WHO The Interagency list of Essential Medicines for Reproductive Health

Publication date: 2006

In many developing countries maternal mortality and morbidity are unacceptably high, and the incidence of sexually transmitted infections, including HIV/AIDS, is rising, while preventive measures and treatment are often inadequate. Lack of access to reproductive health medicines and commodities is becoming a critical issue in developing countries, with family planning and other reproductive health care needs unmet. The Interagency List of Essential Medicines for Reproductive Health has been developed by WHO in collaboration with major international and nongovernmental organizations active in the field of reproductive health. The list presents the current international consensus on a rational selection of medicines essential to the provision of quality reproductive health services. Essential medicines for reproductive health include contraceptives, medicines for prevention and treatment of sexually transmitted infections and HIV/AIDS, and medicines to ensure healthy pregnancy and delivery. All medicines on the Interagency List are also in the WHO Model List of Essential Medicines. This publication presents the Interagency List in two formats: by clinical group and by therapeutic category. It is intended to support decisions regarding the selection, production, quality assurance, national procurement and reimbursement schemes of these medicines. This is an interagency consensus document published by the WHO Departments of Medicines Policy and Standards and Reproductive Health and Research on behalf of the organizations listed. The Interagency List of Essential Medicines for Reproductive Health 2006 World Bank I N T E R A G E N C Y G U I D E L I N E S WHO/PSM/PAR/2006.1 WHO/RHR/2006.1 THE INTERAGENCY LIST OF ESSENTIAL MEDICINES FOR REPRODUCTIVE HEALTH 2006 WORLD HEALTH ORGANIZATION INTERNATIONAL PLANNED PARENTHOOD FEDERATION JOHN SNOW, INC. PATH POPULATION SERVICES INTERNATIONAL UNITED NATIONS POPULATION FUND WORLD BANK © World Health Organization 2006 All rights reserved. Publications of the World Health Organization can be obtained from Marketing and Dissemination, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel: +41 22 791 2476; fax: +41 22 791 4857; email: bookorders@who.int). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to Publications, at the above address (fax: +41 22 791 4806; email: permissions@who.int). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. The World Health Organization and the organizations listed on the title page do not warrant that the information contained in this publication is complete and correct and shall not be liable for any damages incurred as a result of its use. Contents Acknowledgements. v Background. 1 The Interagency List of Essential Medicines for Reproductive Health . 1 Development process . 1 Next steps: request for comments and suggestions . 2 Additional references . 2 Format 1 . 3 Explanation. 3 Format 2 . 15 Explanation. 15 Annex 1: Major medicine changes in the Interagency List. 27 Medicines included in the Interagency List . 27 Medicines deleted from the Interagency List. 28 Acknowledgements The following individuals and organizations are thanked for their contributions to the revision of the Interagency List of Essential Medicines for Reproductive Health. Kabir Ahmed (UNFPA), Gloria Bassets (Médecins Sans Frontières, Spain), Hedia Belhadj (UNFPA), Wolfgang Bichmann (KfW Development Bank, Germany), Eli Carter (Family Health International, USA), Luis Gabriel Cuervo-Amore (Consultant, UK), Catherine D'Arcangues (WHO/RHR), Sibongile Dludlu (WHO/RHR), Nick Dodd (UNFPA), Wilma Doedens (UNFPA), Lindsay Edouard (UNFPA), Patrick Friel (UNFPA), Robin Gray (WHO/PSM), Fiona Godley (BMJ-Knowledge, UK), Ahmet Metin Gulmezoglu (WHO/RHR), Carolyn Hart (John Snow, Inc. USA), Suzanne Hill (The University of Newcastle, Australia), Hans V. Hogerzeil (WHO/PSM), Jane Hutchings (PATH, USA), Kathleen Hurst (WHO/PSM), Monir Islam (WHO/MPS), Shalini Jayasekar (WHO/PSM), Rita Kabra (WHO/MPS), Regina Kullier (Geneva Foundation for Medical Education and Research), Trevor Lessey (UNFPA), Sophie Logez (WHO/PSM), Nicolaus Lorenz (Gesellschaft für Technische Zusammenarbeit, Germany), Elizabeth Lule (World Bank), Mathews Mathai (WHO/MPS), Francis J. Ndowa (WHO/RHR), Clive Ondari (WHO/PSM), Hanne Bak Pedersen (UNICEF), Monique Renevier (WHO/PSM), Murtada Sesay (UNICEF), David Smith (UNFPA), Monique Supiot (UNICEF), Jagdish Upadhyay (UNFPA), Margaret Usher-Patel (WHO/RHR), Paul Van Look (WHO/RHR), Godfrey Walker (UNFPA). This work was financially supported by the Bill and Melinda Gates Foundation, the Mellon Foundation and the WHO Departments of Medicines Policy and Standards (PSM) and Reproductive Health and Research (RHR). v The Interagency List of Essential Medicines for Reproductive Health Background Reproductive health medicines are essential to the provision of quality reproductive health services. Rational selection is a vital component to ensure improved access to these medicines, followed by efficient procurement, logistic systems and rational use, which are equally important. Essential medicines for reproductive health include contraceptives, medicines for prevention and treatment of sexually transmitted infections and HIV/AIDS, and medicines to ensure healthy pregnancy and delivery. In 2002, UNFPA and WHO jointly published the draft UNFPA/WHO Essential Drugs and Other Commodities for Reproductive Health Services List. This joint publication was the catalyst for the development of an interagency list of essential medicines for reproductive health. In the same year a study was started to compare the existing essential medicines lists of the various UN agencies, including (1) the 2002 draft UNFPA/WHO list, (2) the Interagency UNFPA/UNAIDS/WHO Reproductive Health Medicines and Commodities List and (3) the 13th WHO Model List of Essential Medicines of 2003. This study found a certain lack of consistency between various United Nations agencies on essential medicines for reproductive health, and identified 36 "discrepancy medicines" which figured on one list but not on another. Since that time intensive discussions and consultations have taken place in order to realign the selection of essential medicines for reproductive health. The basic objective has been to ensure that all reproductive health medicines on the interagency list are also part of the WHO Model List of Essential Medicines. In other words, the interagency list will be a subset of the Model List. The Interagency List of Essential Medicines for Reproductive Health This revised Interagency List of Essential Medicines for Reproductive Health presents the current international consensus on rational selection of essential reproductive health medicines. The list is intended to support decisions regarding the production, quality assurance, national procurement and reimbursement schemes of these medicines. Development process The Interagency List of Essential Medicines for Reproductive Health has been developed by WHO in collaboration with major international and nongovernmental organizations active in the field of reproductive health. In 2004 meetings were held with these organizations to discuss the discrepancy medicines. During these consultations decisions were taken, based on evidence-based reviews, to either (1) delete certain medicines