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DEPARTMENT OF HEALTH National Drug Policy - Pharmaceutical Management Unit 50 National Formulary Committee Philippine National Drug Formulary EssentialEssential MedicinesMedicines ListList Volume I, 7th Edition ( 2008 ) Published by: The National Formulary Committee National Drug Policy ‐ Pharmaceutical Management Unit 50 DEPARTMENT OF HEALTH Manila, Philippines All rights reserved 2008 The National Formulary Committee National Drug Policy‐Pharmaceutical Management Unit 50 (NDP‐PMU 50) Department of Health San Lazaro Cmpd., Rizal Ave., Sta. Cruz, Manila, Philippines 1003 ISBN 978‐971‐91620‐7‐0 Any part or the whole book may be reproduced or transmitted without any alteration, in any form or by any means, with permission from DOH provided it is not sold commercially. ii PHILIPPINE NATIONAL DRUG FORMULARY Volume I, 7th Edition 2 0 0 8 Francisco T. Duque III, MD, MSc Secretary of Health Alexander A. Padilla Undersecretary of Health, Office for External Affairs Robert Louie P. So, MD Program Manager, NDP-PMU 50 Dennis S. Quiambao, MD Proj. Mgmt. Operating Officer & Coordinator (PMOOC) NDP-PMU 50 NATIONAL FORMULARY COMMITTEE Estrella B. Paje-Villar, MD, DTM & H Chairperson Jose M. Acuin, MD, MSc Alma L. Jimenez, MD Alejandro C. Baroque II, MD Marieta B. de Luna, MD Bu C. Castro, MD Nelia P. Cortes-Maramba, MD Dina V. Diaz, MD Yolanda R. Robles, PhD Pharm Mario R. Festin, MD, MS, MHPEd Isidro C. Sia, MD BFAD Representative SECRETARIAT Luzviminda O. Marquez, RPh, RMT Mary Love C. Victoria, RPh Michael D. Junsay, RPh Ermalyn M. Magturo iii Republic of the Philippines DEPARTMENT OF HEALTH OFFICE OF THE SECRETARY 2/F Bldg. 1, San Lazaro Cmpd., Rizal Avenue, Sta. Cruz, 1003 Manila TL: 743-83-01; DL: 711-9501; Fax: 743-1829; 743-1829; 743-1786 M E S S A G E Republic Act 9502 , also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, and its Implementing Rules and Regulations (IRR) have been signed. As stated in IRR Rule #36, "All government agencies, including local government units, shall procure drugs and medicines within the Philippine National Drug Formulary (PNDF) current edition in accordance with Republic Act 9184 and any other pertinent procurement reforms". Likewise, pursuant to Executive Order 49, that "all government entities concerned are mandated to use the current PNDF (Volume I) as the basis for procurement of drug products". The National Drug Policy-Pharmaceutical Management Unit 50 of the Department of Health (DOH) proudly presents the 7th edition of the PNDF, Volume I, Essential Medicines List. The PNDF is a dynamic list which is regularly reviewed and updated to make it truly relevant to the health needs of the majority of the population. In behalf of the DOH, we would like to thank and recognize the dedication and support of all members of the National Formulary Committee and the National Drug Information Center, and various resource persons in the preparation and completion of this edition. FRANCISCO T. DUQUE III, M.D., M.Sc. Secretary of Health v ACKNOWLEDGEMENTS The preparation and publication of this 7th Edition of the Philippine National Drug Formulary (PNDF) Volume I was made possible with the exceptional dedication and commitment of Dr. Estrella B. Paje‐Villar, Chairperson and Dr. Nelia P. Cortes‐Maramba, Vice‐Chairperson, together with the members of the National Formulary Committee (NFC) namely: Dr. Marieta B. de Luna, Dr. Isidro C. Sia, Dr. Bu C. Castro, Dr. Alma L. Jimenez, Dr. Dina V. Diaz and Dean Yolanda R. Robles. We are grateful for the invaluable administrative and clerical services rendered by Ms. Luzviminda O. Marquez, Ms. Mary Love C. Victoria, Mr. Michael D. Junsay and Ms. Ermalyn M. Magturo of the National Drug Policy‐Pharmaceutical Management Unit 50 (NDP‐PMU 50) of the Department of Health. We wish to thank also the NDP‐PMU 50 staff namely: Ms. Amor Cita M. Pallera, Ms. Catalina C. Sanchez and Dr. Teresita dela Cruz, Consultants, Ms. Jesselle Anne M. Navarro, Ms. Karina A. Sison, Ms. Mariane P. Dioso and Ms. Eden U. Campos for their technical help and for the non‐technical support of Ms. Jeany Vi M. Abayon, Ms. Lina G. Dancel, Ms. Marivic V. Gañgan, Ms. Alice C. Laquindanum, Ms. Sheila C. Caragay, Ms. Rojanie Marquez, Mr. Rodrigo Palma and Ms. Rowena Paseos. Lastly, we acknowledge that this volume would not have been made possible without the wholehearted encouragement and support of DR. DENNIS S. QUIAMBAO, PMOOC, NDP‐PMU 50, DR. ROBERT LOUIE P. SO, Program Manager, NDP‐PMU 50, ATTY. ALEXANDER A. PADILLA, Undersecretary of Health for External Affairs and DR. FRANCISCO T. DUQUE III, the Secretary of Health of the Philippines. April 16, 2009 Manila, Philippines vi THE PHILIPPINE NATIONAL DRUG POLICY The Philippine National Drug Policy (PNDP) is the government's response to the problem of inadequate provision of good quality essential drugs to the people. Part of the problem is the high cost drugs, which renders them inaccessible to the majority of the population. The PNDP stands on five pillars designed to eventually bring about the availability and affordability of safe, effective, and good quality drugs for all sectors of the country, especially for the poor who need them most, but who can least afford them. These five pillars form an integral unit, mutually complementary and supportive of each other. The first pillar is the assurance of the safety, efficacy and usefulness of pharmaceutical products through quality control. This will involve the regulation of the importation, manufacture, marketing, and consumer utilization of all drugs and their intermediates. The second pillar rests on the promotion of the rational use of drugs by both health professionals and the general public. Rational use of drugs refer to a carefully considered pattern of behavior on the part of the prescriber and the consumer. This will limit the