Challenges in Changing Diarrhea Treatment Policy in Senegal

Challenges in Changing Diarrhea Treatment Policy in Senegal Michael Derosena February 2011 Strengthening Pharmaceutical Systems Center for Pharmaceutical Management Management Sciences for Health 4301 N. Fairfax Drive, Suite 400 Arlington, VA 22203 USA Phone: 703.524.6575 Fax: 703.524.7898 E-mail: sps@msh.org

Challenges in Changing Diarrhea Treatment Policy in Senegal This report is made possible by the generous support of the American people through the US Agency for International Development (USAID), under the terms of cooperative agreement number GHN-A-00-07-00002-00. The contents are the responsibility of Management Sciences for Health and do not necessarily reflect the views of USAID or the United States Government. About SPS The Strengthening Pharmaceutical Systems (SPS) Program strives to build capacity within developing countries to effectively manage all aspects of pharmaceutical systems and services. SPS focuses on improving governance in the pharmaceutical sector, strengthening pharmaceutical management systems and financing mechanisms, containing antimicrobial resistance, and enhancing access to and appropriate use of medicines. Recommended Citation This report may be reproduced if credit is given to SPS. Please use the following citation. Derosena, M. 2011. Challenges in Changing Diarrhea Treatment Policy in Senegal. Submitted to the US Agency for International Development by the Strengthening Pharmaceutical Systems (SPS) Program. Arlington, VA: Management Sciences for Health. Strengthening Pharmaceutical Systems Center for Pharmaceutical Management Management Sciences for Health 4301 North Fairfax Drive, Suite 400 Arlington, VA 22203 USA Telephone: 703.524.6575 Fax: 703.524.7898 E-mail: sps@msh.org Web: www.msh.org/sps ii

TABLE OF CONTENTS Acronyms and Abbreviations... iv Background... 1 Key Issues in Implementing the New Policy... 3 Zinc Pilot Committee... 3 Change of Policy and its Directives... 3 Technical Documents and Materials... 3 Training of Personnel... 3 Procurement Process and Availability of Zinc... 4 Leadership and Governance Issues... 4 Partners Coordination... 5 Achievements... 6 Zinc Pilot Committee... 6 Change of Policy and its Directives... 6 Technical Documents and Materials... 6 Training of Personnel... 7 Procurement Process and Availability of Zinc... 7 Leadership and Governance Issues... 7 Partners Coordination... 8 Challenges... 9 Conclusion... 11 Annex A. Zinc Status 2010... 12 iii

ACRONYMS AND ABBREVIATIONS DANSE DPL EDL IMCI MCH MI MOH ORS PNA SPS UNICEF WHO ZPC la Division de l alimentation, de la Nutrition et de la Survie de l enfant Directorate of Pharmacy and Laboratories Essential Drug List Integrated Management of Childhood Illness Maternal and child health Micronutrients International Ministry of Health Oral rehydration salts (solution) Pharmacie Nationale d approvisionnement (Central Medical Stores) Strengthening Pharmaceutical Systems [Program] United Nation s Children s Fund World Health Organization Zinc Pilot Committee iv