from all reproductive health medicines lists or (2) commission applications to add them to the 14th WHO Model List of Essential Medicines. In March 2005, the WHO Expert Committee on the Selection and Use of Essential Medicines made final decisions to include or reject proposals for a number of new reproductive health medicines for the 14th WHO Model List of Essential Medicines. The next opportunity to modify the interagency list will be after the 2007 meeting of this WHO Expert Committee. Annex 1 presents more detailed information on the recent changes in the list. 1 The Interagency List of Essential Medicines for Reproductive Health The Interagency List of Essential Medicines for Reproductive Health is presented in two formats: (1) the traditional format used in previous lists, which presents medicines in clinical groups (which implies that some medicines are listed more than once); and (2) by therapeutic class as in the WHO Model List, but including only the numbered sections of the Model List in which reproductive health medicines are mentioned. Next steps: request for comments and suggestions The WHO Department of Medicines Policy and Standards and the Department of Reproductive Health and Research together with UNFPA and other stakeholders intend to update the Interagency List of Essential Medicines for Reproductive Health every two years, with the next update due in 2007. Meanwhile, any comments or suggestions regarding the list can be addressed to the Secretary of the WHO Expert Committee on the Selection and Use of Essential Medicines, Department of Medicines Policy and Standards, World Health Organization, 20 Avenue Appia, CH-1211 Geneva 27, Switzerland. Additional references World Health Organization (WHO) Medicines web site: http://www.who.int/medicines/ WHO Reproductive Health web site: http://www.who.int/reproductive-health/ WHO Model Formulary. Available at: http://mednet3.who.int/EMLib/ModelFormulary/modelFormulary.asp WHO Reproductive Health Library. Available at: http://www.who.int/reproductive-health/rhl/index.html Laing R, Waning B, Gray A, Ford N, ‘t Hoen E. Twenty-five years of the WHO essential medicines lists: progress and challenges. Lancet 2003;361:1723–1729. Interagency guidelines for drug donations. Geneva: World Health Organization; 1999. Available at: http://www.who.int/medicines/publications The selection of essential medicines. WHO Policy Perspectives on Medicines, No.4. Geneva: World Health Organization; 2002. Available at: http://www.who.int/medicines/publications Reproductive health strategy. Geneva: World Health Organization; 2004. Available at: http://www.who.int/reproductive-health/strategy.htm/ The world health report 2005: Investing in maternal and newborn health. Geneva: World Health Organization; 2005. Available at: http://www.who.int/making_pregnancy_safer/en/ 2 The Interagency List of Essential Medicines for Reproductive Health Format 1 Explanation The Interagency List of Essential Medicines for Reproductive Health is first presented in the format used in previous reproductive health lists - by clinical groups, with certain medicines repeated in different groups. Relevant standard treatment guidelines developed by the WHO Department of Reproductive Health and Research are included for each clinical group. Information regarding the WHO Model List of Essential Medicines' therapeutic categories are included for each medicine. This list presents the minimum medicine needs for a basic health care system, listing the most efficacious, safe and cost-effective medicines for priority conditions. Priority conditions are selected on the basis of current and estimated future public health relevance, and potential for safe and cost-effective treatment. Complementary medicines (indicated with a "c" in the first column of the table) are also listed; these medicines need specialized diagnostic or monitoring facilities, and/or specialist medical care, and/or specialist training. In case of doubt, medicines may also be listed as complementary on the basis of consistently higher costs or less attractive cost-effectiveness in a variety of settings. When the strength of a medicine is specified in terms of a selected salt or ester, this is mentioned in brackets; when it refers to the active moiety, the name of the salt or ester in brackets is preceded by the word "as". 3 The Interagency List of Essential Medicines for Reproductive Health 4 The Interagency List of Essential Medicines for Reproductive Health Medicine Dosage Therapeutic category (14th WHO Model List) Maternal and Neonatal Health 1. Managing complications in pregnancy and childbirth: a guide for midwives and doctors. Geneva: World Health Organization; 2000. http://www.who.int/reproductive-health/impac/index.html 2. Pregnancy, childbirth, postpartum and newborn care: A guide for essential practice. Geneva: World Health Organization; 2003. http://www.who.int/reproductive-health/publications/pcpnc/index.html 3. Managing new born problems: A guide for doctors, nurses, and midwives. Geneva: World Health Organization; 2003. http://www.who.int/reproductive-health/publications/mnp/index.html 4. The WHO Reproductive Health Library; http://www.who.int/reproductive-health/rhl/index.html 5. Additional information: http://www.who.int/reproductive-health/ Anaesthetics, general halothane inhalation 1.1 ketamine injection, 50 mg (as hydrochloride)/ml in 10-ml ovial 1.1 nitrous oxide inhalation 1.1 oxygen inhalation (medicinal gas) 1.1 thiopental powder for injection, 0.5 g, 1.0 g (sodium salt) in ampoule 1.1 atropine injection, 1 mg (sulfate) in 1-ml ampoule 1.3 suxamethonium chloride injection, 50 mg (chloride)/ml in 2-ml ampoule; powder for injection (chloride), in vial 20 Anaesthetics, local 1.2 lidocaine injection, 1%, 2% (hydrochloride) in vial, injection for spinal anaesthesia, 5% (hydrochloride) in 2-ml ampoule to be mixed with 7.5% glucose solution topical forms, 2-4% (hydrochloride) 1.2 lidocaine + epinephrine (adrenaline) injection, 1%, 2% (hydrochloride) + epinephrine 1:200 000 in vial; dental cartridge 2% (hydrochloride) + epinephrine 1:80 000 c ephedrine injection, 30 mg (hydrochloride)/ml in 1-ml ampoule (for use in spinal anaesthesia during delivery, to prevent hypotension) 1.2 Analgesics Opioid morphine injection, 10 mg in 1-ml ampoule (sulfate or hydrochloride); oral solution, 10 mg (hydrochloride or sulfate)/5-ml; tablet, 10 mg (sulfate) 2.2 Non-opioid 2.1 paracetamol* tablet, 100-500 mg; suppository, 100 mg; syrup, 125 mg/5ml * not recommended for anti-inflammatory use due to lack of proven benefit to that effect acetylsalicylic acid tablet, 100-500 mg; suppository, 50-150 mg 2.1 Antianaemia ferrous salt tablet, equivalent to 60 mg iron; oral solution equivalent to 25 mg iron (as sulfate)/ml 10.1 folic acid tablet 1 mg, 5 mg 10.1 ferrous salt + folic acid tablet equivalent to 60 mg iron + 400 micrograms folic acid (nutritional supplement for use during pregnancy) 10.1 5 The Interagency List of Essential Medicines for Reproductive Health Medicine Dosage Therapeutic category (14th EML) Antibacterials amoxicillin capsule or tablet, 250 mg, 500 mg (anhydrous); powder for oral suspension, 125 mg (anhydrous)/5 ml 6.2.1 ampicillin powder for injection, 500 mg, 1 g (as sodium salt) in vial 6.2.1 benzylpenicillin powder for injection, 600 mg (= 1 million IU), 3 g (= 5 million IU) (sodium or potassium salt) in vial 6.2.1 benzathine benzylpenicillin