Pharmacy Standard Operating Procedure: Adverse Drug Reactions

I. OBJECTIVE: To participate actively in phamacovigilance.

To provide procedure on handling ADRs.

II. SCOPE: All complaints that caused from the unusual side effects of drugs that may appear after the

the clinical studies of the drug and/or phase IV and that only specific group of individuals can experience it.

III. RESPONSIBILITY

• Pharmacist

IV. PROCEDURE

1. Give courtesy greeting to the customer and ask what his concern all about.
2. After hearing the complaint, conduct an interview. The interview should be personal and private.
3. While interviewing the client, there should be a documentation of it, and if possible there must be proof of the adverse reaction of the drug such as pictures of it, recording of the talk and so on to forth.
4. Ask about his lifestyle and other medicines that he is taking.
5. The answers should be true and valid.
6. The ADR should be categorized according to its type and classification.
7. A form must be filled up and let the interviewee sign it to prove that all written complaints are true and original.
8. Keep the ADR form and report it to the company that involved and to the nearest FDA office, so that analyses, tests and studies on that event can be performed.

V. QUALITY OF RECORDS: Shall be written on the ADR and kept it for proof.

VI. FORMS: See figure 1A.

VII. END OF DOCUMENT

Types of ADRs:

1. Type A – dose related effects (Augmentation)
2. Type B – no dose related effects (Bizarre)
3. Type C – dose and time related effects (Continuous or chronic)
4. Type D – time related effects (Delayed)
5. Type F – therapeutic failure