# \[e-drug\] E-DRUG: Falsified medicines in Africa **URL:** \ **Category:** e-drug\ **Created:** [January 28, 2015, 2:31pm UTC](https://talk.edrugplus.org/t/e-drug-e-drug-falsified-medicines-in-africa/41393 "2015-01-28T14:31:58Z")\ **Posts on this page:** 3\ **Page:** 1
**Author:** ![Siyed\_Rizwanuddin\_Ah](https://avatars.discourse-cdn.com/v4/letter/s/67e7ee/32.png) [@Siyed\_Rizwanuddin\_Ah](https://talk.edrugplus.org/u/Siyed_Rizwanuddin_Ah)\ **Post date:** [January 28, 2015, 2:31pm UTC](https://talk.edrugplus.org/t/e-drug-e-drug-falsified-medicines-in-africa/41393/1 "2015-01-28T14:31:58Z")
E-DRUG: Falsified medicines in Africa ---------------------------------------------------------------------------- Dear E-druggers, At the end of this note, I am posting an interesting letter in response to Paul Newton's original article in Lancet Global Health on 'Falsified medicines in Africa' which was shared in E-DRUG earlier. The author describes a unique US government-funded initiative to combat the epidemic of counterfeit medicines. Best wishes, Rizwan Syed Rizwanuddin Ahmad, MD, MPH, FISPE, FCP Consultant with Special Interest to Strengthen National Medicines Regulatory Authorities in Resource-limited Countries Formerly (1998-2013) with the U.S. Food and Drug Administration Assistant Professor (adjunct), Georgetown University School of Medicine, Washington, DC, USA Email: drugsafetyconsultant@gmail.com www.drugsafetyconsultant.com --------------- Lancet Global Health Vol.3, No. 2, Feb 2015 Correspondence Falsified medicines in Africa Tim Ziemer Open Access DOI: [http://dx.doi.org/10.1016/S2214-109X(14)70363-8](http://dx.doi.org/10.1016/S2214-109X(14)70363-8) In their letter on falsified medicines in Africa (September issue),1 Paul Newton and colleagues lament obstacles to improving the global supply of drugs, especially in unregulated informal markets in Africa. We share their concerns, but the authors do overlook important efforts to curb the flood of fake and substandard malaria medicines. The US President's Malaria Initiative, for one, is teaming up with local police, customs agents, national medicines regulatory authorities, and drug sellers to help reduce the availability of counterfeit drugs in informal private sector outlets and marketplaces. The President's Malaria Initiative is working programmatically with the US Agency for International Development's Office of Inspector General (USAID OIG) to address and mitigate availability of counterfeit drugs in the market place.2 For example, in Benin, in a mostly unregulated market in which shop owners and street vendors sell drugs, including antimalarials, the Initiative is partnering with the USAID OIG, local law enforcement, and Ministry of Health officials to launch an anticounterfeit outreach programme by educating and incentivising shopkeepers to report suspected counterfeit medicine networks, while informing consumers on the dangers of substandard drugs and how to recognise them. Benin is the first of several sub-Saharan African countries where this initiative will be implemented. And, the USAID OIG is actively investigating crimes, working with local law enforcement agencies in several countries, leading to arrests and prosecutions. In all 19 focus countries in Africa, the President's Malaria Initiative is partnering with national medicines regulatory authorities to help strengthen local capacities regarding drug quality as part of the US Government's overall technical assistance towards strengthening health systems. The Initiative is helping countries improve surveillance capacity to better monitor drug quality through randomly testing drugs commonly found in both the private and public sectors,3 including mini-laboratory sentinel sites,4, 5 and pilot activities in collaboration with the US Food and Drug Administration and their CD-3 device.6 Although we agree that medicines regulatory authorities need to be strengthened, we are seeing important progress. Recently, two national drug reference laboratories in sub-Saharan Africa received ISO-17025 accreditation—an internationally recognised standard regarding laboratory competency.7 These long-term gains represent sustainable health systems capacity building, enabling partner country medicines regulatory authorities to perform much needed quality testing. The President's Malaria Initiative is providing substantial support to countries to improve regulation and enforcement capacity of both the public and private sectors, and we are expanding efforts with partner countries to strengthen all areas of their pharmaceutical supply chain, including forecasting, storage, transportation, and inventory management.8 Finally, as a major procurer of artemisinin-based antimalarials,9 the Initiative employs a stringent quality assurance and quality control strategy, ensuring that only good quality drugs are used in support of US Government malaria programmes not only in sub-Saharan Africa, but also the greater Mekong subregion. Although there are various estimates of the burden of fake drugs, WHO believes that fake medicines are now a US$75 billion per year industry.10 We agree with Newton and colleagues that more must be done to assure quality of medicines, and second their call for an international public health convention on the topic. I declare no competing interests. The opinions expressed herein are those of the author and do not necessarily reflect the views of the US Agency for International Development. References 1.Newton, PN, Tabernero, P, Dwivedi, P et al. Falsified medicines in Africa: all talk, no action. Lancet Glob Health. 2014; 2: e509–e510 2.US President's Malaria Initiative (PMI) approach and steps to counter theft and diversion of medicines. [http://www.pmi.gov/docs/default-source/default-document-library/tools-curricula/malariadrugs\_counteringtheft.pdf?sfvrsn=4](http://www.pmi.gov/docs/default-source/default-document-library/tools-curricula/malariadrugs_counteringtheft.pdf?sfvrsn=4). ((accessed Dec 19, 2014). 