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INVESTIGATIONAL DRUG SERVICES IN THE HOSPITAL

INVESTIGATIONAL DRUG SERVICES IN THE HOSPITAL. Sheree Miller, Pharm.D. University of Washington Medical Center 1-13-04. What is an Investigational Drug. new drugs old drugs- new indications, new combinations, new components investigational use of commercially available drugs.

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INVESTIGATIONAL DRUG SERVICES IN THE HOSPITAL

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  1. INVESTIGATIONAL DRUG SERVICES IN THE HOSPITAL Sheree Miller, Pharm.D. University of Washington Medical Center 1-13-04

  2. What is an Investigational Drug • new drugs • old drugs- new indications, new combinations, new components • investigational use of commercially available drugs

  3. Preclinical Trials • acquisition of new agent. screening for activity, formulation and production of agent, toxicology

  4. Investigational New Drug Application (IND) may be filed by: • innovator/manufacturer • physician • academic medical center • governmental agency -NIH, NCI-

  5. Phase I small numbers healthy volunteers toxicity kinetics, administration route safe dose range (MTD)

  6. Phase II treatment or prophylaxis of a specific disease demonstrate safety and efficacy toxicity- first controlled trials

  7. Phase III • expanded clinical trials • compare to existing standard therapy • determine optimum dose and schedule • accumulate information to establish drug effectiveness for specific indications and populations at risk from its use.

  8. If IND is successful, file New Drug Application (NDA)

  9. Institutional Review Board University of Washington Human Subjects Review Board • appointed by institution- • Membership: at least 5 members- • men and women, more than one profession, one non-scientist, one not associated with the institution • FDA holds this board responsible to protect the welfare and rights of human subjects in research

  10. Institutional Review Board • Protocols and Informed consents for study subjects are reviewed and approved by the IRB

  11. Informed Consents Informed Consents should contain information about the treatment or drug and be written in lay language. Objectives of clinical trial should be explained, including risks and benefits, and any alternative therapies available. Outlines the responsibility of the investigator to keep the subject informed about additional information that becomes available as the study progresses

  12. Non Research Use of Investigational agents • Investigational agents may be used emergently or not under the format of a clinical trial. • Informed consent and IRB approval or notification is required for emergent use.

  13. Treatment INDs • to make certain investigational new drugs available to desperately ill patients before the FDA approves them for marketing. • These INDs are for pre-approved protocols using the drug in a specific treatment and disease. -no comparable drug available - immediately life threatening or serious disease - drug under active investigation • - drug shows promise of therapeutic benefit

  14. Compassionate Use • allows the use of a drug for patients who are desperately ill, do not qualify for a clinical trial, or when clinical trial is not available.

  15. Pharmacy Based Investigational Drug Service FDA vs JCAHO Requirements ASHP Guidelines on Clinical Drug Research

  16. Pharmacy Based Investigational Drug Service Basic Activities: • registration of drug's use in hospital • procurement • storage • preparing • dispensing • maintenance of records • Provision of drug information

  17. Pharmacy Based Investigational Drug Service Administrative responsibilities • Reordering Investigational Drugs • Disposal of Used or Unused drug • Computerization of drug ordering and control • Billing for IDS Services

  18. Pharmacy Based Investigational Drug Service • Pharmaceutical Care • IRB Membership • Pharmacotherapeutic monitoring of invest. therapy • Patient counseling and education • Data manager • Adverse Drug Reaction Reporting • Staff development and inservicing education

  19. Pharmacy Based Investigational Drug Service Research and Development Activities: • Protocol development- especially drug delivery and monitoring • Single and double blind studies • Randomization • Pharmaceutical Research- • Formulation, Development • Preparation of dosage forms • Drug analysis & quality control

  20. Pharmacy Based Investigational Drug Service Benefits of Pharmacy Based Investigational Drug Service • to the hospital • to the nurses • to the investigators • to the sponsors • to the patients

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