Worldwide campaign against counterfeit drugs
Ten global health organization, among them the Global Fund, the World Heart Federation and the International Federation of Pharmaceutical Manufacturers (IFPMA), presented the campaign “Fight the Fakes” in Geneva today. The campaign will raise awareness about the danger of fake medicines by giving a voice to those who have been personally impacted and sharing the stories of those working to put a stop to this threat to public health.
Multi-country operation against fake medicine supply points in Southern Africa
At the beginning of October, a wave of raids and inspections of marketplaces, pharmacies, clinics and other drug outlets in around 30 cities and border points took place in Angola, Malawi, Swaziland, Tanzania and Zambia seizing 100 tonnes of illicit medicines worth about 3.5 million USD including counterfeit versions of antibiotic, antimalarial, birth-control and analgesic medicines. All actions from over 900 officers across all five countries and a diverse range of departments have been coordinated by Interpol’s Medical Product Counterfeiting and Pharmaceutical Crime unit in Lyon (France) and its regional office in Harare (Zimbabwe). In addition, The Global Fund to fight AIDS, TB and Malaria joint Operation Giboia by sharing its expertise in capacity building and identifying and investigating the diversion of medicines.
Even Solomon Island affected by counterfeit drugs
A case of counterfeit antimalarial medicines in the Solomon Islands last month brought back the fact that no region and country stays immune regarding the global trade in fake and low quality medicines. Islands in the Pacific forming small nations are particularly vulnerable as they are missing the resources to form strong medicines regulatory agencies or even to run fully-fledged medicines control laboratories to verify the quality of incoming drugs having travelled across the miles and been exposed to heat, humidity, diversion or other pharmaceutical crimes during transport and storage. A pilot study performed in neighbouring Papua New Guinea in 2011 indicated that the quality of medicines in this region may be sometimes far from perfect. For Papua New Guinea, the situation has improved since the World Health Organization acquired and established four Minilabs of the Global Pharma Health Fund (GPHF).
DIFÄM extends Minilab drug quality verification project to Malawi
As an extension to the ongoing drug quality surveillance project initiated by the German Institute for Medical Mission (DIFÄM) in Africa, the Nkhoma Synod Health Department of the Central Africa Presbyterian Church is now included in the network. The Nkhoma Hospital obtained a Minilab donated by DIFÄM just recently and an appropriate introductory training was performed late August this year. The Nkhoma Synod Health Department covers the central area of Malawi and comprises the Nkhoma Hospital, a 220-bed health facility, 10 health centres and the Nkhoma College of Nursing.
GPHF again donates three Minilabs
The board of the Global Pharma Health Fund (GPHF) has now decided to donate three additional minilabs for the identification of counterfeit drugs. Two laboratory units will be delivered to the health authorities of the Sudan, another unit to the Public Health Laboratory Ivo de Carneri in Zanzibar/Tanzania.
Intensified training course for Minilab users from Angola
In July, the Global Pharma Health Fund (GPHF) held a one-week intensified training course on his Minilab specifically designed for five members of staff from the general health inspectorate in Angola, Southwest Africa. All participants stayed in Darmstadt (Germany) and were trained by Dr. Richard Jähnke (GPHF) at Merck in the use of the Minilab field kit far beyond the existing test protocols designed for the identification of counterfeit drugs where the contents are different, much higher or lower than indicated. The training included the testing of medicines sampled in Angola before the trip to Germany. Among them a range of apparently illegal und substandard quality products. Presentations and discussions on the dangerous trade in falsified medicines in Africa and elsewhere completed the programme. Next to the training, 12 Minilabs have been donated by Merck Portugal and the GPHF in the recent months.
Massive seizure of illicit medicines in Africa
The World Customs Organization and the Institute of Research Against Counterfeit Medicines seized together with national customs administrations 550 million doses of illegal medicines within 10 days at 23 African sea ports. The potentially dangerous if not deadly medicines included antibiotics, painkillers, anti-inflammatory drugs, antidiabetics and cardiavascular medicines. The total market value of the medicines seized is about 275 million US Dollars. These results indicate the extent of the traffic of illicit and falsified medicines in Africa and the danger this poses to the health of people across the African continent. Operation BIYELA follows Operation VICE GRIP staged in 16 African ports last year summer already.
