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FEDLIZ 20155th Essential Drugs ListandStandard Treatment GuidelinesForZimbabwe7th Essential Medicines ListandStandard Treatment GuidelinesforZimbabwe

EDLIZ 2015Printed byii

EDLIZ 2015EDLIZ 7TH EDITION 2015PUBLISHED BY:The National Medicine and Therapeutics PolicyAdvisory Committee [NMTPAC]Ministry of Health & Child CareRepublic of ZimbabweFurther copies may be obtained through the relevant Provincial MedicalDirectorate, City Health Directorate, the NMTPAC, Ministry of Health &Child Care (MoHCC), PO Box CY 1122, Causeway, Harare, Zimbabwe,or the MoHCC website www.mohcc.gov.zw. Copies of the text may beobtained on soft copy if required for teaching purposes from emailaddress: dps@mohcc.gov.zw or nmtpac@gmail.com EDLIZ wasprepared using Microsoft Word.The information presented in these guidelines conforms to currentmedical, nursing and pharmaceutical practice. It is provided in goodfaith. Whilst every effort was made to ensure that medicine doses arecorrect, no responsibility can be taken for errors and omissions.EDLIZ Review Co-ordinatorNo part of this publication may be reproduced by any process withoutthe written permission of the copyright holder, exception being made forthe purpose of private study, research, criticism or review, or forteaching, but not for sale or other commercial use.Original Cover Design: Regina Gapa and Charon LessingCover redesign & Layout: Kim HoppenworthCover redesign and layout 2015: Newman B Madzikwa Copyright June 2015, Ministry of Health & Child Careiii

EDLIZ 2015EDLIZ REVIEW COMMITTEEApollo TsitsiSamukange EmmaBorok MargaretMujuru HildaChakanyuka Christine C.Mushavi AngelaHove RopafadzaiMadzikwa Newman B.Mungwadzi GodfreyNdhlovu Chiratidzo E.Bakasa ClemencianaSifeku Florah N.Mudzimu ForwardWellington MaureenTorongo MabelVuragu Davison N.Nyamayaro RaphaelMaunganidze AspectKhoza StarBasopo VictorMadziyire Mugove GChidakwa ClaitosBara WilfredACKNOWLEDGEMENTSWe would like to thank all the individuals who made contributionsthrough colleagues or discussion forums or by communicating throughelectronic mail. We are grateful to all who made this edition a nationalguide that serves as the standard for Zimbabwe. Thank you to all thehealthcare workers for your support.The following attended our review workshops as well as beinginstrumental in current chapter reviews:Akinjide-Obonyo Akindele P, DrApollo Tsitsi, DrBakasa Clemenciana, MsBare Blessing,Basopo Victor, MrBepe Tafadzwa, DrBorok Margaret, DrBurutsa Patricia, MsBwakura Tapiwanashe, DrCakana Andrew, ProfChakanyuka Artmore, DrChakanyuka Christine C., DrChari Godfrey,Charimari Lincoln, DrChemhuru Milton, DrChikanya Sonia Irene, MsChimhini Gwendoline, DrivMaunga Simbarashe, DrMaunganidze Aspect, DrMbuzi Tonnie, MrMhazo Tichatyei, MrMhembere Josephine, DrMidzi Stanley, DrMisihairambwi Silence, MsMlilo Lindiwe, DrMoyo Dothan, MrMoyo Mluleki, MrMoyo Sifiso, MrMudombi Wisdom, DrMudzimu Forward, MrMujuru Hilda A., DrMungwadzi Godfrey, DrMunjanja Stephen P, ProfMushavi Angela, Dr

