THE VALUE CHAIN. The new 2016 Uganda Clinical Guidelines and Essential Medicines and Health Supplies List. In this issue

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1 ISSUE 7, MARCH 2017 MINISTRY OF HEALTH PHARMACY DIVISION NEWSLETTER THE VALUE CHAIN ISSUE 7, MARCH 2017 MINISTRY OF HEALTH PHARMACY DIVISION NEWSLETTER Welcome to the 7th issue of the VALUE CHAIN, a publication of the Pharmacy Division. You will find news and information from activities and events being implemented by the Pharmacy Division and partners to improve medicines management in Uganda. For comments or to contribute to the next issue, please contact uhsc@uhsc.ug. In this issue New 2016 UCG and EMHSL The new 2016 Uganda Clinical Guidelines and Essential Medicines and Health Supplies List Improving safety through NDA s GDP Malaria test and treat has improved as a result of SPARS USAID zero tolerance to fraud Video as a training tool in supportive supervision New pediatric TB medicines formulations Shorter Multi-drug resistant TB Turning in the tide in medicines management Moving to evidence based decision making Does quality of supervision impact medicine management improvement in health facilities? Introducing Implanon NXT The Essential Medicines and Health Supplies List for Uganda 2016 and Uganda Clinical Guidelines Medicine is a fast evolving field: new diseases and treatments emerge and new priorities and strategies are developed at national and international level. Accordingly, the Ministry of Health (MoH) periodically updates the Uganda Clinical Guidelines (UCG) to provide health professionals in Uganda with current recommendations on how best to manage the most common health conditions in Uganda. The guidelines are distillation of scientific evidence, cost evaluation and practical considerations to help health workers achieve the best outcome for patients and the most cost-effective use of the limited resources available. Based on the UCG, the national Essential Medicine and Health Supplies List of Uganda (EMHSLU) is also updated to guide the selection and procurement of appropriate medicines and health supplies. The 2016 UCG and EMHSLU incorporates current recommendations on HIV, TB and Malaria treatment, integrated community case management for child health and non-communicable diseases, among other areas. In updating the manuals, the MoH Clinical Services Department obtained input from 32 specialists from different therapeutic areas. Their recommendations were discussed in a four-day meeting with 120 participants from academic institutions, MoH technical programs, the National Drugs Authority, World Health Organization, National Medical Stores, health facility staff from different levels of care, and some development partners. After a final round of consultation within the Ministry of Health programs and district health representatives, the 2016 UCG and EMHSLU is now being printed for distribution in the near future. For the first time, the manuals were designed based on suggestions from health workers on how to make the presentation and flow of information more user friendly and easy to consult. These important tools if used well, can contribute to the improvement of health care in Uganda.

2 ISSUE 7, MARCH 2017 MINISTRY OF HEALTH PHARMACY DIVISION NEWSLETTER 2 Editorial Morries Seru, Assistant Commissioner, Pharmacy Division. Dear Reader, The Ministry of Health, with support from various implementing partners, is implementing the national Supervision Performance Assessment and Recognition strategy (SPARS) to improve medicines management in all 116 districts. Medicines Management Supervisors (MMS) have received intensive training, motorbikes, computers, annual motorbike repair, services, tires, and air time as well as remuneration to facilitate regular supervision visits to health facilities in their district. Birna Trap, Chief of Party, Uganda Health Supply Chain Program. SPARS has proven to be a very effective strategy in building capacity in medicines management. However, improvements in facility performance are directly linked to the will of the facility staff and the in-charge to make the changes needed but also how often and how thoroughly MMS conduct their supervisory visits. Last year, about 400 MMS made an average of only about one visit per month namely 15 SPARS facility visits/year, ranging from just 1-67 visits. The time between SPARS visits to a facility also varied greatly, from less than 1 month to 4.5 years. The varied performance translates into a high cost of SPARS implementation as fixed repairs and maintenance costs are the same regardless of the number or quality of visits conducted. To address this issue, the Ministry of Health, Pharmacy Department will rigorously monitor MMS performance and Dear Reader, Five years after being introduced, only 50% of higher level and 30% of lower level health facilities are routinely and correctly filing in the stock book (HMIS #083). Why is it important that all facilities use the stock book? When the stock book is used correctly: You will always know what items are in stock, which report to District Health Officers on the performance of each MMS. Subsequent facilitation and rewards will be based on performance of individual MMS. Poor performing MMS will no longer be supported. To further strengthen SPARS we have introduced, Peer Strategy. This strategy is implemented by MOH, Regional Pharmacists, Pharmacy focal persons on the Regional performance Monitoring team and District Health Officers. Peer strategy is aimed at validating SPARS and highlighting challenges that are not reported in SPARS to relevant authorities for action to be taken. We hope that these steps will encourage all District Health Officers to take charge of SPARS implementation so that health facilities receive the full benefits of this important program that has proved to make a huge difference when well implemented. ones are out of stock and for how many days. You can easily calculate the current average monthly consumption of each item. With the average monthly consumption, you will know how many days or months the stock available will last. You will be able to accurately prepare your next order and annual procurement. Together, let us make sure that 2017 is the year that 100% of health facilities correctly fill and use their stock books. You can make the difference if your facility is not yet using the stock book, begin today! A filled out sample stock book page.

