SOP for Adverse Drug Reactions

OBJECTIVE

To participate actively in pharmacovigilance.

To provide procedures for handling ADRs.

SCOPE

All complaints are caused by the unusual side effects of drugs that may appear after the clinical studies of the drug and/or phase IV and that only a specific group of individuals can experience.

RESPONSIBILITY

Pharmacist

PROCEDURE

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

QUALITY OF RECORDS

Shall be written on the ADR and kept it for proof.

REVISION HISTORY

Nil

Types of ADRs:

Type A – dose-related effects (Augmentation)

Type B – no dose-related effects (Bizarre)

Type C – dose and time-related effects (Continuous or chronic)

Type D – time-related effects (Delayed)

Type F – therapeutic failure

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