Tag: public policy

“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.


 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.

Time to rethink fat consumption, if you haven’t already

A study “Association of Dietary, Circulating, and Supplement Fatty Acids With Coronary Risk; A Systematic Review and Meta-analysis” published March 18 in the Annals of Internal Medicine should be the “nail in the coffin” of the lipid hypothesis (linking saturated fat consumption to coronary heart risk). I want to help out, to hammer one tiny nail in the coffin of this zombie idea. Herewith, my hammer swings.

The study is a systematic review of all available evidence on the lipid hypothesis, including observational studies, prospective cohort studies and RCTs. Taken together, the evidence does not support any link between consuming saturated fat and coronary heart risk. Its “surprising” results have come up in several conversations this week; one friend (you know who you are) speculated that the research may have been funded by a nefarious, self-interested funder (the beef industry perhaps?). This is not the case – as you can see if you follow the link above.

My friends, and many others, are suspicious because the finding conflicts with so much existing evidence. Except, they do not; rather, the finding confirms the balance of existing evidence. The findings are at odds with current dietary guidelines and conventional wisdom. This is a very different issue altogether.

Since this issue has come up in several conversations, I want to lay out what I  discovered when I examined the evolution of the evidence for this hypothesis, as well as the evolution of dietary guidelines.

The origin of the lipid hypothesis lay in poor handling of then-available observational data. To wit, Ancel Keys’ Seven Countries Study (1980), which examined observational data on changes in fat consumption and heart disease levels of different countries. It was named for the seven countries that saw an increase in heart disease cases correspond with increased fat consumption; the study ignored considerable additional observational data that was available at the time – which, taken together, supported the linkage – but weakly. Nevertheless, Time magazine covers, and sadly, national dietary guidelines based on the findings followed.There have been many more observational studies since then. Taken together, their findings do not support the lipid hypothesis. Check out this excellent overview of the evidence.

The mechanism? The concern over fat gathered steam when studies showed that saturated fat increases LDL cholesterol — the bad cholesterol — the artery-clogging stuff. They assumed this increased the risk of heart disease. When further studies did not confirm saturated fat elevated coronary heart risk, researchers started to dig more deeply into the mechanism. They found the more important predictor of risk is the ratio a person has of LDL to HDL, the good cholesterol. Note, compared with carbohydrates, saturated fat can increase HDL and lower fat deposits in the blood called triglycerides, which, is protective against heart disease. Heck, even the American Heart Assn admits this. In fact, more recent studies, such as those examining the health effects of consuming full-fat dairy – see here and here, suggest there are health benefits from eating higher saturated fat diets.

Nor do subsequent prospective, cohort studies (e.g. Framingham) support the lipid hypothesis. See this systematic review Siri-Tarino, P. W., Sun, Q., Hu, F. B., & Krauss, R. M. (2010). Meta-analysis of prospective cohort studies evaluating the association of saturated fat with cardiovascular disease. The American journal of clinical nutrition, 91(3), 535-546.  They foundno significant evidence for concluding that dietary saturated fat is associated with an increased risk of CHD or CVD”.

Many RCTs to measure the effects (in terms of fatal or non-fatal heart attacks) of saturated fat have been either inconclusive, poorly designed, or completely unsupportive of the hypothesis. A few such studies are (I could not find a systematic review of only RCTs):

  • Research committee. Low-fat diet in myocardial infarction. A controlled trial. The Lancet 1965;2:501-4.
  • Rose GA, Thomson WB, Williams RT. Corn oil in treatment of ischaemic heart disease. British Medical Journal 1965;i:1531-3.
  • Research committee to the medical research council. Controlled trial of soya-bean oil in myocardial infarction. The Lancet 1968;ii:693-700.
  • Dayton S, and others. A controlled clinical trial of a diet high in unsaturated fat in preventing complications of atherosclerosis. Circulation 1969;40(suppl 2):1-63.
  • Leren P. The effect of plasma cholesterol lowering diet in male survivors of myocardial infarction. A controlled clinical trial. Acta Medica Scandinavica 1966;suppl 466:1-92.
  • Woodhill JM, and others. Low fat, low cholesterol diet in secondary prevention of coronary heart disease. Adv Exp Med Biol 1978;109:317-30.
  • Burr ML, and others. Effects of changes in fat, fish, and fibre intakes on death and myocardial reinfarction: diet and reinfarction trial (DART). The Lancet 1989;2:757-61.
  • Frantz ID, and others. Test of effect of lipid lowering by diet on cardiovascular risk. The Minnesota Coronary Survey. Arteriosclerosis 1989;9:129-35.

This brings me back to the just-published systematic review of the available evidence from all three methods (observational, prospective cohorts; and, RCTs) Chowdhury, R., S. Warnakula, et al. (2014). “Association of Dietary, Circulating, and Supplement Fatty Acids With Coronary Risk: A Systematic Review and Meta-analysis.” Ann Intern Med 160(6): 398-406.

Which, unsurprisingly, found that “current evidence does not clearly support cardiovascular guidelines that encourage high consumption of polyunsaturated fatty acids and low consumption of total saturated fats”.

Let us hope government guidelines will finally be changed to reflect the evidence. We can’t take such a change for granted though. The folks involved with developing dietary guidelines have been ignoring the evidence they are wrong for quite awhile (see here and here).

I am not giving dietary advice. I am encouraging my many econometrically literate friends to take a look at the evidence themselves. Like me, I think you will be surprised what you find.