Tropical Health Matters

Affordable pharmaceuticals play a major role in the control of infectious and tropical diseases. Dr Naveen Anaswara and Dr Ashok Kumar Kanaparthi explore the importance of quality generic medicines in India in a post on the class blog for the course Social and Behavioral Foundations of PHC. See their thoughts below.

Even though National Medical Commission(NMC) emphasizes the importance of prescribing generic drugs in India, it is not being implemented in the ground level. Many stake holders including Indian Medical Association(IMA) are skeptical regarding the quality of generic drugs compared to branded drugs. India is one country with highest out of pocket expenditure especially for drug purchases.Usage of generic drugs can reduce the out of pocket expenditure ensuring equity.

The Hatch-Waxman Act, also known as the Drug Price Competition and Patent Term Restoration Act, was passed on September 24, 1984, during the 98th United States Congress. It created the current system of government regulation for generic drugs in the country and encouraged the pharmaceutical industry to produce generic drugs.Many countries follow the generic drugs prescription.The generic drugs should be with the same efficacy and quality as the branded drugs.

Unlike in US , India lack stringent quality checking mechanisms.India has struggled with the problem of illegal narcotics for a considerable amount of time. The Central Drug Standard Control Organization (CDSCO) found that approximately 4.5% of generic medications sold on the domestic market in 2018 were below par. In the meantime, the country’s dearth of high-quality testing facilities is the root of the problem.

When the Department of Pharmaceuticals introduced the Jan Aushadhi Scheme (JAS) (Public Medicine Scheme) in 2008, the Government of India (GOI) appeared to be taking a strong stand against the private pharmaceutical industry’s outrageous drug prices by providing generic medications at reasonable costs.But due to lack of enough publicity, poor supply chain and lack of prescriptions from doctors this scheme could not flourish.

India have to take the campaign for generic drugs prescription. At the same time Ministry of India should ensure the standard quality of all generic drugs.

Our Stance: Support for Generic Drug Promotion

1. Public Awareness Campaigns: Initiating comprehensive public awareness campaigns can empower patients and families with information about the benefits of generic drugs.
2. Incentives for Healthcare Providers: Offering incentives to physicians, pharmacists, and hospitals for prescribing and dispensing generic drugs can drive adoption.
3. Enforcement of Policy: Stronger enforcement measures by government health authorities are essential both for prescriptions and quality assurance.

Embracing generic drugs in India is not merely a policy suggestion but a pathway to equitable and affordable healthcare. By working collaboratively with stakeholders, advocating for informed choices, and implementing concrete strategies, we can make quality healthcare accessible to all.

Meike Schleiff of the Department of International Health, The JHU Bloomberg School of Public Health has explored how Burkina Faso manages to get essential medicines, including those for malaria, to the front line health services. She explains that the World Health Organization (WHO) has determined essential medicines to be, “those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness.”(WHO, 2018) These medicines should be available as part of health systems functioning to all persons at appropriate amounts, affordable costs, quality standards and sufficient information assured to consumers. Every country develops an essential drug list,

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In Burkina Faso, approval of modern medicines (specialty and generic), traditional pharmacopoeial drugs, medical consumables and medical biology reagents is assigned to the Drug Regulatory Directorate (DRP).

Essential Medicines in Burkina Faso are purchased and distributed primarily through the Centrale d’Achats des Médicaments Essentiels (CAMEG), or Central Purchasing of Essential Drugs system.(CAMEG, 2018) This CAMEG system operates with two agencies in Ouagadougou, and then has seven additional agencies in other zones of the country (see map). From the zonal agencies, the CAMEG supplies 67 District Dispatching Depots (DRDs), and also supplies University Hospital Centers, regional hospitals, and additional services provided by the Ministry of Health. For the private sector, the CAMEG manages supplies for NGOs, faith-based organizations, medical laboratories, pharmaceutical companies, and the Global Fund for HIV, tuberculosis, and malaria.(CAMEG, 2018)

Before the CAMEG was created, access to essential medicines and supplies was very difficult, particularly for rural and other hard to reach populations. This was due to geographical access as well as high prices for specialty drugs, limited availability of generic drugs, and prohibitive regulations against the introduction of generic medicines. In response to this situation, the CAMEG was created under a presidential decree in 1992 and commenced activities in 1994. In 1997, an evaluation was carried out to determine the impact of the CAMEG and decide whether to continue the activities through a long-term structure; the results of this evaluation proposed establishing a legally and financially autonomous non-profit entity to carry forward the work of the CAMEG.(CAMEG, 2018) Today, the CAMEG manages the selection of drug suppliers for the country, ensures compliance with WHO and national regulations on price and quality, and facilitates distribution and storage of drugs across the country. A full product list of the drugs managed by the CAMEG can be found on their website (www.cameg.com).