powder for injection, 1.44 g benzylpenicillin (= 2.4 million IU) in 5-ml vial 6.2.1 c ceftriaxone powder for injection, 250 mg, 1 g (as sodium salt) in vial 6.2.1 cloxacillin capsule, 500 mg, 1 g (as sodium salt); powder for oral solution, 125 mg (as sodium salt)/5 ml; powder for injection, 500 mg (as sodium salt) in vial 6.2.1 6.2.2 chloramphenicol capsule, 250 mg; oral suspension, 150 mg (as palmitate)/5 ml; powder for injection, 1 g (sodium succinate) in vial; oily suspension for injection 0.5 g (as sodium succinate)/ml in 2-ml ampoule ciprofloxacin* tablet 250 mg (as hydrochloride) * final selection depends on indication for use 6.2.2 clotrimazole vaginal tablet, 100 mg, 500 mg, vaginal cream 1%, 10% 6.3 doxycycline* capsule or tablet, 100 mg (hydrochloride) * final selection depends on indication for use 6.2.2 6.2.2 erythromycin capsule or tablet, 250 mg (as stearate or ethyl succinate); powder for oral suspension, 125 mg (as stearate or ethyl succinate); powder for injection, 500 mg (as lactobionate) in vial gentamicin* injection, 10 mg, 40 mg (as sulfate)/ml in 2-ml vial * final selection depends on indication for use 6.2.2 metronidazole tablet, 200-500 mg; injection, 500 mg in 100-ml vial; suppository, 500 mg, 1 g; oral suspension, 200 mg (as benzoate)/5 ml 6.2.2 miconazole ointment or cream, 2% (nitrate) 13.1 nitrofurantoin tablet, 100 mg 6.2.2 procaine benzylpenicillin powder for injection, 1 g (= 1 million IU), 3 g (= 3 million IU) in vial 6.2.1 tetracycline eye ointment, 1% (hydrochloride) 21.1 sulfamethoxazole + trimethoprim tablet, 100 mg + 20 mg, 400 mg + 80 mg; oral suspension, 200 mg + 40 mg/5 ml; injection, 80 mg +16 mg/ml in 5-ml and 10-ml ampoules 6.2.2 6 The Interagency List of Essential Medicines for Reproductive Health Medicine Dosage Therapeutic category (14th WHO Model List) Antimalarials It should be noted that the standard treatment guidelines for the treatment and prevention of malaria are currently being updated and should be referred to when available. c artemether injection, 80 mg/ml in 1-ml ampoule 6.5.3.1 c artesunate tablet, 50 mg 6.5.3.1 chloroquine tablet, 150 mg (as phosphate or sulfate); syrup, 50 mg (as phosphate or sulfate)/5 ml 6.5.3.1 6.5.3.2 c mefloquine tablet, 250 mg (as hydrochloride) 6.5.3.1 6.5.3.2 quinine tablet, 300 mg (as bisulfate or sulfate); injection, 300 mg (as dihydrochloride)/ml in 2-ml ampoule 6.5.3.1 c doxycycline capsule or tablet, 100 mg (hydrochloride) (for use only in combination with quinine) 6.5.3.1 6.5.3.2 c sulfadoxine + pyrimethamine tablet, 500 mg + 25 mg 6.5.3.1 proguanil tablet, 100 mg (hydrochloride) (for use only in combination with chloroquine) 6.5.3.2 Antituberculosis ethambutol tablet, 100 mg-400 mg (hydrochloride) 6.2.4 isoniazid tablet, 100 mg-300 mg 6.2.4 isoniazid + ethambutol tablet, 150 mg + 400mg 6.2.4 pyrazinamide tablet, 400 mg 6.2.4 rifampicin capsule or tablet, 150 mg, 300 mg 6.2.4 6.2.4 rifampicin + isoniazid tablet, 60 mg + 30 mg; 150 mg + 75 mg; 300 mg + 150 mg; 60 mg + 60 mg (for intermittent use three times weekly); 150 mg + 150 mg (for intermittent use three times weekly) rifampicin + isoniazid + pyrazinamide tablet, 60 mg + 30 mg + 150 mg; 150 mg + 75 mg + 400 mg; 150 mg + 150 mg + 500 mg (for intermittent use three times weekly) 6.2.4 rifampicin + isoniazid + pyrazinamide + ethambutol tablet, 150 mg + 75 mg + 400 mg + 275 mg 6.2.4 Anthelmintics pyrantel chewable tablet 250 mg (as embonate); oral suspension, 50 mg (as embonate)/ml 6.1.1 mebendazole chewable tablet, 100 mg, 500 mg 6.1.1 Anticonvulsants diazepam injection, 5 mg/ml in 2-ml ampoule (intravenous or rectal) 5 5 magnesium sulfate* injection, 500 mg/ml in 2-ml ampoule; 500 mg/ml in 10-ml ampoule * for use in eclampsia and severe pre-eclampsia and not for other convulsant disorders phenobarbital tablet, 15-100 mg; elixir, 15 mg/5ml 5 phenytoin capsule or tablet, 25 mg, 50 mg, 100 mg (sodium salt); injection, 50 mg/ml in 5-ml vial (sodium salt) 5 7 The Interagency List of Essential Medicines for Reproductive Health Medicine Dosage Therapeutic category (14th WHO Model List) Antihypertensives 12.3 hydralazine* tablet, 25 mg, 50 mg (hydrochloride); powder for injection, 20 mg (hydrochloride) in ampoule * hydralazine is listed for use in the acute management of severe pregnancy-induced hypertension only methyldopa* tablet, 250 mg * methyldopa is listed for use in the management of pregnancy-induced hypertension only 12.3 Diuretics furosemide tablet, 40 mg; injection, 10 mg/ml in 2-ml ampoule 16 IV Fluids glucose injectable solution, 5%, 10% isotonic; 50% hypertonic 26.2 sodium chloride injectable solution, 0.9% isotonic (equivalent to Na+ 154 mmol/l, Cl- 154 mmol/l ) 26.2 Ringer's lactate injectable solution 26.2 glucose with sodium chloride injectable solution, 4% glucose, 0.18% sodium chloride (equivalent to Na+ 30 mmol/l, Cl- 30 mmol/l) 26.2 Plasma substitutes dextran 70* injectable solution, 6% * polygeline, injectable solution, 3.5% is considered as equivalent 11.1 Anticoagulants heparin sodium injection, 1000 IU/ml, 5000 IU/ml, 20,000 IU/ml in 1-ml ampoule 10.2 protamine sulfate injection, 10 mg/ml in 5-ml ampoule 10.2 phytomenadione (vitamin K) injection, 10 mg/ml in 5-ml ampoule; tablet, 10 mg 10.2 Antidiabetics insulin injection, 40 IU/ml in 10-ml vial, 100 IU/ml in 10-ml vial 18.5 intermediate-acting insulin injection, 40 IU/ml in 10-ml vial; 100 IU/ml in 10-ml vial (as compound insulin zinc suspension or isophane insulin) 18.5 Immunologicals and vaccines anti-D immunoglobulin injection, 250 micrograms in single-dose vial 19.2 antitetanus immunoglobulin injection, 500 IU in vial 19.2 BCG vaccine 19.3.1 diphtheria vaccine 19.3.1 hepatitis B vaccine 19.3.1 poliomyelitis vaccine 19.3.1 tetanus vaccine 19.3.1 Dermatologicals methylrosanilinium chloride (gentian violet) aqueous solution, 0.5%; tincture, 0.5% 13.2 8 The Interagency List of Essential Medicines for Reproductive Health Medicine Dosage Therapeutic category (14th WHO Model List) Disinfectants and antiseptics polyvidone iodine solution, 10% 15.1 chlorhexidine solution, 5% ( digluconate) for dilution 15.1 calcium hypochlorite (chlorine base compound) powder (0.1% available chlorine) for solution 15.2 ethanol solution, 70% (denatured) 15.1 Oxytocics 22.1 c mifepristone* + misoprostol* tablet 200 mg - tablet 200 micrograms, * requires close medical supervision where permitted under national law and where culturally acceptable c misoprostol vaginal tablet, 25 micrograms 22.1 oxytocin injection, 10 IU in 1-ml ampoule 22.1 ergometrine injection, 200 micrograms (hydrogen maleate) in 1-ml ampoule 22.1 Tocolytics nifedipine immediate release capsule, 10 mg 22.2 Sedatives diazepam injection, 5 mg/ml in 2-ml ampoule; tablet, 5 mg 1.3 Antiallergics and medicines used in anaphylaxis epinephrine (adrenaline) injection, 1 mg (as hydrochloride)/ml in ampoule 3 Medicines used in emergencies atropine sulfate injection, 1 mg (sulfate) in 1-ml ampoule 4.2 digoxin tablet, 62.5 micrograms, 250 micrograms; oral solution 50 micrograms/ml; injection 250 micrograms/ml in 2-ml ampoule 12.2 12.4 epinephrine (adrenaline) injection, 1 mg (hydrochloride)/ml in ampoule 12.2 promethazine elixir or syrup, 5 mg (hydrochloride)/5 ml 1.3 glyceryl trinitrate tablet (sublingual), 500 micrograms 12.1 calcium gluconate injection, 100 mg/ml in 10-ml ampoule 4.2 naloxone injection, 400 micrograms (hydrochloride) in 1-ml ampoule 4.2 furosemide tablet, 