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Drug Control in the Americas

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Drug Control in the Americas SEMINAR ON DRUG CONTROL IN THE AMERICAS PAN AMERICAN HEALTH ORGANIZATION Pan American Sanitary Bureau, Regional Office of the WORLD HEALTH ORGANIZATION 1971 SEMINAR ON DRUG CONTROL IN THE AMERICAS (Maracay, Venezuela, 15-20 November 1970) Scientific Publication No. 225 PAN AMERICAN HEALTH ORGANIZATION Pan American Sanitary Bureau, Regional Office of the WORLD HEALTH ORGANIZATION 525 Twenty-Third Street, N.W. Washington, D.C. 20037, U.S.A. 1971 CONTENTS Introduction ...................................................... v Statement by the Minister of Health and Social Welfare of Venezuela, Dr. J. J. Mays Lyon ............................................ 3 Statement by the Chief of the Office of International Public Health, Minis- try of Health and Social Welfare of Venezuela, Dr. Daniel Orellana . .. 5 Statement by the Director of the Pan American Sanitary Bureau, Dr. Abraham Horwitz ........................................... 7 SEMINAR REPORT Recommendations ................................................. 13 Acknowledgment .................................................. 15 Vote of Thanks ................................................... 15 Annex 1: Basic Requirements for the Registration Application for a Drug .......................................................... 16 Annex 2: Recommendation 5 (Chapter XIV) of the Final Report of the Special Meeting of Ministers of Health of the Americas .............. 17 WORKING DOCUMENTS The Present Drug Control Situation in the Countries of the Region- M orris L. Yakowitz ............................................ 21 Current Problems in Drug Control-Marcelo J. Vernengo ............ 24 Essential Elements of a National Drug Control Agency-Denys Cook ... 33 Support of Drug Control by the Pan American Health Organization-Alejandro Sotelo ................................... 39 Modern Drug Control Legislation-Robert S. Roe ................... 43 Health Registration Procedures for New-Drug Pharmaceuticals- Siegbert Holz ................................................... 49 Efficacy and Safety: Elements of Drug Registration-H. H. Friebel ...... 56 The Expiry Date of Medicines-Alberto Lezerovich .................. 63 Control of Biological Products-L. Greenberg ........................ 69 Drug Manufacturing Practices-CharlesM. Mitchell, Jr .............. 73 The Drug Inspection-Joseph J. DiLorenzo .......................... 79 Annex: Suggested Guidelines for the Drug Inspection ............... 84 Limited Review of Veterinary Drug Problems-PedroN. Acha and Harold B. Hubbard ............................................. 90 iii iv Contents International Aspects of Drug Monitoring: Role of the World Health Organization (Abstract)-B. W. Royall ............................ 98 The International Pharmacopoeia-O. Wallén ........................ 103 Annex: Table Relating to Use of Chemical Reference Substances in the Second Edition of the International Pharmacopoeia .............. 107 Organization and Operation of a Drug Control Laboratory- Jerónimo Averza ................................................ 109 Drug Testing Equipment: A Survey of Current Usage-Daniel Banes and George Schwartzman ............................................ 114 Research Needs of a Drug Testing Laboratory-MarceloJ. Vernengo .... 126 Restricting Drugs to Dispensing on Prescription-RobertS. Roe ....... 132 APPENDICES 1. The Drug Control Situation in the Countries of the Americas ....... 139 2. Model of National Drug Control Law ............................ 147 3. Participants ................ ........................ 155 4. Officers and Working Groups of the Seminar ...................... 158 Introduction Many of the recent advances in medical science have resulted from the availability of new synthetic chemicals and purified principles obtained from natural sources by modern technological processes. These new medicaments have provided great benefits for humanity but at the same time have given rise to a number of complex problems. The difficulties surrounding the new medicaments have been considered at numerous meetings of the World Health Assembly, which, as is well known, constitutes a global forum for the study of the world's most important health problems. It is a measure of the seriousness of the current drug control problems to note that during the last 10 years the Assembly has passed not less than 27 resolutions dealing with various aspects of drug control. The problems that are treated in the World Health Assembly resolutions can be summarized in the following questions: 1. What proof of efficacy and safety must be required from the sponsor of a new drug before the article is allowed to enter the market? 