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Biomedical subjects

B Vrhovac

Publications and source records attributed to B Vrhovac.

At least 91 records · Page 5Linked to original sources

[Critical review of drugs in 1990].

New chemical entities approved abroad (43) and in Yugoslavia (37) were presented. Discussions on several "old" drugs (41) open at the Yugoslav Federal Drug Committee for any reason (new formulation, new dose, new packaging, dosage regimen or indication) and renewal of registration (114) were also included. Special attention was given to the drugs which had been refused the renewal of registration (8). Critical drug re-evaluation as an important element of the improvement of pharmacotherapy was emphasized. A total of 78 drugs was discussed or registered in 1990-1.28% of drugs from the group A (vancomycin), 10.2% from the group B (aclarubicin, dexfenfluramine, warfarin, alprazolam, colestipol, lovastatin, combination: cetrimonium + lidocain and estradiol vag.), 87.1% (the greatest number so far!) from the group C and 1.28% from the group D. Surveys of the most prescribed drugs in Zagreb, in Yugoslavia and in the world were also given having proved largely non-rational drug prescribing in this country. Further development of drug formulary concept was discussed, primarily for the drugs paid by the Health Insurance, as well as the unsatisfactory ADR reporting in Yugoslavia. Presented were also the activities of the Committee for Diagnosis, Pharmacotherapy and ADR of the Yugoslav Federal Institute for Health Protection. Publishing of Yugoslav daily defined doses is, according to the authors essential for further systematic monitoring of drug consumption on different levels in this country. It would be impossible to rationalize pharmacotherapy without these data.

Pharmaceutical Preparations↗

[Critical analysis of drugs in 1989].

Changes and trends in the drug field in the world and in Yugoslavia in 1989 are presented and discussed. 1. World. There appeared only a few new drugs all over the world, and new chemical entities (NCE) rather rarely represent a significant contribution to materia medica. Japan is the first in producing NCE (12) followed by United Kingdom and the USA (4 NCE each). 2. Yugoslavia. In Yugoslavia were 125 drugs discussed approval, new dose, new formulation or generic parallel. More than 84% of these have been related to generic or clinical ("me too") parallels; less than 9% of drugs had a certain contribution to materia medica, while, according to the authors, the number of drugs that contributed significantly to the materia medica and of those which should not have been approved was equal (3.2%). Octreotide, erythropoietin, almitrine and flumazenil were placed in category A. Insulin appeared in the largest number of parallels (as many as 19) succeeded by cardiovascular, antimicrobial and gastrointestinal drugs. 3. Drug formularies exist in all the developed countries and represent a way of limiting prescribing. Yugoslav list of drugs expenses of which will be covered by the Health Insurance will be prepared. 4. The Federal Institute for Health Protection through its special committee for diagnostics, pharmacotherapy and side effects represents a useful activity in rationalizing drug use. 5. Yugoslav publication of defined daily doses (DDD) is being prepared. 6. A review of causes of deficient or inadequate drug supply in Yugoslavia, which still represents a major problem in this country, has been given at the end.

Legislation, Drug↗

[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)

Drug Industry↗