Using Accreditation and Regulation to Improve Dispensing and Use of Medicines in Retail Drug Shops

by Edmund Rutta, Keith Johnson, Martha Embrey, Center for Pharmaceutical Management, Management Sciences for Health

Many people in developing countries buy medicines from retail drug shops, because they are convenient and often have drugs available when public health facilities are out of stock. In Tanzania, these shops are called duka la dawa baridi, which historically have been authorized by the Tanzania Food and Drugs Authority (TFDA) to provide only nonprescription medicines. With thousands of shops located around the country, often in rural and periurban areas, duka la dawa baridi have been the most widespread source of medicines for purchase in Tanzania. However, a 2001 assessment showed that the shops’ dispensing staff generally lacked basic qualifications and training and often sold prescription-only medicines illegally; in addition, the shops had little regulation enforcement or supervision. Inappropriate dispensing of medicines resulting in inappropriate patient use is one of the key factors driving drug resistance around the world.

To address issues with duka la dawa baridi, Management Sciences for Health’s Strategies for Enhancing Access to Medicines Program¹ began working with the government of Tanzania to create a public-private partnership with the goal of improving access to affordable, quality medicines and pharmaceutical services where few or no registered pharmacies exist. The accredited drug dispensing outlet (ADDO) program established new shops called Duka La Dawa Muhimu (Swahili for “essential drug shop”) that must adhere to standards related to product and service quality to achieve and maintain government accreditation. One of the ADDO program objectives was to improve community awareness of the importance of pharmaceutical quality and treatment compliance and for customers to associate ADDOs with high quality drugs and services. In exit interviews, 94% of customers said they thought the quality of medicines sold in ADDOs was good or excellent compared with 83% of duka la dawa baridi customers; in addition, 28% of ADDO customers thought they had received excellent information about how to take their medicines compared with 15% of the duka la dawa baridi customers. Anecdotally, we heard that consumers called ADDOs “full dose shops” because dispensers encouraged them to take the full dose of their medicines.

To carry out its objectives, the ADDO program developed a dispenser training curriculum that covers issues such as how to identify and counsel patients on common health problems and dispense appropriate treatment. The initiative also provides owners with business incentives and strengthens the supervision and regulatory system by delegating certain inspection functions to local government authorities. A major program incentive permits ADDOs to legally dispense select antibiotics and other essential medicines, which was not allowed before.

TFDA accredited the first ADDO shops in August 2003. As of 2006, more than 200 shops were accredited across the Ruvuma region, where ADDOs were piloted. A 2004 evaluation of drug availability, quality, price, and dispensing services compared the Ruvuma ADDOs with a control group of duka la dawa baridi in the Singida region. ADDO dispensers showed significant improvements in appropriate dispensing of antibiotics; endline data showed that fewer ADDO dispensers (14%) sold or recommended antibiotics for upper respiratory tract infections in Ruvuma than during a nationwide assessment of duka la dawa baridi in 2001 (39%) or in Singida during the endline evaluation (25%). In addition, 32% of malaria treatment encounters at ADDOs included the sale of an appropriate first-line antimalarial (sulfadoxine-pyrimethamine at that time), compared with only 16% at baseline. ADDOs in Ruvuma now have a legal right to sell selected antibiotics and are selling them more responsibly than they were in 2001.

The success of the ADDO pilot led to the Tanzanian government’s decision in 2006 to expand the program nationwide. Since then, the government and the U.S. Agency for International Development have funded ADDO rollout in three additional regions, and the Global Fund to Fight AIDS, Tuberculosis and Malaria is funding scale-up in six to eight more regions. In addition to expanding the geographical reach, the government and donors are expanding the scope of other services that ADDOs provide by using them to strengthen community-based health care interventions; for example, Tanzania’s National Malaria Control Programme adopted the ADDO concept as part of its national strategy to increase access to artemisinin-based combination therapy (ACT) for malaria, and the President’s Malaria Initiative is using ADDOs as a platform for providing subsidized ACTs. As a result, over 1,000 ADDO dispensers have been trained on how to provide the new malaria medicines properly. In addition, the Ministry of Health and Social Welfare announced its support of incorporating a child health component based on integrated management of childhood illness methodology into the ADDO package of services focusing on increasing the number of children correctly treated for malaria, acute respiratory infection, and diarrhea.

To address overall issues of rational medicine use, MSH’s Strengthening Pharmaceutical Systems Program² is working with TFDA to improve appropriate use of medicines in children under five years of age by training dispensers in Kilosa district to correctly identify general danger signs and provide appropriate treatment or referral. In 2008, after the training, 85%³ of ADDO dispensers identified at least three out of the four danger signs for children ages two months to five years. The dispensers also consistently gave customers the following essential information when counseling them on medication use: when and how to take the medicine (96%), the appropriate dose (73%), the importance of completing the full dose (54%), and side effects (47%).⁴

As part of the intervention in Kilosa, dispensers have received job aids to help reinforce the knowledge they learned and informational materials to share with ADDO customers about the importance of using medicines correctly. In addition, dispensers are continuing to strengthen their counseling and medicine labeling skills to promote good treatment adherence among customers. Finally, the intervention is building the capacity of ADDO supervisors to reinforce the promotion of rational medicine use. The plan is to add the medicine use initiative in other districts and regions where ADDOs have already been implemented and incorporate the child health and medicine use elements into ADDO roll out in new regions and districts.

Tanzania’s innovative public-private partnership relying on government accreditation has caught the attention of those who recognize the need to improve community-based medicine use.⁵ With additional funding from the Gates Foundation, Management Sciences for Health is working with the government of Uganda to extend the ADDO concept to the Kibale district. Uganda expects to launch the new shops, called Accredited Drug Shops, in October 2009.