Ensuring the quality and safety of COVID-19 treatment medicines
Taking up the fight against substandard and falsified (SF) medicines to ensure the quality and safety of COVID-19 treatment medicines and protect public health and patient health is the current mission of the United States Pharmacopeial (USP) Convention, WHO's International Pharmacopeia, the US Center for Disease Control (CDC) and the Global Pharma Health Fund's Minilab project work (GPHF-Minilab).
“Combating SF Medicines during the COVID-19 Pandemic” is the title of several online work-shops USP is conducting in June and July this year for relevant stakeholders in the South Asian, Latin American, African, Middle Eastern and Western Pacific regions. Join the virtual workshop to learn more about the different types of "Analytical Tools" available to assist regu-lators, quality control laboratories, manufacturers and others in ensuring quality and reducing risks associated with medicines such as Remdesivir, Dexamethasone and Favipiravir used in the treatment of COVID-19. Free access to the next virtual workshop is available after registration at the link.
It is critical that COVID-19 treatments meet quality expectations. USP methods to assist in the detection of falsified remdesivir can be accessed here free of charge. Free access to the new GPHF-Minilab™ screening tool for dexamethasone tablets and injections can also be found via the previous link and directly here.
900th GPHF Minilab™ Delivered
It is another milestone for the GPHF: last month, the 900th mobile compact laboratory for the identification of counterfeit drugs was delivered and has meanwhile arrived safely at its destination, the national control laboratory of the health authorities in the Democratic Republic of Congo. The laboratory was funded by the United States Pharmacopoeia (USP) and the U.S. Agency for International Development (USAID) as part of the Promoting the Quality of Medicines Program (PQM+).
The GPHF has also received good news from West Africa, where the West African Health Organization (WAHO) will soon be deploying a further 19 GPHF minilabs within the framework of an international study in a total of 17 countries.
More than 900 GPHF minilabs are now in operation worldwide, more than half of them on the African continent alone.
Cameroon: Pharmacists also discussed drug counterfeiting
Against the backdrop of the COVID-19 pandemic, Cameroon's pharmacists discussed, among other things, the counterfeits of the active ingredient chloroquiun, which were also detected with the GPHF-Minilab.
GPHF expands Minilab portfolio to include dexamethasone
The GPHF has reacted swiftly to the challenges posed by the COVID-19 pandemic and has developed dexamethasone test methods for its Minilab project work. The new methods can be used to test both tablets and injectable solutions. Dexamethasone has been known for decades and has recently been successfully repurposed for the treatment of COVID-19 intensive care patients. Since then, dexamethasone preparations are considered a scarce and precious commodity in many places.
The new GPHF-Minilab test methods are available for free download here in English and French.
Also in 2020 numerous minilabs delivered
Despite the COVID-19 pandemic with all its restrictions the Global Pharma Health Fund together with his distribution partner Technology Transfer Marburg (TTM) has delivered 29 more GPHF-Minilabs in 2020. Most of them will be used in African countries. In total nearly 900 mobile labs to detect counterfeit drugs are now in mission in 98 countries worldwide.
Back in 2020 also the review of the minilab manuals was completed. Now for the first time all the knowledge of how to use the GPHF-Minilab is collected in only one manual which is available in an English, French or Spanish version. So far A Concise Quality Control Guide on Essential Drugs and other Medicines has met a decidedly positive response.
Real COVID-19 vaccines won't come from Amazon or Alibaba
by Dr. Richard Jähnke, Project Manager GPHF-Minilab™, Global Pharma Health Fund (GPHF)
The global COVID-19 pandemic has profound social, economic and geopolitical implications around the world. Weak medical regulations, lack of post-marketing surveillance and poor enforcement have been challenges in the fight against organised crime in the medicinal arena for many years. Facing limited COVID-19 vaccine production, billions of people are waiting for their turn to receive a COVID-19 vaccine that could be still months away.
