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Category 2
Tanzania Food and Drugs Authority
Tanzania

The Problem

To be clarified if needed

Solution and Key Benefits

 What is the initiative about? (the solution)
In response to the problems mentioned, the Ministry of Health and Social Welfare through the Tanzania Food and Drugs Authority (TFDA) in collaboration with Management Science for Health (MSH), in 2002, developed a strategy for a pilot programme establishing a network of Accredited Drug Dispensing Outlets (ADDOs), popularly known as Duka la Dawa Muhimu (DLDM), to provide selected essential medicines and other health supplies in the five districts of Ruvuma Region. The intent was to ensure that Tanzanians living in rural, peri-urban, and underserved urban communities have the opportunity to purchase quality, affordable non-prescription and a limited number of prescription medicines from regulated and properly operated drug outlets staffed by trained and supervised drug dispensers.

To achieve this goal, it was necessary to approach the problems of Part II Poisons shops in a systematic and holistic fashion, with the standards of premises improved, training provided to both owners and dispensers, and inspection and supervision activities delegated down to the Ward level.

Other strategies employed included the creation of an incentive package for drug shop owners by providing business training (including training on regulations and ethics), facilitating the provision of loans, and encouraging the establishment of a wholesaler pharmaceutical business in the region.

The first ADDOs were launched in Ruvuma by the Minister for Health in August 2003. Evaluation of the pilot project revealed a significant improvement in access to quality medicines. The success was a result of support from the central and local government authorities and other stakeholders (public and private). The specific achievements as compared to baseline information obtained in a survey conducted by Strategies for Enhancing Access to Medicines (SEAM) in 2001 are as follows; Increased availability of medicines, Improved dispensing practices, Availability of unregistered drugs decreased from 26% to 2%, Establishment of a micro-financing system in which ADDO owners were able to obtain and repay loans, Establishment of a functioning decentralized regulatory system, Premises were found to adhere to set standards in operating their businesses, All ADDOs were manned by certified dispensers and Improvement in reporting and communication from grassroots to national level.

The overall benefit to be accrued from the programme is improved livelihood of the people which will contribute towards poverty reduction in the regions and the nation at large.

Actors and Stakeholders

 Who proposed the solution, who implemented it and who were the stakeholders?
TFDA in collaboration with MSH, in 2002, proposed the solution to address the above mentioned problems by developing a strategy for a pilot programme The Program which is a network of Accredited Drug Dispensing Outlets (ADDOs) also known in Swahili as “Duka la Dawa Muhimu (DLDM)” was initiated to provide selected essential prescription medicines and other medical supplies in rural and peri-urban areas.

Both the TFDA and MSH implemented the piloted Accredited Drugs Dispensing Outlets (ADDOs) in collaboration with Regional and Local Government Authorities in Ruvuma Region from 2002-2005.

Evaluation of the pilot Program in Ruvuma proved that the project was very successful hence the Government decided to roll out the program to other regions. In order to ensure, the program is implemented in cost effective way, it is was decided to involve Local Government Authorities

Stakeholders of the programme include but not limited to the Ministry of Health and Social Welfare; Regional and Local Authorities; Management Sciences for Health (MSH); Global Fund to fight AIDS, Tuberculosis and Malaria (GFATM); HSPS-DANIDA; USAID, the Bill & Melinda Gates Foundation, MEDA, Clinton Health Access Initiative, T-MARC, PSI, Family Health International and ADDO owners.

The Government of Tanzania through Ministry of Health and Social Welfare approved roll out of ADDO Program to Tanzania Mainland and funded the rollout in Mtwara and Rukwa regions. DANIDA sponsored an independent evaluation of the ADDO program in Ruvuma to assess viability, cost, time and sustainability where USAID through MSH’s Rational Pharmaceutical Management Plus Program provided funds for ADDO rollout in Morogoro region using President’s Emergency Plan resources.

(a) Strategies

 Describe how and when the initiative was implemented by answering these questions
 a.      What were the strategies used to implement the initiative? In no more than 500 words, provide a summary of the main objectives and strategies of the initiative, how they were established and by whom.
ADDO Programme is a Government programme that intends to ensure that Tanzanians living in rural, peri-urban and underserved urban communities have an opportunity to purchase quality, affordable non-prescription and a limited number of prescription medicines from regulated and properly operated drug outlets staffed and supervised by trained drug dispensers.

The overall ADDO programme objective is to provide improved access to affordable, quality, and effective medicines and pharmaceutical services to 80% of the rural, peri-urban, and other underserved populations of the Tanzania mainland by July 2012

During the pilot phase, donor fund with direct oversight from the Central level was used in establishing ADDOs. With limited resources from Central level it was necessary to establish ADDOs in one district after another as it was not possible to implement in two regions simultaneously. This approach proved to be costly and time consuming. This necessitated to adopt a Decentralised approach. In the decentralised approach training of trainers was conducted to build the capacity of Local Government Authorities in implementation of ADDO activities.