Operation Pangea VI targets online sale of illicit, potentially fake and harmful medicines
A crackdown of illegal online sales of prescription medicines was coordinated by Interpol and carried out by some 100 countries for one week across the globe in June this year. Operation Pangea VI screened 522,000 patient packs and resulted in 58 arrests, the closure of 9610 illegal websites and the seizure of 9.9 million doses of unlicensed and counterfeit medicines worth approximately USD 41 million. The operation targeted three main elements misused in the illegal website trade: the internet infrastructure, the electronic payment system and the mail delivery service. For more information on pharmaceutical crime go to www.interpol.int/Crime-areas/Pharmaceutical-crime.
Minilab Workshop in Mozambique
From June 17 – 21, 2013, the Global Pharma Health Fund (GPHF) performed a Minilab training in Maputo, the capital of Mozambique. Led by Dr. Richard Jähnke from the GPHF, nine pharmacists were trained in the use of the mobile test laboratory to detect counterfeit drugs. The workshop was called a major success and was organized in close cooperation with national health authorities and appropriate military departments of the Southeast African State.
Minilab number 600 supplied
Minilab number 600 just supplied to the medicines inspectorate in Angola. Building medicines testing capacity around the world since fifteen years. A sincere vote of thanks to all our partners and supporters. A lab in a box. The step from bench to population to identify fake, unsafe medicines. Vital antimalarials are life-saving, their fake and zero-content counterparts life-taking. Minilabs save lives! For full dissemination pattern see map.
Minilab training in Kenya
On behalf of its partner, the Promoting the Quality of Medicines (PQM) programme of the U.S. Pharmacopeia (USP), the GPHF carried out another five-days training on the use of Minilabs in Nairobi (Kenya) end of April. Participants were ten pharmacists from the local Pharmacy and Poisons Board (PPB) and National Quality Control Laboratory (NQCL). Training on Minilab basic tests was given by Dr. Richard Jähnke from GPHF and sampling procedures for a medicines quality monitoring study by Dr. Latifa El Hadri from USP/PQM. The range of medicines tested included antimalarial, antituberculosis and antiretroviral medicines. Overall, 67 Minilabs have been supplied to Kenya and its neighbouring countries Tanzania, Uganda, South Sudan and Somalia throughout the years, a region where the proliferation of fake drugs is known to be prominent. The training supports drug quality monitoring studies in the field in Kenya and the identification of local talents from NQCL for future Minilab South-South cooperations.
GPHF at German parliament hearing
Invited by the German parliament, the GPHF obtained the opportunity to present his work on the detection of fake medicines to the members of the Committee on Healthcare in Developing Countries. In a meeting focused on the menace of counterfeit pharmaceuticals for global healthcare, the GPHF reported his experiences with the GPHF-Minilab® used in more than 80 countries worldwide. The members of the Committee were impressed by the way the Minilab employs reliable tests for non-sophisticated medicines quality monitoring to protect people from the deadly danger of counterfeit drugs. Other experts at the hearing were representatives of Medécins Sans Frontiers, the German Ministry for Economic Cooperation and Development and the German Ministry of Health.
Counterfeit drugs and organized crime
The United Nations Office on Drugs and Crime (UNDOC) has published a report on „Transnational Organized Crime in East Asia and the Pacific” where the issue of counterfeit medicines is described as a growing part of international organized crime. The report includes a chapter on fraudulent essential medicines travelling from East Asia to Southeast Asia and Africa containing lots of information especially on the falsification of anti-malaria drugs. The full report is accessible online at the UNODC website.
Petition against counterfeit drugs
The Dutch Malaria Foundation calls to sign a petition addressed to the Governments of India and China to stop the production of counterfeit malaria drugs in their countries promptly. According to the Dutch foundation hundreds of children die in Africa every day because of fake malaria drugs, mostly produced in India and China.
GPHF-Minilab® detects counterfeits in Cameroon
Today, a press release of the German Institute for Medical Mission (DIFAEM) tells that a batch of counterfeit antimalarial drugs was detected in Cameroon using the GPHF-Minilab®. Due to a vigilant pharmacist observing that some Coartem tablets apparently had no effect, the concerned batch of Coartem was subjected to Minilab testing showing that all actives were missing. A confirmatory analysis at a fully-fledged lab of the Mission of Essential Supplies (MEDS) in Nairobi (Kenya) came to the same conclusion. The batch under investigation neither contained artemether nor lumefantrine. In recent years, DIFAEM equipped a number of local mission pharmacies in Cameroon with Minilabs for monitoring the quality of their pharmaceutical supplies. For more information, consult DIFEAM's press release unfortunately issued in German only.
