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Healthy Skepticism Library item: 8108

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.


Publication type: Journal Article

Stein GC.
Current federal regulatory trends
ASHP Midyear Clinical Meeting 1999 Dec; 34:


New and ongoing federal regulatory issues will be discussed. The primary focus will be the impact on health-system pharmacy of: (1) FDA and HCFA efforts at preventing medication errors; (2) implementation of the FDA Modernization Act; (3) HCFA’s Hospital Conditions of Participation; (4) reimbursement for pharmacists, services; (5) prescribing and dispensing drugs over the Internet; and (6) Y2K readiness of the pharmaceutical distribution system. Learning objectives: 1. Describe the Principles of Understanding that the FDA has developed in regard to the Internet prescribing and dispensing of drugs. 2. Describe HCFA’s latest position regarding its Hospital Conditions of Participation. 3. State the FDA’s position on drug stockpiling due to concerns over Y2K. Self-assessment questions: True or False: 1. The pharmaceutical industry has had major difficulties in assuring that prescription drugs will be available as the date changes to the year 2000. 2. New information about the important role of pharmacists in hospitals has been submitted to HCFA. 3. Federal courts have determined that FDAMA’s requirements for the distribution of information on unlabeled uses of drugs are unconstitutional. 4. The FDA is the only federal agency that has authority to deal with Internet pharmacies. 5. Under the Patients’ Rights standard of the Hospital Conditions of Participation, drugs cannot be used to restrain patients. Answers: 1. F; 2. T; 3. T; 4. F; 5. F.


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