Question

The VA Pharmacy Service is responsible for which of the following activities in trials involving investigational drugs?

1) Dispensing investigational drugs to patients
2) Monitoring the safety and efficacy of investigational drugs
3) Managing the inventory of investigational drugs
4) Providing counseling to patients participating in trials

Answer 1

The VA Pharmacy Service is responsible for dispensing investigational drugs, monitoring their safety and efficacy, managing drug inventory, and providing counseling to trial participants.

Step-by-step explanation:

The VA Pharmacy Service is involved in various activities when it comes to trials involving investigational drugs. These activities include:

1. Dispensing investigational drugs to patients participating in trials.
2. Monitoring the safety and efficacy of investigational drugs during the clinical trial phases to ensure patient safety and reliable results.
3. Managing the inventory of investigational drugs to maintain adequate supply and account for all dosages used in clinical trials.
4. Providing counseling to patients to ensure they understand the use, potential side effects, and importance of adherence to the investigational drug regimen.

After a drug has been approved for marketing, the pharmaceutical company, with oversight by the FDA, must continue to monitor it through pharmacovigilance systems and may be required to conduct additional clinical trials, known as Phase IV trials, to ensure long-term safety and effectiveness, especially in different subgroups of patients.