ABSTRACT
BACKGROUND: The WHO Executive Board revised the guidance that governs the procedures for the WHO review of psychoactive substances for international drug control in 2010. To meet the standards defined in these guidelines, the current evaluation methodology at WHO must be an evidence-based assessment. METHODS: We describe the history of substance evaluation from 1912 to the present and the development of the evaluation methods over time including a description of the current assessment system, using reports from WHO and its predecessor, the League of Nations. Furthermore, we describe the current review system. RESULTS: We found that some substances under international control were never reviewed; other substances were reviewed decades ago. CONCLUSIONS: We argue that assessments do not have unlimited validity, and therefore, substances need to be re-assessed periodically, as already recommended by the Expert Committee on Drug Dependence in 1982. We propose that the evaluation time be shortened; that the influence of the route of administration and/or dosage form of the preparation is considered in the evaluation; and we recommend studying national and regional assessment systems and adopting their best practices. With this article, we make a case for the inclusion of systematic review and other methods of comprehensive analysis of substance evaluation to arrive at a process of equal rigour and quality as already applied by WHO for the development of treatment guidelines.
Subject(s)
Drug and Narcotic Control/legislation & jurisprudence , Drug and Narcotic Control/trends , Substance-Related Disorders/epidemiology , Substance-Related Disorders/therapy , World Health Organization , Drug and Narcotic Control/methods , HumansABSTRACT
4,6-Dimethoxy-5-hydroxyphthalide 2 was obtained on three routes: by selective demethylation of 4,5,6-trimethoxyphthalide and by the action of formaldehyde on either syringic acid or acetylsyringic acid. Pharmacological tests carried out on rats showed that the product significantly increased bile excretion, its activity being five times higher than those of dehydrocholic acid.
Subject(s)
Phthalic Acids/chemical synthesis , Animals , Bile/drug effects , Female , Lethal Dose 50 , Male , Methyl Ethers/chemical synthesis , Phthalic Acids/pharmacology , Phthalic Acids/toxicity , Rats , Time FactorsABSTRACT
The role of a modern pharmacopoeia is to furnish quality specifications for drug substances and general requirements for dosage forms. The existence of such specifications and requirements is necessary for the proper functioning or regulatory control of drugs. Parmacopoeial requirements form a base for establishing quality requirements for individual pharmaceutical preparations in their final form. One hundred and forty independent countries are at present employing some 30 national and 3 regional pharmacopoeias. The aim of the international Pharmacopoeia issued by the World Health Organization as a recommendation, is to achieve a possibly wide global uniformity of quality specifications. The actual second edition of the International Pharmacopoeia was published in 1967 followed by a supplement in 1971. The Expert Committee on Specifications for Pharmaceutical Preparations, which is the body established by the World Health Organization to advise on quality specifications for drugs, during its 25th meeting, held in November 1974, recommended that the new edition of the International Pharmacopoeia should primarily include: -specifications for raw material comprising active and inactive ingredients used in pharmaceutical products; -general methods and tests necessary to support such specifications. Work on the new edition of the International Pharmacopoeia will comprise the revision of existing specifications and requirements, establishing specifications for new pharmaceutical substances, as well as establishing chemical reference substances, necessary to support such specifications. The actual procedure foresees appropriate consultations among the members of the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations. Extensive consultations with pharmacopoeia commissions are taking place to achieve a possibly high degree of unanimity on a global scale towards the quality requirements for pharmaceutical substances.