use of medicines to situations where there are clear valid indications for them. Furthermore, only the most necessary and scientifically proven efficacious drugs should be used. A key strategy under the rational drug use pillar is the development and implementation of a Philippine National Drug Formulary (PNDF) which shall list those drugs which are most essential for the diseases and conditions encountered in the Philippines, and describe the appropriate use of these essential drugs. Aside from this, the rules and regulations governing the promotion and advertising of pharmaceutical products shall be reviewed and amended in order to contribute towards the promotion of rational use of drugs. With these twin moves, consumers will now be properly guided as to which drugs to use for their particular needs and conditions. The third pillar is the development of self‐reliance in the local pharmaceutical industry. This pillar seeks to strengthen Filipino capabilities for the manufacture of basic and intermediate ingredients for drugs and medicines. By developing a capability to produce strategic essential drugs locally, the country's dependence on imported drugs can be greatly reduced. This will also enable local drug manufacturers to be competitive with the transnational drug firms. The fourth pillar relates to the tailored or targeted procurement of drugs by government with the objective of making available to its own clientele, particularly the lower‐income sectors of the society, the best drugs at the lowest possible cost. It is widely acknowledged that the government is the single largest purchaser of drugs in the country, allocating major part of its health budget for drugs and medicines. The fifth pillar is on people empowerment. This cuts across all the four pillars and aims to assist people in exercising an informed choice in the purchase of cost‐effective medicines. vii The five pillars of the PNDP form a dynamic whole and each pillar is meant to be mutually reinforcing. Quality assurance is a prerequisite for any National Drug Policy. The tenets of rational use will serve as bases for regulation in both government and private sectors. In turn, fair and thorough regulation should promote rational use. The active participation of government in the procurement, distribution and use of drugs will lead the way towards some measures of self‐ reliance and self‐sufficiency. This should also provide impetus for private enterprise to move towards the manufacture of some basic ingredients of drugs, if private industry is to retain its competitive edge. Finally, the PNDP recognizes the value of all sectors of society and seeks their support in the implementation of the National Drug Policy (NDP). The NDP relates to the health and welfare of each and every Filipino and certainly deserves the support of all. viii P R E F A C E to the 7th edition The Philippine National Drug Formulary (PNDF) is an integral component of the Philippine National Drug Policy, aimed at making available and accessible, essential medicines of proven efficacy, safety and quality at affordable cost. It's formulation by the Department of Health (DOH) through the National Formulary Committee (NFC), formerly called the National Drug Committee, has been mandated by R.A. 6675, otherwise known as the Generics Act of 1988. The PNDF Volume I, the Essential Medicines List, is a major step towards rational use of medicines in the country. The medicines are selected with due regard to public health relevance, evidence of efficacy and safety and comparative cost‐effectiveness. The national list of essential medicines is a subset of registered medicines divided according to different levels of care. A carefully selected limited list of essential medicines leads to higher quality of care, better management of medicines including improved quality control, more cost‐effective use of health resources and ensures regular supply of essential medicines, resulting in real health gain and increased confidence on the health system. The 7th edition of the PNDF Volume I has maintained basically the same objectives and organization as in the previous editions.
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    COl.V.MISSION OF THE EUROPEAN COMMUNITIES SEC(90) 1985 final· Brussels, 29 October 1990 Proposa I for a COUNCIL DIRECTIVE on the approximation of the laws of the Member States relat.ing to cosmetic products -2- EXPLANATORY UEUORANDUM 1. In the context of a people's Europe, the Commission attaches great Importance to simplifying and clarifying Community law so as to make It clearer and more accessible to the ordinary citizen, thus giving hIm new opportunItIes and the chance to make use of the spec if i c rights It gives him. This aim cannot be achieved so long as numerous provisions that have been amended several times, often QUite substantially, remain scattered, so that they must be sought partly In the original Instrument and partly In later amending ones. Considerable research work, comparing many different Instruments, Is thus needed to Identify the current rules. For this reason a consot tdatton of rules that have freQuently been amended Is essential If Community law Is to be clear and transparent. 2. In Its resolution of 26 November 1974 concerning consolidation of Its acts (1), the Council recommended that those of Its acts which have been amended several times be assembled Into a single text. It stressed that, In the Interests of legal certainty, a genuine legislative consolidation, Involving the repeal of earlier acts, should wherever possible be effected (as Is being done In this case). it conseQuently Invited the Commission to let it have proposals for consol !dation and undertook ·to examine them "as Quickly as possible, whltout bringing Into QUestion, during that consol ldatlon, the substantive solutions contained In the consol !dated texts".