40 mg; injection, 10 mg/ml in 2-ml ampoule 12.4 3 prednisolone* tablet, 5 mg, 25 mg * there is no evidence for complete clinical similarity between prednisolone and dexamethasone at high doses chlorphenamine tablet, 4 mg (hydrogen maleate); injection, 10 mg (hydrogen maleate) in 1-ml ampoule 3 Steroids dexamethasone injection, 4 mg dexamethasone phosphate (as disodium salt) in 1-ml ampoule 3 hydrocortisone powder for injection, 100 mg (as sodium succinate) in vial 3 9 The Interagency List of Essential Medicines for Reproductive Health Medicine Dosage Therapeutic category (14th WHO Model List) Others 17.5.1 oral rehydration salts* (for glucose-electrolyte solution) glucose: 75 mEq sodium: 75 mEq or mmol/l chloride: 65 mEq or mmol/l potassium: 20 mEq or mmol/l citrate: 10 mmol/l osmolarity: 245 mOsm/l zinc sulfate* tablet or syrup in 10 mg per unit dosage forms * in acute diarrhoea zinc sulfate should be used as an adjunct to oral rehydration salts 17.5.2 27 retinol sugar-coated tablet, 10 000 IU (as palmitate) (5.5 mg); capsule, 200 000 IU (as palmitate) (110 mg); oral oily solution 100 000 IU (as palmitate)/ml in multidose dispenser; water- miscible injection 100 000 IU (as palmitate) (55 mg) in 2-ml ampoule 10 The Interagency List of Essential Medicines for Reproductive Health Medicine Dosage Therapeutic category (14th WHO Model List) Family Planning 1. Medical eligibility criteria for contraceptive use. 3rd ed. Geneva: World Health Organization; 2004. http://www.who.int/reproductive-health/publications/mec/index.htm Oral hormonal contraceptives ethinylestradiol + levonorgestrel tablet, 30 micrograms + 150 micrograms 18.3.1 levonorgestrel tablet, 30 micrograms, 750 micrograms (pack of two), 1.5 mg 18.3.1 ethinylestradiol + norethisterone tablet, 35 micrograms + 1.0 mg 18.3.1 Injectable hormonal contraceptives medroxyprogesterone acetate depot injection, 150 mg/ml in 1-ml vial 18.3.2 norethisterone enanthate oily solution, 200 mg/ml in 1-ml ampoule 18.3.2 IUD copper IUD 18.3.3 Barrier methods condoms 18.3.4 diaphragms 18.3.4 Reproductive Tract Infections/Sexually Transmitted Diseases 1. Pregnancy, childbirth, postpartum and newborn care: A guide for essential practice. Geneva: World Health Organization; 2003. http://www.who.int/reproductive-health/publications/pcpnc/index.html 2. Managing complications in pregnancy and childbirth: a guide for midwives and doctors. Geneva: World Health Organization; 2000. http://www.who.int/reproductive-health/impac/index.html 3. Managing new born problems: A guide for doctors, nurses and midwives. Geneva: World Health Organization; 2003. http://www.who.int/reproductive-health/publications/mnp/index.html 4. Guidelines for the management of sexually transmitted infections. Geneva: World Health Organization; 2003. http://www.who.int/reproductive-health/publications/rhr_01_10_mngt_stis/index.html c ceftriaxone powder for injection, 250 mg, 1 g (as sodium salt) in vial 6.2.1 cefixime* capsule 400 mg * only listed for single-dose treatment of uncomplicated ano-genital gonorrhoea 6.2.1 6.2.2 azithromycin* capsule, 250 mg or 500 mg; suspension 200 mg/5ml * only listed for single-dose treatment of genital C. trachomatis and of trachoma spectinomycin powder for injection, 2 g (as hydrochloride) in vial 6.2.2 amoxicillin capsule or tablet, 250 mg, 500 mg (anhydrous); powder for oral suspension, 125 mg (anhydrous)/ 5 ml 6.2.1 sulfamethoxazole + trimethoprim tablet, 100 mg + 20 mg, 400 mg + 80 mg; oral suspension, 200 mg + 40 mg/5 ml; injection, 80 mg + 16 mg/ml in 5-ml and 10-ml ampoules 6.2.2 doxycycline* capsule or tablet, 100 mg (hydrochloride) * final selection depends on indication for use 6.2.2 erythromycin capsule or tablet, 250 mg (as stearate or ethyl succinate); powder for oral suspension, 125 mg (as stearate or ethyl succinate); powder for injection, 500 mg (as lactobionate) in vial 6.2.2 11 The Interagency List of Essential Medicines for Reproductive Health Medicine Dosage Therapeutic category (14th EML) tetracycline eye ointment, 1% (hydrochloride) 21.1 benzathine benzylpenicillin powder for injection, 1.44 g benzylpenicillin (= 2.4 million IU) in 5-ml vial 6.2.1 metronidazole tablet, 200-500 mg; injection, 500 mg in 100-ml vial; suppository, 500 mg, 1 g; oral suspension, 200 mg (as benzoate)/5 ml 6.2.2 c clindamycin capsule, 150 mg; injection, 150 mg (as phosphate)/ml 6.2.2 miconazole ointment or cream, 2% (nitrate) 13.1 clotrimazole vaginal tablet, 100 mg, 500 mg, vaginal cream 1%, 10% 6.3 fluconazole capsule 50 mg; injection 2 mg/ml in vial; oral suspension 50 mg/5 ml 6.3 nystatin tablet, 100 000, 500 000 IU; lozenge 100 000 IU; pessary, 100 000 IU 6.3 gentamicin* injection, 10 mg, 40 mg (as sulfate)/ml in 2-ml vial * final selection depends on indication for use 6.2.2 6.2.2 chloramphenicol capsule, 250 mg; oral suspension, 150 mg (as palmitate)/5 ml; powder for injection, 1 g (sodium succinate) in vial; oily suspension for injection 0.5 g (as sodium succinate)/ml in 2 ml ampoule procaine benzylpenicillin powder for injection, 1 g (= 1 million IU), 3 g (= 3 million IU) in vial 6.2.1 HIV Medicines (ART, MTCT and Opportunistic Infections) 1. Scaling up antiretroviral therapy in resource-limited settings. Treatment guidelines for a public health approach. Geneva: World Health Organization; 2004. http://www.who.int/3by5/publications/documents/arv_guidelines/en/index.html zidovudine tablet, 300 mg; capsule 100 mg, 250 mg; oral solution or syrup, 50 mg/5 ml; solution for IV infusion injection, 10 mg/ml in 20-ml vial 6.4.2.1 6.4.2.1 didanosine buffered chewable, dispersible tablet, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg buffered powder for oral solution, 100 mg, 167 mg, 250 mg packets unbuffered enteric coated capsule, 125 mg, 200 mg, 250 mg, 400 mg stavudine capsule 15 mg, 20 mg, 30 mg, 40 mg, powder for oral solution, 5 mg/5 ml 6.4.2.1 lamivudine tablet, 150 mg, oral solution 50 mg/5 ml 6.4.2.1 abacavir tablet, 300 mg (as sulfate), oral solution, 100 mg (as sulfate)/5 ml 6.4.2.1 Non-nucleoside reverse transcriptase inhibitors nevirapine tablet 200 mg; oral suspension 50 mg/5 ml 6.4.2.2 efavirenz capsule, 50 mg, 100 mg, 200 mg oral solution, 150 mg/5 ml 6.4.2.2 Protease inhibitors saquinavir capsule, 200 mg 6.4.2.3 ritonavir capsule, 100 mg, oral solution 400 mg/5 ml 6.4.2.3 indinavir capsule, 200 mg, 333 mg, 400 mg (as sulfate) 6.4.2.3 nelfinavir tablet, 250 mg (as mesilate), oral powder 50 mg/g 6.4.2.3 lopinavir + ritonavir capsule, 133.3 mg + 33.3 mg, oral solution, 400 mg + 100 mg/5 ml 6.4.2.3 12 The Interagency List of Essential Medicines for Reproductive Health Medicine Dosage Therapeutic category (14th EML) Medicines used in opportunistic infections c ceftriaxone powder for injection, 250 mg, 1 g (as sodium salt) in vial 6.2.1 c clindamycin capsule, 150 mg; injection, 150 mg (as phosphate)/ml 6.2.2 ciprofloxacin* tablet 250 mg (as hydrochloride) * final selection depends on indication for use 6.2.2 c sulfadiazine tablet, 500 mg; injection, 250 mg (sodium salt) in 4-ml ampoule 6.2.2 fluconazole capsule 50 mg; injection 2 mg/ml in vial; oral suspension 50 mg/5 ml 6.3 aciclovir tablet, 200 mg; powder for injection 250 mg (as sodium salt) in vial 6.4.1 c pentamidine tablet, 200 mg, 300 mg 6.5.4 pyrimethamine tablet, 25 mg 6.5.4 6.5.4 sulfamethoxazole + trimethoprim injection 80 mg + 16 mg/ml in 5-ml ampoule 80 mg + 16 mg/ml in 10-ml ampoule 13 The Interagency List of Essential