Assessment of Generic Drugs in the Caribbean
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Drug Informution Journal. Vol. 32, pp. 145-150, 1998 Printed in the USA. All rights I C S ~ N ~ ~ .
ASSESSMENT OF GENERIC DRUGS IN THE CARIBBEAN LEXLEYM. PINTOPEREIRA,MBBS, MD Lecturer in Pharmacology, Faculty of Medical Sciences, University of the West Indies, St. Augustine. Trinidad
HENRYFRASER,PHD, FRCP, FACP Professor of Medicine and Clinical Pharmacology. Faculty of Medical Sciences, University of the West Indies, Queen Elizabeth Hospital, Bridgetown, Barbados
FRANCISBUFWE’IT,Bsc, €%ARM Manager, Eastern Caribbean Drug Service, Castries, St. Lucia
In Caribbean countries the public sector is the largest purchaser of medicines. Patients may receive these medicines either at no cost or for very nominal charges at primary, secondary, or tertiary health care institutions. A limited drug list determined by the country S experts or the national formulary influences decisions for purchase of medications. Patent rights on branded drugs are honored and generic equivalents are not purchased untilpatent expiry. Though cost-containment issues are forceful determinants of the selection of generic products, brand name products may be offered at more economical prices, as in Trinidad. Currently, approximately 35-55% of each country 5 requirement is generic substitution; this is likely to increase. Bioavailability data are usually submitted while tendering for new introductions of generic products. Standard bioavailability laboratories doing drug testing are not present in the region. The Caribbean Regional Drug Testing Laboratory in Jamaica undertakes analysis for Caribbean countries on government requests and for a fee for private consumers. Production of generic drugs in the English speaking Caribbean is undertaken predominantly in Barbados, Trinidad and Tobago, and Jamaica. Together with the eastern Caribbean countries they are the major buyers of generic products. Certification of the generic equivalent in the country of origin is mandatory. In Trinidad and Tobago the Minstry of Health is drafting a national drug policy which will address evaluation of generic susbstitutes. Concerns about the standards of generic equivalents from prescribers, regulatory authorities, and academia are discussed. Key Words: Generic products; Controls; Caribbean countries
THE CARIBBEAN COUNTRIES comprise a population of approximately six million
Presented at the 32nd DM ti^^ ‘me lenge of Worldwide Pharmaceutical Development in an Era of Regulatory Change: Accelerated Approval with Quality and Contained Cost,” June 9-13, 1996. San Diego, California. Reprint address: Lexley M. Pinto Pereira, University of the West Indies, EWMSC, Champs Flew, Trinidad, West Indies.
people and are distributed along an archipelago extending from South America and Venezuela to the tip of Florida in the north. In the Caribbean, pharmaceutical manufacturers are represented by various marketing agencies. Divisions of the parent multinational and international drug houses are not to ~ ~ c u s t o m ~ l ypresent, in America’ Europe’ and many Of the Far East Countr
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