Role of Pharmacist in Investigational Drugs

Role of Pharmacist in Investigational Drugs

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.

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