BACKGROUND With the adoption of the World Health Organization s (WHO)/United Nations Children s Fund s (UNICEF) recommendations to treat diarrhea with zinc salts and low-osmolarity oral rehydration solution (ORS), 1,2 Senegal has redirected its efforts to address the high morbidity and mortality rates due to diarrheal diseases among the country s children. Several studies show that during 2003 2006, diarrhea was consistently in the fourth position among the top five diseases affecting children. Looking at the mortality rate, diarrhea jumped from fifth place in 2003 to second place in 2006. This change was probably due to the limited use of ORS because only between 15 and 20 percent of cases seen in health facilities were prescribed the recommended ORS. 3 For the same period, it was noted that an average of 67 percent of cases were seen in the case de santé (health huts) at community level, but only 14 percent of mothers were prescribed ORS to treat children s diarrhea. 4 Generally, antibiotics and nonessential medicines were used to treat diarrhea. 5 In 2007, the Senegalese Ministry of Health (MOH) opted for the new ORS formulation and zinc dispersible tablets on the basis of scientific evidence and the WHO/UNICEF recommendations. Before introducing zinc in Senegal, MOH, through the Division de l Alimentation, de la Nutrition et de la Survie de l Enfant (DANSE), created the Zinc Pilot Committee (ZPC) which was mandated to define MOH s vision and identify and support activities to provide a smooth introduction of the recommended products. The ZPC decided that a situational analysis would provide updated information on the status of diarrhea cases and treatment in the country; the assessment would also provide guidance in setting up a step-by-step management approach to make sure that the use of zinc for treatment of diarrhea was quickly made available and acceptable. In June 2008, the Strengthening Pharmaceutical Systems (SPS) Program joined with UNICEF in supporting the analysis. In the meantime, UNICEF provided 500,000 dispersible zinc tablets and 100,000 ORS packs to the coordination unit of the US Agency for International Development (USAID)-funded community health project (Christian Children s Fund [CCF]) in the Thiès health district to begin implementing the new policy. The Central Medical Stores (PNA [Pharmacie Nationale d Approvisionnement]) of Senegal has been mandated to make essential pharmaceuticals available for public health facilities nationwide. Two suppliers were selected by PNA to procure 750,000 and 250,000 packs, respectively, of low-osmolarity ORS that have been available in Senegal since 2008. PNA was also contacted by DANSE to get the zinc needed for the new policy. However, no supplier had 1 World Health Organization and United Nations Children s Fund. 2004. Clinical Management of Acute Diarrhoea (WHO/FCH/CAH/04.07). Geneva & New York: 2004. 2 Jones, G., R. W. et al. 2003. How Many Child Deaths Can We Prevent This Year? Lancet 362: 65-71. 3 Ministère de la Santé et de la Prévention Médicale/Division de l alimentation de la Nutrition et Survie de l Enfant. 2008. Analyse situationnelle pour l introduction des nouvelles directives (SRO-Zinc) dans la prise en charge de la diarrhée au Sénégal: Rapport Final. Université Cheikh Anta Diop de Dakar, Groupe Institut de Pédiatrie Sociale et Institut de Population et de la Santé de la reproduction. 4 Idem 5 Briggs, J., M. Gabra., and P. Ickx. 2002. Senegal Assessment Drug Management for Childhood Illness, Arlington, VA: Management Sciences for Health. 1

Challenges in Changing Diarrhea Treatment Policy in Senegal shown interest in bidding for the 5,000,000 tablets estimated by PNA to be needed in the country. The quantities of ORS and zinc estimated by PNA were not based on any rational quantification. However, in the past, PNA had not experienced large shortages of ORS with the exception of a gap that occurred during the transition period when a stock of old ORS formulation was destroyed before the new low-osmolarity ORS formulation arrived in country. Also, it was noted that MOH and DANSE did not opt for a phased introduction process of the new ORS and zinc, which generated some problems in the implementation process of the policy. As zinc is a new product in the country, there are no figures on which to base consumption (or what is needed) at PNA, regional depots, and health facilities. The point of evaluating the introduction of zinc in the pilot districts was to provide guidance to MOH for the expansion of the new policy. However, this evaluation was not performed before the zinc actually arrived. MOH/DANSE relied on external assistance at all stages of the implementation process, from the change of policy to the delivery of zinc to the health districts. UNICEF support and SPS s technical assistance were critical to DANSE in its operations. Now that the SPS program is closing out, it is expected that DANSE will have to take full responsibility for managing ORS and zinc. 2

