CHILDREN S MEDICINES IN UGANDA

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1 Medicines for Children CHILDREN S MEDICINES IN UGANDA An investigation into availability and factors impacting access INTRODUCTION The continuous availability of affordable medicines for children is necessary for countries to reduce infant mortality, in keeping with Millennium Development Goal (MDG) 4 (UNDP, 2010). In recognition of the importance of availability of medicines for children to the success of MDG 4, the World Health Assembly (WHA) passed Resolution WHA60.20 in 2007, titled better medicine for children. In November 2010, the Ecumenical Pharmaceutical Network (EPN) conducted a study to determine the availability and pricing of essential medicines for children in church health facilities in Uganda. The EPN study followed up on a 2007 World Health Organization (WHO) survey of children s medicines availability in 14 African capitals. This study revealed poor availability of medicines for children in both public and private facilities (Robertson et al., 2009). The objectives of this study were to determine the availability and pricing of selected children s medicines including antiretrovirals (ARVs); to describe facility-level practices that affect access to medicines and to document the opinions of health facility professionals regarding barriers to access. METHODS EPN notified the Ministry of Health (MOH) as well as the Uganda Catholic and Uganda Protestant Medical Bureaus (UCMB and UPMB) about the study. Facilities in hard-to-reach areas, those outside the geographically delimited study zones and those in the capital, Kampala, were excluded from the survey. A representative study sample of 61 facilities was drawn from the resultant study population of 165 church health facilities. Four study zones, western, northern, eastern 1 and eastern 2 were created (see Table 1). The facilities were categorized as dispensary, health centre and hospital; corresponding to health centre levels II, III and IV respectively, of the Uganda health facility Table 1: Nature and location of facilities Region classification system. The regional referral and the national referral hospitals were excluded from this survey as they are all public entities. District hospitals were grouped together with health centre level IV to form the hospital category as has been done in previous studies (Kavuma, 2009). The survey covered 29 medicines in 33 formulations suitable for children. Majority of the medicines investigated are included in the 2 nd edition of the WHO model list of essential medicines for children (WHO, 2009). Two different questionnaires were administered at every health facility. The first investigated availability and pricing of children s medicines and the second looked into factors that affect access to children s medicines. Respondents included facility in-charges, pharmacy in-charges, or other designated health professionals. The questionnaires took between one to two hours to administer, depending on the facility level of care. All the data from health facility questionnaires was analyzed using Epi Info TM. Price and availability data was further analyzed using Stata. RESULTS Hospital Health Centre Dispensary Total Western Eastern Eastern Northern Total Essential Medicines Lists and Treatment Guidelines Researchers investigated the existence of a standard list of medicines at each facility. Of the 56 facilities that gave a response, only 32% reported that they had a standard medicines list but only 13 of these facilities could produce the list at the time of the survey. However, none indicated that the list was broken down into medicines for children and adults. This study and report were made possible by the generous support of Wemos, Netherlands and the United Church of Canada. The contents are the responsibility of EPN and do not necessarily reflect those of Wemos or United Church of Canada. The Ecumenical Pharmaceutical Network (EPN) is an independent Christian membership organization whose mission is to support churches and church health systems provide and promote just and compassionate quality pharmaceutical services. EPN has been actively involved in various ways in promoting increased access to and rational use of medicines.