EDLIZ 2015Chirenje Mike Z., Prof.Chiro Erick, MrCowan Frances M, Prof.Deda Petunia, MsDliwayo Thokozile, MsDube Siphathisiwe Noreen, MrsDube Tirivashoma, MrFana Golden, DrGambanga Pauline, DrGlavintcheva Iskra L, DrGunguwo Hillary, DrGwanzura Lovemore, Prof.Gwata Beatrice, MrsHove Ropafadzai MrsKambarani Rose, ProfKandawasvika Petronella, DrKhoza Star, DrKhumalo Brian, MrKhumalo Mhlawempi,Kufa Tarisai, DrKusemwa Muyambi Preetyosa, MsLatif AS, ProfMachisa Vimbainashe, MsMadhombiro Munyaradzi, DrMadzikwa Newman B. MrMagombeyi Rudo, MsMagunda Farai,Mandimika, FlorenceMandire Joice, MsMangezi Walter, DrMangoma Tariro, MsMangwiro John C, DrMasanganise Rangarirai, ProfMasendu Maureen, DrMashinge Farayi, MrMashoko Tsungai, MsMashumba Azza, DrMaswaure Laucas,Matonhodze Alex, MrMusiya N, DrMusungwa Alexio, MrMusvipa Mary, MsMutsvairo Sitembile, MsMwaramba Charles, MrMwonzora Muchaneta, MrsNathoo Kusum J, Prof.Ncube Phumuzile, MsNdamukwa Pikirai, MrNdhlovu Chiratidzo E, ProfNdlovu Misheck, MrNdowa Francis, DrNembiri Tinashe, MsNgwende Gift W, DrNkala Lee, MrNyadzayo Tasiana K, MrNyakabau Anna M, DrNyamayaro Raphael, DrNyaruwanga Albert, MrPasi Christopher, DrPhiri Isaac, DrReid Andrew, DrRimai Ruth, MsSamukange Emma, MrsSandy Charles, DrSanyanga Arthur, MrShumba Godfrey, MrSibanda Elopy N, ProfSifeku Florah N, MrsSithole Dorcas, MsTagwirei Dexter, ProfTakaruza Kelvin, MrTambudze Gaundencia, MsTekasala Lumbu Jerry, MrTicklay Ismail, DrVuragu Davison N, MrWellington Maureen, DrZaranyika Trust, DrThank you!Mrs R.F. HoveProf. C. E. NdhlovuDirector of Pharmacy ServicesNMTPAC Chairpersonv

EDLIZ 2015FOREWORDIt is the national objective that the health care needs of Zimbabweansare met through the provision and proper use of essential medicines.Sometimes we do not need to give medicines, that is, there is notalways a “pill for every ill”. Thus, there is need to use medicinesappropriately, efficiently, and effectively.The guidelines in EDLIZ have always reflected the consensus of localexperts, and takes into consideration factors such as the Zimbabweansetting, prevailing economic climate, practical experience as well asevidence-based therapeutics.This new EDLIZ has taken into account the dynamic changes in theBurden of Disease as reflected by the inclusion of antiretroviralmedicines and treatment of other opportunistic infections other thanTuberculosis (TB). Many of the therapeutic regimens of the previousEDLIZ still hold true and remain the same, and should reinforce theconfidence of the prescriber in making reliable therapeutic choices.I urge all health workers to familiarise themselves with the revisedguidelines, to prescribe within the bounds of this publication, and torecognise the critical importance of providing a quality service to allhealth care recipients through the rational use of medicines.EDLIZ REMAINS good medicine! Use it.Hon. Dr. P.D. ParirenyatwaMinister of Health & Child Carevi