3 ISSUE 7, MARCH 2017 MINISTRY OF HEALTH PHARMACY DIVISION NEWSLETTER 3 Improving patient safety through NDA s good distribution practice guidelines By Brian Sekayombya A model warehousing arrangement. The public will soon benefit from the stronger quality assurance regulations being put in place by the National Drug Authority (NDA). Weak licensing standards have allowed pharmaceutical wholesalers in Uganda to operate without proper documentation systems, uncontrolled supply lines and poor storage and transportation conditions which can affect not only the safety and efficacy of pharmaceutical products, but also compromises patient treatment outcomes. In 2016, NDA finalized the development of Good Distribution Practice (GDP) guidelines based on World Health Organization standards to strengthen regulatory oversight over Uganda s pharmaceutical product distribution chain. The new guidelines require wholesalers to have well documented quality assurance processes and procedures to control their supply chain from source to end users in order to maintain a quality product. The improved traceability of products from the source of supply to the end user will enable NDA to implement product recalls when needed. The GDP guidelines also stipulate that only licensed wholesalers will only be able to sell to pharmacy retailers and retailers only buy from licensed wholesalers. In rolling-out the GDP guidelines, NDA conducted country wide consultative and training meetings with 299 wholesalers and distributors in the Ugandan market to jointly develop a road map for implementing by January 2017, the start of the annual licensing period. Wholesalers welcomed the stronger regulations. As one participant said, it is high time that normalcy returns to the private pharmaceutical sector. The onus is on NDA to ensure that GDP happens. NDA please take the lead. NDA and the wholesalers agreed that because of the costs involved in implementing all the standards and regulations, the GDP guidelines will be Malaria test and treat has improved as a result of SPARS By Jimmy Opoka and Denis Okidi Malaria remains the leading cause of morbidity in Uganda contributing to 43% of mortality in children under 5 years due to poor diagnosis and treatment. In 2010 just 20% of malaria cases were treated in accordance to standard treatment guidelines. As part of addressing this challenge, the Ministry of Health in 2011 adopted the multipronged Supervision, Performance Assessment and Recognition Strategy (SPARS) to improve health worker capacity in medicines management. Over the last five years, the SPARS intervention has positively impacted on appropriate treatment of single diagnosed malaria. Malaria testing has improved by 51% (p<0.001), appropriate treatment improved at all levels of care by 42% (p<0.001) and use of antibiotics in malaria treatment reduced by 63% (p<0.001). SPARS has proven effective in strengthening test and treatment in malaria cases at all health facility levels and with the new revised SPARS form, medicines management supervisors will now improve linking tests results to treatment. implemented in a phased approach over three years with all wholesalers being GDP-compliant by licensing year Wholesalers requested that NDA: Enforce compliance to GDP guidelines uniformly across all wholesalers Have further consultations before implementing the transportation standards Set-up a help desk at NDA to provide wholesalers with technical support in areas such as developing standard operating procedures and quality assurance manuals. As NDA our mission is to ensure access to quality, safe and efficacious human and veterinary medicines and other health care products through the regulation and control of their production, importation, distribution and sale. GDP fits very well into the mission of NDA and we shall ensure that GDP is implemented by all wholesalers in the country. ~Senior Inspector, NDA~