Community Level

The availability of essential generic medicines at health and social welfare centres in Burkina Faso is 74.5%, compared with an average of 40% across the African region and less than 60% globally.(World Health, 2016, Ministry of Health, 2010) For hospitals, rates are slightly lower with 61% of generics available and regional hospital centers and 39% at university hospital centers (Saouadogo and Compaore, 2010), but only 1.2% of branded medicines; this situation results in patients who are referred to hospitals from lower level facilities often being forced to purchase medicines from more expensive private pharmacies in order to receive the necessary care at higher levels of the health system.(Vervoort, 2012)

While immense progress has been made in ensuring affordability and accessibility of essential medicines in Burkina Faso, mark-ups at different points along the supply chain still result in prohibitively high prices at final points of sale; patients still pay for 37% of the cost of essential medicines and remain the single greatest healthcare cost for households in Burkina and a burden for the majority of the population who still live on less than $1.25 per day.(Vervoort, 2012)

References

CAMEG 2018. Centrale d’Achats des Médicaments Essentiels. Ouagadougou, Burkina Faso.

Ministry of Health 2010. Measuring the Price, Availability, Financial Accessibility, and Price Composition of Medicines in Burkina Faso. Ouagadougou, Burkina Faso: Ministry of Health of Burkina Faso.

Saouadogo, H. and Compaore, M. (2010) ‘Essential Medicines Access Survey in Public Hospitals in Burkina Faso’, 4(6), pp. 373-380.

Vervoort, K. 2012. Ensuring the Availability of Essential Medicines in Burkina Faso: A Shared Responsibility.

WHO 2018. Essential Medicines. Geneva, Switzerland.

World Health, O. (2016) Burkina Faso: Country Cooperation Strategy. Available at: http://apps.who.int/iris/bitstream/handle/10665/136973/ccsbrief_bfa_en.pdf (Accessed: May).

On their website Sproxil says that, “Sproxil actively supports Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) in the fight against counterfeiting by pioneering Nigeria’s first Mobile Authentication Service.” They note further that …

“On February 2, 2010, NAFDAC launched the NAFDAC MAS, putting the power of product verification right in the hands of the consumer. MAS is powered by Sproxil’s award-winning cloud-based Mobile Product Authentication™ technology, and remains the world’s largest nation-wide implementation of consumer-facing SMS anti-counterfeiting technology in the world.”

Below are two malaria medicine packets recently purchased. After scratching the small label (see it circled, we got the SMS messages as posted.  The NAFDAC registration number alone is not enough to ascertain the validity. This is a smart procedure, even without a smart phone. Of course one still needs to read the expiry dates!

1. OK Genuine P-Alaxin Tablet. Your PIN:949769012921 NRN:04-9495 Problem? Call 08039012929 NAFDAC & Bliss Care Sproxil SMS

2. OK Original Lonart DS tabs NRN:04-9927 Use mosquito nets to help avoid malaria Problem? Call 08039012929 NAFDAC & GREENLIFE CARE Sproxil Solution

A special World Malaria Day 2015 Blog has been established. So far nine postings are available at http://www.worldmalariaday.org/blog. Please read and share with colleagues.

The recently concluded Global Health Systems Research Symposium in Cape Town featured a number of abstracts that touched directly or indirectly on malaria. Malaria services and movement toward malaria elimination cannot be achieved in a country without a strong health system that involves both communities, program staff and policy makers.

Below is an abstract by Freddy Kitutu, Chrispus Mayora, Phyllis Awor, Forsberg  Birger, Stefan  Peterson, and Henry Wamani of Makerere University and the Karolinska Institute on use of medicine shops in Uganda.

“Under-five child mortality in Uganda is still high and majority is caused by easily treatable pneumonia, malaria and diarrhoeal diseases among the poorest people. One of the reasons for these deaths is the lack of timely access to proven life saving medicines. This hinders progress towards attainment of MDG 4 target by 2015.

