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Using this form healthcare professionals can report any suspected Adverse Reaction (AR), Medication Error (ME) and Adverse Event experienced from any of the drug product within the stipulated timeframe as defined in DoH policies, even if reporters are not certain that the particular medicinal product was the cause.

Unintended adverse effects, drug abuse, overdose, interaction (including drug-drug and drug-food interactions) and unusual lack of therapeutic efficacy are all considered to be reportable suspected Adverse Reactions (AR).

A. Patient Details (See Confidentiality section)

Health Care Institution:

B. Medical products used:

Medical product Name “Generic & Brand” (Manufacturer and Batch No. if known)

Dose, Route and Frequency

Therapy Starting Date

Therapy Stopping Date

Description of the reaction(s):

Onset date of reaction:

End date of reaction:

Action taken towards Adverse Reaction:

Reaction abated after use stopped or dose reduced:

Yes No Not applicable

Reaction reappeared after reintroduction:

Yes No Not applicable

Treatment of Adverse Reaction:

No Yes(medications and/or other therapy) include dates

Relevant tests / laboratory data including dates:

Other relevant History, including pre-existing medical conditions (e.g. allergies, pregnancy, smoking, renal dysfunction etc)

D. Outcome of Adverse Reaction

Recovered Recovering No improvement Unknown

E. Seriousness of Adverse Reaction:

Serious (If yes, tick all applicable below) Non serious

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Arabian Ethicals Pharmacovigilance Form