2 Furthermore only twenty-one percent of the surveyed 61 health facilities had the 2007 Uganda Essential Medicines List (EML) (MOH, 2007), the most current EML at the time of the survey. Even though 53 of 57 facilities reported having treatment guidelines for the management of common conditions, only 26 indicated that they had treatment guidelines specifically for children. The guidelines commonly available included those on integrated management of childhood illnesses (IMCI), dosing of paediatric antiretroviral therapy, as well as anti-malaria medicine. Selection In the majority of facilities (85%), the head of the facility was responsible for medicine selection. A committee was responsible for medicine selection in only 21% of the facilities surveyed, all of which were hospitals. Pharmacy in-charges had considerable influence (44%) in selecting medicine. Six of the 61 surveyed facilities had a checklist or standard operating procedures for the selection of medicines. Procurement Current consumption patterns were cited as the most common influencers of medicine purchases by 82% of the facilities. Other influencers were affordability, perceived disease prevalence, reliability of supply source and treatment guidelines. Quarterly purchases were most common, preferred by 57% of the facilities. One-third of the facilities restocked medicines on a monthly basis. Lack of funds was reported to be the main reason for failure to purchase medicines for children by 56% of the facilities. Availability of adult formulations that could substitute for paediatric formulations was the next most important barrier, reported by 20% of the facilities. Eighteen percent of the facilities also cited non-availability and unreliable supply sources as barriers to purchases of medicines for children. Sources Just over half of the surveyed facilities (55%) bought almost three-quarters of their supplies from Joint Medical Store. Twenty percent of the surveyed facilities bought most of their supplies from private wholesalers and distributors and all of them reported buying at least some supplies from the private sector. Surveyed facilities did not consider donations as important sources of children s medicines. Only 13% of the facilities received donations of children s medicines. Sources included projects run by the Catholic Medical Mission Board (CMMB), Catholic Relief Services (CRS), NUMAT and Baylor project, among others. Inventory Management Stock cards were the most popular inventory tools at 95% reported use. Only nine facilities (15%) had a computerized inventory management system (IMS) but less than half of the respondents reported having a problem with reporting on medicine consumption. Fig 1: Number of facilities using selected IM tools Computerized IMS Issue Book Dispensing log Stock/bin cards Human Resources Only 2 of 19 hospitals employed a pharmacist compared with 18 which employed a medical officer. Pharmacy technicians were employed by 15% of the surveyed facilities, compared to their counterparts with diplomas in medicine or laboratory technology (48% and 26% respectively). No pharmacy professionals were employed at health centres or dispensaries. Information Sources The main sources of information about children s medicines were external training workshops, professional journals and in-house seminars (Fig. 2). Fig 2: Information sources for medicines for children Journals 20% Other 17% Seminars 17% Internet 13% Workshops 33% 2 Ecumenical Pharmaceutical Network 2011 EPN From the Shelf Series

3 Availability of Children s Medicines As shown in Table 2, availability was very high (>90%) for benzyl penicillin injection, oral rehydration salts (ORS), mebendazole tablets and tetracycline eye ointment. Overall availability of diazepam injection was good (85%). Medicines with low availability (<40%) included ferrous oral liquid, salbutamol inhaler, zinc tablets and ceftriaxone 250 mg injection. Table 2: Availability of selected children s medicines in church health facilities in Uganda Medicine Name facilities with medicine * hospitals with medicine health centres with medicine dispensaries with medicine Level of Use ** Abacavir solution 100 mg/5 ml c Amoxicillin powder for oral liquid 125 mg/5 ml 37 (61) 14 (74) 11 (69) 12 (46) 1 Artemether 20 mg + Lumefantrine 120 mg 34 (56) 14 (74) 10 (63) 10 (39) 1 Benzyl penicillin injection 1 MU 60 (98) 19 (100) 16 (100) 25 (96) 1 Ceftriaxone 250 mg injection 9 (15) 5 (26) 2 (13) 2 (8) 2 Cotrimoxazole oral liquid 240 mg/5 ml 35 (57) 10 (53) 12 (75) 13 (50) 1 Diazepam injection 10 mg 52 (85) 19 (100) 16 (100) 17 (65) 2 Efavirenz capsule 50 