“Better Practice” Regulation Can Work: Lessons from Tanzania’s Accredited Drug Dispensing Outlets initiative.

“The quality of care in the private sector is unreliable. The regulatory framework needs to be strengthened.” How many times have you read that? Or, “the regulatory agency needs to do more to enforce the rules”? Do you recall any successes along these lines? No? Yeah, me neither. Until I learned about Tanzania’s Accredited Drug Dispensing Outlet (ADDO) initiative.

Drugshops constitute an important part of the primary care system in many developing countries. They provide a lot of care, especially in rural areas, especially to the poor. They provide care for a lot of illnesses which are especially important to children. They typically “practice” way beyond their skills. The quality is not reliable quality. However, they are not going away. Generally, little is done to address this cadre. Invariably, regulations exist that prohibit them from doing more than dispense a “safe” lists of medicines. They don’t comply. And if they did, diabetics who live in rural Ghana would have to travel 1,2, even 6 hours to get their insulin. Same for Nigeria, etc. Some donor-disease projects have sought to improve their practice in one area or another e.g. family planning, malaria. Education activities targeting drugs shops and their customers usually succeed in improving practice (Wafula Goodman 2011). But none have been done at a large scale, and since the better practice often requires drugshops to lose income, sustainability is questionable.

Then comes the ADDO initiative. ADDO initiative demonstrated that with a “better practice” approach to regulation it is possible to reach the entire cadre of drug shops, to change their practice for the better, and to bring them in to play a considered role in a country’s primary care system. The ADDO experience showed that by using this approach to engaging private providers, it is possible to recover regulation as a social policy instrument.

Missing-in-action: regulation policy instrument. In most countries, drugshops daily practices go well beyond what regulation permits. And this gap is a big (big) problem. Why? Because it means that policymakers no longer have regulation as an instrument to influence behavior.  Let me explain.

Keep in mind, outside of police states, most citizens’ rule-compliance behavior is voluntary – it is not done in fear that doing otherwise may lead to being caught and punished. Buy-in to the rules is likewise a very important element of health practitioner and facilities compliance in all well-functioning health systems (Hort et al 2013). Practitioners’ associations’ involvement in developing the rules, and the responsibility that take in bringing along their members towards compliant behavior is an essential ingredient. And, with respect to drugshops in many developing countries, they are so many, and so widely geographically dispersed, virtually all compliance with rules will have to be achieved through practitioners’ voluntary decisions.

The large practice-vs-regulation gap in most countries tells us that the content of existing rules is not seen as legitimate. Neither the individuals nor their colleagues nor their association feels “it is the right thing to do” to follow all the provisions in the rules. They feel neither intrinsic nor social pressure to comply.  Hence, policymakers can pull on the regulation policy “lever” all they want, but nothing happens, because it is no longer attached to the practitioner cadre’s domain.

Tanzania’s ADDO initiative showed it is possible to recover regulation as a policy instrument. It’s not easy. But it’s doable. And it is doable – even for this hard-to-reach, but hugely important practitioner cadre.

 THIS IS A BIG DEAL.

 How did they do it? From discussions in a recent workshop on drugshops and pharmacies in developing countries hosted by PATH, my understanding of the process is:

 

1.      “Start where you are” principle. Professionals involved with ADDO emphasized how much time and effort they devoted to characterizing what was going on with the drugshops at the beginning. Who was using them? For what? What did drugshops do? Really? What medicines did they sell? With what advice? Where did they get their medicines? This is a core practice of the “whole systems approach” to improving service delivery, which emphasizes starting off with mapping existing provision capacity and utilization patterns to identify providers/ services which may otherwise be overlooked. See Stevenson 2001.

2.      Inclusive policy dialogue. They started and sustained dialogue between practitioner representatives, regulators and other key stakeholders.

3.      Negotiate to a middleground. They negotiated their way to a new scope of practice – in consultation and sustained interaction between practitioner representatives and technical experts and other politically important stakeholders (e.g. pharmacists) which constituted a better, safer scope of practice. The scope was more limited than their actual, current practices, but broader than the scope permitted in current regulations. Drugshop representatives thought their members could comply without undermining their ability to operate as sustainable businesses.

4.      Elaborate the policy element of the new arrangement. In Tanzania they settled on using an accreditation regulatory instrument. This is  a regulatory instrument where providers’ participation is voluntary, and participation is motivated at least partly by improvement in market position (e.g. more customers because accreditation “mark” is valued by would-be clients).

5.      Pilot – they tested the new parameters for the initiative (scope of practice, role of practitioner assn, other implementation issues).

6.      Review and adapt.  Officials reviewed the pilot implementation experience and results in consultation with drugshop representatives and other stakeholders; and, together, they agreed on adapted parameters based on those insights.

7.      Strategic communication. They made conscious efforts to get buy-in from key public officials (e.g. parliamentarians, regulatory agency officials).

8.      Scale- up. With all this in place, they moved to scale up and roll out the initiative.

Initiatives to improve services in developed countries virtually always exhibit these features; they “start where they are”, they adapt the strategy as they go. And, critically, policy formulation and implementation is inclusive of those providers whose behavior and activities are targeted. Such efforts are rarely inclusive in developing countries, especially where the relevant providers are private. Surender et al noted the glaring omission when they compared South Africa’s approach to reforming primary care to that taken in developed countries. The low influence of regulations and low impact of regulatory efforts in developing countries surely derives significantly from this non-consultative, exclusive approach to policy. My take on the ADDO initiative is that it is important because it illustrates that if health policymakers shift to “better practice” approaches to regulation, they can reestablish regulation as a functioning instrument to exercise stewardship. And, they can do so even for drugshops – which constitute a critically important but hard-to-engage part of many countries’ primary care systems.


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