EDLIZ 2015THE ESSENTIAL MEDICINES LIST FORZIMBABWE – EDLIZ 7TH EDITIONThis 7th essential medicines list and standard treatment guidelines forthe most common health conditions in Zimbabwe has been endorsed bythe National Medicine & Therapeutics Policy Advisory Committee[NMTPAC]. It is the product of many years of combined efforts byhundreds of health workers at all levels of the health care system inZimbabwe – from the front line health care providers to the providers ofspecialist care. It has been refined over the years as a result of itswidespread use by our healthcare workers. We continue to revise thestandard treatment guidelines and take into account medicinedevelopments and new healthcare problems. Thus this latest edition hasincluded more essential medicines.The essential medicine list is based on the Essential MedicinesConcept. Medicines in EDLIZ are chosen to meet the health care needsof the majority of the population, and should therefore always beavailable and accessible at a price that both the patient and the nationcan afford.Selection of medicines for inclusionSelection of medicines for inclusion in EDLIZ has been based on thefollowing criteria, with special emphasis on proven evidence for their usein the Zimbabwean setting: relevance to prevalent diseases proven efficacy and safety adequate scientific data in a variety ofsettings adequate quality favourable cost-benefit ratio desirable pharmacokinetics possibilities for local manufacture available as single ingredient ssibleRationally usedGENERIC MEDICINESEvery medicine has a chemical name and a generic name. Forexample, paracetamol, its chemical name is N-(4-Hydroxyphenol)acetamide and the international non-proprietary name (INN) or genericname is paracetamol. The INN is the medicine's official nameregardless of who manufactures or markets it. An additional brand namevii

EDLIZ 2015is chosen by the manufacturer to facilitate recognition and association ofthe product with a particular manufacturer for marketing purposes.For most common medicines there are several branded products that allcontain the same active ingredient and therefore share the same INN.The use of generic names for medicine procurement as well asprescribing carries considerations of clarity, quality, and price.Proponents of generic medicines procurement and prescribing point outthat:generic names are more informative than brand names and facilitatepurchasing of products from multiple suppliers, whether as brandname or as generic products; generic medicines are generally cheaper than products sold bybrand name; this is demonstrated very clearly when it comes toantiretroviral medicines generic prescribing also facilitates product substitution, wheneverappropriate.Opponents argue that the quality of generic medicines is inferior to thatof brand (innovator) products. However quality assurance and naming ofmedicines are completely separate issues. Generic medicines fromreliable suppliers are as safe, effective, and high in quality as medicineswith brand names. At the same time, branded medicines from amanufacturer with inadequate procedures for quality control can be ofpoor quality, despite the brand name. Also, although any medicine canbe counterfeited, there are more incentives for counterfeiting brandname medicines than generic medicines. Some pharmaceuticalcompanies also sell their branded products under the generic name, fora much lower price. Bio-equivalence is often misused as an argument against the use ofgeneric equivalents. For many medicines, the variation in bioavailabilityamong individual patients is much larger than the variation amongproducts of different manufacturers. In fact, bioavailability is clinicallyrelevant for only a relatively small number of medicines such asfurosemide, digoxin, levodopa, isoniazid, theophylline and phenytoin.Zimbabwe has a well understood generic policy which requires that allprescribing is in the generic name and the dispenser can make genericsubstitutions (unless bioavailability is an issue in which case theprescriber should indicate accordingly).ADVANTAGES OF EDLIZThe benefits of the selection and use of a limited number of essentialmedicines are: Improved medicines supply More rational prescribingviii

EDLIZ 2015 Lower costs Improved patient useIMPROVED MEDICINES SUPPLYThe regular supply of medicines is difficult in many countries, and theconsequent health implications are many. Improved medicinesavailability should lead to improved clinical outcomes.With fewer essential medicines beingpurchased, the mechanisms and easier procurement,logistics for procurement, storage &storage & distributiondistribution will clearly be easier. It is lower holding stocksnot practical for each clinic in lower lossesZimbabwe to attempt to procure,transport and warehouse all the better quality assurancehundreds of items in EDLIZ.Conversely, limiting the number of medicines available at the primaryhealth care level makes a regular supply of medicines more practicaland possible.With an improved supply the possibilities of holding lower quantitiesexist. This has financial implications as well as reducing the likelihood ofmedicines expiring or being damaged during storage.Quality assurance can be better managed when the number ofmedicines is limited, and quality checks can be performed morefrequently.MORERATIONALPRESCRIBING focused, more effective training more experience with fewer medicines no irrational treatment alternativesavailable focused medicine information better recognition of adverse medicinereactionsIn the absence of limitedlists, the large variety ofproducts available on themarketcontributestoinconsistent prescribing andconsequently, variation inclinical practice even within the same health care facility. Irrationalprescribing may lead to therapeutic hazards and increased costs.When the number of medicines is limited, training can be more focusedand the quality of care enhanced. This is especially true when the listrepresents a consensus of opinion on first choice of treatment such asin EDLIZ.Using EDLIZ enables the prescriber to become more familiar with themedicines they use, and better able to recognise adverse effects.ix