Medicines for Reproductive Health 14 The Interagency List of Essential Medicines for Reproductive Health Format 2 Explanation The second format follows the format and section numbering of the WHO Model List of Essential Medicines, and as in Format 1 only relevant sections are included. The core list presents a list of minimum medicine needs for a basic health care system, listing the most efficacious, safe and cost-effective medicines for priority conditions. Priority conditions are selected on the basis of current and estimated future public health relevance, and potential for safe and cost-effective treatment. The complementary list presents essential medicines for priority diseases, for which specialized diagnostic or monitoring facilities, and/or specialist medical care, and/or specialist training are needed. In case of doubt, medicines may also be listed as complementary on the basis of consistent higher costs or less attractive cost-effectiveness in a variety of settings. When the strength of a drug is specified in terms of a selected salt or ester, this is mentioned in brackets; when it refers to the active moiety, the name of the salt or ester in brackets is preceded by the word "as". The square box symbol (�) is primarily intended to indicate similar clinical performance within a pharmacological class. The listed medicine should be the example of the class for which there is the best evidence for effectiveness and safety. In some cases, this may be the first medicine that is licensed for marketing; in other instances, subsequently licensed compounds may be safer or more effective. Where there is no difference in terms of efficacy and safety data, the listed medicine should be the one that is generally available at the lowest price, based on international drug price information sources. Therapeutic equivalence is only indicated on the basis of reviews of efficacy and safety and when consistent with WHO clinical guidelines. National lists should not use a similar symbol and should be specific in their final selection, which would depend on local availability and price. Medicines are listed in alphabetical order, within sections. 15 The Interagency List of Essential Medicines for Reproductive Health 16 The Interagency List of Essential Medicines for Reproductive Health 1. ANAESTHETICS 1.1 General anaesthetics and oxygen inhalation � halothane ketamine injection, 50 mg (as hydrochloride)/ml in 10-ml vial nitrous oxide inhalation oxygen inhalation (medicinal gas) � thiopental powder for injection, 0.5 g, 1.0 g (sodium salt) in ampoule 1.2 Local anaesthetics injection, 1%, 2% (hydrochloride) in vial injection for spinal anaesthesia, 5% (hydrochloride) in 2-ml ampoule to be mixed with 7.5% glucose solution topical forms, 2-4% (hydrochloride) � lidocaine lidocaine + epinephrine (adrenaline) injection 1%, 2% (hydrochloride) + epinephrine 1:200 000 in vial; dental cartridge 2% (hydrochloride) + epinephrine 1:80 000 Complementary List ephedrine injection, 30 mg (hydrochloride)/ml in 1-ml ampoule (for use in spinal anaesthesia during delivery, to prevent hypotension) 1.3 Preoperative medication and sedation for short-term procedures atropine injection, 1 mg (sulfate) in 1-ml ampoule injection, 5 mg/ml in 2-ml ampoule; tablet, 5 mg � diazepam morphine injection, 10 mg (sulfate or hydrochloride) in 1-ml ampoule promethazine elixir or syrup, 5 mg (hydrochloride)/5 ml 2. ANALGESICS, ANTIPYRETICS, NON-STEROIDAL ANTI-INFLAMMATORY MEDICINES (NSAIMs), MEDICINES USED TO TREAT GOUT AND DISEASE MODIFYING AGENTS IN RHEUMATOID DISORDERS (DMARDs) 2.1 Non-opioids and non-steroidal anti-inflammatory medicines (NSAIMs) acetylsalicylic acid tablet, 100-500 mg; suppository, 50-150 mg paracetamol* tablet, 100-500 mg; suppository, 100 mg; syrup, 125 mg/5 ml * not recommended for anti-inflammatory use due to lack of proven benefit to that effect 2.2 Opioid analgesics morphine injection, 10 mg in 1-ml ampoule (sulfate or hydrochloride); oral solution, 10 mg (hydrochloride or sulfate)/5 ml; tablet, 10 mg (sulfate) 17 The Interagency List of Essential Medicines for Reproductive Health 3. ANTIALLERGICS AND MEDICINES USED IN ANAPHYLAXIS � chlorphenamine tablet, 4 mg (hydrogen maleate); injection, 10 mg (hydrogen maleate) in 1-ml ampoule dexamethasone injection, 4 mg dexamethasone phosphate (as disodium salt) in 1-ml ampoule epinephrine (adrenaline) injection, 1 mg (as hydrochloride or hydrogen tartrate) in 1-ml ampoule hydrocortisone powder for injection, 100 mg (as sodium succinate) in vial � prednisolone* tablet, 5 mg, 25 mg * there is no evidence for complete clinical similarity between prednisolone and dexamethasone at high doses 4. ANTIDOTES AND OTHER SUBSTANCES USED IN POISONINGS Section 4 will be reviewed at the next meeting of the Expert Committee. 4.2 Specific atropine injection, 1 mg (sulfate) in 1-ml ampoule calcium gluconate injection, 100 mg/ml in 10-ml ampoule naloxone injection, 400 micrograms (hydrochloride) in 1-ml ampoule 5. ANTICONVULSANTS/ANTIEPILEPTICS � diazepam injection, 5 mg/ml in 2-ml ampoule (intravenous or rectal) magnesium sulfate* injection, 500 mg/ml in 2-ml ampoule; 500 mg/ml in 10-ml ampoule * for use in eclampsia and severe pre-eclampsia and not for other convulsant disorders phenobarbital tablet, 15-100 mg; elixir, 15 mg/5 ml phenytoin capsule or tablet, 25 mg, 50 mg, 100 mg (sodium salt); injection, 50 mg/ml in 5-ml vial (sodium salt) 6. ANTI-INFECTIVE MEDICINES 6.1 Anthelmintics 6.1.1 Intestinal anthelmintics � mebendazole chewable tablet, 100 mg, 500 mg pyrantel chewable tablet 250 mg (as embonate); oral suspension, 50 mg (as embonate)/ml 6.2 Antibacterials 6.2.1 Beta-Lactam medicines Applications for cefalexin and cefazolin are anticipated for the next meeting of the Expert Committee. amoxicillin capsule or tablet, 250 mg, 500 mg (anhydrous); powder for oral suspension, 125 mg (anhydrous)/5 ml ampicillin powder for injection, 500 mg, 1 g (as sodium salt) in vial 18 The Interagency List of Essential Medicines for Reproductive Health benzathine benzylpenicillin powder for injection, 1.44 g benzylpenicillin (= 2.4 million IU) in 5-ml vial benzylpenicillin powder for injection, 600 mg (= 1 million IU), 3 g (= 5 million IU) (sodium or potassium salt) in vial cefixime* capsule 400 mg * only listed for single-dose treatment of uncomplicated ano- genital gonorrhoea � cloxacillin capsule, 500 mg, 1 g (as sodium salt); powder for oral solution, 125 mg (as sodium salt)/5 ml; powder for injection, 500 mg (as sodium salt) in vial procaine benzylpenicillin powder for injection, 1 g (= 1 million IU), 3 g (= 3 million IU) in vial Complementary List � ceftriaxone powder for injection, 250 mg, 1 g (as sodium salt) in vial 6.2.2 Other antibacterials azithromycin* capsule, 250 mg or 500 mg; suspension 200 mg/5 ml * only listed for single-dose treatment of genital C. trachomatis and of trachoma chloramphenicol capsule, 250 mg; oral suspension, 150 mg (as palmitate)/5 ml; powder for injection, 1 g (sodium succinate) in vial; oily suspension for injection 0.5 g (as sodium succinate)/ml in 2-ml ampoule � ciprofloxacin* tablet, 250 mg (as hydrochloride) * final selection depends on indication for use doxycycline* capsule or tablet, 100 mg (hydrochloride) * final selection depends on indication for use � erythromycin capsule or tablet, 250 mg (as stearate or ethyl succinate); powder for oral suspension, 125 mg (as stearate or ethyl