscular, intrathecal or intravenous route. Its use includes treatment for acute pain, such as in severe physical trauma, myocardial infarction, post-surgical pain, and chronic pain, including end-stage cancer and other terminal illnesses. In other countries it is more common to use morphine or other strong opioids in these situations.
LSD 1960’s (Lysergic acid diethylamide): as an analgesic for serious and chronic pain caused by cancer or other major trauma (Some psychological effects may include an experience of radiant colors, objects and surfaces appearing to ripple or "breathe," colored patterns behind the closed eyelids (eidetic imagery), an altered sense of time (time seems to be stretching, repeating itself, changing speed or stopping), crawling geometric patterns overlaying walls and other objects, morphing objects, a sense that one's thoughts are spiraling into themselves, loss of a sense of identity or the ego (known as "ego death"), and other powerful psycho-physical reactions): Introduced by Sandoz Laboratories, with trade-name Delysid, as a drug with various psychiatric uses in 1947, LSD quickly became a therapeutic agent that appeared to show great promise.[7] In the 1950s the CIA thought it might be applicable to mind control and chemical warfare;
LSD has been used in psychiatry for its perceived therapeutic value, in the treatment of alcoholism, pain and cluster headache relief, for spiritual purposes, and to enhance creativity. However, government organizations like the United States Drug Enforcement Administration maintain that LSD "produces no aphrodisiac effects, does not increase creativity, has no lasting positive effect in treating alcoholics or criminals, does not produce a 'model psychosis', and does not generate immediate personality change."[
PCP (phenylcyclohexyl)piperidine) formerly used as an anesthetic agent, exhibiting hallucinogenic and neurotoxic effects.[1] PCP was first synthesized in 1926, and later tested after World War II as a surgical anesthetic. Because of its adverse side effects, such as hallucinations, mania, delirium, and disorientation, it was shelved until the 1950s.
Symptoms are summarized by the mnemonic device RED DANES: rage, erythema (redness of skin), dilated pupils, delusions, amnesia, nystagmus (oscillation of the eyeball when moving laterally), excitation, and skin dryness.[33]
Psychological effects include severe changes in body image, loss of ego boundaries, paranoia and depersonalization. Hallucinations, euphoria, suicidal impulses and aggressive behavior

15. U.S. Drug schedules Schedule II -IV:
Require special order form to obtain
Must be written and signed by health care provider
Telephone orders to pharmacies/refills not permitted
Patients must visit health care provider first

16. Teratogenic Risks Category A Category B Category C Category D
Category X

17. Chronic pain patient in the emergency room