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WHO Drug Information Vol. 21, No. 3, 2007

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WHO Drug Information Vol. 21, No. 3, 2007 WHO DRUG INFORMATION VOLUME 21 • NUMBER 3 • 2007 RECOMMENDED INN LIST 58 INTERNATIONAL NONPROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES WORLD HEALTH ORGANIZATION • GENEVA WHO Drug Information Vol 21, No. 3, 2007 World Health Organization WHO Drug Information Contents Pharmacovigilance Focus Current Topics Challenges of pharmacovigilance in Global strategy to prevent transmission Ukraine 193 of Chagas disease 211 Adverse reaction reporting in Canada 197 Educational modules for health professionals reporting adverse Consultation Documents reactions 197 International Pharmacopoeia WHO pharmacovigilance capacity Amodiaquine hydrochloride tablets 212 building 202 Chloroquine sulfate oral solution 214 Paediatric artemether and lumefantrine oral suspension 216 Safety and Efficacy Issues Sulfadoxine and pyrimethamine tablets 221 Rosiglitazone: cardiac safety 203 Quinine sulfate tablets 223 Rosiglitazone: cardiac safety profile 204 Rifampicin, isoniazid and ethambutol Bevacizumab: tracheoesophageal hydrochloride tablets 226 fistula 204 Rifampicin and isoniazid dispersible NSAIDS and cardiovascular risk 205 tablets 229 Rosiglitazone and parotid gland Rifampicin, isoniazid and pyrazinamide enlargement 206 dispersible tablets 232 Cinacalcet: indication changes 206 Efavirenz capsules 236 Omalizumab and anaphylaxis 207 Nevirapine oral solution 238 Vinca alkaloids: intravenous Nevirapine tablets 241 administration 207 Pioglitazone: fractures in women 207 Recent Publications, Regulatory Action and News Information and Events Viracept®: suspension pending quality Pharmacogenomics guidance from and safety assessment 208 Health Canada 245 Nimesulide: suspension following liver Untangling the web: tenth edition 245 failure 209 Priorities for dengue control 246 Tegeserod temporarily suspended 210 PLoS Neglected Tropical Disease open Withdrawal of products containing access journal 246 veralipride 210 Recommended International Nonproprietary Names: 247 List 58 191 World Health Organization WHO Drug Information Vol 21, No. 3, 2007 Announcement The 13th International Conference of Drug Regulatory Authorities (ICDRA) will be hosted by the Swiss Agency for Therapeutic Products (Swissmedic) in collaboration with the World Health Organization The ICDRA will take place in Berne, Switzerland from 16 to 19 September 2008 Updated information will be provided regularly at: http://www.icdra.ch or http://www.who.int/medicines/icdra/en/index/html 192 WHO Drug Information Vol 21, No. 3, 2007 Pharmacovigilance Focus Challenges of pharmaco- been translated and published in a book entitled “Pharmaceutical Sector: Pharma- vigilance in Ukraine covigilance of Medicinal Products for Human Use” (3). Regulatory guidance Assuring the safety of medicinal products documents have also been issued to is a key component of Ukraine’s national provide a framework for pharmacovigi- medicines policy. Activities involving lance practices (4). safety and monitoring of adverse reac- tions are part of a pharmacovigilance The early existence of an operational system operated by the State Pharmaco- pharmacovigilance system in Ukraine logical Centre. Quality assurance of greatly facilitated harmonization and medicinal products remains the responsi- introduction of European Union stand- bility of the State Inspectorate for Quality ards. A Ministry of Health Order (5) laid Control of Medicinal Products. down future requirements for pharmaco- vigilance procedures with the aim of In Ukraine, information provided by the reinforcing medicines safety and ensuring pharmacovigilance system allows for the access to effective and safe products for collection and scientific assessment of the population. adverse reactions data reported following use of medicinal products. A fully func- The State Pharmacological Centre tioning pharmacovigilance system is coordinates all pharmacovigilance-related essential for providing scientific and activities. Information on adverse reac- evidence-based information to support tions to medicinal products is processed regulatory decisions. and analysed by the Pharmacovigilance Department. This Department is also The pharmacovigilance system in Ukraine linked to Regional Centres where staff has been operational since 1996 and, work with health care programmes and over time, monitoring and reporting of medical doctors throughout Ukraine. adverse reactions has largely been Department staff handle over 4000 cases integrated into the health care system of adverse reaction reports annually and through relevant legislation. The State during the period 1996–2006, the Phar- Pharmacological Centre became a full macovigilance Department received over member of the WHO Programme for 18 600 