Scammers are luring victims online, in emails and on messaging apps with claims that they can deliver the vaccine within days for as little as US$150. The black market in Mexico shows how quickly criminal groups have adapted to the rising demand for coronavirus treatments. A stolen flu vaccine is the latest drug to surface on Latin America's burgeoning black market medicine trade, showing how criminal gangs are increasingly offering items believed to help against COVID-19. Mexico says organised criminal networks have set up laboratories to produce fake COVID-19 vaccines and also plan to steal supplies during distribution. The Mexican government has promised to make vaccinations available free of charge throughout the country of nearly 129 million people, but with lawlessness and cargo theft a massive problem in the country, that appears to becoming a major challenge. Actually, Mexico could become an epicentre for criminal activities around COVID-19 vaccines.
Last month, Interpol issued an "Orange Notice" to police forces in its 194 member countries, warning them to prepare for counterfeiting, theft and illegal promotion of COVID-19 and flu vaccines this winter and beyond. Interpol has warned that organised criminals are preparing to profit from the launch of COVID-19 vaccines. Criminal gangs are making billions from counterfeit medical products during the pandemic. When demand exceeds supply, it creates an environment where substandard and falsified medical products proliferate. Myanmar's Food and Drug Administration has warned the public about so-called COVID-19 vaccines being sold in the country. The government said it is taking steps to prevent the smuggling and sale of fake vaccines and other medicines. On Facebook, traders sell COVID-19 tests for 20,000 kyat (US$15) and, moreover, COVID-19 treatments that they claim are made in China. However, COVID vaccines are not sold via WeChat or Alibaba.
The first mRNA vaccines have temperature control requirements and cannot simply be sent to customers by post. They are not even available through a brick and mortar pharmacy or hospital. In most countries, they are only available through licensed vaccination centres. In January this year, MEDISAFE launched an awareness campaign to inform the public in Kenya about the risks of counterfeit COVID-19 products. Other East African countries will follow. Falsified medicines are very difficult to detect and may appear identical to the genuine product. However, they fail to treat the patient and in some cases can lead to serious illness or death. This could feed the opponents of vaccination with arguments.
When demand exceeds supply, an environment is created where substandard and falsified medical products proliferate. While consumers obey the commands of social distancing and stock up on vital medicines in e-commerce, supposedly to prevent and cure COVID-19, transnational organised crime networks quickly enter the scene to meet the growing demand with falsified medical products and fake personal protective equipment.
Fight the Fakes Week
From 7 to 13 December the international partners of the Fight the Fakes campaign, one of them is the Global Pharma Health Fund (GPHF), will be running the third Fight the Fakes Week. On a global level and focusing on diverse social media activities the Fight the Fakes will raise awareness on the danger of counterfeit drugs. The motto will be “LET’S FIGHT THE FAKES – THROUGH THE PANDEMIC AND BEYOND.”
One of the partner of the Fight The Fakes campaign, the King’s College London, has set up a special webinar series on the occasion of the Fight The Fakes Week. Each webinar is dedicated to a different topic concerning substandard and falsified medicines.
Fight the Fakes is a global campaign aiming at education the public about the danger of substandard and falsified medicines. Founded in 2013 the campaign now counts numerous international Partners. For more information please see here.
New GPHF Manual in Spanish edition too
In addition to the English and the French version the new manual on the GPHF-Minilab™ now is published in a Spanish edition too. On more than 400 pages the manual offers all necessary information on the 100 test method of the mobile lab to identify counterfeit drugs. For a demo version of the Spanish edition and information on subscription please see here.
GPHF-Minilab™ unmasked plenty of fake chloroquine pills in Africa
In the face of the COVID19 pandemic, criminal gangs will take advantage of the general shortage of medicines and markets may be flooded with falsified, inferior, defective, ineffective or even dangerous medicines. This is all the more true when a traditional antimalarial drug is intended for a potential COVID19 cure and treatment. As a result, many fake versions of chloroquine have recently appeared in French-speaking Africa and reported by the World Health Organization. For more information please see here.
