[A critical review of the drug field in Yugoslavia 1985-1988].
Developments in the drug field are presented under the following headings: 1. Drug approval. About 220 new drugs have been discussed (including new formulations and dosages). The number of drugs belonging to the group A (important) and those which should not, according to the author's opinion, have been approved (group D) is similar 6.3/9.1%. About 64% are clinical or generic repetitions (i.e. "me too" drugs). Considerable difficulties with pricing, which is haphazard, and performed in an unsatisfactory way, is the reason why the industry tries to introduce "new drugs" which are often not new and do not present an advance to pharmacotherapy. 2. Drug regulation got (up till now with modest success) an important impetus through Conclusions of the Federal Council of the Parliament of Yugoslavia asking the Federal Committee for Health to elaborate the Yugoslav Essential Drugs List and revise the list of drugs approved in the country--the Federal Institute for Health Protection to prepare diagnostic and therapeutic standards. 3. Drug legislation was "enriched" by the Regulation of Adverse Drug Reaction Reporting (which dos not exist in other countries) and controversial Regulation on Auxiliary Therapeutic Substances, the latter being greatly insufficient. Finally, the List of Essential (unavoidable) Drugs comprising 1/3 (= 336) of drugs approved in Yugoslavia has been accepted. It is hoped that this will improve the availability of drugs, which availability is essential. The greatest problem in the Yugoslav drug field remains irrational prescribing, inadequate pricing (linear increases without observing the grade of necessity of various agents) and consecutive repetitive deficit even of most needed therapeutic agents.(ABSTRACT TRUNCATED AT 250 WORDS)
B
B
Vrhovac
D004345:Drug Industry; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations; D015022:Yugoslavia
D004364:Pharmaceutical Preparations
Kriticki prikaz podrucja lijekova u nasoj zemlji u razdoblju 1985-1988.