3.PMI. President's Malaria Initiative Increases Vigilance, Global Response To Combat Counterfeit Antimalarial Drugs. [http://www.pmi.gov/news/all/news-full-view/president-s-malaria-initiative-increases-vigilance-global-response-to-combat-counterfeit-antimalarial-drugs](http://www.pmi.gov/news/all/news-full-view/president-s-malaria-initiative-increases-vigilance-global-response-to-combat-counterfeit-antimalarial-drugs). ((accessed Dec 19, 2014). 4.PMI. Countering Unregistered and Illegal Antimalarial Drugs in Ethiopia. [http://www.pmi.gov/news/stories-from-the-field/stories-from-the-field---detail/countering-unregistered-and-illegal-antimalarial-drugs-in-ethiopia](http://www.pmi.gov/news/stories-from-the-field/stories-from-the-field---detail/countering-unregistered-and-illegal-antimalarial-drugs-in-ethiopia). ((accessed Dec 19, 2014). 5. Global Pharma Health Fund. [http://www.gphf.org/web/en/gphf/projekte.htm](http://www.gphf.org/web/en/gphf/projekte.htm). ((accessed Dec 19, 2014). 6. US Pharmacopeial Convention. Field testing for rapid counterfeit drug screening tool begins in Africa. [http://www.usp.org/news/field-testing-rapid-counterfeit-drug-screening-tool-begins-africa](http://www.usp.org/news/field-testing-rapid-counterfeit-drug-screening-tool-begins-africa). ((accessed Dec 19, 2014). 7. ISO. General requirements for the competence of testing and calibration laboratories.[https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed-2:v1:en](https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed-2:v1:en). ((accessed Dec 19, 2014). 8. PMI. US President's Malaria Initiative (PMI) approach to health systems strengthening. [http://www.pmi.gov/docs/default-source/default-document-library/tools-curricula/pmi-and-health-systems-strengthening\_final.pdf?sfvrsn=4](http://www.pmi.gov/docs/default-source/default-document-library/tools-curricula/pmi-and-health-systems-strengthening_final.pdf?sfvrsn=4). ((accessed Dec 19, 2014). 9. PMI. Eighth annual report to Congress. [http://www.pmi.gov/docs/default-source/default-document-library/pmi-reports/pmireport\_final.pdf?sfvrsn=16](http://www.pmi.gov/docs/default-source/default-document-library/pmi-reports/pmireport_final.pdf?sfvrsn=16). ((accessed Dec 19, 2014). 10. Beard, S. Fake pharmaceuticals are a $75 billion global industry. [http://www.marketplace.org/topics/world/fake-pharmaceuticals-are-75-billion-global-industry](http://www.marketplace.org/topics/world/fake-pharmaceuticals-are-75-billion-global-industry). ((accessed Dec 19, 2014). ---
**Author:** ![William\_Mwatu](https://avatars.discourse-cdn.com/v4/letter/w/91b2a8/32.png) [@William\_Mwatu](https://talk.edrugplus.org/u/William_Mwatu)\ **Post date:** [January 29, 2015, 8:09am UTC](https://talk.edrugplus.org/t/e-drug-e-drug-falsified-medicines-in-africa/41393/2 "2015-01-29T08:09:45Z")
E-DRUG: Sustainability after donor support --------------------------------------------------------------------------------- Being on the ground and having worked across many sub Saharan countries, it is important to note tremendous work that has been done especially in the area of antiretrovirals and antimalarials, but the same efforts are not replicated in other therapeutic areas. One of the key questions and concerns is around sustainability of the current efforts especially in absence of donor support. Dr William Mwatu Team lead Tried Approach limited Kenya Email. Bmwatu@ yahoo.com or bmwatu@triedapproach.com ---
**Author:** ![Pascal](https://dub1.discourse-cdn.com/flex013/user_avatar/talk.edrugplus.org/pascal/32/301_2.png) [@Pascal](https://talk.edrugplus.org/u/Pascal)\ **Post date:** [February 3, 2015, 6:41am UTC](https://talk.edrugplus.org/t/e-drug-e-drug-falsified-medicines-in-africa/41393/3 "2015-02-03T06:41:39Z")
E-DRUG: Sustainability after donor support (2) --------------------------------------------------------------------------- Dear William I agree, being close to national disease programs run by Government institutions, but funded by donors particularly the GF, i see impact i.e. reducing disease now but at the same time there are inefficiencies and the GF is de facto sustaining unsustainable health care systems for the post era and long term. The larger programs, at least HIV, are more likely to get governments taking responsibility e.g. procure the ARVs for treatment programs (but less on prevention?) and whereas it is the smaller epidemics, concentrated pockets of affected and vulnerable people in the lower prevalence countries that seem to be going to miss out on the promise of zero infections and life long care when the country GDP starts growing and donors (eventually) phase out the funding. Counterpart financing and sustainability are higher on the GF agenda now and starting to take shape hopefully under GF's New Funding Model (NFM) through defining 'sustainability', developing and implementation of sustainability plans for the three diseases. Together with the GF's eligibility criteria and thus more predictable/equitable funding levels allocated to countries makes it more clear ahead of time on the receiving end that the external support can not last forever. These will start to change the rules of the game quite a bit for transitioning countries affected by HIV, TB and or Malaria epidemics. On the GF website you can find the TERG Evaluation on GF Thematic Review on GF Sustainability (74 pages) which is worth reading in this case. PS while checking the GF Grant Regulations 2014 and the Framework Agreement (for NFM to be signed at high level government) it is surprising that the word "sustainability plan" does not appear (mandatory tax exemption, respect for human rights and privileges & immunity for the GF do) best, Pascal with kind regards Pascal Verhoeven MPH/pharmacist Lao PDR Mobile +856(0)2077596717 +856(0)2097141783 Pascal Verhoeven \