KEY ISSUES IN IMPLEMENTING THE NEW POLICY Zinc Pilot Committee Built on the efforts of the previous Integrated Management of Childhood Illness (IMCI) pilot committee, the ZPCdid not initially follow through with its responsibilities following the preliminary discussions for the preparation of the situational analysis. The first meeting of the ZPC took place in August 2007 and the second meeting did not occur until April 2009. Taking into account the ZPC s mandate, this long period of inaction impeded the policy s implementation. (The ZPC is composed of MOH/DANSE, MOH/Lutte contre la Maladie, MOH/Directorate of Pharmacy and Laboratories (DPL), PNA, Helen Keller International, Micronutrients International (MI), IntraHealth International, WHO, UNICEF, CCF, AFRICARE, and the Population Development and Reproductive Health Institute.) Change of Policy and its Directives Although MOH/DANSE quickly adopted the new treatment regimen as official policy in 2007, it was too slow to take action to support its rapid implementation. DANSE did not officially notify the regions of the policy change until 2009, which meant that no information on the new treatment policy was disseminated to the district and health facility personnel until then. As a result, district and health facility personnel were not familiar with the new medicines or their use. Technical Documents and Materials With support from partners, the IMCI materials were reviewed to incorporate the changes in the management of diarrhea in early childhood. This included changes to the Livret des Tableaux, the main training package on IMCI for health workers. Because low-osmolarity ORS and zinc are new products in Senegal, the National Regulatory Authority (Direction de la Pharmacie et du Laboratoire) received financial and technical assistance from WHO to update the last version of the national essential drug list (EDL) printed in 2006. However, upon review, SPS identified several important technical errors in the document including an error that listed the zinc and low-osmolarity ORS as one product instead of two separate products. SPS worked with WHO and DANSE to make the appropriate changes to the document and have a final revised copy available. This assistance included the editing and dissemination of the updated EDL. Training of Personnel Per the MOH/DANSE workplan for 2008-2010, some training for service providers in different regions for either refresher courses or basic training in IMCI did occur during 2008, although most of the training sessions took place in 2009 and 2010. Post-training activities, including 3

Challenges in Changing Diarrhea Treatment Policy in Senegal planned supervision visits, scheduled since 2008, did not occur as planned though they remained on the training schedule in 2009 and 2010. With regard to the new policy for diarrhea treatment, central and regional staff did receive appropriate orientation on the new guidelines. The regional staff was also required to have an orientation plan for service providers and care givers in each health district. However, this did not occur as planned and the orientation of providers has not extended beyond the original pilot zones. Procurement Process and Availability of Zinc Procuring zinc through the national pharmaceutical supply system was the key obstacle in the national scale-up of the implementation of the new policy. The procurement specifications prepared by the PNA were for zinc capsules whereas the presentation recommended by WHO is dispersible tablets. This mistake originated with DANSE, which asked the PNA to procure 3,000,000 capsules instead of the dispersible tablets and did not realize that there was a difference between the two formulations. As a result of this error, no reliable suppliers responded when the tender was launched in 2007. In late 2008, one Indian manufacturer, who had no previous experience manufacturing medicines, responded and was awarded the tender. Leadership and Governance Issues Leadership and governance continue to be key issues for DANSE and PNA. DANSE has been dealing with an overload of work in a difficult environment because of the lack of human resources for IMCI development in the country. Created under DANSE leadership, the ZPC was non-functional until SPS took the responsibility to revive the committee and take the lead in its operations. With regard to human resources, SPS met with the WHO child health officer who confirmed that the organization was looking for assistance from WHO/AFRO to reinforce human capacity at DANSE, but it was unlikely that DANSE would receive long-term support. For the evaluation of the zinc introduction in the pilot districts, it was agreed that the first results of the implementation process would be available at the end of July 2008 and that a final evaluation would take place in March 2009. However, nothing was done until July 2010. PNA also was a source of concern particularly with respect to the tender for the zinc capsules. Once the error in the specification for the zinc was identified by SPS in early 2009, a request was made to the PNA to cancel the order because it was the wrong product and because the manufacturer was already late in fulfilling the order as per to the requirements of the tender. Notwithstanding discussions and pressure from SPS and other partners to cancel the order, PNA went ahead with procuring the product from the supplier. In fact, PNA received 2,000,000 out of 3,000,000 zinc capsules more than one year after the due date of delivery in the original contract from the supplier whose noncompliance with the terms of the tender award had already provided them with a legal basis to cancel the contract. In addition, when the capsules entered Senegal, 300,000 were distributed by PNA to the regional depots against all recommendations and without informing DANSE, the ZPC, and other partners of the product s arrival. Through its activities of tracking ORS and zinc at the district level, SPS discovered that the zinc capsules 4