mg 9 (15) 9 (47) 0-2 c Efavirenz oral liquid 150 mg/5 ml 1 (2) 1 (5) 0-2 c Erythromycin oral liquid 125 mg/5 ml 29 (48) 8 (42) 10 (63) 11 (42) 1 Ferrous oral liquid 24 (39) 4 (21) 10 (63) 10 (39) 1 Lamivudine 30 mg + Nevirapine 50 mg +Zidovudine 60 mg tablet 9 (15) 8 (42) 1 (6) - 2 c Lamivudine oral solution 10 mg/ml 3 (5) 3 (19) 0-2 c Mebendazole tablet 100 mg 57 (93) 17 (90) 15 (94) 25 (96) 1 Nevirapine oral liquid 50 mg/5 ml 16 (26) 10 (53) 6 (38) - 2 c Nevirapine tablet 200 mg 16 (26) 10 (53) 6 (38) - 2 c Nystatin drops 19 (31) 9 (47) 6 (38) 4 (15) 1 Oral rehydration salts (for 1,000 ml solution) 60 (98) 19 (100) 16 (100) 25 (96) 1 Paracetamol syrup 120 mg/5 ml 28 (46) 6 (32) 11 (69) 11 (42) 1 Phenytoin tablet 100 mg 27 (44) 17 (90) 3 (19) 7 (27) 2 Prednisolone tablet 5 mg 42 (69) 18 (95) 13 (81) 11 (42) 2 Quinine Injection 300 mg/ml 2 ml 57 (93) 19 (100) 14 (88) 24 (92) 1 Rifampicin 60 mg + Isoniazid 30 mg 8 (13) 8 (42) 0-2 c Rifampicin 60 mg+ Isoniazid 30 mg + Pyrazinamide 150 mg 14 (23) 12 (63) 2 (13) - 2 c Salbutamol inhaler 17 (28) 13 (68) 2 (13) 2 (8) 2 Tetracycline eye ointment 1% 56 (92) 18 (95) 16 (100) 22 (85) 1 Vitamin A capsule 100,000 IU 38 (62) 9 (47) 12 (75) 17 (65) 1 Zidovudine capsule 100 mg 5 (8) 5 (26) 0-2 c Zidovudine oral liquid 10 mg/ml 7 (12) 6 (32) 1 (6) - 2 c Zinc tablet 20 mg 19 (31) 12 (63) 4 (25) 3 (12) 1 * The percentage represents all facilities that gave a response on a particular item, rather than all facilities visited. ** Level of use represents the lowest level of use where the medicine is expected to be distributed, prescribed and dispensed according to the Uganda Clinical Guidelines 2010 (MOH, 2010) although this is not explicitly stated for HIV management. Level 1 corresponds with dispensary and level 2 with health centre. c ARV or TB paediatric formulations. EPN From the Shelf Series Ecumenical Pharmaceutical Network

4 In general, hospitals had higher availability than health centres or dispensaries except for cotrimoxazole syrup, erythromycin syrup, paracetamol syrup, ferrous oral liquid and vitamin A capsules. Children s medicines that were barely available included fluconazole capsule 50 mg, salbutamol syrup 2 mg/5 ml (3%) and chlorpheniramine syrup 2 mg/5 ml (1%). All these medicines were expected at the health centre level with the exception of chlorpheniramine syrup which is expected right from the primary (dispensary) level. Paediatric ARVs and TB medicines had very low availability (0% to 26%). A high majority of facilities (83%) reported not stocking ARVs or TB medicines even though they were expected from the health centre level. Only nevirapine and RHZ (rifampicin, isoniazid and pyrazinamide combination) tablets had >50% availability at the hospital level. Time out of stock for children s medicines Six medicines were out of stock in at least 20% of the facilities on the day of the survey. The medicines were Artemether Lumefantrine, amoxicillin, erythromycin syrup, nystatin drops, cotrimoxazole oral liquid and paracetamol syrup. Artemether Lumefantrine was most often out of stock (25 facilities) and had the longest mean stock-out duration (199 days). Fig 3: No of facilities with a stock-out of selected formulations Paracetamol syrup Cotrimoxazole oral liquid Nystatin drops Erythromycin syrup Amoxicillin oral liquid Artemether/Lumefantr Adults medicines availability comparison Availability of adult formulations was consistently better than those for children across all levels of care and medicines surveyed. Notably, adult formulations were at least twice as readily available as paediatric ones for ferrous tablets, ceftriaxone injection and salbutamol tablets. However, adult formulations of ceftriaxone, nystatin and fluconazole, whose paediatric formulations were also not readily available, had low availability overall (no more than 55%). Cost of children s medicines The use of flat fees as well as the provision of children s medicines free of charge was investigated. Medicines were considered as being offered at a flat fee both if flat fees were charged for the entire patient visit or for the medicines specifically. Vitamin A was provided free of charge by 82% of the facilities that stocked it. Mebendazole tablets, ORS and Zinc tablets were offered free or at a flat fee by at least 40% of the facilities that stocked them. Artemether Lumefantrine was only offered free or at a flat fee by less than 25% of the facilities that stocked it. Fig 4: Pricing policies for selected children s medicines Cotrimoxazole syrup Paracetamol syrup Tetracycline eye oint Ferrous oral liquid Diazepam inj Phenytoin tab Artemether/Lumef. tab Mebendazole tab Zinc sulphate tab ORS Vitamin A cap Cost plus Free Prednisolone tab Amoxicillin syrup Flat fee X pen inj Quinine inj 0% 50% 100% DISCUSSION AND RECOMMENDATIONS This study is the first significant attempt to collect data on the availability of children s medicines in church health facilities in Uganda. A previous study (Robertson et al., 2009) focused on the availability of children s medicines in 14 African capitals, Kampala, Uganda included. Uganda has a vibrant churchsupported health sector with 530 facilities operating under the oversight of Uganda Protestant Medical 4 Ecumenical Pharmaceutical Network 2011 EPN From the Shelf Series

