Category Archives: Drug Quality

Verifying Malaria Medicines on Your Mobile

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!

P-Alaxin front scratch off1. OK Genuine P-Alaxin Tablet. Your PIN:949769012921 NRN:04-9495 Problem? Call 08039012929 NAFDAC & Bliss Care Sproxil SMS

Lonart DS back PIN2. OK Original Lonart DS tabs NRN:04-9927 Use mosquito nets to help avoid malaria Problem? Call 08039012929 NAFDAC & GREENLIFE CARE Sproxil Solution

World Malaria Day 2015 Blog Postings Help #DefeatMalaria

wmd2015logoA 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.

1. “Investing in integrated health services to defeat malaria”BY ELAINE ROMAN, MCSP Malaria Team Lead.

2. “Fake antimalarials: how big is the problem?”

BY DÉBORA MIRANDA, Technical Communications Officer, ACT Consortium (UK).

3. “Why antimalarial medicines matter”WMD15_7_Facebook_Final

BY PROFESSOR PAUL NEWTON AND ANDREA STEWART, Worldwide Antimalarial Resistance Network and Laos Oxford University Mahosot Hospital Wellcome Trust Research Unit.

4. “Malaria as an entry point for addressing other conditions”

BY HELEN COUNIHAN, Senior Public Health Specialist, Community Health Systems.

5. “Bridging the Care-Seeking Gap with ProAct”

BY MATT McLAUGHLIN, Program Manager of Peace Corps Stomping Out Malaria in Africa initiative.

WMD15_6a_Facebook_Final6. “Defeating Malaria in Pregnancy”

BY CATHERINE NDUNGU, ELAINE ROMAN AND AUGUSTINE NGINDU, Jhpiego.

7. “Intermittent Preventive Treatment, a Key Tool to Prevent and Control Malaria in Pregnancy”

BY CLARA MENÉNDEZ, Director of ISGlobal’s Maternal Child and Reproductive Health Initiative.

8. “Widespread artemisinin resistance could wipe out a decade of malaria investment”

BY TIM FRANCE, Asia Pacific Leaders Malaria Alliance.

9. “The long walk to a malaria-free world”

BY DAVID REDDY, CEO Medicines for Malaria Venture.

Registered drug shops are preferred for treating acute febrile illness in rural Uganda

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.

globalsymposium_logosBelow 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 Vending: vendors’ perspectives on business and health

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.

DSCN3873 Pharmacies see many malaria patients, but do they keep malaria records 2Access 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.

Time to Stop Selling SP in Pharmacy and Medicine Shops

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.

dscn3695-sm.jpgIt 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.

AMFm – more than empty boxes?

dscn2941-sm.jpgThe 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.

dscn2801-sm.jpgOne 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.

Revisiting the AMFm Controversy

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.

amfm-2010-04-23_malaria-shipment-abuja-novartis.jpgPhoto shows Workers load AFMm medications in Abuja, Nigeria (courtesy Novartis International AG)

Yet even though the project has been found to increase the supply of medications, criticisms have been raised regarding the program’s long-term benefits. A recent report by Oxfam, an international aid group, claims that although these medications are now broadly available, they are not being used appropriately to treat patients with malaria. They also claim that many patients that do need these medications, including women and children, still do not have access to them.

Another aid group, Doctors without Borders/Médecins Sans Frontières (MSF), claims that a project like AMFm cannot be successful if it is not carefully integrated into a larger strategy to combat malaria. Instead MSF recommends a plan whereby not only the medication but also treatment by knowledgeable providers is subsidized.

These criticisms raise important questions about the nature of complex global diseases such as malaria. Focusing efforts and resources on a particular aspect of a problem without considering the larger context may not only fail to improve the situation, but potentially make it worse.

TB setbacks: lessons for malaria control

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.
dscn3873sm.JPG

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.

Fakes and Fraud: another threat to malaria funds

While some countries are being praised this week for their progress in controlling malaria, Uganda seems to be suffering from a double knock out punch when it comes to malaria financing. Challenges have appeared in both the private and public sectors.

In the most recent scorecard from the African Leaders Malaria Alliance (ALMA) scored poorly in terms of long lasting insecticide treated net distribution and low on the measure of government financial support for the health sector.

herbshop2a-sm.jpgThe private sector challenge has come in the form of fake medicines in local shops. This comes in the form of a threat to individuals and families who spend their hard earned cash, that is out-of-pocket expenditure (OOP) of malaria medicines that at best inappropriate and at worse are devoid of active ingredients, increasing the likelihood that the sick person will develop severe disease and maybe die.

Specifically the Washington Post reported that an indigenous medical practitioner “in Kampala, says he has seen a big increase in business as patients turned off by the prospect of dangerous fake drugs seek relief from illness.” The article explains that although “Officials and international aid agencies have long encouraged the sick to place their trust in modern medicine. But fake pharmaceuticals believed to have come from Asia have flooded” African Markets including Uganda.

The irony is that Uganda is part of the testing of the Affordable Medicines Facility malaria (AMFm) project that was supposed to drive out fake and inappropriate medicines by making low cost (subsidized) quality antimalarials available in both public and private sectors. While Uganda witnessed an increase in market share of the green-leaf branded quality assured artemisinin-based combination therapy drugs, it did not achieve other benchmarks such as supportive behavior change communication and low cost targets (mark-up averaged 133% – highest among the 8 pilots).

