Document No.

STANDARD OPERATING
PROCEDURE Revision No.

ADVERSE DRUG REACTIONS Page 1 of 2

Revision History
Revised on: Prepared by: Reviewed by: Approved by:

Daniel Yves A. Paez IV, RPh Denice P. Mesias Denice P. Mesias

Pharmacist Owner/Proprietress Owner/Proprietress
Issue No.:
Effective Date:

References
Document No.: Title No.

I. OBJECTIVE:
1. To participate actively in phamacovigilance.
2. To provide procedure on handling ADRs.

II. SCOPE: All complaints that caused from the unusual side effects of drugs that may appear
after 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.
3. The interview should be personal and private.
4. 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.

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 5. Ask about his lifestyle and other medicines that he is taking.
6. The answers should be true and valid.
7. The ADR should be categorized according to its type and classification.
8. A form must be filled up and let the interviewee sign it to prove that all written complaints
are true and original.
9. 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 record book and kept it for proof.

VI. FORMS:
See figure 1A.

VII. END OF DOCUMENT

Fig. 1A Types of ADRs:

 Type A – Dose-related effects (Augmentation)
 Type B – Non dose-related effects (Bizarre)
 Type C – Dose- and time-related effects (Continuous or Chronic)
 Type D – Time-related effects (Delayed)
 Type F – Therapeutic failure (Failure of Efficacy)

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