succinate); powder for injection, 500 mg (as lactobionate) in vial � gentamicin* injection, 10 mg, 40 mg (as sulfate)/ml in 2-ml vial * final selection depends on indication for use nitrofurantoin tablet, 100 mg � metronidazole tablet, 200-500 mg; injection, 500 mg in 100-ml vial; suppository, 500 mg, 1 g; oral suspension, 200 mg (as benzoate)/5 ml spectinomycin powder for injection, 2 g (as hydrochloride) in vial sulfamethoxazole + trimethoprim tablet, 100 mg + 20 mg, 400 mg + 80 mg; oral suspension, 200 mg + 40 mg/5 ml; injection, 80 mg + 16 mg/ml in 5-ml and 10-ml ampoules Complementary List clindamycin capsule, 150 mg; injection, 150 mg (as phosphate)/ml sulfadiazine tablet, 500 mg; injection, 250 mg (sodium salt) in 4-ml ampoule 19 The Interagency List of Essential Medicines for Reproductive Health 6.2.4 Antituberculosis medicines ethambutol tablet, 100 mg-400 mg (hydrochloride) isoniazid tablet, 100 mg-300 mg isoniazid + ethambutol tablet, 150 mg + 400mg pyrazinamide tablet, 400 mg rifampicin capsule or tablet, 150 mg, 300 mg rifampicin + isoniazid tablet, 60 mg + 30 mg; 150 mg + 75 mg; 300 mg + 150 mg; 60 mg + 60 mg (for intermittent use three times weekly); 150 mg + 150 mg (for intermittent use three times weekly) rifampicin + isoniazid + pyrazinamide tablet, 60 mg + 30 mg + 150 mg; 150 mg + 75 mg + 400 mg; 150 mg + 150 mg + 500 mg (for intermittent use three times weekly) rifampicin + isoniazid + pyrazinamide + ethambutol tablet, 150 mg + 75 mg + 400 mg + 275 mg 6.3 Antifungal medicines clotrimazole vaginal tablet, 100 mg, 500 mg, vaginal cream 1%, 10% � fluconazole capsule, 50 mg; injection 2 mg/ml in vial; oral suspension 50 mg/ 5-ml nystatin tablet, 100 000, 500 000 IU; lozenge 100 000 IU; pessary, 100 000 IU 6.4 Antiviral medicines 6.4.1 Antiherpes medicines � aciclovir tablet, 200 mg; powder for injection 250 mg (as sodium salt) in vial 6.4.2 Antiretrovirals Adequate resources and specialist oversight are prerequisites for the introduction of this class of drugs. The antiretroviral drugs do not cure the HIV infection, they only temporarily suppress viral replication and improve symptoms. They have various adverse effects and patients receiving these drugs require careful monitoring by adequately trained health professionals. For these reasons, continued rigorous promotion of measures to prevent new infections is essential and the need for this has not been diminished in any way by the addition of antiretroviral drugs to the Model List. Sufficient resources and trained health professionals are prerequisites for the introduction of this class of drugs. Effective therapy requires commencement of three or four drugs simultaneously, and alternative regimens are necessary to meet specific requirements at start-up, to substitute for first-line regimens in the case of toxicity, or to replace failing regimens. In order to simplify treatment, facilitate storage and distribution, and improve patients’ adherence to the treatment plan, the Committee recommends and endorses the use of fixed-dose combinations and the development of appropriate new fixed-dose combinations. These include modified dosage forms, non-refrigerated formulations and paediatric formulations with assured pharmaceutical quality and interchangeability with the single products as approved by the relevant drug regulatory authority. 6.4.2.1 Nucleoside reverse transcriptase inhibitors abacavir (ABC) tablet, 300 mg (as sulfate), oral solution, 100 mg (as sulfate)/5 ml didanosine (ddI) buffered chewable, dispersible tablet, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg buffered powder for oral solution, 100 mg, 167 mg, 250 mg packets unbuffered enteric coated capsule, 125 mg, 200 mg, 250 mg, 400 mg lamivudine (3TC) tablet, 150 mg, oral solution 50 mg/5 ml stavudine (d4T) capsule 15 mg, 20 mg, 30 mg, 40 mg, powder for oral solution, 5 mg/5 ml 20 The Interagency List of Essential Medicines for Reproductive Health zidovudine (ZDV or AZT) tablet, 300 mg capsule, 100 mg, 250 mg oral solution or syrup, 50 mg/5 ml solution for IV infusion injection, 10 mg/ml in 20-ml vial 6.4.2.2 Non-nucleoside reverse transcriptase inhibitors efavirenz (EFV or EFZ) capsule, 50 mg, 100 mg, 200 mg oral solution, 150 mg/5 ml nevirapine (NVP) tablet 200 mg; oral suspension 50 mg/5-ml 6.4.2.3 Protease inhibitors Selection of two or three protease inhibitors from the Model List will need to be determined by each country after consideration of local treatment guidelines and experience, as well as the comparative costs of available products. Ritonavir is recommended for use in combination with indinavir, lopinavir and saquinavir as a booster, and not as a drug in its own right. indinavir (IDV) capsule, 200 mg, 333 mg, 400 mg (as sulfate) ritonavir capsule, 100 mg, oral solution 400 mg/5 ml lopinavir + ritonavir (LPV/r) capsule, 133.3 mg + 33.3 mg, oral solution, 400 mg + 100 mg/5 ml nelfinavir (NFV) tablet, 250 mg (as mesilate), oral powder 50 mg/g saquinavir (SQV) capsule, 200 mg 6.5.3 Antimalarial medicines1 6.5.3.1 For curative treatment Medicines for the treatment of P. falciparum malaria cases should be used in combination. chloroquine tablet 100 mg, 150 mg (as phosphate or sulfate); syrup, 50 mg (as phosphate or sulfate)/5 ml; injection 40 mg (as hydrochloride, phosphate or sulfate)/ml in 5-ml ampoule quinine tablet, 300 mg (as bisulfate or sulfate); injection, 300 mg (as dihydrochloride)/ml in 2-ml ampoule Complementary List artemether injection, 80 mg/ml in 1-ml ampoule artesunate tablet, 50 mg doxycycline capsule or tablet, 100 mg (hydrochloride) (for use only in combination with quinine) mefloquine tablet, 250 mg (as hydrochloride) sulfadoxine + pyrimethamine tablet, 500 mg + 25 mg 1 It should be noted that the standard treatment guidelines for the treatment and prevention of malaria are currently being updated and should be referred to when available. 21 The Interagency List of Essential Medicines for Reproductive Health 6.5.3.2 For prophylaxis chloroquine tablet, 150 mg (as phosphate or sulfate); syrup, 50 mg (as phosphate or sulfate)/5 ml doxycycline capsule or tablet, 100 mg ( hydrochloride) mefloquine tablet, 250 mg (as hydrochloride) proguanil tablet, 100 mg (hydrochloride) (for use only in combination with chloroquine) 6.5.4 Antipneumocystosis and antitoxoplasmosis medicines pyrimethamine tablet, 25 mg sulfamethoxazole + trimethoprim injection, 80 mg + 16 mg/ml in 5-ml ampoule 80 mg + 16 mg/ml in 10-ml ampoule Complementary List pentamidine tablet, 200 mg, 300 mg 6.5.5 Antitrypanosomal medicines 6.5.5.1 African trypanosomiasis Complementary List pentamidine powder for injection, 200 mg, 300 mg (isetionate) in vial 10. MEDICINES AFFECTING THE BLOOD 10.1 Antianaemia medicines ferrous salt tablet, equivalent to 60 mg iron; oral solution equivalent to 25 mg iron (as sulfate)/ml ferrous salt + folic acid tablet, equivalent to 60 mg iron + 400 micrograms folic acid (nutritional supplement for use during pregnancy) folic acid tablet, 1 mg, 5 mg 10.2 Medicines affecting coagulation heparin sodium injection, 1000 IU/ml, 5000 IU/ml, 20,000 IU/ml in 1-ml ampoule phytomenadione injection, 10 mg/ml in 5-ml ampoule; tablet, 10 mg protamine sulfate injection, 10 mg/ml in 5-ml ampoule 11. BLOOD PRODUCTS AND PLASMA SUBSTITUTES 11.1 Plasma substitutes � dextran 70* injectable solution, 6% * polygeline, injectable solution, 3.5% is considered as equivalent 22 The Interagency List of Essential