2. How can a drug be monitored after it has entered the market and is being used on a large scale, in order to determine whether it is really effective and whether it causes adverse effects that were not observed or adequately evalu- ated at the time the drug was permitted to enter the market? 3. What assurances should be required that each lot of medication on the market complies with applicable standards of quality? 4. What requirements should be established to ensure that the claims made for a drug in its advertising are accurate and expressed with scientific objectivity? 5. What measures should be taken to minimize the abuse of drugs that cause dependence and other social injury when employed for nonmedical purposes? These problems have been a source of great concern to the Ministers of Health of the countries of the Americas, as reflected by their active discussion of the subject at the World Health Assembly and in regional meetings of the Health Ministers such as the Pan American Sanitary Conference. With the objective of obtaining expert advice regarding solutions to the existing drug control problems of the Region, the Pan American Health Organi- zation, acting in collaboration with the Government of Venezuela, convened the first Seminar on Drug Control in the Americas, at Maracay, Venezuela, from 15 to 20 November 1970. The Seminar was attended by 29 senior drug control officials chosen by the Ministers of Health of 24 countries. After considering the pertinent documents of the World Health Organization and the Pan American Health Organization, and having heard speakers deliver the papers that are reproduced in this volume, the Seminar participants formed v vi Introduction three working groups to consider selected topics and prepare recommendations thereon. Subsequently, the participants met in plenary session to discuss, modify, and adopt the recommendations emanating from the working groups. The recommendations contained in the Seminar Report constitute the fruit of their labors at this important meeting. OPENING STATEMENTS STATEMENT BY DR. J. J. MAYZ LYON MINISTER OF HEALTH AND SOCIAL WELFARE OF VENEZUELA It is a source of just satisfaction and encouragement to the Ministry of Health and Social Welfare that our country is the host for this Seminar, sponsored by the Pan American Sanitary Bureau. The holding of this meeting is, for us, the culmination of an idea. Since 1946 a gradual and persistent effort has been under way here to review drugs and pharmaceutical products, with a view to better control of those substances. At the same time, improvement has been sought in all aspects of their processing, packaging, distribution, and sale. In that earlier year there was a multitude of medications, sonme of themi enjoying great popular acclaim, but without any real therapeutic value. Many of them were nothing more than the products of their manufacturers' imagination, while others were based on ancient ideas-ob- viously incorrect-of the properties of certain substances. The Pharmaceutical Specialties Review Board, established at that time, undertook, in collaboration with the Ministry's Pharmacy Division, a rigorous program to suppress those substances and combinations that were not backed by well-founded scientific criteria. This work was most arduous at the outset, for it meant direct conflict with diverse interests that were difficult to overcome. Nevertheless, the objective was realized in progressive fashion, and after a cer- tain time the results of what I may call this purification of our therapeutic arsenal became apparent. Concurrently, foundations were laid for standards to provide the most effective possible regulation of the processing and registration of new drugs manufactured in the country. In those days most therapeutic substances were imported, and an intensive effort was required to make foreign companies aware of the goals sought by the Ministry. This was not always easy, but slowly an attitude of cooperation developed as these firms acquired an understanding of the reasons for this important campaign. Today most of these products are manufactured within the country. Their processing is the work of a dynamic industry, which should examine itself closely and subject itself to appropriate and continuing controls, so that its development will proceed on sound bases ensuring that the industry's scientific and social objectives will be fulfilled. The fundamental and sole purpose of drug processing is to see that drugs fully perform the action expected of them by the physician. Put another way, that they genuinely and adequately possess the active pharmacological properties attributed to them, without harmful collateral effects or in any case with the minimum of these, so as not to interfere with or nullify the therapeutic action. Further, that they be prepared under rigorous technical
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