5 Bureau and Uganda Catholic Medical Bureau (UCMB, 2010). Any improvements in the availability of children s medicines in this sector are therefore likely to positively affect national health targets, particularly MDG 4. Medicine selection A committee was responsible for selection of medicines in only one-third of the facilities. Moreover, most facilities (90%) used neither checklists nor standard operating procedures to guide medicine selection. Management Sciences for Health (MSH) recommend that a participatory multidisciplinary team takes responsibility for medicine selection at a health facility (MSH, 2009). This factor ties in to the fact that qualified staff are required and proper protocols that are clearly defined are needed to ensure proper selection and procurement. It is notable that children s formulations are generally more costly than their adult formulations and it is likely that they may more easily be dropped off a purchase order with a view to use adult formulations as a substitute. Unfortunately in the course of use, adverse outcomes for children arising from sub therapeutic doses or overdosing may arise. Medicine sources and procurement The use of consumption data as the primary basis for determining order quantities is disadvantageous in that situations of insufficient supply are perpetuated. However, consumption methods are often the easiest to use especially where human resources are limited. Most of the facilities surveyed didn t consider donations as an important source of medicine. This explains why the fee payments levied at the point of delivery are the most important source of funding for medicine. The revenue from the fees or from the sale of medicines is used to generate or as a minimum supplement the income of these facilities. It would appear that there is room for the government to increase subsidies and support for the church health facilities for medicine supply because when the facilities buy medicines with their own resources, all the costs are transferred to the patients. Overall Children s medicine availability The overall availability of children s medicines was was quite low at 43%. Out of the 22 medicines in the study, only 6 had an overall availability of >70 % at the HC II and HC III levels. Medicines with very poor availability and no substitute formulations included zinc dispersible tablets 20 mgs, ferrous oral liquid and salbutamol (syrup and inhaler). Some facilities were found to have stocking policies that excluded vital medicines such as quinine injection, Artemether Lumefantrine (AL) tablets, tetracycline eye ointment, ORS and Vitamin A capsules. These medicines are fundamental for the achievement of particularly MDG 4 that seeks to reduce child mortality (UNDP 2010). Malaria and diarrheal diseases are the leading causes of death in children under five years in Uganda. Therefore medicines like AL and ORS should be readily available at all levels of health care including at the household. Much of the low availability of these medicines could be attributed to these non-stocking policies. The study found lower than expected average overall availability (56%) of Artemether Lumefantrine, an important anti-malarial medicine. The shortage could be attributed to dependence on a single supply source. Most of the AL for government and faithbased health facilities is provided under a Global Fund grant through a centralised procurement and supply system. The medicine is also supposed to be provided free of charge. Therefore if the system fails, a large number of facilities would be affected and yet they are not able to invest their own money to buy their own stocks since the medicine has to be provided free. Critical medicines were reported out of stock for prolonged periods up to one year or more in a few cases. This is alarming. According to the government of Uganda, the right to health is a must for every Ugandan (National Health Policy), however this right