The pharmacist is responsible to the institution and the principal investigator for seeing that procedures for control of the investigational drugs should be developed and implemented. Pharmacists should follow the following guidelines in the case of investigational drugs:
1. The copy of the Research
Protocol should be kept in the pharmacy after its approval from Institutional Review Committee.
2. The pharmacist should
prepare the “Investigational Drug Data Sheet” which gives information about
investigational drugs. The drug data sheet gives information to the Medical, Pharmacy, and Nursing staff. The
form should contain:
• Drug designation and common synonyms.
• Dosage forms and strengths available.
• Dosage schedule and route of administration.
• Indication.
• Expected therapeutic effects.
• Expected and potential untoward effects.
• Contraindications.
• Storage requirement.
• Instructions for dosage preparation and
administration.
• Instruction for disposition of unused doses.
• Names and telephone numbers of principal and
authorized co-investigators.
The drug data sheet should be reviewed by the
principal investigator and along with the study protocol should be submitted to
the I. R. C. Copies should be submitted, and distributed to the appropriate
pharmacy staff and all patient care units where the drug will be used.
3. The dispensing of
investigational drugs should be integrated with the rest of the drug
distribution system. The prescription labels for investigational drugs should
be distinguishable from other labels by an appropriate legend for example, “Investigational Drugs”.
4. Investigational drugs
supplied must be kept only at the pharmacy. The pharmacy should maintain an
Investigational Drug Inventory Record. This form should contain the drug's
name, dosage form and strength, lot number and name, address and telephone
number of the manufacturer, and other information needed for ordering the drug.
5. The pharmacy should
return all unused drugs to the principal investigator or manufacturer after the
study.
6. The pharmacy should give the institutions administrator an annual or semi-annual statistical summary of investigational drugs use, including the information as:
• Number of drugs studied in progress.
• Listing of all drugs studied during the previous
year.
7. Drug costs and other
expenses associated with investigational drug studies should be properly
allocated and reimbursed.
8. Monitoring of therapy
and patient education are two clinical functions that are particularly
important and applicable to investigational drugs. These functions should be
provided by the pharmacy and nursing staff and authorized investigators.