EDLIZ 2015The use of EDLIZ also eliminates irrational products from beingavailable for prescribing, and allows for more focused medicineinformation to be provided on suitable essential medicines.LOWER COSTSImproved effectiveness and efficiency inpatient treatment leads to lower health carecosts. The essential medicines concept isincreasingly being accepted as a universaltool to promote both quality of care and costcontrol. more competition lower pricesEssential medicines are usually available from multiple suppliers. Withincreased competition, more favourable prices can be negotiated.By limiting the number of different medicines that can be used to treat aparticular clinical problem, larger quantities of the selected medicine willbe needed, with potential opportunities to achieve economies of scale.IMPROVED PATIENT USEFocusing on fewer medicines can enhance patient education and effortsto promote the proper use of medicines in both patients and prescribers.Additionally, with improvedmedicine availability changes focused education effortstochronicmedication reduced confusion & increasedregimens are less likely andadherence to treatmentas a consequence patientshave a better understanding of their disease, their medication and theneed for compliance.IMPLEMENTATION OF EDLIZ AND SETTING UP OFHOSPITAL MEDICINE AND THERAPEUTICS COMMITTEES(HMTCS)The advantages presented here however do not just happen. EDLIZitself will not ensure rational prescribing or facilitate good procurementor quality assurance. Educational, regulatory, financial or managerialstrategies on their own are less effective in promoting the rational use ofmedicines than combined strategies. The production of EDLIZ is onesuch regulatory strategy, but further steps such as training and retraining, patient education and the establishment and effectivefunctioning of hospital medicine and therapeutic committees (HMTCs)have to be taken to ensure cost-effective prescribing and patient care. Itis therefore necessary for every hospital to have a forum wheremedicine issues can be discussed. Ideally, a separate hospital medicinex

EDLIZ 2015and therapeutics committee (HMTC) should be formed. Given thecurrent manpower constraints, we encourage hospitals to exploit everyopportunity such as the regular divisional meetings held in CentralHospitals to discuss and address medicine related problems.TheNMTPAC is available to assist those hospitals that are ready to set upan HMTC. A technical guideline to set up a HMTC developed by theNMTPAC is available.EXPLANATIONS & CHANGES FROM THE PREVIOUSVERSIONThis edition is essentially the same in format and layout, categorisationas the last edition. You will need to read it carefully to note changes inrecommendations that apply to your areas of interest. Extra bulletins willbe sent out where drastic changes in medicine recommendations haveoccurred.All medicines in EDLIZ are categorised firstly by level of availability(ABCS) in the health care system, and secondly, according to priority(VEN). Hence in the example below, amoxicillin is available at primaryhealth care facility (C) level and is ranked vital (V).MedicineCodes Adult doseFrequencyDurationamoxicillin poC3 times a day7 daysV500mgLEVEL OF AVAILABILITYC medicines are those required at primary health care level and shouldbe available at all levels of care.B medicines are found at district hospital level or secondary and higherlevels of care. Some B medicines may be held at primary health carefacilities on a named patient basis – for example in the managementand follow up of chronic illnesses.A medicines are prescribed at provincial or central hospital levels.S medicines (specialist only) have been brought back into this edition.These are medicines that require special expertise and /or diagnostictests before being prescribed.VEN CLASSIFICATIONAll medicines are also classified according to their priority. This is mostlya tool to assist in giving priority to medicines based on economicconsiderations. Thus V medicines are vital, they are consideredxi

