Prescribing information in 26 countries: a comparative study

Abstract

This study was set up to document the variability of prescribing information from different sources concerning indications, side effects and cautions of selected drugs. An original method to measure the degree of information agreement among different written materials, such as summaries of product characteristics, package inserts and data sheets, and a widely accepted reference text was developed. The results show that there is substantial disagreement in the materials available to prescribers and patients in different countries. Disagreement was even found within a single country when written materials from different brands of the same drug were compared. The discordance can be explained by the fact that the evidence available for each drug is considered/assessed differently by separate countries. It is argued that the discrepancies found may mislead prescribers, patients and those comparing drug-use patterns across countries. National regulatory authorities have a key role to play in remedying this situation, and a two-pronged approach is proposed. At the international level, national authorities should strengthen collaboration and information interchange and, at the national level, should implement appropriate measures aimed at removing contradictory statements on drug-information materials that have no reason to be different. Finally, further training and continued education aimed at drug regulatory officials could provide the necessary knowledge and enable national authorities to meet the need for drug information that is independent of commercial interests.

Appendix

Contributors

L. Rägo and V. Reggi developed the initiative, and with R. Balocco-Mattavelli, M. Bonati, A. Figueras and C. Kopp designed the study. V. Reggi, R. Balocco-Mattavelli, M. Bonati, A. Figueras and C. Kopp wrote the initial protocol and drafted the operations manual. R. Balocco-Mattavelli and E. Jambert obtained the material. I. Breton, E. Jambert, E. Montane and F. Rocchi organised the materials, constructed and maintained the database, and did the analyses with M. Bonati, V. Reggi and A. Figueras, who supervised the process of work. The co-ordinating group read and commented on the paper, which was jointly written with the collaboration of C. Pandolfini. M. Bonati will act as guarantor for the paper.

The International Comparative Study On Drug Information (ICSODI) Collaborative Group

Coordinating group: see authors' list

National participants Argentina: Martín Cañás, FEMEBA- Federación Médica de la Provincia de Buenos Aires, Calle 5 entre 41 y 42, 1900 La Plata (macanas@network.com.ar); Australia: Peter Mansfield, MaLAM, PO Box 172, Daw Park, South Australia 5041 (peter.mansfield@flinders.edu.au); India: Pijus Sarkar, P 254–Block B, Lake Town, Calcutta 700 089 (fha@cla.vsnl.net.in); Brazil: Marisa Lima, Secretaria de Saúde de Sao Paulo, Centro de Vigiláncia Sanitária, Av. Sao luis, 99–8° andar, Sao Paulo-SP – CEP 01046–001 (marisalima@cvs.saude.sp.gov.br); Canada: Ciprian D. Jauca, Evidence-based Drug Therapy, University of British Columbia, Department of Pharmacology and Therapeutics, 2176 Health Sciences Mall, Vancouver, BC, V6T 1Z3 (jauca@ti.ubc.ca); Colombia: Claudia Vacca, Consultora OPS/OMS, Instituto de Ortopedia Infantil Roosevelt, Cra 69 B No 40–39 apto 15–101, Santa Fe de Bogotá (Cvaquis@hotmail.com); Croatia: Bozidar Vrhovac, University Hospital Rebro, 12 Kispaticeva, 10000 Zagreb (vrhovac@rebro.mef.hr); Egypt: Abdulla M. Molokhia, National Organization for Drug Control and Research, Drug information Centre, Pyramidis Ave 6 Abou Hazem str., Agouza: 51 W.ezaret El Ziraa St, Cairo (pharinfo@pharmaco.sti.sci.eg); Estonia: Maia Uusküla, 19 Ravila St, 50411 Tartu (maia.uuskula@sam.ee); France: Danielle Bardelay, La Revue Prescrire, BP 459,75527 Paris Cedex 11 (revue@prescrire.org); Kenya: Sarah Chuchu, Pharmacy and Poisons Board, P.O. Box 27663, Nairobi (kndpsc@net2000ke.com); Mexico: Dolores Mino, División de Investigación Clínica, Instituto Mexicano del Seguro Social, Centro Médico Siglo XXI, Edif. "B" de la U. de Congresos, Av. Cuauhtemoc, 330 - Colonia Doctores, 06725 México DF (mino@cim.spin.com.mx); Mozambique: Joaquim Durão, Departamento Farmacêutico, Ministério da Saúde, Caixa Postal 264, Maputo (jdurao@mail.tropical.co.mz); Pakistan: Zafar Mirza, Network for Rational Use of Medicines in Pakistan, 60-A, St 39, F-10/4, P.O.Box 2563, Islamabad (zafar@arump.sdnpk.undp.org); Perú: Germán Rojas Caro, AIS Perú, Marchand 314 - San Borja, Lima – 41 (ais@amauta.rcp.net.pe); Philippines: Isidro C Sia, RDU update, Department of Pharmacology, College of Medicine- Medical Annex Building, Univerity of Philippines, 547 Pedro Gil Street, PO Box 593, Manila (isidro@kulog.upm.edu); Poland: Paul Mazurek, State Institute of Drug Control, Ministry of Health and Social Welfare, 30 Chelmska Str., PL-00725 Warszawa (paulm@il.waw.pl); Switzerland: Jules Desmeules, Clinical Pharmacology Division, University Hospital, CH-1211 Geneva 14 (jules.desmeules@hcuge.ch); Syrian Arab Republic: Suheila Akim, Pharmaceutical Affairs, Ministry of Health, Sahel El Nejme, Damascus (Health-min@net.sy); Thailand: Sauwakon Ratanawijitrasin, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Phayathai Rd. Bangkok 10330 (rsauwako@chula.ac.th); Tunisia: Amor Toumi, Direction de la Pharmacie et du Médicament, 31 Rue de Khartoum, 1002 Tunis Belvedere (amor.toumi@rns.tn); United Kingdom: Andrea Tarr, 2 Marylebone Road, London NW1 4DF (andrea.tarr@which.co.uk); United States of America: Larry Sasich, Public Citizen Health Research group, 1600 20th St, NW, Washington, DC 20009 (hrg1@citizen.org); Venezuela: Esperanza Briceño Godoy, Directora de Drogas Medicamentos y Cosmeticos, Ministerio de Salud y Desarrollo Social, Torre Sur. Centro Simon Bolivar, Caracas (drogasycosmeticos@msds.gov.ve).