Eight new test protocols for the GPHF-Minilab®
Due to the recent extension of its method inventory, the GPHF-Minilab® holds now 72 test protocols ready for drug identity and drug content verification on 63 active pharmaceutical ingredients including their most common fixed-dose combinations. The new test protocols are focusing on antituberculosis and other antibacterial medicines. Demo versions of the latest extension with all details on the active ingredients involved can now be accessed in English, French and Spanish. The latest Minilab supplement is published jointly with the Promoting the Quality of Medicines programme maintained by the U. S. Pharmacopeia and the United States Agency for International Development. The number of Minilabs supplied approaches 600 units based in 80 countries. Here, they help developing nations in boosting their medicines testing capacity to protect people from the danger of counterfeit medicines.
INTERPOL and pharmaceutical industry launch global initiative to combat fake medicines
Combating the global scourge of fake medicines which threatens the health of millions of people is the focus of a landmark agreement between INTERPOL and 29 of the world’s largest pharmaceutical companies. The three-year deal, worth EUR 4.5 million, will see the creation of INTERPOL’s Pharmaceutical Crime Programme to further build on the work of its Medical Product Counterfeiting and Pharmaceutical Crime (MPCPC) unit. This will enhance the law enforcement community’s response to pharmaceutical crime through stronger partnership development. The programme will focus on the prevention of all types of pharmaceutical crime including branded and generic drug counterfeiting as well as the identification and dismantling of organized crime networks linked to this illegal activity, which generates millions in illicit profits every year. For more information please go to www.interpol.int.
Most Successful year in the history of the GPHF
The Global Pharma Health Fund (GPHF), a Frankfurt based non-profit organization, is able to look back on one of his most successful years in project history. During the general meeting this year February, chairman Frank Gotthardt said that overall 100 GPHF-Minilabs were disseminated in 2012 to detect falsified medicines, for example, 40 of them went to Vietnam and 10 more to Angola. GPHF-Minilabs have been and are being used in 86 countries around the world today. Gotthardt announced that the GPHF will go on to extend the Minilab’s method inventory to increase its range of applications even further.
Myanmar: Donation of three GPHF-Minilabs
Dr. Karl-Ludwig Kley, Chairman of the Executive Board of Merck KGaA, now handed over three GPHF-Minilabs to the representatives of the Ministry of Health in Myanmar. Kley visited the country during a business trip to Southeast Asia. The three mobil units will be part of a local programme to promote the quality of the medicines in the country formally known as Birma. The program is run by the World Health Organization and the United States Pharmacopoeia in cooperation with the Myanmar ministry of health since 2012. The Minilabs (amounting to about 19.000 USD) are a charitable donation by Merck Singapore.
WHO: Roadmap To Fight Poor Quality Medicines
The first meeting of the World Health Organization (WHO) mechanism intended to promote the prevention and control of “substandard/spurious/falsely-labelled/falsified/counterfeit” (SSFFC) medical products, held in Buenos Aires (Argentina) last week, is being called a success. Member states agreed on a work plan that focuses on strengthening regulatory capacities and decided to form a steering committee to monitor country compliance to the plan.
Officials and experts from 76 countries launched a road map to combat the counterfeiting of medications, a global public health problem that demands a joint response. The mechanism will focus on strengthening regulatory capacities and increasing cooperation between drug authorities in order to prevent and control poor quality medicines. Additionally, the mechanism will seek to identify the activities and behaviours that drive the propagation of poor quality medicines across the globe.
“Drug counterfeiting causes death and disease, regardless of gender or age. It is an international public health problem,” said Argentina’s Minister of Health, Juan Manzur, during the opening of the meeting.
Africa: Millions of counterfeit drugs detected
The World Costums Organization (WCO) in Brussels has now announced that an operation spanning 16 African countries led to the seizure of more than 82 million doses of illicit medicines including antimalarial and antiparasitic drugs, antibiotics, cough syrups, and even contraceptive pills and infertility treatments, estimated to be worth over 40 million US dollars.
