ACCREDITED DRUG DISPENSING OUTLETS (ADDO) PROGRAM: PUBLIC PRIVATE INITIATIVE TOWARDS ADDRESSING MEDI
Tanzania Food and Drugs Authority
Tanzania

The Problem

Tanzania is located in the Eastern part of Africa. It is among the poorest countries in the world whereby the majority of the rural population is living on less than a dollar per day. It has a population of 35 million with about 80% living in rural area depending on subsistence farming. Majority of the urban population are engaged in micro and small business to earn their living. Tanzania has 21 regions, 119 districts and 2,766 wards which form 8 zones as per Ministry of Health and Social Welfare description. Among the indicators of abject poverty is failure of being able to access quality primary health care for a majority of the people, particularly those in rural and peri-urban areas. This has lead to reduced economic growth due to disease burden, reduced life expectancy, maternal, child and adult mortalities; and high medical services costs at both individual citizen and the government levels.

Among the components of quality primary health care is access to essential medicines and other health commodities. In view of the fact that there are a limited number of health facilities and pharmacies countrywide, particularly in rural and peri-urban areas, a provision was made under the repealed Pharmaceuticals and Poisons Act, 1978, for establishment of Part II Poisons shops. Such shops were allowed to sell non-prescription medicines to supplement services provided by health facilities, including pharmacies. It is estimated that, there are 10,000 Part II Poisons shops which deliver approximately 80% of the medicines and health commodities provided by private drug outlets by June 2009.

A countrywide inspections conducted by the then Pharmacy Board and an assessment conducted by Management Science for Health (MSH) and Tanzania Food and Drugs Authority (TFDA) in 2001 revealed a number of anomalies regarding operations of the Part II Poisons shops which call for redress. Anomalies found including selling of unauthorized medicines, dispensing of medicines by unqualified personnel, and inadequate record keeping. Other anomalies are weak regulatory system, poor and inadequate storage and dispensing space with no cooling facilities and uneven distribution of shops geographically resulting in limited access to essential affordable, quality, safe and effective medicines in rural, peri-urban and underserved urban communities.

In view of this state of affair TFDA, in the year 2002 derived a comprehensive and holistic approach to the problem by devising an Accredited Drug Dispensing Outlet (ADDO) program as an initiative to address such identified anomalies. The program establishes a network of Accredited Drug Dispensing Outlets (ADDOs), popularly known as Duka la Dawa Muhimu (DLDM), to provide essential medicines and other health supplies 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.

Under the program, training is being provided to dispensers on management and dispensing medicines, hygiene, record keeping whereby owners are trained in business management and ADDO regulations. Also premises standards are improved by owners before can be accredited, the general community is sensitized to use services from approved premises and enforcement of the standards has been delegated to Local Authorities. The program was first launched in Ruvuma region in August 2003 and has been extended to other 12 regions by December 2009.

Solution and Key Benefits

 What is the initiative about? (the solution)
The 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, decrease of unregistered drugs 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, 80% of 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 program benefited the people living in the peri-urban and rural areas particularly children and women.

Actors and Stakeholders

 Who proposed the solution, who implemented it and who were the stakeholders?
TFDA proposed the solution to address the above mentioned problems and Management Science for Health (MSH) were collaborators at project design and implementation stages. Other collaborators at ADDO implementation are Regional and 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, Tuberculosis and Malaria (GFATM), Health Sector Program Support (HSPS)-DANIDA, USAID, the Bill & Melinda Gates Foundation, Mennonite Economic Development Agency (MEDA), Clinton Health Access Initiative (CHAI), T-MARC, Population Service International (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 and 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.
The objective of ADDO programme is to provide for 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 National level was used in establishing ADDOs. With limited human resources from National level it was necessary to establish ADDOs in one district after another as it was not possible to implement in two districts 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 National 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 National level is left with the duty of providing Technical Assistance. All these are aimed at reducing the cost, fast tracking the program roll-out, building the sense of ownership of the program and thus program sustainability.

