Martin Kondža
@MartinKondza
Pharmacovigilance Expert, Agency for Drugs and Medical Devices
Assistant Professor, University of Mostar
The Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina (ALMBiH) is the authorised body for drugs and medical devices in the country. Since the agency began operating in 2009, the national pharmacovigilance centre has been located in Mostar, the country’s fifth largest city. But the Mostar office has had a few setbacks. Bosnia and Herzegovina and its neighbouring countries Croatia, Serbia, and Montenegro were part of Yugoslavia until 1991. Yugoslavia had a well-organised pharmacovigilance system, and was one of the early members of the WHO Programme for International Drug Monitoring from 1974. Given such a long and successful history of medicines safety practice in the region, one would expect all countries in the former Yugoslavia to fare equally well. But with the war and the break-up of Yugoslavia, the good pharmacovigilance tradition in Bosnia and Herzegovina dissolved.
Over time, and even though relevant regulations were in place in the region, Bosnia and Herzegovina’s pharmacovigilance system fell behind. The country had no national ADR reporting after 1991, and there have been no online reporting systems so far. Unlike its neighbours, which have been full members of the WHO programme for several years, Bosnia and Herzegovina only became one in March 2019, and there is a generally low awareness of pharmacovigilance issues among the public. A recent study in the Croatian Medical Journal found that the country collects fewer individual case safety reports (ICSRs) – and often of lower quality – compared to Croatia, Serbia, and Montenegro. But why is that?
Due to the complex political situation, for a long time the Mostar centre lacked pharmacy and medical professionals with the right skills and training. Add to that the absence of pharmacovigilance education among healthcare professionals, and one can see why Bosnia and Herzegovina suffered from low ADR reporting numbers. Some changes had to be made.
Under the lead of Dr Biljana Tubić, deputy director of ALMBiH and head of the Medicinal Products division, the Mostar team has been working hard to establish the serious vigilance system that Bosnia and Herzegovina so desperately needs. In 2017, two pharmacists were hired to conduct vigilance work as external experts. The centre then launched a number of initiatives to promote strict and analytical gathering and assessing of ADR reports, and to improve communication with pharma-ceutical companies, marketing authorisation holders, and healthcare workers. A national database for ADRs was launched, and collaboration with similar authorities in the region initiated. The team also improved communication with Uppsala Monitoring Centre, by forwarding all ICSRs from Bosnia and Herzegovina to VigiBase, and by attending UMC webinars to find out about pharmacovigilance news from around the world.
Efforts were also made to raise awareness of the importance of ADR reporting. One of the centre’s first missions was to meet colleagues from the Croatian Agency for Medicinal Products and Medical Devices (HALMED), and to learn from their experience. The former Yugoslavian pharmacovigilance centre was located in Croatia’s capital city Zagreb, so perhaps unsurprisingly, Croatia’s is the most developed pharmacovigilance system in the Balkan region. It has the highest number of ADR reports per inhabitant (and one of the highest in the EU), a higher percentage of pharmacist reporters, and a patient reporting system in place. Meetings with HALMED produced plenty of constructive ideas. ALMBiH staff learned from their rich experience, and gained insight into the change of practice following Bosnia and Herzegovina’s possible accession to the EU.
As an incentive for health professionals to report, ALMBiH advised the country’s health professional chambers, which assign licenses for healthcare workers, to reward their members with license renewal points for reporting an adverse drug reaction. ALMBiH staff also attended national and international conferences, where they presented their work and ideas for future development of the Mostar office, including the implementation of a new online system to collect ICSRs.
These activities have produced great results. In 2017, the centre published its first annual ADR report, a collection of safety issues around medical products and medical devices gathered during the year. The number of ADR reports received in 2017 was the highest since the agency’s founding, and represented an increase of 127% (to 283 total reports) compared to 2016. Last year saw a 23% increase (to 349 total reports) compared to 2017, and a second annual report, with detailed data from 2018, will follow.
ALMBiH is now planning new activities for 2019. The agency will expand its online reporting system to healthcare professionals and market authorisation holders, and to include medical devices. Also, national campaigns and educational initiatives will be held around the country to raise awareness of ADR reporting. A strong and efficient pharmacovigilance system is in our best interests, and we are giving our utmost to bring Bosnia and Herzegovina back on the global medicines safety map.
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