4 ISSUE 7, MARCH 2017 MINISTRY OF HEALTH PHARMACY DIVISION NEWSLETTER 4 Zero tolerance to fraud in USAID-funded programs By Narine Sorayan USAID, the US government agency in charge of distributing tax dollars to foreign aid projects, believes that every dollar counts and has zero tolerance for fraud, corruption and waste. USAID spends millions of dollars in implementation, coordination and management of the Supervision Performance Assessment and Recognition Strategy (SPARS) by district health teams to strengthen capacity for medicines management through the Uganda Health Supply Chain program (UHSC). Implementation of SPARS is done by district-based Medicines Management Supervisors (MMS) who are supposed to demonstrate ethical conduct and a commitment to compliance at all times. However, a recent MMS supervision visit audit conducted by UHSC detected fraudulent practices by two MMS in two different districts: they reported supervisory visits to four facilities that had not actually taken place. This malpractice greatly undermines the huge investments directed to development and touches on the good work of the majority of the MMS. The MoH Pharmacy Department sent letters to the two District Health Officers to reiterate that MoH and USAID have a zero tolerance policy to fraud and such a breach of trust by MMS would jeopardize future USAID support to the SPARS program and the health sector in general. The District Health Officers were requested to take appropriate preventive and corrective actions to address the incidents of SPARS supervision fraud in those two districts. The MoH approach to the prevention, detection and remediation of fraud is based on the following principles: Fraud and corruption seriously impact achievement of the goals of the UHSC and other donorfunded programs MMS are held to the highest ethical standards in their conduct and work It is the responsibility of the MoH as a whole and each individual MMS to help deter and prevent fraud. USAID support to the MoH and district health authorities is meant for health sector interventions to benefit the population. Serious misconduct such as fraud and concerns about professional integrity can have negative ramifications for future aid work in the country. Video as a training tool in supportive supervision By Richard Odoi A discussion group acting out a typical feedback support supervision meeting by a medicines management supervisor. An innovative new training course in Uganda is using videography to help Medicine Management Supervisors (MMS) learn and practice skills in communication, motivational interviewing and behavior change so that they can be more effective in improving health worker practices. The use of video as a training tool has been shown to be effective in improving self-awareness through selfobservation and behavior change through constructive feedback from peers. In designing the course the Makerere University College of Health Sciences Pharmacy Department training team first underwent one week of training on videography. They then produced several video vignettes (5-8 minutes long) of MMS interacting with health workers in facilities to demonstrate the ideal supportive supervision behaviors and practices in different areas such as effective communication skills, behavior change and problem identification. After viewing each vignette, participants were asked to act out what they learned. Three or four groups of participants each made a video which was then critiqued in a plenary session. The topics most liked by participants were effective communication skills and behavior change. The whole course is very interactive, very focused and participants are really engaged, says Richard Odoi. In the beginning the weaknesses in participant skills were very apparent but as they went through the training modules their skills built up. By the end of the one week course, the improvements were noticeable. To reinforce what the MMS learned in the course, Regional Pharmacists who were also trained on videography will in 2017 videotape MMS during their regular facility visits so that they can see and critique their performance.