New Study shows: Counterfeit pharmaceuticals traded worldwide
A new report released by the European Union Intellectual Property Office (EUIPO) and the Organisation for Economic Cooperation and Development (OECD) shows that meanwhile counterfeit pharmaceuticals are traded worldwide, that the total value of counterfeit pharmaceuticals reaches billions of Euro, that antibiotics, lifestyle drugs and painkillers are most targeted and that China and India are identified as largest producers of those counterfeits. For more information on the report please see here.
GPHF-Minilab presented at the African Medical Quality Forum
The African Medical Quality Forum (AMQF2020) aims to improve access to quality assured medicines across Africa, and this year's forum in Abuja (Nigeria) was focussing on the fight against counterfeit and substandard medicines. The GPHF-Minilab as well as corresponding experiences and case studies from sub-Saharan Africa were presented by Prof. Heide of the University of Tübingen and Nigerian members of the faith-based Ecumenical Pharmaceutical Network (EPN) in Africa. The EPN currently maintains 14 sites equipped with Minilabs to monitor the quality of priority medicines on site and to protect patients from consuming fake and poor-quality medicines. The AMQF is a technical forum composed of official national medicines quality control laboratories from across the continent.
Presentation of the GPHF-Minilab during the African Medical Quality Forum.
New GPHF Manual in French edition too
In addition to the English version the new manual on the GPHF-Minilab™ now is published in a French edition too. On more than 400 pages the manual offers all necessary information on the 100 test method of the mobile lab to identify counterfeit drugs. For a demo version of the French edition and information on subscription please see here.
African governments agree to criminalize falsified drugs trafficking
Heads of state of seven African countries met in Lomé, Togo, to sign the Lomé Initiative, a political declaration to tackle fake medicine distribution on the continent. For more information please see here.
Donation of GPHF-Minilab™ in Mongolia
For the first time a GPHF-Minilab™ was given to the healthcare authorities in Mongolia. The mobile lab for the detection of counterfeit drugs is a donation of Merck und was presented during a press event in the capital Ulaanbaatar. The picture shows Amar Bazarragchaa, General Director of the Mongolian Government Regulatory Agency for Specialized Inspection (right), who takes a look on the lab and its components in front of the media representatives.
2. Fight the Fakes Week
From 2 to 8 December the international partners of the Fight the Fakes campaign, one of them is the Global Pharma Health Fund (GPHF), will be running the second Fight the Fakes Week. On a global level and focusing on diverse social media activities the second Fight the Fakes will raise awareness on the danger of counterfeit drugs. The motto will be “BE AWARE, SPEAK UP, FIGHT THE FAKES.”
Fight the Fakes is a global campaign aiming at education the public about the danger of substandard and falsified medicines. Founded in 2013 the campaign has now 37 Partners. For more information please see here.
One of the social media cards of the Fight the Fakes week 2019.
GPHF-Minilab™: Once again counterfeit drugs unmasked
Once again the GPHF-Minilab has exposed counterfeit drugs. The counterfeits were detected in the Chad and the Central African Republic during routine drug quality surveys. The fakes were counterfeits of antimalarial products. For more information please see here.
GPHF-Minilab™: Manual and further tests set a new standard
The Global Pharma Health Fund has completely revised the contents of its manuals for the GPHF-Minilab and for the first time summarized them in a single volume, now comprising 450 pages. At the same time, test methods for ten new active pharmaceutical ingredients have been added. Now, the GPHF-Minilab comes with a total of 100 thin-layer chromatographic test protocols for 100 prevailing active pharmaceutical ingredients to be found in a plethora of priority medicines for the treatment of transmissible and non-transmissible diseases. A demo version and more information can be found here.
The new Minilab manual.
Once again Minilab detect counterfeit medicine
Due to the GPHF-Minilab™ once again a counterfeit medicine has now been exposed. With the help of the mobile lab local healthcare organizations in Cameroon identified blood pressure tablets without the declared active ingredient. The relevant authorities were informed immediately and have released relevant alerts. For more information please see here.