EDLIZ 2015lifesaving or their unavailability would cause serious harm and effortsshould always be aimed at making them 100% available.E medicines are essential, and are given second priority. Without Emedicines there would be major discomfort or irreversible harm. And Nmedicines are still necessary but are lower in priority than V and Emedicines.This edition of EDLIZ has been produced as a result of a highlyconsultative process and represents both the practical nature of theinput from health care workers and the changing nature of medicineespecially over the recent years. It has adopted an evidence-basedapproach wherever possible and has balanced this with the resourcesavailable to the health care system.The NMTPAC is a standing committee that reviews the therapeuticguidelines in EDLIZ on a continual basis, and always looks forward tofeedback from the providers of health care in Zimbabwe. Contact theNMTPAC through Directorate of Pharmacy Services ondps@mohcc.gov.zw or nmtpac@gmail.com with your comments.Brigadier General (Dr) G. GwinjiPermanent SecretaryMinistry of Health & Child CareRepublic of Zimbabwexii

EDLIZ 2015MAJOR HIGHLIGHTS IN THE LATESTEDLIZPreambleThe major changes in this latest edition of EDLIZ will be highlighted hereso that you are aware of recommendations that you need to consider inyour medicine management or supply issues. Ideally each hospital shouldcreate its own local medicine formulary which shows which medicines areconsidered very useful in that setting so that you do not have to ordermedicines that your doctors will not prescribe or use. For instance youshould not keep specialist medicines if there is no specialist to prescribethem. Hospital Medicine and Therapeutics Committees should selectmedicines for use in their hospital using the EDLIZ.New chapterThere is one new chapter – Overview of Surgical Conditions. We welcomeany comments on the utility of this chapter. Your comments will be used infuture revisions.AntibioticsA new cephalosporin, Cefixime, has been added to the treatment ofsexually transmitted illnesses. Azithromycin has also been added for thetreatment of gonococcus.ImmunisationRotavirus immunisation has now become routinely available. HumanPapilloma Virus (HPV) vaccination is currently being used in a limitedsetting but it is hoped that it will be rolled out nationally in 2016.Asthma TreatmentGiven that salbutamol inhalers are more accessible, oral salbutamol hasbeen phased out completely. You will need to ensure that your patientsare aware of this change. Use of steroids as an inhaler should beencouraged in place of regular oral Salbutamol. Health care workers willneed to always check that their clients can use the inhalers appropriately.ART Guidelines (use latest ART guidelines)Stavudine containing regimens are being phased out and will not beavailable except for a limited number of patients who will still need them.For first line therapy, tenofovir/lamivudine and efavirenz will be used inmost instances for adults, adolescents and children as well as pregnantwomen.Third line antiretroviral medicines will be available in selected hospitals.These third line medicines will include raltegravir and darunavir. Pleasexiii

EDLIZ 2015familiarise yourself with the dosing of these new medicines and thealgorithm for their use.Malaria TreatmentThe malaria medicines have also been revised. The first line therapyremains the same as before i.e. Artemether Lumefantrine (AL).However, where oral quinine would have been used, we now recommendoral artesunate and amodiaquine as a combined medicine. For prereferral use, rectal artesunate will be used instead of IM quinine. This

EDLIZ 2015 x The use of EDLIZ also eliminates irrational products from being available for prescribing, and allows for more focused medicine information to be provided on suitable essential medicines. LOWER COSTS Improved eff

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not know; am I my brother’s keeper?’ (Genesis 4:9) N NOVEMBER 2014 the Obama administration in the United States announced an extension of relief for immigrant families, prompting one cartoonist to caricature ‘an immigrant family climbing through a window to crash a white family’s Thanksgiving dinner’ with the ‘white father unhappily telling his family, “Thanks to the president .