Governments use different approaches to ensure that private for-profit healthcare services meet certain quality standards. Such government guidance, referred to as public stewardship, encompasses government policies, regulatory mechanisms, and implementation strategies for ensuring accountability in the delivery of services. However, the effectiveness of these strategies in low- and middle-income countries (LMICs) have not been the subject of a systematic review.
To assess the effects of public sector regulation, training, or co-ordination of the private for-profit health sector in low- and middle-income countries.
For related systematic reviews, we searched the Cochrane Database of Systematic Reviews (CDSR) 2015, Issue 4; Database of Abstracts of Reviews of Effectiveness (DARE) 2015, Issue 1; Health Technology Assessment Database (HTA) 2015, Issue 1; all part of The Cochrane Library, and searched 28 April 2015. For primary studies, we searched MEDLINE, Epub Ahead of Print, In-Process & Other Non-Indexed Citations, MEDLINE Daily and MEDLINE 1946 to Present, OvidSP (searched 16 June 2016); Science Citation Index and Social Sciences Citation Index 1987 to present, and Emerging Sources Citation Index 2015 to present, ISI Web of Science (searched 3 May 2016 for papers citing included studies); Cochrane Central Register of Controlled Trials (CENTRAL), 2015, Issue 3, part of The Cochrane Library (including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register) (searched 28 April 2015); Embase 1980 to 2015 Week 17, OvidSP (searched 28 April 2015); Global Health 1973 to 2015 Week 16, OvidSP (searched 30 April 2015); WHOLIS, WHO (searched 30 April 2015); Science Citation Index and Social Sciences Citation Index 1975 to present, ISI Web of Science (searched 30 April 2015); Health Management, ProQuest (searched 22 November 2013). In addition, in April 2016, we searched the reference lists of relevant articles, WHO International Clinical Trials Registry Platform, Clinicaltrials.gov, and various electronic databases of grey literature.
Randomised trials, non-randomised trials, interrupted time series studies, or controlled before-after studies.
Data collection and analysis
Two authors independently assessed study eligibility and extracted data, comparing their results and resolving discrepancies by consensus. We expressed study results as risk ratios (RR) or mean differences (MD) with 95% confidence intervals (CI), where appropriate, and assessed the certainty of the evidence using Grades of Recommendation, Assessment, Development and Evaluation (GRADE). We did not conduct meta-analysis because of heterogeneity of interventions and study designs.
We identified 20,177 records, 50 of them potentially eligible. We excluded 39 potentially eligible studies because they did not involve a rigorous evaluation of training, regulation, or co-ordination of private for-profit healthcare providers in LMICs; five studies identified after the review was submitted are awaiting assessment; and six studies met our inclusion criteria. Two included studies assessed training alone; one assessed regulation alone; three assessed a multifaceted intervention involving training and regulation; and none assessed co-ordination. All six included studies targeted private for-profit pharmacy workers in Africa and Asia.
Three studies found that training probably increases sale of oral rehydration solution (one trial in Kenya, 106 pharmacies: RR 3.04, 95% CI 1.37 to 6.75; and one trial in Indonesia, 87 pharmacies: RR 1.41, 95% CI 1.03 to 1.93) and dispensing of anti-malarial drugs (one trial in Kenya, 293 pharmacies: RR 8.76, 95% CI 0.94 to 81.81); moderate-certainty evidence.
One study conducted in the Lao People's Democratic Republic shows that regulation of the distribution and sale of registered pharmaceutical products may improve composite pharmacy indicators (one trial, 115 pharmacies: improvements in four of six pharmacy indicators; low-certainty evidence).
The outcome in three multifaceted intervention studies was the quality of pharmacy practice; including the ability to ask questions, give advice, and provide appropriate treatment. The trials applied regulation, training, and peer influence in sequence; and the study design does not permit separation of the effects of the different interventions. Two trials conducted among 136 pharmacies in Vietnam found that the multifaceted intervention may improve the quality of pharmacy practice; but the third study, involving 146 pharmacies in Vietnam and Thailand, found that the intervention may have little or no effects on the quality of pharmacy practice (low-certainty evidence).
Only two studies (both conducted in Vietnam) reported cost data, with no rigorous assessment of the economic implications of implementing the interventions in resource-constrained settings. No study reported data on equity, mortality, morbidity, adverse effects, satisfaction, or attitudes.
Training probably improves quality of care (i.e. adherence to recommended practice), regulation may improve quality of care, and we are uncertain about the effects of co-ordination on quality of private for-profit healthcare services in LMICs. The likelihood that further research will find the effect of training to be substantially different from the results of this review is moderate; implying that monitoring of the impact is likely to be needed if training is implemented. The low certainty of the evidence for regulation implies that the likelihood of further research finding the effect of regulation to be substantially different from the results of this review is high. Therefore, an impact evaluation is warranted if government regulation of private for-profit providers is implemented in LMICs. Rigorous evaluations of these interventions should also assess other outcomes such as impacts on equity, cost implications, mortality, morbidity, and adverse effects.
Government regulation, training, or co-ordination of private for-profit health care in low- and middle-income countries
What is the aim of this review?
The aim of this Cochrane review was to evaluate the effect of government regulation, training, or co-ordination of private for-profit health care in low- and middle-income countries.
We collected and analysed all relevant studies to answer this question and included six studies in the review.
Why do governments regulate, train or co-ordinate private healthcare providers?
In many low- and middle-income countries, the public sector is not able to provide high quality healthcare services to all citizens, and private healthcare providers therefore play a major role. However, there is concern that health care provided by the private sector is not always of high quality and that recommended practices and guidelines are not always followed. Governments therefore use different approaches to ensure that private for-profit healthcare services meet certain quality standards. This type of government guidance is referred to as 'public stewardship' and can for instance involve training and education for private for-profit healthcare providers; introduction of regulations where quality standards are set and enforced; and co-ordination between private for-profit and public sector healthcare providers, for instance, creating referral systems between the private for-profit and public sectors.
What happens when governments regulate, train or co-ordinate private, for-profit health care providers?
In two studies in Kenya and Indonesia, the Ministry of Health offered private drug sellers short training sessions on prescribing and dispensing drugs. These sellers were compared to drug sellers who were not offered training. The studies suggested that training probably improves the quality of healthcare services.
In one study in the Lao People's Democratic Republic, the Ministry of Health supervised private pharmacy services in certain districts over a three-month period, applied sanctions when rules were broken, and offered information about areas needing improvement. These districts were compared to districts without this enhanced supervision. The study suggested that this enhanced regulation may make little or no difference to quality of care.
Training and regulation
In three studies in Vietnam and Thailand, private pharmacies in some districts received educational visits as well as visits from pharmacy inspectors to enforce regulations. These districts were compared to districts that did not receive any visits. The studies suggested that these types of visits may improve quality of care.
The review did not find any eligible study that assessed the effects of co-ordination on quality of care.
How up-to-date is this review?
The review authors searched for studies that had been published up to June 2016.