Improving pharmacovigilance in Saudi Arabia

The National Pharmacovigilance Center in Saudi Arabia was established on early 2009 withspecial focus on adverse drug reactions detection (ADR), assessment and prevention.1The aim of this letter to highlight the issues related to improvement of pharmacovigilance in Saudi Arabia.

On 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.2Lack 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 are lack of research about pharmacovigilance issues on Saudi Arabia, there are few researches were available with focus only on knowledge and awareness of pharmacists and health care professionals towards ADR.3,5 Many health care professionals mentioned on the first scientific meeting on Medication Safety on 26-27 February 2013. Riyadh, KSA that there was no feedback to there ADR reports.Counterfeit medicineis an increasing problem worldwide especially on developing countries6; there is a lack of research about counterfeit medicine on Saudi Arabia. Pharmacovigilance program on government and private hospitals either does not exist or the health care professionals not aware about it. Lack of the awareness among patients about ADR report.1Lack of training and workshops about ADR is reported.4There is 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 Centerrole 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.
  • Reevaluate 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 researches about pharmacovigilance issues are very important to improve it.
  • Send ADR feed back to health care professionals about their reports are necessary to motivate them for further collaboration.
  • Address all issues of counterfeit medicines are needed 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 are critical to improve the pharmacovigilance in Saudi Arabia.
  • Introduce pharmacovigilance concepts is very essential to pharmacy, nursing and medical education to improve the pharmacovigilance in Saudi Arabia.

Competing interests: None declared

REFERENCES

1.Saudi Food & Drug Authority. National Pharmacovigilance Center. [ Cited 2014 9th May]; Available from:

2. 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 journal33, no. 8 (2012): 863-868.

4.Bawazir, Saleh A. "Attitude of community pharmacists in Saudi Arabia towards adverse drug reaction reporting."Saudi Pharmaceutical Journal14, 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]; 2010.

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