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Conference floats proposals for pharmacovigilance in Arab world
By Mariecar Jara-Puyod April 25, 2017
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DUBAI: It is important that pharmacovigilance will not only be included in the curricula of medical education but in basic education as well.

This is among the 10 recommendations of over 100 delegates—healthcare professionals (HCPs) and industry players from the UAE and nearby countries—from the recently-held “Sixth National Pharmacovigilance Conference” held in Dubai.

Pharmacovigilance refers to the awareness, attention and alertness of every community or country in the monitoring and consequent reporting of the undesirable effects of licensed and approved drugs including related products due to abuse and misuse. The undesirable effects are termed as adverse drug reactions (ADRs) which may become fatal since aside from the improper or incorrect usage, the medicinal substances or medical components may also be counterfeit or substandard.

The 10 recommendations, arising from the two-day conference, were released to the media on Sunday by the Ministry of Health and Prevention (MoHP).

In his conference keynote address, MoHP-Public Health Policy & Licensing Sector assistant undersecretary Dr Amin Hussain Al Amiri, who traced the roots of pharmacovigilance to the scientific-medical discoveries of Persian polymath Ibn Sina, also said that the “outcome of the conference will be known as the Dubai Declaration.”

He said the paper will be submitted to the regional Gulf Health Council for Cooperation Council States and to the 22-member Arab League with the hope that this “would benefit the Arab World.”

The 10 recommendations are:

1. Building trust in the critical role of testing medicines following registration and testing random sample from the field.

2. Pharmacovigilance as a culture in the region that must be supported by policies, programmes and regulations.

3. Enhancement of pharmacovigilance education programmes among the HCPs in the region.

4. Inclusion of pharmacovigilance education in the academic curricula of medical and scientific schools and making it among the basics of education.

5. Reinforcement of the importance of pharmacovigilance programmes in maintaining the health, safety and protection of the community from ADRs.

6. ADRs reporting to be a culture of HCPs who must not be embarrassed in doing so.

7. Continuing enhancement of health education in order to continually raise public awareness on expected ADRs.

8. Reported ADRs to be categorised and separated according to originator medicine, generic, and the biological view of the difference in chemical compositions.

9. Enhancement of the regulatory role of pharmacovigilance and supporting it with policies that enhances its effectiveness around the world.

10. Focus on the educational role of pharmacovigilance officers among the various healthcare establishments in the region.

From the conference, Centre for Medicine in the Public Interest president & co-founder Prof. Peter J. Pitts lectured on “The Urgency of Regulatory Democracy.”

The former US Food and Drug Administration (FDA)-External Relations associate commissioner reminded the delegates “not to look at the EMEA (European Medicines Agency) and the FDA (as the ultimate in pharmacovigilance).”

This is so since “each country and each region have their own cultures and environments; not everything workable in the developed countries is workable everywhere; and there is no single solution to all problems.”

Pitts said regulation is about the utilisation of all traditional and contemporary means in order to achieve a certain goal.

He also stressed that the best mindset is to implement guidelines best suitable to “a certain group of people in a certain place” taking into consideration that “each of us is also continually evolving and we cannot afford to be at a standstill.”

Resource speakers MoHP-Public Health Policy & Licensing Sector-Continuing Professional Development-Pharma Programme manager/Pharmaceutical adviser Dr Ola Ghaleb Al Ahdab, International Society for Pharmacoepidemiology-Gulf Chapter vice president Dr Thamir Al Shammari and Common Arab Guidelines for Pharmacovigilance founder Amr Saad were on the same page.

They said at the panel discussions that the pharmacovigilance guidelines and systems, taking into consideration the socio-economics of each country, must be “custom-made” for each country and for the entire region.

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