Key Issues in Implementing the New Policy were in fact distributed to the regional depots; some boxes had already been sold to a number of health facilities. Partners Coordination Numerous partners have been involved in IMCI activities in Senegal WHO; UNICEF; the Basic Support for Institutionalizing Child Survival project, which terminated its operations in 2009; the consortium of nongovernmental organizations supported by USAID which includes CCF (later changed to Child Fund/Senegal), AFRICARE, Plan/Senegal, World Vision, Counterpart International, and Catholic Relief Services; the Micronutrient Initiative project; and Helen Keller International. In spite of the fact that these partners are key members of the ZPC and assist DANSE in its interventions, each organization is more inclined to give priority to its own work and not necessarily work together in a coordinated way. 5

ACHIEVEMENTS Zinc Pilot Committee For the past eight to nine years, technical assistance to the child health programs in Senegal was provided first through RPM Plus and then through SPS; this assistance primarily supported the Syndicate of Private Pharmacists of Senegal to develop a solid private-public partnership to reinforce and promote IMCI activities. Beginning in 2009, in the light of persistent difficulties faced by DANSE in trying to implement the new diarrhea treatment policy and because of budget constraints, SPS technical assistance focused on providing support to MOH/DANSE to identify and address the bottlenecks in the introduction of zinc and improve IMCI drug management in general. The first step SPS took in trying to improve the implementation of the new policy was to take the lead in encouraging the revitalization of the ZPC. As a result of these efforts, the ZPC begun to meet regularly once again and conducted five meetings between September 2009 and March 2010. SPS participated in these meetings and worked closely with the ZPC to identify solutions to address the various issues that affected implementation of the new diarrhea treatment policy. In particular, SPS was interested in obtaining the assistance of the ZPC to address the issues related to the procurement of the zinc salts through the PNA that were discussed earlier. SPS also brought the issue of the evaluation of the pilot phase of the zinc introduction to the attention of the ZPC; this had not been done and was an important component of the efforts to move forward on the scale-up of the new policy. Change of Policy and its Directives SPS worked closely with UNICEF and the ZPC to encourage and facilitate DANSE s efforts to disseminate the new policy documents and directives to health personnel and to the public in general. SPS provided direct support for the preparation of the policy document and directives, including the printing and distribution of 1,000 copies of the documents to the staff at the central and regional levels. SPS also worked with DANSE to identify other sources of support for printing and distribution of additional copies of the documents needed. SPS also worked with DANSE to notify the regional staff on the issues that arose from having the unapproved zinc capsules in the regional depots and some health facilities. Technical Documents and Materials In coordination with UNICEF and WHO, SPS worked with DANSE to ensure the updating and availability of the technical documents and materials needed to support its interventions and to develop and implement appropriate tools for building skills and improving practices in IMCI medicine management (storage, inventory management, estimating requirements and purchasing, and dispensing). SPS provided direct support for the preparation, approval, and printing of 500 copies of the revised national EDL that incorporated the new ORS formulation and the 6

Achievements recommended zinc tablet and also updated the information on the artemisinin-based combination treatment for malaria. The program also worked with the DPL on distributing the EDL to the regional teams and also helped the DPL identify potential sources of funds for printing additional copies if needed. Training of Personnel To support implementation of the new policy, SPS worked with DANSE in revising and fieldtesting the IMCI materials, namely, the Livret des Tableaux module that is used for training service providers. The SPS program also assisted in editing and formatting the final versions of these materials and supported DANSE in identifying alternative sources for printing. WHO and the MI project in particular were able and willing to help in the printing of these materials. Procurement Process and Availability of Zinc SPS met several times with the PNA staff to explain the WHO recommendations on the presentation of zinc. The program provided PNA with a list of credible suppliers capable of procuring zinc tablets and offered its assistance in the procurement process. SPS met individually with the key stakeholders to point out the issue of the zinc capsules now present in the regional depots and having DANSE work with PNA to withdraw the capsules delivered. In the meantime, the SPS program worked extensively with UNICEF to support a new procurement while PNA was preparing its regular order for essential medicines that would include zinc tablets. In the absence of historical consumption data, the SPS program referred to the diarrhea morbidity profile to assist in quantification of an emergency order of zinc tablets to be procured by UNICEF. SPS also ensured follow-up with UNICEF and communicated progress on the zinc procurement to DANSE on a regular basis. SPS also worked with DANSE and the ZPC to prepare a distribution plan for all health districts. This close work and the excellent collaboration with UNICEF helped SPS discover that, because of an error at the UNICEF procurement section, only 15 percent of the estimated zinc quantity was ordered. A contingency plan was prepared to distribute this quantity among the pilot districts to avoid stock-outs while UNICEF worked on the rest of the procurement. In May 2010, SPS was informed that all the zinc needed had been procured by UNICEF and was available in the country for distribution. Leadership and Governance Issues The SPS program facilitated the rehabilitation of the ZPC and, more importantly, brought the leadership and governance issue to the cabinet level of the Ministry. The second technical advisor to the Minister was assigned to assist DANSE and the ZPC in implementing the new policy. He was personally involved in all technical and administrative issues and was a key player in leading the ZPC meetings. The advisor had PNA clarify issues affecting the availability of zinc dispersible tablets in the country and present progress in the procurement process. In May 7