5 ISSUE 7, MARCH 2017 MINISTRY OF HEALTH PHARMACY DIVISION NEWSLETTER 5 New pediatric TB medicines formulations By Victoria Nakiganda New pediatric TB medicine formulations are now available and being introduced in Uganda and other countries which will make it easier to achieve the optimum dosing for children. The new formulations, which are expected to arrive in Uganda in April 2017, will do away with the previous practice of crushing adult formulations which are unpalatable and make accurate dosing very difficult. The World Health Organization (WHO) revised the guidelines for drugsensitive TB treatment for children in 2010, recognizing that children need higher doses of the TB medicines than what they were receiving. There were, however, no companies producing products conforming to the new guidelines. In December 2015, TB Alliance, an international non-profit organization and its partners WHO and others with funding from UNITAID and USAID announced the global availability of quality-assured, affordable, childfriendly TB medicines in the correct internationally-recommended dosages to market. They are dispersible, palatable, simple to administer and affordable. The availability of correctly dosed medications will improve treatment for children everywhere. This is an important step toward ending the neglect that has characterized the care of children with TB for far too long, said TB Alliance President Dr. Mel Spigelman. The new medicines are fixed dose combinations (FDCs) that contain the proper doses for children of multiple drugs. They are available in a fruit flavor that is palatable for children. These medicines are not new treatments, but are improved formulations that are simple for providers and parents to administer and easy for children to take. No crushing or breaking is needed. They are made to dissolve in water in just a few seconds. For more information about the products, visit tballiance.org/child-friendlymedicines. TB Alliance is working with WHO, UNICEF, Management Sciences for Health and other organizations to encourage uptake in countries with Shorter Multi-drug resistant TB regimen high TB burdens. In Uganda, the MSH project Uganda Health Supply Chain is supporting the National TB and Leprosy Programme to ensure a smooth introduction of the new medicines with clear communication messages and job aids for health workers. One important message is that the current pediatric formulations (RHZ 60/30/150mg, RH 60/30mg, RHZ 75/50/150mg and RH 75/50mg) are still effective using the 2010 dosing guidelines and should not be wasted. Dosing chart of the new pediatric TB formulations Weight bands Intensive Phase RHZ (75/50/150mg) E (100mg) 4-7 kg kg kg kg kg and above Use adult dosages and formulations Continuation Phase Features of the shorter Multi drug resistant TB regimen RH (75/50mg) National TB & Leprosy programme Standard Operating procedures on how to use the new pediatric TB formulations. By Dr Frank Mugabe In May 2016, the World Health Organization updated its treatment guidelines for multidrug-resistant tuberculosis (MDR-TB) and included a recommendation on the use of the shorter MDR-TB regimen under specific conditions. Multi-drug resistant (MDR) tuberculosis is a growing public health crisis in many countries. In Uganda, 252 patients are currently being treated for MDR TB, a relatively small number. But the National TB and Leprosy Program (NTLP) estimates this will increase to more than 1,000 patients in the near future. The long treatment period 20 months presents a major burden on patients to adhere to the daily regimen, including the side effects of the medicines. The new WHO guidelines shortens the treatment period to less than 12 months for patients meeting certain criteria. The NTLP will begin using the shorter MDR TB regimen sometime in late The shorter regimen is already in use in 14 countries in Africa and Asia with promising results. The shorter regimen is expected to benefit majority of MDR-TB patients. However, the World Health Organization cautions that there are serious risks for worsening resistance if the regimen is used inappropriately for example in XDR-TB patients. Standardized shorter MDR-TB regimen with seven drugs and a treatment duration of 9-12 months Indicated conditionally in MDR-TB or rifampicin resistant-tb, regardless of patient age or HIV status Monitoring for effectiveness, harms and relapse will be needed, with patient-centered care and social support to enable adherence Programmatic use is feasible in most settings worldwide Lowered costs (<US$1,000 in drug costs/patient) and reduced patient loss expected Exclusion criteria: 2nd line drug resistance, extrapulmonary disease and pregnancy Exclusion criteria: 2nd line drug resistance, extrapulmonary disease and pregnancy World Health Organization May