Also the Central level developed training materials and reviewed the ADDO program regulations. In addition, Local Government officials were sensitized to include program activities in their annual plans. The Central level arrived with the duty of providing Technical Assistance. All these were aimed at reducing the cost, fast tracking the program roll-out, building the sense of ownership of the program and thus make the program sustainable.

TFDA in collaboration with MSH, in 2002, proposed the strategies, implemented them and where challenges observed arrived together to find solution.

(b) Implementation

 b.      What were the key development and implementation steps and the chronology? No more than 500 words
The implementation process of the ADDO Program during roll –out involves number of steps to be followed, resources needed, time frame and expected output for each activity.

Mobilization and sensitisation is the first step in implementation of ADDO Program. Its objective is to create awareness, build sense of ownership and outline the responsibilities of stakeholders. This will be done through sensitisation seminars and mass media communication. Sensitisation meetings are conducted at different levels within the district and involve stakeholders from district, wards and villages. The activity is organized and coordinated in collaboration with Council.

Mapping and pre-inspection of Part II poison outlets (DLDBs) is the second step of Program implementation. These activities should be conducted at the same time using available checklists. Mapping is conducted to determine the location and distribution of existing DLDBs, potential new ADDO owners/sites, profile of DLDB owners and drug sellers as well as demographic information of the community. On the other hand, Pre- inspection is carried out to provide guidance to existing DLDB and potential ADDO owners on how to modify or construct their premises as per standards stipulated in the ADDO Regulations in force. The expected time frame for the activities is ten to twenty (10 – 20) days per district depending on the existing infrastructure, size, number of DLDBs, human resources and season of the year.

Training of ADDO owners, dispensers, inspectors and supervisors is the third step in Program implementation. Its objective is to impart knowledge on principles and standards of operations, business management and laws and regulations governing ADDO Program.

Final pre – accreditation is the fourth step in program implementation. This should be conducted based on the duration for premises renovation given to business owners during mapping and pre-inspection. The objective of this step is to verify whether premises identified, comply with ADDO standards prior to accreditation.

Accreditation is the fifth step in program implementation. The objective of this activity is to officially authorize DLDBs and new premises which have met standards to operate as ADDOs. The Council Food and Drug Committee (CFDC) should arrange for accreditation meeting after receiving recommendations from inspectors. The CFDC should make a decision and forward a list of approved outlets to TFDA for preparation of accreditation certificates. Minutes of the meeting and final pre-accreditation inspection report should also be sent to TFDA and copy thereof to RFDC. The time taken from CFDC’s meeting to issuance of certificates is 14 days.

Inception of the program marks the official recognition and commencement of ADDO program in a district. The district may decide on its own way of launching the program. This will draw the attention of consumers and district officials on the existence and operation of ADDOs. All DLDBs which failed to comply with standards during final pre-accreditation inspection will be given a three month notice from the date of inception of the Program to upgrade their premises. Failure to do so will result into closure of the premises

Supervision is an essential element for sustainability of the Program. It includes routine monitoring of records and dispensing practices. Its objective is to support dispensers and owners in order to strengthen/ maintain the quality of services provided.

Inspection is an essential activity in monitoring the performance of ADDOs to ensure that they comply with set standards and regulations. The activity begins three months after inception of the Program.

The last step is Monitoring and evaluation. This is an important tool for ADDO Program implementation. It involves continuous assessment of the performance through a systematic comparison of ADDO inputs and expected outputs at regular intervals.

(c) Overcoming Obstacles

 c.      What were the main obstacles encountered? How were they overcome? No more than 500 words
The major challenges to nationwide roll out of the ADDO initiative based on lessons learned from implementation of ADDO can be discussed under the Central level and decentralised approaches.

Challenges that encountered under the Central level implementation approach includes; Adequate availability of trainers and training institutions to conduct dispenser and owners’ training at local level. To overcome this challenge a total of 260 facilitators have been trained countrywide to train ADDO dispensers and Owners.

The other challenge is availability of dispenser candidates with necessary qualifications as stipulated in ADDO regulations. To solve this, TFDA have reviewed ADDO regulations to accommodate secondary school graduates (form four leavers) if proved that the Nurse Assistants are not available.

The challenge of inadequate capacity for ADDO owners to mobilize resources required to cover cost-sharing expenses (e.g. renovation of outlets, stocking of medicines and other running costs). In solving this TFDA started to link ADDO owners with micro financing institutions to loans.

Also, the challenge of Local brain drain of qualified dispensers from rural areas to urban cities and Commitment of all stakeholders towards successful implementation of the program have been solved by starting conducting training to create a pool of dispensers to fill the gap with cost of training covered by dispensers themselves.