Challenges in Changing Diarrhea Treatment Policy in Senegal 2010, the DANSE director was assigned to another service of MOH; a technical staff member from DANSE was assigned as the interim director, providing an opportunity for DANSE to address some of the persistent management issues that it faced. The SPS program also met several times with the WHO child health officer to advocate for additional assistance to DANSE; the goal of the additional assistance was to reinforce human resources capacity and skills and support the development of the behavior change communication and education strategy for the implementation of the zinc policy. WHO/Senegal approached WHO/AFRO to look at possibilities for hiring one or two people to work with DANSE or at least to provide DANSE with a short-term consultant to assist with key issues in developing IMCI interventions; however, a formal request from DANSE to WHO was needed to clearly express the identified needs. Partners Coordination This is an area where the SPS program has been very active. Close and constant contact and follow-up with partners involved in IMCI activities helped the ZPC regain functionality which is the cornerstone for discussions on IMCI interventions, especially the implementation of the diarrhea treatment policy. Specifically, the SPS program multiplied its efforts to have UNICEF agree to an additional procurement of zinc, and in fact, procured the zinc needed to fill the gap generated by PNA s difficulties. The SPS program staff worked with the WHO logistics expert to finalize and print the national EDL. The program staff also worked with the WHO child health specialist on key priorities and immediate support to DANSE for human capacity reinforcement and assistance in orienting district health personnel to the new diarrhea treatment policy. The program worked with the MI project which agreed to assist the ZPC in evaluating the pilot program in the selected health districts and the printing of the key updated IMCI materials. 8

CHALLENGES In spite of extensive support from SPS to DANSE, some issues still persist and require the continuous attention of MOH authorities and partners. Leadership and governance remain one of the main obstacles to more significant progress in implementation of the new policy. This is of particular importance with respect to resolving the issues related to the procurement of zinc tablets and the retrieval and disposal of the zinc capsules that were erroneously procured. The availability and involvement of the DANSE staff in drug management activities, especially coordinating zinc management with PNA and UNICEF, and tracking consumption and use of the IMCI tracer drugs in health facilities and at the community level remains a challenge. The DANSE staff has a work load and a work style that make it difficult to get them involved in IMCI drug management; the personnel are more focused on the clinical aspects of IMCI, on-site training, and other issues. The importance of IMCI drug management is not yet as clear to them as it should be, and they have not yet fully integrated IMCI drug management tools (developed through SPS assistance) into their regular activities. IMCI drug management activities require more support to guarantee their integration and to facilitate decision making at the central level. SPS is trying to negotiate with the MI program the possibility of taking over the tracking of ORS and zinc, which is needed to adjust the distribution plan of the zinc procured by UNICEF and to provide more accurate figures on consumption and use for the next quantification exercise. The figures obtained from UNICEF to date are shown in annex A. The tracking tools (which include the tracer list of IMCI drugs) are available and have already been presented to the ZPC, which favors their use. Another option would be to have the Service regional DANSE involved in data collection on consumption and use of ORS and zinc. Data collected at the district level could be consolidated and sent to DANSE central for decision making. Another issue is the reinforcement of DANSE s institutional capacity. The SPS program informed DANSE of WHO s reaction to the request to hire one or two people to support the central staff and the immediate availability of funds for orientation of the district personnel. WHO confirmed that it is unlikely that WHO/AFRO will agree to pay a long-term consultant at DANSE, but there might be some possibilities for short-term assistance. SPS is more concerned about the resources needed at the central level to oversee IMCI drug management. Discussions with the DANSE acting director indicated that she shares the concerns and preoccupations and envisions exploring the possibility to get some support from the MI program. The preliminary evaluation of the zinc pilot program should have been done in 2008 and the final review in 2009 to guide the decision makers on the best approach to expand the policy nationwide; however, this has not happened. SPS contacted the MI project which wants to assist DANSE with this evaluation. Now that the zinc is already in Senegal and available in most regions, the opportunity to conduct such a study is questionable. SPS will discuss this issue with the MI program. SPS would suggest using these resources to assist DANSE in IMCI drug management. 9