reports of adverse reactions to International Drug Monitoring in 2002. medicinal products (Figure 1, next page). Pharmacovigilance in Ukraine is currently based on European Union guidelines and The Pharmacovigilance Department is rules governing medicinal products in the responsible for the organization, metho- European Union which have been devel- dology and educational activities related oped as a result of the International to pharmacovigilance. Since 2001, Conference on Harmonization (ICH) twenty-two workshops on organization process (1, 2). These regulations have and management have been held in Ukraine and were attended by over 2000 Article prepared by O.P. Viktorov, O.V. health care professionals. Participants Matveyeva, I.O. Logvina. State Pharmacologi- included full-time specialists, chiefs of cal Centre, Ministry of Health, Ukraine health departments of the State Adminis- 193 Pharmacovigilance Focus WHO Drug Information Vol 21, No. 3, 2007 Figure 1. Dynamics of adverse reaction reports received from doctors trations, chief doctors, departmental A book entitled “Organization of the heads, and physicians from different pharmacovigilance system in Ukraine” health care specialities in Ukraine. Four was published in 2002 (6) describing the of these workshops dealt with establish- main objectives and resources needed to ment and implementation of a pharma- set up a pharmacovigilance system and covigilance system targeting manufactur- the legislative basis required for conduct- ers of medicinal products. ing pharmacovigilance. Recommenda- tions for doctors have also been pub- In Ukraine, the spontaneous reporting lished under the title “Principles of report- system currently comprises: ing information about adverse reactions to medicinal products in human use” (7). • Methodologies and organizational In addition, personnel from the Pharma- activities managed by the Pharmaco- covigilance Department and Regional vigilance Department and Regional Centres have published more than 200 Centres; articles related to safety in medical journals. • Collection of data on adverse reactions which is incorporated and utilized in The document “Medicines Safety. Guide- generating state health statistics; lines on Pharmacovigilance” (8) urges pharmaceutical manufacturers, health • Studies conducted during the postmar- practitioners, pharmacists, researchers, keting phase, which allow publication of lecturers and students of medical and safety profiles on selected medicinal pharmaceutical colleges to take a more products; professional approach to safety issues. Established in 2006, the magazine • Educational programmes for pre- and “Rational Pharmacotherapy” (9) reflects postgraduate training of doctors and challenges and progress made in phar- pharmacists on collection and reporting macovigilance activities both in Ukraine of adverse reactions; and throughout the world. The magazine focuses on many of the changes in • Networking and links to international attitude taking place concerning use of activities. medicinal products and patient safety. 194 WHO Drug Information Vol 21, No. 3, 2007 Pharmacovigilance Focus Since the main source of adverse reac- • Fostering understanding and awareness tion reports is physicians, Ministry of of the importance of medicinal product Health Order 898 of 27 December 2006 safety through educational tools. instructs doctors to complete a reporting form (form 137/0) (4) and transmit this to • Identifying new means of communica- the Regional Centre or directly to the tion with administrators of health care State Pharmacological Centre (Figure 2). facilities. In an effort to improve reporting of ad- • Facilitating use of the reporting form. In verse reactions, the following activities this respect, the format and visual have been identified as important by the presentation have been revised. A new State Pharmacological Centre: wording simplifies use and the improved form should now take a physician less • Promotion in all regions of Ukraine — than 10 minutes to complete. through information, education and improved communications — of the Reporting adverse reactions is consid- importance of pharmacovigilance and ered a civil and medical duty for doctors adverse reaction reporting. since delay in reporting could lead to or prolong the use of unsafe and inefficient • Improving physician knowledge, attitude medicinal products. The reporting form and behaviour of the need for organiza- is now provided in two models: in- tion and implementation of pharmaco- patient medical card and outpatient vigilance in health care settings. coupon, designed to facilitate reporting even further. • Identifying ways for health care facilities to promote and integrate systems of An important aspect of medicinal product adverse reaction reporting by physi- safety is the close links which need to be
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