The second threat comes from extensive embezzlement by national malaria program staff.  Earlier this month Uganda was in the news for returning 4 million Euro of misappropriated funds to the Irish Government.

Then an ongoing investigation into embezzlement came to light a few days ago. The Observer Newspaper as shared on AllAfrica.com reported that …

“An investigation into the financial practices of officials running the ministry of Health’s Malaria Control programme (MCP) shows they forged almost everything from workshops, car hires, allowances and fuel expenses. The investigation has now shifted its focus to the extent of the forgery and theft by officials implicated in the loss of nearly Shs 78bn (US $29m). The shift in the focus of the inquiry follows a review of stacks of documents provided by three suspects involved in the MCP scandal. Police confirm that the documents show the extent of the forgery by some officials involved in the anti-malaria campaign.”

In these times when it is difficult to increase health development spending for malaria both domestically and from international donors, all efforts are needed to ensure that waste and fraud are eliminated.

AMFm – the importance of training malaria medicine providers

When the Affordable Medicines Facility malaria (AMFm) was conceptualized, designers clearly identified several ‘supportive mechanisms’ that would be needed at the country level. In particular guidance called for “RESPONSIBLE INTRODUCTION: IN-COUNTRY SUPPORTING INTERVENTIONS” [1] in five key areas:

  • National policy and regulatory preparedness
  • Wholesaler incentives and pricing/margin-control mechanisms
  • Public education and awareness (IEC)
  • Provider training
  • National monitoring and quality preparedness (resistance monitoring, pharmacovigilance, and quality surveillance)

dscn7970-ghana-shop-amfm.jpgThe planners envisioned the need to, “Train health professionals and private wholesalers/retailers to promote safe and effective use of ACTs, including diagnosis, prescription, and treatment,” since many of these would be in the private and/or informal sector without the benefit of more orthodox health training or recent updated in-service training. Such training could also reinforce other supportive interventions such as consumer education and adherence to recommended pricing levels.

AMFm was designed as a two-year ‘pilot’ to determine subsidized antimalarials could get into the market – both private and public – in such a was as not only to increase overall supply of quality medicines, but also drive out more expensive and inappropriate drugs. As the project comes to a close at the end of this year, many people are looking to see if it would make a difference.

Earlier this year Yamey, Schäferhoff and Montagu [2] raised the question – what would AMFm’s success look like.  Would the subsidized quality drugs really ‘crowd out’ the costlier share of the market?  In the process they too addressed the importance of supportive interventions, noting that, “In addition to the price subsidy, the AMFm involves supportive interventions aimed at boosting ACT use, including in-country branding and associated awareness campaigns for sellers and patients, training for ACT providers and greater access to rapid diagnostic tests for malaria.”

dscn7972-ghana-amfm-meds.jpgNow a preliminary report has come out looking at the outcome issues of Artemisinin-based Combination Therapy (ACT) availability, affordability, use and market share. [3]  A key finding so far has been that, “It is notable that the major benchmarks for success for the upstream indicators of availability, price and market share of quality-assured ACTs have been met or exceeded in 6 of 8 pilot countries, particularly in light of the short implementation period.”

The Advisory group was concerned that, “the evaluated implementation period in each pilot was less than 12 months for assessing the full combined effect of the three components of the model: (i) manufacturer negotiations; (ii) buyer co-payment; and (iii) supporting interventions,” but were excited that even with such drawbacks, progress was evident.

They focused their definition of the ‘supporting interventions’ on consumer education and awareness (IEC/BCC) and provider training and observed that these were, “integral to assuring success of the program objectives of increasing availability and market share and decreasing price” of quality ACTs. They found that “Pilots with higher achievement had the following characteristics: longer period of co-paid ACTs in-country with simultaneous implementation of key supporting interventions (i.e., IEC/BCC and provider training) …”

The initial model for AMFm envisioned that almost 20% of the grant should be devoted to these supportive interventions, and the pay-off seems to be confirmed. The training component will become even more crucial as malaria rapid diagnostic tests (RDTs) become a more common part of provider skill sets, especially those in the private sector.

Not every health management problem can be solved by training and education, but the AMFm experience seems to show that these are crucial components in a comprehensive program to increase access to affordable quality medicines.  Whether the actual structure of AMFm continues past this year or not, we need to take the lessons and apply them in guaranteeing that those in need receive appropriate and affordable malaria medicines at the closest point of care.
[1] Technical Design for the Affordable Medicines Facility-malaria. November 2007. Prepared with guidance from the AMFm Task Force of the Roll Back Malaria Partnership. http://rbm.who.int

[2] Yamey G, Schäferhoff M & Montagu D. Piloting the Affordable Medicines Facility-malaria: what will success look like? Bull World Health Organ 2012;90:452–460.

[3] Expert Advisory Group on the Affordable Medicines Facility-malaria (AMFm) Review of the AMFm Phase 1 Independent Evaluation Preliminary Report Friday 22 June 2012, Geneva