(b) Implementation

 b.      What were the key development and implementation steps and the chronology? No more than 500 words
Development steps of ADDO program involves; brainstorming by experts to generate ideas on how best to develop the project document, Planning sessions, presentation of the draft program document to stakeholders, approval of the program document by the Ministry of Health and Social Welfare and Solicitation of financing.

The implementation steps of the ADDO Program includes; Mobilization and sensitisation of stakeholders at all levels from national to village level with the purpose of creating awareness, building the sense of ownership and outline the responsibilities of stakeholders. This is done through seminars and mass media communication.

Mapping and pre-inspection of Part II poison outlets (DLDBs) is the second step of Program implementation. These activities are 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. The expected time frame for the activities is 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 is conducted to verify compliance of the premises standards as provided in the regulations.

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.

Launching of the program marks the official recognition and commencement of ADDO program in a district. All DLDBs which fails to comply with standards during final pre-accreditation inspection are given a three month notice from the date of launching the program in a district with the directive 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. Supervision and inspection are the key components of monitoring the program.

Evaluation is conducted to determine whether the overall objective and impact of the program are achieved, mid and final evaluations are envisaged.

(c) Overcoming Obstacles

 c.      What were the main obstacles encountered? How were they overcome? No more than 500 words
The major obstacles 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.

Obstacles that encountered under the National level implementation approach includes; inadequate 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.

The other obstacle is unavailability of dispenser candidates with necessary qualifications as stipulated in ADDO regulations. To address this, TFDA have reviewed ADDO regulations to accommodate secondary school graduates (form four and form six leavers)

The obstacle 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 obstacle 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. ADDO Dispensers training is being integrated in the Health training Institution curriculums.

Obstacles 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 work plans.

(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 approximately TZS 1,240,350,138, where by under the decentralised approach costs have been reduced to approximately TZS 500 Million per region with an average of 6 districts.

In addition to the Government of Tanzania funding, other development partners who are contributors to financing the program are DANIDA, Global Fund, Bill and Melinda Gate Foundation, Clinton Health Access Initiative, USAID and Population Services International. Further more ADDO Dispensers and owners are also contributing to the costs for training.

Human resources include those from TFDA and Local Authorities whereby Technical support is provided by MSH based on the Memorandum of Understanding signed between two parties.

Sustainability and Transferability

  Is the initiative sustainable and transferable?
The initiative is sustainable and transferable. The pilot project in Ruvuma demonstrated that ADDO shops are economically sustainable businesses as most shops are making profit.

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 of 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. Local Authorities have been sensitized to include regulatory activities in their respective annual plans.

So far the program has been rolled-out to 12 out of 21 regions in the country. The program will be roll-out to the remaining 9 regions in the financial year 2010/11.

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 subsidised anti-malarial medicines as part of malaria initiatives).

Also, the linking of 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 such as National Health Insurance Fund and Community Health Fund programmes and the malaria bed net voucher initiative.

Lessons Learned

 What are the impact of your initiative and the lessons learned?
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 goal of improving quality of life and well being of rural, peri-urban and underserved population and impact the following National indicators: Reduce malaria-related mortality among under 5s from 12% (2002) to 8% and maternal mortality from 529 to 265 by 2010. Also 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.

In general the impact of the ADDO initiative includes; improvement of Pharmaceutical services delivery and provision of a window for other health service initiatives.

The success of the initiative is the results of stakeholders involvement at all levels; the implementation of the program is focused at a population that is in need such as underserved areas which attracted support from donors. Other factors are; the involvement of local authority in the implementation of program, involvement of ADDO owners and dispensers to meet costs and the political support.

Contact Information

Institution Name:   Tanzania Food and Drugs Authority
Institution Type:   Government Agency  
Contact Person:   Sikubwabo Sentoke Ngendabanka
Title:   Director of Business Services  
Telephone/ Fax:   +255 22 2450752/ 0754664042
Institution's / Project's Website:   +255 22 2450793
E-mail:   ssngenda@yahoo.co.uk  
Address:   Box 77150
Postal Code:   +255
City:   Dar Es Salaam
State/Province:   East Africa
Country:   Tanzania

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