Challenges that were encountered under the decentralised approach includes; Financial gaps; resources are needed to complete scaling up in the remaining 9 regions by June 2010, different number of donors have been approached to support the program: Limited capacity for Local Authorities to accommodate additional responsibilities of ADDO implementation; to address this Local Authorities have been sensitized to include regulatory activities in their annual plans:

Resistance by outlet owners to relocate to new areas close to rural communities for fear of loosing business especially in urban areas, to solve this sufficient time is given and meeting are conducted to achieve consensus with stakeholders on the criteria used for classification of areas:

(d) Use of Resources

 d.      What resources were used for the initiative and what were its key benefits? In no more than 500 words, specify what were the financial, technical and human resources’ costs associated with this initiative. Describe how resources were mobilized
During the pilot phase the cost per region was estimated to be US$1,895,000 not including TFDA costs, micro-financing administration costs, and costs of international technical assistance. However the cost were further revised to average to TZS 1,240,350,138 per region

Under the decentralised approach costs have been reduced even further approximately TZS 500 Million per region with 6 districts.

Despite that the program was funded by the Government of Tanzania and after the Development Partners, a number of donors have been contributed to the ADDO program. So far it includes Bill and Melinda Gate Foundation, DANIDA, Global Fund R7, CHAI, USAID, PSI and T-MARC. Of late Dispensers and owners have started to incur costs for training which include basic training fees, accommodation and evening meals.

Since the program is a Government initiative, the Human resources included is under the Ministry of Health and Social Welfare. Technical support is provided by staff under MSH.

Sustainability and Transferability

  Is the initiative sustainable and transferable?
Yes the initiative is sustainable and transferable. The pilot project in Ruvuma demonstrated that private sector ADDO shops can be economically sustainable businesses with most shops making a profit. If they are not adequately regulated, however, public health and welfare may be endangered. Thus, both the private sector and government regulatory sides of the equation must be addressed in ensuring sustainability.

Several efforts have been done to sustain the ADDO program. The program has two key components that are used in sustaining the program, namely Training and Regulatory oversight. Training to trainers have been done up to a district level so as to reduce cost and time. Structural frame work of inspectors has been improved where by inspectors are located to the grass root level. Council have been sensitized to include regulatory activities in their respective annual plans.

So far the results of the pilot have been transferred to 12 out of 21 regions in the country. The program will be roll-out to the remained 9 regions in the year 2009/10.

In addition, the Tanzania ADDO model kit has been adopted by neighbouring countries of Uganda and Zambia.

The other factor that support sustainability of government role in maintaining the program is the use of ADDOs as an economical and accessible base for implementing various public health initiatives (e.g., being an outreach post for supplying public health information, providing a reliable source of medicines during disease outbreaks, supporting community-based commodity supply initiatives, and supplying anti-malarial medicines as part of malaria initiatives).

Also, the linking ADDOs with health financing schemes that pay for all or a portion of medicines and health-related commodities needed by certain segments of the population (e.g.National Health Insurance Fund and Community Health Fund programmes and the malaria bednet voucher initiative).

Lessons Learned

 What are the impact of your initiative and the lessons learned?
The first ADDOs were launched in Ruvuma by the Minister for Health in August 2003. Evaluation of the pilot project revealed a significant improvement in access to quality medicines. The success was a result of support from the central and local government authorities and other stakeholders (public and private). The specific achievements as compared to baseline information obtained in a survey conducted by SEAM in 2001 are as follows; Increased availability of medicines, Improved dispensing practices, Availability of unregistered drugs decreased from 26% to 2%, Establishment of a micro-financing system in which ADDO owners were able to obtain and repay loans, Establishment of a functioning decentralized regulatory system, Premises were found to adhere to set standards in operating their businesses, All ADDOs were manned by certified dispensers and Improvement in reporting and communication from grassroots to national level.

After successful piloting in Ruvuma, the government decided to roll out the program to other regions of Tanzania.

The ultimate benefits from ADDO programme is to improve the livelihood of the people to participate fully in poverty reduction which is Tanzania’s development agenda as stipulated in the National Strategy for Growth and Poverty Reduction (NSGPR) also known as MKUKUTA (Swahili version), a national framework focusing on reduction of poverty and economic growth, hence is a strategy for implementing vision 2025 and a commitment to achieving Millennium Development Goals (MDGs).

Once the program is roll-out through out the country, it is anticipated that the quality of pharmaceutical services to 80% of the Tanzanians living in rural and peri-urban areas will be improved. This outcome is expected to contribute to the achievements of the overall national health outcomes goal of improving quality of life and well being of rural, peri-urban and underserved population and impact the following indicators: Reduce malaria-related mortality among under 5s from 12% (2002) to 8 %, maternal mortality from 529 to 265 in twenty per 100,000 by 2010, child under 5 mortality from 154 to 79 per 1000 live birth by 2010 and infant mortality from 95 to 50 in 1000 live birth by 2010. Therefore this calls for attention, commitment and support of all involved stakeholders in this programme.

Contact Information

Institution Name:   Tanzania Food and Drugs Authority
Institution Type:   Government Agency  
Contact Person:   Sikubwabo Ngendabanka
Title:   Director of Business Support  
Telephone/ Fax:   +255-22-2450751/2450512/2452108
Institution's / Project's Website:   www.tfda.or.tz
E-mail:   kwiyanse@yahoo.com  
Address:   TFDA
Postal Code:   +255
City:   DAR ES SALAAM
State/Province:   DAR ES SALAAM
Country:   Tanzania

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