Introduction
Pharmacovigilance has been defined by the World Health Organization (WHO) as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem (i). It is also known as Drug Safety
The legal framework in Saudi Arabia for Pharmacovigilance of pharmaceutical products for human use in the community is given in the law of pharmaceutical products and pharmaceutical institutions number (M/31) dated 01/06/1425H, and the Saudi Council of Ministers Directives (31) and (168) dated 24/01/1428H and 24/06/1423H, respectively (ii).
Pharmacovigilance focuses on adverse drug reactions (ADRs), which are defined as any response to a drug that is noxious and unintended, including lack of efficacy, which occurs at doses normally used for the prophylaxis, diagnosis or therapy of disease, or the modification of physiological function. Medication errors such as overdose, and misuse and abuse of a drug, are also of interest because they may result in an ADR (iii).
Why It Is Important?
Pharmacovigilance Aims To (Iv) :
- Improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions
- Improve public health and safety in relation to the use of medicines.
- Contribute to the assessment of benefit, harm, effectiveness, and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use.
- Promote understanding, education, and clinical training in Pharmacovigilance and its effective communication to the public.
Who Is Involved In Pharmacovigilance?
With The Purpose Of Ensuring The Protection Of Public Health And The Usage Of Medicinal Products Safer, Pharmacovigilance Is A Responsibility Shared Between:
- Saudi Food and Drug Authority (SFDA) as the regulatory agency.
- Pharmaceutical Manufacturer and Marketing Authorization Holder (MAH) .
- Healthcare Professionals, including but not limited to: doctors, pharmacist and nurses.
- Patients / Consumers / Public.
Our Commitment
Yahmaa supports and adheres to the Pharmacovigilance policy and system established by SFDA. This is in line with our company’s core value and code of ethics.
Reporting To Yahmaa’s Pharmacovigilance Section
Address:
69 Al Kindi Plaza
Diplomatic Quarter
P.O. Box 67864
Riyadh 11517
Kingdom of Saudi Arabia
Telefax: +966 11 281 5152 , Fax: 222
Email: info@yahmaa.com
- (WHO, The Importance of Pharmacovigilance: Safety Monitoring of Medicinal Products, 2002)
- (SFDA, Saudi Pharmacovigilance Guideline of Registered Medicines, 2009)
- (WHO, International Drug Monitoring, The Role of National Centres , 1972)
- (WHO, The Importance of Pharmacovigilance: Safety Monitoring of Medicinal Products, 2002)