cannot be guaranteed without access to medicines for the common diseases that affect the population. The problem of stock-outs in Uganda has been documented in other studies with the Ministry of Health reporting on one occasion that only 28% of health facilities on average had constant supply of medicines throughout the year (MOH 2008b). The reasons for failure to guarantee continuous availability are often multifaceted and may keep changing over time. One of the dimensions that this study revealed was the choice that some health facilities make not to stock certain medicines even the first line treatment for malaria which is endemic in Uganda. It is possible that some of the unusually long stock-out periods there is an unspoken decision not to stock the medicine. EPN From the Shelf Series Ecumenical Pharmaceutical Network

6 Pricing and financing Pricing and financing of medicines is a controversial subject (Rannan-Eliya, 2009). Prices must be low in order to ensure that the poor and vulnerable are not disadvantaged but at the same time church health facilities need to be able to generate the resources they need to survive and continue to provide the care that is so desperately needed. Efforts have been made in the past to build the capacity of church health facilities to do proper costing of their services and have a logical approach to the way patient fees are determined. It is important that such efforts continue especially if social health insurance becomes a reality and government subventions for any reason become unreliable. CONCLUSION It appears that a mix of policies and strategies need to be adopted to make medicines for children more available in Uganda. Although further investigation is required to obtain a more in-depth understanding of the availability and the factors that lead to poor availability of medicines, the results of this survey highlight areas that could be prioritized for quick wins in the effort to reduce child morbidity and mortality. ACKNOWLEDGEMENTS EPN wishes to express appreciation to the following people: Mr Emmanuel Higenyi who managed and coordinated all research activities; the Uganda Catholic and the Uganda Protestant Medical Bureau for supporting the study; Joint Medical Store for overseeing and supporting this study; all the health professionals and health facility staff who participated in this study; Ms Aidah Nanziri, Mr Samuel Bandobera and Mr Valentine Bayogera who were responsible for data collection; Ms Mary Muthama and Dr Francis Wafula who assisted with data analysis; the technical team who developed the tools: Dr Eva Ombaka, Dr Jane Masiga, Dr Regina Mbindyo, Dr Chris Ouma and Dr Joseph Mukoko; Dr Sue Hill of WHO for technical support on the project concept; Ms Annelies den Boer of Wemos for technical support; and ICCO and Kerk in Actie, Netherlands for providing the financial resources for the study. REFERENCES The Global Fund 2011 Roll Back Malaria Program Retrieved from: Management Sciences for Health and World Health Organisation Managing drug supply: the selection, procurement and use of pharmaceuticals. 2d ed. West Hartford, CT: Kumarian Press, Inc. Ministry of Health Uganda Clinical Guidelines Republic of Uganda. Kampala, Uganda. Ministry of Health Uganda Essential Medicines List Republic of Uganda. Kampala, Uganda Ministry of Health. 2008b. Health Sector strategic plan 2005/ /10, mid term review. Kampala, Uganda. Ministry of Health Pharmaceutical Situation Assessment level II. Kampala, Uganda. Rannan-Eliya, P Strengthening Health Financing in partner developing countries. Available Kavuma, R. M Uganda healthcare system explained. Retrieved from: Robertson, J. et al What essential medicines for children are on the shelf? Bull World Health Organ, 87, Sixtieth World Health Assembly Resolution WHA Better medicines for children. Retrieved from: en.pdf Management Sciences for Health Building teams: An Overview. Retrieved from: United Nations Development Program Assessing progress in Africa toward the Millennium Development Goals. New York, NY: Author. Retrieved from World Health Organisation WHO model list of essential medicines for children, 2nd list. Geneva, Switzerland. Retrieved from: http // World Health Organisation and Health Action International Medicine Prices. A new approach to measurement. Retrieved from: pdf To learn more about the EPN From the Shelf Series or this study, contact: Donna Kusemererwa Ecumenical Pharmaceutical Network P.O. Box Nairobi, Kenya Tel: Fax: info@epnetwork.org 6 Ecumenical Pharmaceutical Network 2011 EPN From the Shelf Series

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