Chapter 2: Drug Approval and Regulation Flashcards
Identify key U.S. drug regulations that have provided guidelines for the safe and effective use of drugs and drug therapy.
- 1902: Biologics Control Act helped to standardize the quality of serums and other blood-related products
- 1906: The Pure Food and Drug Act gave the government to control the labeling of medicines
- 1912: Sherley Amendment prohibited the sale of drugs labeled with false therapeutic claims
- 1938: Food, Drug, and Cosmetic Act prevented sale of drugs that had not been thoroughly tested before marketing
- Later amendments required companies to prove efficacy and safety of drugs
- 1988 US Food and Drug Administration (FDA) officially established
- 1994: Dietary Supplement Health and Education Act (DSHEA) attempts to control misleading industry claims
- 1996 Health Insurance Portability and Accountability Act (HIPAA) required health-related organizations and schools to keep private all health information, including vaccinations
- 1997 Boxed warnings were created for drugs with adverse reactions discovered
Discuss the role of the U.S. Food and Drug Administration (FDA) in the drug approval process.
The FDA reviews New Drug Applications (NDA) for effectiveness and safety of the drug. Once they appprove the drug, the monitor the drug for continued safety.
Explain the four phases of approval for therapeutic and biologic drugs.
- Preclinical investigation
- Tests on human and microbial cells to observe effectiveness and adverse effects
- Clinical investigation
- Longest part
- Performs tests on volunteers to determine dosage and assess for adverse effects
- Patients with the disease will be given the drug
- Review of the New Drug Application (NDA)
- Reviews the effectiveness and the safety of the drug
- Postmarketing surveillance
- Surveys for harmful effects in the larger population
Discuss how the FDA has increased the speed with which new drugs reach consumers.
1992 Prescription Drug User Fee Act required manufacturers to provide yearly product user fees
- Allowed FDA to restructure and hire more employees and as a result, approved double the number of drugs while cutting review times in half
1997 FDA Modernization Act reauthorized Prescription Drug User Fee Act
2007 FDA Amendments ACt allowed more of US resources to be used for comprehensive reviews of new drugs
Accelerated Approval Program allows for earlier approval of drugs that treat serious medical conditions
Identify the advanced practice registered nurse’s role in prescribing drugs.
Advanced practice registered nurses are allowed to prescribe drugs under state regulations; laws continue to change, certain states require prescription to be collaborated with a physician
Explain the U.S. Controlled Substance Act of 1970 and the role of the U.S. Drug Enforcement Administration in controlling drug abuse and misuse.
Placed drugs in categorizes based on their abuse potential and restricted on they are prescribed and administered to reduce the chances of abuse.
Discuss why drugs are sometimes placed on a restrictive list, and the controversy surrounding the issue.
Some drugs are restricted beause there are no apparent therpeutic effects, or the effects do not outweight the adverse effects.
Controversy around certain drugs like marijuana.
Explain the meaning of a controlled substance and teratogenic risk in pregnancy.
Teratogen: substance that has the potential to cause a defect in an unborn child during the mother’s pregnancy
Teratogenic risk places drugs into categories: A, B, C, D, and X
A is the safest, while X poses the most danger to the fetus
Identify the five drug schedules and give examples of drugs at each level.
- Schedule I: Highest abuse potential, high potential for physcial dependency, high potential for psycholgoical dependency; limited or no therapeutic use
- Schedule II: High abuse potential, high potential for physcial dependency, high potential for psycholgoical dependency; limited or no therapeutic use
- Schedule III: Moderate abuse potential, moderate potential for physcial dependency, high potential for psycholgoical dependency; used therapeutically with prescription
- Schedcule IV: Lower abuse potential, Lower potential for physcial dependency, Lower potential for psycholgoical dependency; used therpeutically with prescription
- Schedule V: Lowest abuse potential, lowest potential for physical dependency, lowers potential for psychological dependency, used therpeutically without prescription
Identify the five categories of teratogenic drug classification.
A - low risk
B
C
D
X - highest risk
How does the FDA ensure the safety and effectiveness of drugs? What types of drugs does the FDA regulate or control?
The FDA, through its Center for Drug Evaluation and Research (CDER), exercises control over whether prescription drugs and OTC drugs many be used or therapy. The mission of the CDER is to facilitate the availability of safe, effective drugs; keep unsafe or ineffective drugs off the market; improve the health of Americans; and provide clear, easily understandable drug information for safe and effective use. The FDA’s Center for Biologics Evaluation and Research (CBER) regulates the use of biologics including serums, vaccines, and blood products.
What is a black box warning? Why is it important for nurses to consider these when reading drug information materials?
A black box warning is a special alert required by the FDA to note that a drug, or a class of drugs, has the potential for causing serious injury or death. These extreme adverse effects are discovered during and after the drug review process and are often identified by the user after the drug becomes available on the market. They are so-named for the black box appearing around the drug safety information. Nurses should always read the warnings and consider the implications for the patient prescribed that drug. If the nurse has questions about the appropriateness of the drug for a given patient, the nurse should consult the healthcare provider before administering the drug.
Identify opportunities the nurse has in educating about, administering, and monitoring the proper use of drugs.
The nurse is responsible for the safe administration of medications, monitoring for therapeutic and adverse effects of those drugs, and for providing education to patients who are taking drugs. Learning pharmacology, the proper administration of medications, and patient education are all nursing responsibilities. During the drug approval process, some nurses may administer medications to patients participating in phases II and III clinical trials, but all nurses participate in phase IV, postmarketing surveillance, by reporting adverse drug reactions. Advanced practice registered nurses have the authority to prescribe medications.
Why are certain drugs placed in schedules? What does the nurse need to know when a scheduled drug is ordered?
Schedules refer tot he potential for abuse. These schedules help the nurse to identify the potential for abuse and require the nurse to maintain complete records for all quantities prescribed. The higher the abuse potential, the more restrictions are placed on the prescriber and the filling of refills. When educating the patient about a prescription, the nurse should also include this information on any prescription or refills as part of the education.
A nurse is preparing to give a patient a medication and notes that a scheduled drug to be given is marked as a Schedule III drug. What does this information tell the nurse about this medication?
This schedule III drug is a controlled substance restricted by the Controlled Substance Act of 1970 and regulated by the DEA. A Schedule III drug has a moderate abuse potential, moderate potential for physical dependency, and high potential for psychologic dependency.