Challenges in Changing Diarrhea Treatment Policy in Senegal External assistance is an important concern for sustainability of interventions, even though the operations staff has lots of experience and seems to be dedicated to good work. This situation calls for good coordination and a concerted plan of action between donors, a position shared by WHO. According to different studies, approximately 30 percent of the population goes to private pharmacies and/or the community to get their medicines. SPS conducted training and refresher courses for the sales agents from private pharmacies in USAID-supported regions in light of the new policy. However, the zinc is not available yet and only ORS is delivered to private pharmacy clients to treat diarrhea. SPS worked with the Syndicate of Private Pharmacists to address this situation, but it is still an issue. SPS is proposing that, from the approximately 3,000,000 tablets to be transferred to PNA, a flat number (to be determined) could be given to the pharmacies in the USAID-supported regions where the pharmacists and the sales agents were recently trained. As a fresh start, approximately 127 private pharmacies would receive the zinc free of charge to be sold at the recommended price of FCFA 150 fixed by DANSE, and then their stock would be replenished from PNA (at a preferential price) with the money from the sale. 10

CONCLUSION The SPS technical assistance and support from other donors, especially UNICEF, were critical to implementing the new diarrhea treatment policy. SPS activities in Senegal will be discontinued at the end of September 2011 and DANSE will need more support to accomplish the process and reinforce IMCI interventions in general. The leadership and governance issues need to be addressed shortly. In the meantime, the ZPC should continue to provide immediate backup to DANSE with support from the Ministry s second technical advisor in particular who is familiar with the situation. The ZPC could assist DANSE in preparing and updating a plan of action that would include the ZPC s commitment to follow progress through regularly scheduled meetings, the search for additional financial and human resources, and to prepare a supervision and inservice training plans. In addition, the ZPC and DANSE could work together to identify mechanisms for collecting IMCI drug management data and quantify, prepare, and adjust the procurement and distribution plans according to needs. Assuming that coordination among donors will be reinforced and maintained however, DANSE will need to put in place appropriate mechanisms to continue IMCI drug management activities. The success of IMCI interventions and implementation of the diarrhea treatment policy in particular depend largely on the existence of operational mechanisms for follow-up and effective coordination of the technical assistance being provided by partners and the commitment of the ZPC. 11

ANNEX A. ZINC STATUS 2010 Table 1. UNICEF Procurement Date Zinc dispersible tablets Expiration date Observation received in country April 2008 500,000 - Used during the pilot phase December 2009 900,000 03/2012 May 2010 5,900,000 06/2012 Available for use 6,800,000 Table 2. Health Districts and Regions Where Zinc is Available Region District Health facility Quantity of tablets delivered Thies Regional Directorate 371,500 Joal Popenguine Pout 42,000 21,000 44,000 Thies Hospital 20,000 Fatick Regional Directorate 351,000 Saint Louis Regional Directorate 230,000 Kolda Regional Directorate Kolda Hospital 310,000 12,000 Louga Regional Directorate 225,000 Kaolack Kaolack Hospital 20,000 Ziguinchor Regional Directorate 135,000 Albert Royer Hospital 20,000 Total zinc tablets distributed 1,801,000 Estimated balance 4,999,000 Table 3. Regions That Have Not Yet Picked Up the Zinc Region Quantity of tablets to be delivered Dakar 720,000 Sedhiou 120,000 Tambacounda 170,000 Diourbel 350,000 Matam 150,000 Kaolack 217,000 Kaffrine 140,000 Kedougou 35,000 Total to be delivered 1,902,000 Quantity to be transferred to PNA: 4,999,000 1,902,000 3,097,000 12