6 ISSUE 7, MARCH 2017 MINISTRY OF HEALTH PHARMACY DIVISION NEWSLETTER 6 Turning the tide in medicines management: Pharmacist at Arua Regional Referral Hospital talks about how their work has changed Regional pharmacist Harriet Akello of Arua Regional Hospital in her well managed store. In 2011, Harriet Akello chose to leave her private sector job to take up the pharmacist position at Arua Regional Referral Hospital because she saw it as an opportunity to serve a much wider community. She was immediately faced, however, with the many challenges of working in a public hospital with limited resources. Instead of the two pharmacists and four dispensers that Arua Regional Referral Hospital is supposed to have, Harriet works with only two dispensers. The team puts in extra hours of work to meet patient needs and keep the systems running. Medicines management systems were imperfect. Quantification and ordering for essential medicines and health supplies was largely done irrationally, leading to regular stock outs and expiries. Everything from record keeping to preparing routine reports had to be done manually, she said. The area outside the pharmacy was always congested; patients stayed in the queue for hours to get medicines, yet sometimes ended up with nothing or less than what they required. The situation was not any better in the lower-level health facilities in the eight districts served by the hospital. There are 3.5 million people in need of my services, she said. Harriet and her team s duties include planning for the pharmacy department, quantifying pharmaceutical supplies, placing orders with the National Medical Stores, maintaining appropriate storage conditions, tracking the stock levels of the hospital s large inventory of supplies, and ensuring appropriate distribution to all hospital wards and dispensing units. She also provides regular reports to the Ministry of Health and carries out peer supportive supervision of other pharmacists and health workers who manage medicines in the hospital and the region. Harriet and her colleagues can now do their work much more efficiently and serve their patients better, thanks to support from the U.S Agency for International Development (USAID) through the Uganda Health Supply Chain (UHSC) program. UHSC is working in 79 districts to improve facility stores, computerize inventory management systems and upgrade staff knowledge and skills in medicines management. Arua Regional Referral Hospital now has ample space to properly organize supplies after receiving eight high quality shelves for their store. With training, new computer hardware and RxSolution electronic inventory management software, they are able to track stock levels, expiry dates and consumption of pharmaceutical supplies efficiently on their computers and can now generate information for ordering and reporting in minutes. We place our orders with the National Medical Stores two weeks earlier than the deadline date because the required information is available, she said. Although the situation at Arua Regional Referral Hospital is not perfect, Harriet is glad that it is not where it used to be. Do we still experience drug stock outs and late deliveries? Yes, occasionally. Do patients sometimes go away without medicine? Yes. What is important is that we are not the cause of the problem. We are doing our best. When people get the medicines they need, they are happy, and that makes me happy, she says. Moving to evidence-based decision making By Belinda Blick Belinda Blick, M & E Advisor at Pharmacy Department presenting on the facility stock status situation for Essential Medicines and Health Supplies 1. For those of us dealing with pharmaceutical sector data, one of our main issues is that many managers and program staff are not aware of the useful information they have at their fingertips. Or they know, but they don t use the information to enhance their work, says Belinda Blick, M&E Advisor at the Pharmacy Department. Decisions should be based on the evidence wherever possible, particularly when related to the supply of medicines and pharmaceutical services as they have important consequences for patients. Establishing a common understanding of the data available and how the information can be used to identify issues is the aim of the quarterly monitoring and evaluation health commodity meetings that the Pharmacy Department started in January, 2016.

7 ISSUE 7, MARCH 2017 MINISTRY OF HEALTH PHARMACY DIVISION NEWSLETTER 7 These meetings, the first of their kind, provide an important opportunity for people with different roles and responsibilities in supply chain management to review current data and trends, identify problems and discuss ways to address the issues and improve system performance. All the participants have some role in managing health commodity logistics data: program M&E specialists, logistics management specialists, central warehouse managers, regional pharmacists and district biostatisticians. Interest in the meetings rapidly grew and now the head of District Health Officers and Chief Administrative Officers are among the more than 60 regular participants. In the meetings, data from routine reports on the stock status of tracer medicines and health supplies and other supply chain performance indicators are presented, including the monthly HMIS 105 facility reports, SPARS supervision reports and the web-based ARV ordering system (WAOS). The data are broken down by program area (TB, HIV, family planning etc.), level of care, district and region. Results from special studies and information about new reporting tools and procedures that are relevant to the group are also shared. Following review of the data, participants break into groups to further discuss specific issues identified and develop activity plans to address problems in their work place whether it be a warehouse, program or district. Their experiences are then shared in the subsequent meeting. The head of District Health Officers, Dr. Ssesimba Badru, values these meetings because they are not just sharing information but building skills in using the available data, tools and resources. District health officers and biostatisticians are now better able to target their efforts and solve problems of medicines management in the districts. Does the quality of supervision impact medicine management improvement in health facilities? By Rachael Henry SPARS has proved to be very effective in improving medicines management in all health facilities. Although