Company Title of Document: Standard Operating Topic:Pharmacovigilance

name: Procedure

Prepared by: Date prepared: February 12,

2024

Approved by: Date Approved:

Revised by: Date Revised:

I. POLICY: The owner and its personnel have a responsibility to assure that the products
that are offered for sale are safe and effective.
II. OBJECTIVES:
1. To provide advice to the clients on the proper use of medication to prevent
harmful effects of the drugs.
2. To record ADR occurrences.
3. To report to the FDA when ADR occurs.
III. RESPONSIBLE PERSONNEL:
1. Pharmacist
2. Pharmacy Assistant
3. Owner
IV. MATERIALS:
1. Complaint logbook
V. EQUIPMENT:
1. Desktop
2. Internet Connection
VI. PROCEDURES:
I. Medication Counseling
A. Over the Counter Drugs (OTC)
1. The pharmacy assistant will advise the client about the proper use
of the drug.
2. The pharmacy assistant will assess the condition of the client
before recommending an over the counter drug.
3. The pharmacy assistant seeks the expertise of the pharmacist to
provide counseling to the patient.
B. Prescription Drug
1. The pharmacy assistant will refer the prescription to the pharmacist
for checking and approval before dispensing the prescription.
2. The pharmacist will advise the patient on the proper use of the
drug.
3. The pharmacist will advise the patient to inform her if the side
effects occur when taking the drug.
II. Product Complain
A. The pharmacist will interview the customer about his concern on the product
 B. The pharmacist will record the complaint of the client in a log book with the
following information
1. Date of complaint
2. Name, address, and contact number of the complainant
3. Details regarding the complaint
4. Signature of the complainant.
C. The pharmacist will also record the details of the product complaint with
following information.
1. Name of the product (Generic and Brand name)
2. Dosage strength of the product
3. Name of the manufacturer and the product
4. Name of the distributor and address
5. Lot and Batch number of the product
6. Expiry date of the product
7. Nature of complaint of the product
D. The pharmacist will report the complaint to the supplier and FDA website
respectively.
III. Adverse Drug Reporting
A. The pharmacist will accomplish the ADR form found in the FDA website to
report the adverse drug reaction occurred to a patient.