Medicines for Reproductive Health 12. CARDIOVASCULAR MEDICINES 12.1 Antianginal medicines glyceryl trinitrate tablet (sublingual), 500 micrograms 12.2 Antiarrhythmic medicines This subsection will be reviewed at the next meeting of the Expert Committee when it is anticipated that applications for amiodarone and sotalol will be received. digoxin tablet, 62.5 micrograms, 250 micrograms; oral solution 50 micrograms/ml; injection 250 micrograms/ml in 2-ml ampoule epinephrine (adrenaline) injection, 1 mg (as hydrochloride)/ml in ampoule lidocaine injection, 20 mg (hydrochloride)/ml in 5-ml ampoule 12.3 Antihypertensive medicines hydralazine* tablet, 25 mg, 50 mg (hydrochloride); powder for injection, 20 mg (hydrochloride) in ampoule * hydralazine is listed for use in the acute management of severe pregnancy-induced hypertension only. Its use in the treatment of essential hypertension is not recommended in view of the availability of more evidence of efficacy and safety of other medicines methyldopa* tablet, 250 mg * methyldopa is listed for use in the management of pregnancy- induced hypertension only. Its use in the treatment of essential hypertension is not recommended in view of the availability of more evidence of efficacy and safety of other medicines 12.4 Medicines used in heart failure This subsection will be reviewed at the next meeting of the Expert Committee. digoxin tablet, 62.5 micrograms, 250 micrograms; oral solution, 50 micrograms/ml; injection, 250 micrograms/ml in 2-ml ampoule � furosemide tablet, 40 mg; injection, 10 mg/ml in 2-ml ampoule 13. DERMATOLOGICAL MEDICINES (topical) 13.1 Antifungal medicines � miconazole ointment or cream, 2% (nitrate) 13.2 Anti-infective medicines methylrosanilinium chloride (gentian violet) aqueous solution, 0.5%; tincture, 0.5% 15. DISINFECTANTS AND ANTISEPTICS 15.1 Antiseptics � chlorhexidine solution, 5% (digluconate) for dilution � ethanol solution, 70% (denatured) � polyvidone iodine solution, 10% 23 The Interagency List of Essential Medicines for Reproductive Health 15.2 Disinfectants � chlorine base compound powder (0.1% available chlorine) for solution/calcium hypochlorite 16. DIURETICS � furosemide tablet, 40 mg; injection, 10 mg/ml in 2-ml ampoule 17.5 Medicines used in diarrhoea 17.5.1 Oral rehydration oral rehydration salts* (for glucose-electrolyte solution) glucose: 75 mEq sodium: 75 mEq or mmol/l chloride: 65 mEq or mmol/l potassium: 20 mEq or mmol/l citrate: 10 mmol/l osmolarity: 245 mOsm/l glucose: 13.5 g/l sodium chloride: 2.6 g/l potassium chloride: 1.5 g/l trisodium citrate dihydrate+: 2.9 g/l + trisodium citrate dihydrate may be replaced by sodium hydrogen carbonate (sodium bicarbonate) 2.5 g/l. However, as the stability of this latter formulation is very poor under tropical conditions, it is only recommended when manufactured for immediate use * in cases of cholera a higher concentration of sodium may be required 17.5.2 Medicines for diarrhoea in children zinc sulfate* tablet or syrup in 10 mg per unit dosage forms * in acute diarrhoea zinc sulfate should be used as an adjunct to oral rehydration salts 18. HORMONES, OTHER ENDOCRINE MEDICINES AND CONTRACEPTIVES 18.3 Contraceptives This subsection will be reviewed at the next meeting of the Expert Committee. 18.3.1 Oral hormonal contraceptives � ethinylestradiol + � levonorgestrel tablet, 30 micrograms + 150 micrograms � ethinylestradiol + � norethisterone tablet, 35 micrograms + 1.0 mg levonorgestrel tablet, 30 micrograms, 750 micrograms (pack of two), 1.5 mg 18.3.2 Injectable hormonal contraceptives medroxyprogesterone acetate depot injection, 150 mg/ml in 1-ml vial norethisterone enanthate oily solution, 200 mg/ml in 1-ml ampoule 24 The Interagency List of Essential Medicines for Reproductive Health 18.3.3 Intrauterine devices copper-containing device 18.3.4 Barrier methods condoms diaphragms 18.5 Insulins and other antidiabetic agents insulin injection (soluble) injection, 40 IU/ml in 10-ml vial, 100 IU/ml in 10-ml vial intermediate-acting insulin injection, 40 IU/ml in 10 ml vial; 100 IU/ml in 10 ml vial (as compound insulin zinc suspension or isophane insulin) 19. IMMUNOLOGICALS 19.2 Sera and immunoglobulins All plasma fractions should comply with the WHO Requirements for the Collection, Processing and Quality Control of Blood, Blood Components and Plasma Derivatives (Revised 1992). WHO Expert Committee on Biological Standardization, Forty-third report, (WHO Technical Report Series, No. 840, 1994, Annex 2). anti-D immunoglobulin (human) injection, 250 micrograms in single-dose vial antitetanus immunoglobulin (human) injection, 500 IU in vial 19.3 Vaccines All vaccines should comply with the WHO Requirements for Biological Substances. 19.3.1 For universal immunization BCG vaccine diphtheria vaccine hepatitis B vaccine poliomyelitis vaccine tetanus vaccine 20. MUSCLE RELAXANTS (PERIPHERALLY-ACTING) AND CHOLINESTERASE INHIBITORS suxamethonium injection, 50 mg (chloride)/ml in 2-ml ampoule; powder for injection (chloride), in vial 21. OPHTHALMOLOGICAL PREPARATIONS This section will be reviewed at the next meeting of the Expert Committee 21.1 Anti-infective agents eye ointment, 1% (hydrochloride) � tetracycline 25 The Interagency List of Essential Medicines for Reproductive Health 22. OXYTOCICS AND ANTIOXYTOCICS 22.1 Oxytocics injection, 200 micrograms (hydrogen maleate) in 1-ml ampoule � ergometrine oxytocin injection, 10 IU in 1-ml ampoule Complementary List misoprostol vaginal tablet, 25 micrograms mifepristone* - misoprostol* tablet 200 mg - tablet 200 micrograms * requires close medical supervision 22.2 Antioxytocics nifedipine immediate release capsule, 10 mg 26. SOLUTIONS CORRECTING WATER, ELECTROLYTE AND ACID-BASE DISTURBANCES 26.1 Oral Where permitted under national law and where culturally acceptable. oral rehydration salts (for glucose-electrolyte solution) see section 17.5.1 26.2 Parenteral glucose injectable solution, 5%, 10% isotonic; 50% hypertonic glucose with sodium chloride injectable solution, 4% glucose, 0.18% sodium chloride (equivalent to Na+ 30 mmol/l, Cl- 30 mmol/l) sodium chloride injectable solution, 0.9% isotonic (equivalent to Na+ 154 mmol/l, Cl- 154 mmol/l) � sodium lactate, compound solution injectable solution 26.3 Miscellaneous water for injection 2-ml, 5-ml, 10-ml ampoules 27. VITAMINS AND MINERALS retinol sugar-coated tablet, 10 000 IU (as palmitate) (5.5 mg); capsule, 200 000 IU (as palmitate) (110 mg); oral oily solution 100 000 IU (as palmitate)/ml in multidose dispenser; water-miscible injection 100 000 IU (as palmitate) (55 mg) in 2-ml ampoule 26 The Interagency List of Essential Medicines for Reproductive Health Annex 1: Major medicine changes in the Interagency List Medicines added to the Interagency List The 14th WHO Expert Committee meeting on the Selection and Use of Essential Medicines accepted four medicines applications in the field of reproductive health. The medicines added to the 14th WHO Model List and consequently on the Interagency List of Essential Medicines for Reproductive Health are summarized below. Medicines added For more information, please refer to: http://mednet3.who.int/EML/edl/expcom14/expertcomm14.shtml and http://mednet3.who.int/EMLib/DiseaseTreatments/Medicines.aspx WHO Reproductive Health Library, available at: http://www.who.int/reproductive-health/rhl/index.html cefixime, tablet Cefixime was added to the 14th Model List for the treatment