we have seen an average 65 percent improvement after five supervisory visits by a medicine management supervisor (MMS), the pace and degree of improvement varies considerably. Upon further examination of the facility data, it looked like some MMS were more effective than other MMS in having facilities improve. To explore this further, Uganda Health Supply Chain (UHSC) carried out a study to see how well supportive supervision is implemented by the MMS and explore the relationship between supportive supervision and quality improvement in facility SPARS score. Studies in other countries have highlighted the importance of supervisors applying supportive supervision rather than more traditional "police-like" supervision to improve service delivery. Supportive supervision involve the health workers in joint problem solving and open discussions, and are part of the team rather than an outside supervisor. The supervisor should provide training and constructive feedback and set targets to empower the supervisees to improve their standard of work. The supervisees should feel they have a valued voice that shapes decisions. In the study, 10 MMS were observed by trained researchers during a routine facility supervisory visit and their performance scored on eleven behaviors and skill categories critical for effective supportive supervision. We found that the MMS implemented supportive supervision poorly, with an average total score of only 40% (out of 100%). They were best in communication with a score of 54% and worst in continuing what had been discussed and agreed on the last visit. There was a striking difference between individual MMS. The highest individual MMS score was 77% and the lowest was 9%. The study also found that there was a ration between how well an MMS practices supportive supervision and how much the facility improved their medicines management or SPARS score at each visit. The better supportive supervision the better impact the SPARS visits would have. On the background of this study it was decided to develop a training course in supportive supervision for all MMS. The course was developed in collaboration with UHSC, Makerere University Department of Pharmacy and Harvard University. By the end of December 2016 all MMS should have been trained. Reference: Henry, R., Nantongo, L., Wagner, K.A., Embrey, M., Trap, B. (in press) Competency in supportive supervision: A study of public sector medicines management supervisors in Uganda. Journal of Pharmaceutical Policy and Practice. To access this article please send an to Sheila Mwebaze, smwebaze@uhsc.ug

8 Introducing Implanon NXT ISSUE 7, MARCH 2017 MINISTRY OF HEALTH PHARMACY DIVISION NEWSLETTER 8 By Dennis Buwembo Most family planning providers are familiar with the onerod three-year Implanon implant, a long-acting reversible contraception method. The manufacturer, Merck & Co, is replacing Implanon classic with Implanon NXT. Implanon NXT is a single-rod subdermal progestagen-only contraceptive (contains etonogestrel 68mg) implant that is inserted just under the skin of a woman's upper arm. It is different from Implanon classic in that it has a pre-loaded non-reusable applicator operable with one hand to help facilitate correct subdermal insertion. It is also radiopaque for identification on X-ray which will aid removal. Planning is underway at the Ministry of Health to enable a smooth transition to Implanon NXT effective in January, Implanon NXT will be phased in over a 6-9 month period to ensure that existing viable Implanon classic stocks are used up to avoid wastage and adequate time is given to training of health workers on the new product. Procurement agencies will synchronise procurement and delivery of Implanon NXT and supplies needed for health worker training (placebos and arm models). A Ministry of Health task team has conducted a rapid assessment of Implanon stock available at national and heath facility levels and is collaborating with implementing partners to map out consumption trends and the numbers of health workers already trained in implant insertion and removal. This information will guide the selection of geographical regions where the transition will be prioritized. District medicines management supervisors will be instrumental in monitoring the implementation of the plan and health facility stock levels throughout the transition period. The Pharmacy Division acknowledges support from District Health and Administrative Officers Health Laboratories, National Malaria Control Euro Health Group Programme and Reproductive Health programme) Implementing partners National Drug Authority Joint Medical Store Imperial Health Sciences Makerere University Uganda Medicines and Therapeutic Advisory Management Sciences for Health Committee Ministry of Health Resource Centre and Technical US Agency for International Development programs (AIDS Control Programme, National US Centre for Disease Control Tuberculosis and Leprosy programme, Central Public US President s Emergency Plan for AIDS Relief (PEPFAR) Ministry of Health Plot 6 Lourdel Road, Wandegeya P. O. Box 7272, Kampala, Uganda Tel: info@health.go.ug Website: Management Sciences for Health Plot 15, Princess Anne, Bugolobi P. O. Box 71419, Kampala, Uganda Tel: uhsc@uhsc.ug Website: This newsletter is made possible by the generous support of the American people through the President s Emergency Plan for AIDS Relief (PEPFAR) and the US Agency for International Development (USAID), under the terms of Cooperative Agreement number AID-617-A The contents are the responsibility of Management Sciences for Health and do not necessarily reflect the views of USAID or the US government.