“To increase access to quality medicines and diagnostics for child febrile illnesses, Makerere University School of Public Health (MakSPH) in collaboration with WHO Alliance for Health Policy and Systems Research, is doing a project to assess the potential to deliver quality integrated care for malaria, pneumonia and diarrhoea using integrated community case management (iCCM) strategies and tools. Hence, an assessment was conducted to determine baseline care seeking preferences.

“A baseline household survey interviewed caregivers of children under-five years. The study protocol and data collection tools had been reviewed and approved by Research and Ethics Committees at WHO, MakSPH and Uganda National Council of Science and Technology.

“A total of 2606 households were surveyed. The main childhood diseases reported included fever (70%), cough (77%), and diarrhoea (40%) convulsions (16%) Most households use private drug shops to purchase medicines to manage these illnesses. Use of drug shops was attributed to long distances to public health facilities, availability and reliability of drug stocks at drug shops, perceived high quality of services, and options for credit.

“Interventions that target public health facilities are likely to miss many healthcare seekers especially the poor in rural distant areas. Conclusion: Drug shops are the convenient and preferred outlets for rural poor communities, and therefore need to be included in interventions such as iCCM strategy.

“Significance for the selected field-building dimension: This abstract presents findings from the baseline assessment prior to introducing a health system intervention in drug shops to improve access to and quality of care for under-five children.”

Patent medicine vendors (PMVs) , also known as medicine shop owners, are a major source of malaria medicines. This qualitative examination of how PMVs perceive their business was conducted by Kabiru Salami, Bill Brieger and Stephen Kodish.

Access to high-quality, affordable medicines is a global concern but manifests in distinctly local ways. In Nigeria, patent medicine vendors (PMVs) are a major source of medicines.  Criticism of PMVs focuses on drug quality, dispensing practices, and their lack of formal health care training.

This qualitative investigation approached PMVs as small business people and sought their business perspectives in comparison with views of other small business owners in Igbo-Ora, Nigeria.  This study utilized an iterative approach to data collection among 51 entrepreneurs.

In-depth interviews about participants’ businesses were collected from PMVs (16), Food (7), Clothing (7), Provisions (9), Motor Parts (n7), and others (n5). A codebook containing 27 themes was inductively developed from emergent data and combined into broader themes for interpretation using Atlas.ti v7.1.

Accounts from participants reveal differences between PMVs and other businesses including amount of education necessary to learn the trade, as well as the level of professionalism and cleanliness required to operate successfully. Unlike other groups, PMVs routinely are asked for highly technical information at point of purchase.

PMVs work largely under strong trade associations due to more controls imposed by regulatory agencies. Although selling medicine is a small-scale enterprise, the purveyors of the trade see their work differently from other small business people. Their business model is based on having adequate knowledge about their products and maintaining standards. PMVs can increase human resources for health because they want to improve both their work and business prospects.

The use of sulphadoxine-pyrimethamine (SP) intermittent preventive treatment of malaria in pregnancy (IPTp) has been offered in stable malaria transmission countries for over a decade.  As observations continued that SP resistance was growing in children treated for malaria, SP was dropped as a recommended treatment drug in all malaria-endemic countries in Africa.  Ironically SP is still commonly found in pharmacy and medicine shops in many countries.

While SP resistance in child treatment has been documented, studies directly testing this in pregnant women have not been designed due to the usual concerns about  the effect of medicines in pregnancy. Already the recommendation for IPTp excluded its use in the first trimester. What has been observed though not that SP does not work, but that its half-life or period of effectiveness has been reduced. Therefore WHO still recommends SP for IPTp, but more frequently.

The new guidelines call for SP as IPTp to be given at every focused antenatal care (FANC) visit after quickening. There are four FANC visits recommended and depending when a woman comes for her first FANC visit, she may be eligible for 3 or 4 monthly IPTp doses.

In order to prevent SP efficacy as used in IPTp from eroding further, there have been strong calls for stopping its use for treatment. This has proved challenging since SP may cost less that one US dollar per dose, while ACTs, if not available free in government clinics (if no stock-outs), cost up to $6-$8 for adult doses. No wonder there is an economic appear to continue to stock SP in private shops for sale as an antimalarial. Even in public clinics SP meant for IPTp may be used by staff when there are ACT stock-outs.

It would seem that most of our national health authorities believe more in the economic laws of supply and demand than in the technical guidelines of WHO. Otherwise SP would not be so widely available in shops. Whether private sector sales of SP are ignored by health authorities or actually tolerated by them, the result is still a threat to mothers and unborn children whose lives can be saved by maintaining the efficacy of SP and banning sales and inappropriate use of SP.  Courage to stand up to private sales is needed.

