Counterfeit drugs: UNDOC report with shocking facts
A report now published by the United Nations Office on Drugs and Crime (UNDOC) comes to shocking conclusions. According to the report, in the sub-Saharan part of the African continent alone, up to 500,000 people fall victim to counterfeit or low-quality medicines every year. Those affected are mainly antibiotics and drugs to protect against malaria. This not only causes untold human suffering, but also immense economic damage. Further information on the report can be found here.
GPHF General Meeting
Despite the difficult general conditions caused by the Corona pandemic, the Global Pharma Health Fund e.V. (GPHF) has now been able to draw a positive balance of its project work of the past three years at its general meeting. In the meantime, the number of active pharmaceutical ingredients that can be identified with the GPHF-Minilab™ has not only been increased to 107, but numerous additional laboratory units have also been ordered by international partners, so that the total number has now already risen to more than 960. The GPHF also regards it as a very positive signal that the German Association of Research-based Pharmaceutical Companies has become a member of the GPHF and has also declared its willingness to specifically promote the further technological development of the mobile test laboratory for the identification of counterfeit or low-quality drugs in the future.
In the course of the board elections, Dr. Johannes Waltz and Dr. Jutta Reinhardt-Rupp were confirmed in their positions as chairman and deputy chairman, respectively. Birgit Kröling-Neumann will also join the GPHF board as treasurer.
Minilab Training on the Fiji Islands
For the first time since the beginning of the corona pandemic, the GPHF has now been able to conduct another minilab training course. At the invitation of the World Health Organisation (WHO), Dr Richard Jähnke of the GPHF travelled to the Fiji Islands at the end of November and instructed 15 staff members of the national health authorities and local hospitals at the WHO training center in Nadi in the handling of the mobile test laboratory for the identification of counterfeit or qualitatively inferior drugs. According to the GPHF, the one-week training course was very successful, as the participants, most of them pharmacists, were well qualified and highly motivated.
The WHO Regional Office for the Western Pacific, based in Manila, Philippines, had procured and distributed five GPHF minilabs for its Department of Pacific Technical Support (DPS) in Suva, Fiji, in late 2019, just before the start of the Corona pandemic. Five Pacific island countries (Fiji, Tonga, Nauru, Tuvalu, and the Solomon Islands) each subsequently received a GPHF minilab to strengthen drug safety in the field.
Impressions from the Minilab training in Fiji
Fight The Fakes action week 2022
For the fifth time, the international action week of the Fight The Fakes initiative will take place from December 5 to 11. This year's theme is "Keeping Patents Safe By Securing The Global Medicines Supply Chain" and aims to highlight the importance of a safe and reliable supply chain for the global supply of medicines and patient safety.
The Fight The Fakes initiative is a coalition of international organizations and is also supported by the Global Pharma Health Fund e.V. (GPHF). Its aim is to draw worldwide attention to the health hazards posed by low-quality and counterfeit medicines and to protect people from the associated risks to their health.
Further information on this year's campaign week can be found here:
The GPHF Minilab™ in Practice - A Systematic Observation
Under the title "Surveillance for substandard and falsified medicines by local faith-based organizations in 13 low- and middle-income countries using the GPHF Minilab", a study has now been published which for the first time documents, analyses and evaluates the use of the mobile test laboratory for the identification of falsified and low-quality medicines in larger geographical contexts - thirteen countries on two continents - and over a longer period of time - two years. The compact laboratory is proving to be a reliable, effective and cost-efficient method of monitoring drug quality in the field. The 13-page report of the study can be found here.
USD 11 million in illicit medicines seized in global INTERPOL operation
Every day, advertisements for medicines invade the Internet, posted on social media networks or other websites. However, behind this slick marketing often lies fraudulent products that threaten consumers’ health instead of healing them.
The global trade in illicit pharmaceuticals is a vast and lucrative crime area – valued at USD 4.4 billion – which attracts the involvement of organized crime groups around the world.
