The Adverse Drug Reaction Evaluation Department

Dr. Nasser Al-Qahtani, Head, Adverse Drug Reactions Evaluations Department, Saudi FDA, joins Pharma IQ to discuss the Saudi FDA’s pharmacovigilance system and what new guidelines he predicts will be areas for discussion amongst pharma/biodiversity companies. Pharma IQ: What new guidelines do you predict will be areas for discussion amongst pharma and bio companies in 2012? And also, going into next year, what will be your department’s core priorities? N Al-Qahtani: The new European Pharmacovigilance Legislation is a heated topic nowadays. However, our pharmacovigilance centre is adopting the European pharmacovigilance most of the time. Besides, we are reviewing our guideline for updates to ensure compliance with the new pharmacovigilance legislation in order to unify our guideline with the current global guidelines with respect to pharmacovigilance. Pharma IQ: Reducing medical errors has become an international concern. How is the Saudi FDA working with industry to improve the reporting of adverse reactions? N Al-Qahtani: That is a good question. Our scope and our responsibility is to encourage healthcare professionals and the marketing authorisation, all those drug manufacturers, to report any drug related problems such as ADRs, medication errors, quality issues, etc. However, the marketing authorisation or drug manufacturers are required to report any suspected adverse drug events to Saudi FDA as declared and as dictated by the Saudi pharmacovigilance guidelines. Nevertheless, we started receiving some reports from healthcare professionals continuously and from drug manufacturers, which is obligatory. I believe that it is a matter of time to get all healthcare professionals and companies committed to our system. Pharma IQ: Why is it so important that individuals or healthcare organisations report adverse events and errors? N Al-Qahtani: This is one of the most important questions that we should answer. Actually, our main goal here at the Saudi Vigilance and National Pharmacovigilance Centre is to ensure delivery of safe medicines to our community in order to improve the public health perception as well as the patient’s quality of life. There are some objectives that we are running too, which is early detection of adverse drug reactions, and this is one of the areas of benefits that we are aiming to develop over time - detection of frequency of known adverse drug reactions - because sometimes known adverse drug reactions might be more frequent here in Saudi Arabia than any other region because of the genetic variation of the Saudi population. One of our objectives is to identify the risk factors and possible mechanisms underlying the adverse drug reactions. After we discover all of this information, we are aiming to prevent the adverse drug reactions, if possible, and to encourage the rational and safe use of medicines and to establish a communication with national and international institutions which are specifically working in the field of pharmacovigilance to get alerted about any emerging drug safety issues. Pharma IQ: What impact do you think social media has had or will have on the pharmacovigilance system? N Al-Qahtani: Actually, the mass media adverts and the social media has an important impact on pharmacovigilance. It has an unbelievable effect. We have signed some agreements with local news agents to disseminate our message and adverts and slogans to the community as well as the healthcare professionals, in order to get them more involved in the reporting culture. Most of these newspapers and magazines are published on a daily basis. We noticed an increase in the rate of reporting as well as patients’ understanding, with respect to the adverse drug reaction reporting and the importance of their role in reporting of adverse drug events, and quality issues. And, at the end of the day, that will have potential impact on the public health in general. Pharma IQ: What initiatives are you seeking to implement to establish the importance of pharmacovigilance for the safety of the patients? N Al-Qahtani: The National Pharmacovigilance centre has some safety initiatives to encourage the clients to report more and more adverse drug reaction and to get them alerted to the importance of this centre. Therefore, the Saudi Vigilance has many initiatives to improve the reporting culture between healthcare professionals, marketing authorisation orders and patients. We have developed some lectures and established some specific sessions to discuss pharmacovigilance within the agenda of international medical congresses. We have also run workshops specifically to help medical teams in all the major hospitals in Saudi Arabia. The same thing applies to the qualified persons for pharmacovigilance or local safety officers of the drug companies. We just invite them to give them the required education about our centre, about our guidelines and regulations here in Saudi Arabia just to make them aware of what we require them to do through specific lectures and seminars to public members. We are also hoping to involve the students of the medical colleges in an attempt to improve the reporting concepts. Pharma IQ : You are speaking at the drug safety MENA summit, What will be your key take-home message, and what are you looking forward to at the event? N Al-Qahtani: I’m looking forward to having a unified pharmacovigilance system all around the MENA region and the Gulf region. As you know, pharmacovigilance is a newly introduced concept here in this region; however, Saudi Arabia is still one of the leading health authorities among the regional authorities who adopt this pharmacovigilance centre. My key take-home messages include: making the audience aware that adverse drug reaction reporting is a priority and pharmacovigilance is an important issue, an important science that we should take care of. Companies are required to work hand in hand and to establish a very good collaboration with the regulators to enhance patient safety concepts. Interview conducted by Andrea Charles.

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