The National Pharmacovigilance Center in Saudi Arabia was established in early 2009 with special focus on adverse drug reactions detection (ADR), assessment and prevention.1 The aim of this letter to highlight the issues related to improvement of pharmacovigilance in Saudi Arabia.
in 2013 the National Pharmacovigilance Center in Saudi Arabia reported that there was underreporting of ADR and the main reasons were unaware of pharmacovigilance issues, complicating reporting system and lack of motivation.2 Lack of awareness towards ADR and ADR reporting among community pharmacists in community pharmacies as well as health care professionals on hospitals was reported on other studies on Saudi Arabia. 3,4 There is a lack of research about pharmacovigilance issues on Saudi Arabia, there are few studies available with focus only on knowledge and awareness of pharmacists and health care professionals towards ADR.3,5 Many health care professionals mentioned at the first scientific meeting on Medication Safety on 26-27 February 2013. Riyadh, KSA, that there was no feedback to their ADR reports. Counterfeit medicine is an increasing problem worldwide especially on developing countries6; there is a lack of research about counterfeit medicine in Saudi Arabia. Pharmacovigilance program on government and private hospitals either does not exist or the health care professionals not aware of it. There is a lack of awareness among patients about ADR report.1 Lack of training and workshops about ADR is reported.4 There are no data about pharmacovigilance concepts education in pharmacy, nursing and medical education on Saudi Arabia.
The following recommendations are very important to improve pharmacovogilance in Saudi Arabia:
• Marketing the National Pharmacovigilance Center role and activities through media, workshops, general lectures, brochures and distribute of educational materials are needed to increase the health care professional and patients awareness.
• Motivate health care professional and patients to report ADR is required to improve ADR reporting.
• Re-evaluate the reporting system and make it easy for health professionals and peoples are necessary to facilitating ADR reports.
• Collaboration between the National Pharmacovigilance Center and universities to conduct research about pharmacovigilance issues is very important to improve it.
• Send ADR feed back to health care professionals about their reports to motivate them for further collaboration.
• Address all issues of counterfeit medicines to fight it especially if it is at the beginning. Collaboration between Saudi Food & Drug Authority and other authorities on Saudi Arabia are required to fight counterfeit medicines.
• Establish and activate the pharmacovigilance programs on government and private hospitals as critical in improving pharmacovigilance in Saudi Arabia.
• Introduce pharmacovigilance concepts to pharmacy, nursing and medical education to improve pharmacovigilance in Saudi Arabia.
3.Khan, Lateef M., Sameer E. Al-Harthi, Omar I. Saadah, Ahmed B. Al-Amoudi, Mansour I. Sulaiman, and Ibrahim M. Ibrahim. "Impact of pharmacovigilance on adverse drug reactions reporting in hospitalized internal medicine patients at Saudi Arabian teaching hospital." Saudi medical journal 33, no. 8 (2012): 863-868.
4.Bawazir, Saleh A. "Attitude of community pharmacists in Saudi Arabia towards adverse drug reaction reporting." Saudi Pharmaceutical Journal 14, no. 1 (2006): 75-83.
5.Mahmoud, Mansour Adam, Yazeed Alswaida, Thamir Alshammari, Tahir Mehmood Khan, Alian Alrasheedy, Mohamad Azmi Hassali, and Hisham Aljadhey. "Community pharmacists’ knowledge, behaviors and experiences about adverse drug reaction reporting in Saudi Arabia." Saudi Pharmaceutical Journal (2013).
Rapid Response:
Re: Improving pharmacovigilance in Europe
The National Pharmacovigilance Center in Saudi Arabia was established in early 2009 with special focus on adverse drug reactions detection (ADR), assessment and prevention.1 The aim of this letter to highlight the issues related to improvement of pharmacovigilance in Saudi Arabia.
in 2013 the National Pharmacovigilance Center in Saudi Arabia reported that there was underreporting of ADR and the main reasons were unaware of pharmacovigilance issues, complicating reporting system and lack of motivation.2 Lack of awareness towards ADR and ADR reporting among community pharmacists in community pharmacies as well as health care professionals on hospitals was reported on other studies on Saudi Arabia. 3,4 There is a lack of research about pharmacovigilance issues on Saudi Arabia, there are few studies available with focus only on knowledge and awareness of pharmacists and health care professionals towards ADR.3,5 Many health care professionals mentioned at the first scientific meeting on Medication Safety on 26-27 February 2013. Riyadh, KSA, that there was no feedback to their ADR reports. Counterfeit medicine is an increasing problem worldwide especially on developing countries6; there is a lack of research about counterfeit medicine in Saudi Arabia. Pharmacovigilance program on government and private hospitals either does not exist or the health care professionals not aware of it. There is a lack of awareness among patients about ADR report.1 Lack of training and workshops about ADR is reported.4 There are no data about pharmacovigilance concepts education in pharmacy, nursing and medical education on Saudi Arabia.
The following recommendations are very important to improve pharmacovogilance in Saudi Arabia:
• Marketing the National Pharmacovigilance Center role and activities through media, workshops, general lectures, brochures and distribute of educational materials are needed to increase the health care professional and patients awareness.
• Motivate health care professional and patients to report ADR is required to improve ADR reporting.
• Re-evaluate the reporting system and make it easy for health professionals and peoples are necessary to facilitating ADR reports.
• Collaboration between the National Pharmacovigilance Center and universities to conduct research about pharmacovigilance issues is very important to improve it.
• Send ADR feed back to health care professionals about their reports to motivate them for further collaboration.
• Address all issues of counterfeit medicines to fight it especially if it is at the beginning. Collaboration between Saudi Food & Drug Authority and other authorities on Saudi Arabia are required to fight counterfeit medicines.
• Establish and activate the pharmacovigilance programs on government and private hospitals as critical in improving pharmacovigilance in Saudi Arabia.
• Introduce pharmacovigilance concepts to pharmacy, nursing and medical education to improve pharmacovigilance in Saudi Arabia.
Competing interests: None declared
REFERENCES
1.Saudi Food & Drug Authority. National Pharmacovigilance Center. [ Cited 2014 9th May]; Available from:
http://www.sfda.gov.sa/en/drug/about/sector_departments/national_pharmac...
2. http://www.who-umc.org/graphics/26302.pdf [ Cited 2014 9th May].
3.Khan, Lateef M., Sameer E. Al-Harthi, Omar I. Saadah, Ahmed B. Al-Amoudi, Mansour I. Sulaiman, and Ibrahim M. Ibrahim. "Impact of pharmacovigilance on adverse drug reactions reporting in hospitalized internal medicine patients at Saudi Arabian teaching hospital." Saudi medical journal 33, no. 8 (2012): 863-868.
4.Bawazir, Saleh A. "Attitude of community pharmacists in Saudi Arabia towards adverse drug reaction reporting." Saudi Pharmaceutical Journal 14, no. 1 (2006): 75-83.
5.Mahmoud, Mansour Adam, Yazeed Alswaida, Thamir Alshammari, Tahir Mehmood Khan, Alian Alrasheedy, Mohamad Azmi Hassali, and Hisham Aljadhey. "Community pharmacists’ knowledge, behaviors and experiences about adverse drug reaction reporting in Saudi Arabia." Saudi Pharmaceutical Journal (2013).
6. World Health Organization. Medicines: counterfeit medicines, Fact Sheet 275. [ Cited 2014 9th May]; http://www.who.int/mediacenter/factsheets/fs275/en/. 2010.
Competing interests: No competing interests