Fake HYDROCHLOROTHIAZIDE 50 mg TABLETS currently circulating in Cameroon. Picture credit: Tubingen University
GPHF-Minilab online presentation on 20 February 2019
From 19 to 22 February, the International Pharmaceutical Student Federation (IPSF) will host each day one webinar on the topic of falsified and substandard medicines including the GPHF-Minilab story on Wednesday evening CET.
Understanding the need to educate future healthcare providers about issues they are going to face in their professional life sooner or later, IPSF together with Fight-the-Fakes Members decided to create a course of four online lectures with essential messages to guide, motivate and inspire young people to act and raise awareness about falsified medicines.
Therefore, IPSF engaged with World Healthcare Students' Alliance to reach out to medical, dental and veterinary students thus giving the event also a multidisciplinary dimension.
For seminar registration go to http://bit.ly/2Goiack.
Nigeria: Counterfeiting operation detected
Shortly before the turn of the year a production site for falsified medicines has been raided by police forces near the Nigerian port city Lagos. It is perhaps auspicious that the fight against the criminal activities of the counterfeiters will be successful in 2019 too. For more information please see here.
Fight the Fakes Week
From 3 to 9 December 2018 for the first time the Fight the Fakes campaign will launch an action week on the danger of counterfeit drugs. The Fight the Fakes week will focus on several social media activities to raise awareness and speak up on falsified medicines. The Fight the Fakes campaign is already supported by 37 organizations and one of them is the Global Pharma Health Fund (GPHF). For more information please see here.
Greater Mekong Subregion: Fight against counterfeit drugs
At a conference in the Cambodian capital Phnom Penh the Mekong neighboring states now announced an intensification of their joint efforts to fight substandard and falsified medicines. Experts assume that in Southeast Asia for instance 30 percent of antimalarial drugs are of poor quality.
To control the quality of the medicines offered in the Greater Mekong Subregion already more than 150 GPHF-Minilabs are in place and more training courses in the use of the mobile lab are scheduled for 2019. For more information please see here.
Appeal for global access to quality-assured medicines
“Every person has the right to expect that when they use a medicine or medical product, it works” – with this urgent appeal the conference “Medicine Quality & Public Health”, held in Oxford, UK from 23 to 28 September, has ended. According to figures issued by the WHO in November last year, 1 in 10 medical products in low and middle-income countries being of poor quality, a gross failure or an outright fake. In the so-called Oxford Statement the conference participants demand concrete measures to address this matter.
Dr. Richard Jähnke represented the Global Pharma Health Fund (GPHF) during the conference, attended by 200 experts form 50 countries. Here the GPHF-Minilab™ was praised as an important contribution to fight counterfeit drugs and to improve the quality of the pharmaceutical supply. For more information please see here.
Prof. Dr. Moji Christianah Adeyeye, General Director of the Nigerian Medicines Control Agency and Dr. Richard Jähnke from the GPHF in Oxford.
GPHF will join international congress
The GPHF will participate in the international congress “Medicine Quality in Public Health” in September in Oxford, UK. Representing the GPHF, Dr. Richard Jähnke will speak on the GPHF-Minilab™ and the long-time experiences of the GPHF in fighting counterfeit drugs. The congress will take place from 23 to 28 September at the University of Oxford and is sponsored by the World Health Organization and the Bill & Melinda Gates Foundation among others. For more information please see here.
DIFAEM welcomes GPHF-Minilab™
In its new Annual Report the German Institute for Medical Mission (DIFAEM) welcomes the GPHF-Minilab™ and its benefits for the drug safety in developing countries. In the past years DIFAEM has established a network of minilabs with 17 partners in in eleven African countries to protect people from counterfeit drugs. DIFAEM recalls that back in 2017 a total of 1.032 samples were analyzed within the network and out of this seven samples were classified as serious and dangerous fake. In two cases the World Health Organization thereupon released an international drug alert.