On a closing note, you will have noticed the picture of the SP packet attached here. It is produced by a Kenyan company and was found in a pharmacy in Malawi. The manufacturer is clearly hoping to rebrand its product. The pharmacist admitted though that few have been sold since pregnant women get SP free at ANC.

Fortunately the shop is not promoting this SP for treatment but instead sells a brand of artemether-lumefantrine. Even this newly repackaged SP product for home use is inappropriate as IPTp should be given as directly observed treatment by a health worker. We should not let such inappropriate use of SP be hidden behind clever packaging. National Malaria Programs and Drug Authorities must join hands to restrict SP use for IPTp.

The Affordable Medicines Facility malaria (AMFm) was aimed at ensuring high quality low cost medicines reached the public and saved lives.  Nigeria was one of the biggest challenges for AMFm with having the highest burden of disease of any single country.  Unfortunately the vastness of the problem seemed to work against the effort.

Instead of concentrating the resources on a few pilot states of local government areas, as often happens, the project was spread thinly across the nation. There was no way that enough medicine would be provided to treat the large number of cases seen annually in the country. In the states only selected medicine shops received training and supplies. Out-of-stock syndrome was common.

One can find the AMFm logo on empty boxes of medicine as seen in the attached photos from medicine shops.  The shop keepers do find the boxes useful for storing other things, and then resort to selling chloroquine to their customers. When will we learn how to conduct pilot programs so that thy actually produce meaningful results and guide future policy decisions?

The AMFm Evaluation Phase 1 Report acknowledges the following among the many factors hindering the AMFm implementation in Nigeria:

• Delayed approval of ACT orders to FLBs
• Inadequate supply of ACTs
• Unstable supply of ACTs
• High transport costs to rural areas
• Inadequate ACT supply pipelines
• Inadequate distribution of ACTs to rural areas
• Re-indication of chloroquine
• Interrupted ACT supplies nationally
• Availability of chloroquine in market

These were certainly issues that could have been addressed with focus on a smaller and more clearly defined pilot area.

Paul Kartchner contributes this guest blog via the SBFPHC Policy Advocacy Blog.For years, a major obstacle to controlling malaria in developing countries has been the high cost of effective medications. Yet in recent years a coalition of public health agencies and organizations are targeting this problem by subsidizing the most effective medications. Called the Affordable Medicines Facility – malaria (AMFm), the project hopes to make these medications more available and affordable to hospitals, physicians, and local pharmacies in developing countries.

Tuberculosis is one of the big three receiving Global Fund support, and like HIV and malaria control efforts, the emphasis is on multiple interventions to ensure ultimate success. Compared to the other diseases, TB’s interventions have been mainly limited to immunization and directly observed treatment. Both of these interventions have recently met some major challenges that have also plagued the other big diseases.

Roger Bate and colleagues, who have focused on the problems of fake and substandard malaria drugs have turned their attention to TB. (see http://masetto.ingentaselect.co.uk/fstemp/a5829970064042ab6ec12023d514ef4f.pdf ). Their investigation at pharmacies in 19 Asian and African countries found around 9% of TB drugs were substandard/poor quality. The rate of fake medicines was 16% in Africa and 10% in Asia.

Governments in these countries were encouraged to give these issues greater attention including better regulation and collaboration with international policing efforts.

The need for new vaccines is a necessary development to maintain a strong disease control arsenal. For TB, “A new vaccine, modified Vaccinia Ankara virus expressing antigen 85A (MVA85A), was designed to enhance the protective efficacy of BCG.” (as reported in The Lancet http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2813%2960177-4/abstract )

As the BBC report on this study pointed out, “BCG is only partially effective against the bacterium that causes TB, which is why several international teams are working on new vaccines.” (see BBC at http://www.bbc.co.uk/news/health-21302518 )

While the new vaccine “… was well tolerated and induced modest cell-mediated immune responses. Reasons for the absence of MVA85A efficacy against tuberculosis or M tuberculosis infection in infants need exploration.” Fortunately research on other vaccine candidates is underway.

Continued control and eventual elimination of malaria and TB will require research that is both basic (vaccines) and applied (drug quality) in order to develop, maintain and implement effective strategies. Disease research budgets should not be compromised in the ever changing world of pathogen/parasite evolution.