of uncomplicated ano-genital gonorrhoea only. Cefixime is well tolerated and most adverse drug reactions are related to the gastrointestinal system. clotrimazole, vaginal tablet and cream Clotrimazole (1%, 10% vaginal cream; 100 mg, 500 mg vaginal tablet) was added to the 14th Model List for the treatment of vulvovaginal candidiasis. There has been adequate clinical evidence to support the efficacy and safety of topical and intravaginal clotrimazole in the treatment of vulvovaginal candidiasis. nifedipine, capsule Nifedipine (10 mg immediate release capsules) was included on the 14th Model List in the subsection of tocolytics. Strong evidence supports the use of nifedipine to inhibit preterm labour. Nifedipine is effective and safe for this indication, the sublingual route is pharmacologically equivalent to the conventional oral route as it is absorbed low in the gastrointestinal tract. misoprostol, intravaginal tablet In view of the evidence of its efficacy and safety, misoprostol (25 microgram intravaginal tablet) has been included on the complementary list of the 14th Model List for the induction of at-term labour. Misoprostol has to be administered as low-dose vaginal tablets, and used only in organized health services with facilities to manage negative outcomes. Vaginal administration of misoprostol seems to be cost-effective, it reduces the incidence of operative deliveries which could lead to further indirect cost savings. misoprostol, tablet + mifepristone, tablet Mifepristone (200 mg tablet) followed by misoprostol (200 microgram tablet) have been included on the complementary list of the 14th Model List for medical abortion within nine weeks of the start of pregnancy, with the following footnote: Requires close medical supervision. The use of this medication in medical abortion should be undertaken under close medical supervision, and its efficacy decreases if used after nine weeks of gestation. A note adjacent to the combination states: Where permitted under national law and where culturally acceptable. 27 The Interagency List of Essential Medicines for Reproductive Health Medicines deleted from the Interagency List Consensus among reproductive health stakeholders was reached on deleting certain medicines that (1) were deleted from the WHO Model List or (2) for which alternatives were found on the WHO Model List. These deletions are summarized below. For more information, please refer to: http://whqlibdoc.who.int/trs/WHO_TRS_920.pdf Deleted medicines http://mednet3.who.int/EML/edl/expcom14/14EMLReportFinal- withoutRecomm_040705.pdf indometacin, tablet Removed from the Interagency List as the harms outweigh the benefits. diphenylhydramine, injection Replaced by epinephrine injection, which is already listed on the WHO Model List. ergometrine tablet No robust clinical evidence to establish the effectiveness and safety of ergometrine when used alone for active management of labour and prevention of postpartum haemorrhage. Oxytocin is recommended instead. The WHO Expert Committee therefore deleted ergometrine tablets from the Model List; ergometrine injection was retained for the treatment of acute post-partum haemorrhage. salbutamol, tablet as tocolytic Deleted from the 14th WHO Model List. There is inadequate evidence to support the efficacy of salbutamol as a tocolytic agent. No systematic review is available relating to salbutamol specifically. tinidazole Metronidazole was recommended as the first-line treatment of trichomoniasis. ketoconazole and itraconazole, Replaced by fluconazole that has similar effect and is a broad spectrum antifungal. pethidine, injection Pethidine is considered inferior to morphine due to its toxicity on the central nervous system and it is generally more expensive than morphine. It was deleted from the 13th WHO Model List in 2003. iron dextran, injection Deleted from the 13th WHO Model List in 2003, on the basis of its unfavourable benefit-risk ratio. atenolol, tablet propranolol, tablet hydrochlorothiazide, tablet Not recommended by WHO standard treatment guidelines for the treatment of hypertension in pregnancy. Deleted from the 13spermicides th Model List in 2003, because of the lack of evidence of any additional benefit of diaphragms and condoms with spermicides, and the strong suggestion of the potential of nonoxynol to increase the risk of transmission of HIV infection. (benzalconium, menfegol, nonoxynol and octoxynol) labetalol, tablet A review was received from the Department of Reproductive Health and Research. The Committee noted that insufficient information was available on the efficacy of labetalol in the treatment of chronic hypertension in pregnancy. The Committee recommended no action at this stage, in view of the lack of evidence of better efficacy and safety of labetalol in the treatment of hypertension in pregnancy. 28 In many developing countries maternal mortality and morbidity are unacceptably high, and the incidence of sexually transmitted infections, including HIV/AIDS, is rising, while preventive measures and treatment are often inadequate. Lack of access to reproductive health medicines and commodities is becoming a critical issue in developing countries, with family planning and other reproductive health care needs unmet. The Interagency List of Essential Medicines for Reproductive Health has been developed by WHO in collaboration with major international and nongovernmental organizations active in the field of reproductive health. The list presents the current international consensus on a rational selection of medicines essential to the provision of quality reproductive health services. Essential medicines for reproductive health include contraceptives, medicines for prevention and treatment of sexually transmitted infections and HIV/AIDS, and medicines to ensure healthy pregnancy and delivery. All medicines on the Interagency List are also in the WHO Model List of Essential Medicines. This publication presents the Interagency List in two formats: by clinical group and by therapeutic category. It is intended to support decisions regarding the selection, production, quality assurance, national procurement and reimbursement schemes of these medicines. This is an interagency consensus document published by the WHO Departments of Medicines Policy and Standards and Reproductive Health and Research on behalf of the organizations listed. The Interagency List of Essential Medicines for Reproductive Health 2006 World Bank I N T E R A G E N C Y G U I D E L I N E S Contents Acknowledgements Background The Interagency List of Essential Medicines for Reproductive Health Development process Next steps: request for comments and suggestions Additional references Format 1 Explanation Format 2 Explanation Annex 1: Major medicine changes in the Interagency List Medicines added to the Interagency List Medicines deleted from the Interagency List << /ASCII85EncodePages false /AllowTransparency false /AutoPositionEPSFiles true /AutoRotatePages /None /Binding /Left /CalGrayProfile (Dot Gain 20%) /CalRGBProfile (sRGB IEC61966-2.1) /CalCMYKProfile (U.S. Web Coated \050SWOP\051 v2) /sRGBProfile (sRGB IEC61966-2.1) /CannotEmbedFontPolicy /Error /CompatibilityLevel 1.4 /CompressObjects /Tags /CompressPages true /ConvertImagesToIndexed true /PassThroughJPEGImages true /CreateJDFFile false /CreateJobTicket false /DefaultRenderingIntent 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