Over just one week (23-30 June), 94 INTERPOL member countries representing every continent launched a coordinated crackdown on illicit online pharmacies in Operation Pangea XV. Globally, law enforcement made more than 7,800 seizures of illicit and misbranded medicines and healthcare products, totaling more than 3 million individual units. More information and many photos of the operation can be found here.
Illicit medical products uncovered by law enforcement in Panama. (Picture: INTERPOL)
GPHF-Minilab™ Manual: New Translations
In recent months, the range of applications of the GPHF-Minilab has been further extended by the inclusion of five active substances for the treatment of hypertension. In addition to the English translation, the description of the corresponding methods is now also available in French and Spanish. All three language versions are available for download here.
Further extension of GPHF-Minilab™ portfolio
Five new drug compounds for the treatment of hypertension have now been added to the GPHF-Minilab method inventory. These compounds are irbesartan, losartan, methyldopa, telmisartan and valsartan. Cardiovascular diseases are a leading cause of death globally. Hence, phony cardiovascular medicines may pose a serious public health problem that has so far received limited attention. In order to support more cardiovascular drug quality monitoring within the supply chains of low and middle-income countries (LMIC), fourteen cardiovascular medicines are now found in the Minilab’s method inventory. Overall, the Minilab covers 107 active pharmaceutical ingredients.
The method inventory for the new five antihypertensive drugs, including their common fixed-dose combinations, is now available English for download here. Translations into French and Spanish are pending.
Police operation in Africa: Frightening extend of illegal health products
A pan-African police operation in a total of 20 countries and jointly coordinated by INTERPOL and AFRIPOL has identified hundreds of suspects and resulted in seizures of more than 12 million illicit health products – a frightening result. For more information, click here.
Counterfeit anti-malaria drugs discovered
With the help of the GPHF-Minilab®, counterfeit antimalarial drugs containing no active ingredients were again detected in West Africa in recent months. The counterfeits were detected in Chad, Côte d'Ivoire and Mali during investigations by the West African Health Organization (WAHO) and the Ecumencial Pharmaceutical Network (EPN), each of which made use of the Minilab. The discovery of the counterfeit drug COMBIART led to an official warning from the World Health Organization. For more information, click here.
The counterfeit detected in West Africa with the GPHF-Minilab®. (Picture: WHO HQ).
4th Fight the Fakes action week
From December 6 to 12, 2021, the international partners of the Fight the Fakes initiative, including the Global Pharma Health Fund e.V. (GPHF), will again draw attention to the dangers posed by counterfeit medicines worldwide and with a wide range of activities.
The campaigns, which will make particular use of social media channels, will this time have the motto "Health is not a hoax - Fight the Fakes". Among other things, presentations and webinars are planned that will address issues such as how to counter possible counterfeiting of COVID-19 vaccines. For more information, click here.
The Fight the Fakes initiative was launched in 2013 and is supported by numerous international partners. Its goal is to educate the public worldwide about the health risks posed by counterfeit medicines.
Applications of GPHF-Minilab® to be extended once again
Against the background of the undiminished danger that counterfeit or low-quality drugs pose to health care, the GPHF Board has now decided to further expand the possible applications of the GPHF-Minilab® and to develop test methods for five additional active pharmaceutical ingredients. The focus is on active substances that are used worldwide for the treatment of hypertension.
These are the active ingredients losartan and telmisartan, both of which are on the World Health Organization's Essential Drug List. The third candidate is the active ingredient irbesartan, which is listed in the Guide to Procurement of Medicines published by Management Sciences for Health (MSH) for multilateral drug suppliers in International Public Health. As a very strong-selling active ingredient, valsartan completes the list of three angiotensin receptor blockers. Finally, the fifth active ingredient is the classic antihypertensive methyldopa, the drug of choice for arterial hypertension in pregnancy and therefore particularly relevant for Mother, Newborn and Child Health (MNCH) programs.
All of the aforementioned antihypertensives are frequently combined with other cardiovascular medications, which presents an additional challenge in method development. Methods for the five antihypertensives, including their common multiple combinations, are expected to be available in early summer 2022. Their development will be in the proven hands of Dr. Richard Jähnke of the GPHF.
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.