The operation was conducted simultaneously at 16 major seaports on the East and West coasts of Africa from 11 to 20 July 2012, leading to the seizure of more than 100 million counterfeit products of all categories. Of a total number of 110 sea containers inspected by teams of Customs officials, 84 were found to contain counterfeit or illicit products, with the biggest shipments being discovered in Angola, Togo, Cameroon and Ghana. The vast majority of shipments seized originated from South and East Asia and the Middle East
The operation was organized by the WCO in partnership with the Institute of Research against Counterfeit Medicines (IRACM). These results are alarming and serve as a reminder of the scale of the traffic in illicit medicines in Africa and the danger this illicit trade represents to consumer health and safety.
Minilab now capable of testing all antimalarial co-formulations based on artesunate
Spurious, counterfeit and substandard quality medicines are a global problem which have a highly negative impact on public health and patient safety. In developing countries, subpotent falsified antimalarials even foster the development of drug resistant parasites. Seen as a new way forward to treat Malaria, it now appeared necessary to add artesunate-based co-formulations to the list of antimalarials already existing in the Minilab’s method inventory for the detection of unsafe counterfeit anti-infective medicines. This will allow to include artesunate for testing in due diligence stock control and post-marketing surveillance studies even when combined with amodiaquine, mefloquine, pyronaridine, sulfadoxine and sulfamethoxypyrazine. Adding these new co-formulations has been made possible without changing the Minilab’s technical platform. With the new extension in hand, the current Minilab method inventory covers 58 active pharmaceutical ingredients allowing to verify the quality on an amplitude of finished drug products. Virtually all major antimalarials are now included. The new Minilab supplement is published jointly with the Promoting the Quality of Medicines (PQM) programme maintained by the US Pharmacopeia (USP) and US Agency for International Development (USAID). GPHF-Minilabs have been supplied over 500 times to more than 80 countries across Africa, Asia and Latin America already. Malaria affects 106 countries, half of the world population are at risk
Counterfeit antimalarial tablets detected in Congo
Recently, the German Institute of Medical Mission (DIFÄM) informed its partner organisations about the existence of counterfeit quinine tablets detected in the Democratic Republic of Congo. All declarations on the label had been forged, for example, source, content and batch number. The label pretends that the tablets were manufactured by Shelys in Dar es Salaam (Tanzania) but the batch number 880 is not on their records. Minilab assays proved the almost complete absence of quinine and the existence of an unknown compound. As the counterfeit tablets are associated with failed malaria treatments including death of patients, it is also assumed that the tablets did not contain any antimalarial drug. In the meantime, the fake products have been taken from the shelves and all stakeholders, for example, local drug authorities, the World Health Organization and members of the Ecumenical Pharmaceutical Network have been informed about the fatal product. A second case of counterfeit antimalarial tablets, again with zero quinine content, has been detected by some other Minilab users in Africa throughout the summer. Investigations are pending, one person has been jailed already. Both cases prove the importance of regular post-marketing drug quality testing and the use of simple and affordable thin layer chromatography for the detection of unsafe bogus medicines in particular in places and countries where strong drug regulatory authorities and fully-fledged drug testing labs are missing.
GPHF trains experts from Indonesia at Merck Darmstadt to recognize fake medicines
To complete existing efforts in post-marketing drug quality monitoring including risk assessment of counterfeit and substandard medicines in Indonesia, three governmental pharmacists from Jakarta arrived for a five-days Minilab workshop at Merck Darmstadt Monday last week. The workshop included also a trip to the pharmaceutical crime unit of Germany’s Federal Criminal Police Office in Wiesbaden. The training focused on the detection of falsified anti-infective medicines for high priority disease programmes, for example Malaria, TB and HIV/AIDS. Frequently coming in sub-therapeutic doses, fake anti-infectives are not curing diseases and are promoting the formation of drug-resistant strains. The production and dissemination of them being outright criminal practice. Over the recent years, the Minilab of the Global Pharma Health Fund (GPHF), a charity maintained by Merck Darmstadt, gradually became an important element in post-marketing surveillance studies helping in analysing the status quo of drug quality for a range of anti-infective medicines and ensuring that patients and the general public are not exposed to non-effective counterfeit medicines.
Indonesia: TB medicines quality study using Minilab and compendial tests
With support from the Indonesia Mission of the United States Agency for International Development (USAID), two training workshops on the ‘Quality Analysis of Anti-Tuberculosis Medicines’ were performed by the Promoting the Quality of Medicines (PQM) programme from the United States Pharmacopeia (USP) and the Global Pharma Health Fund (GPHF) at the National Quality Control Laboratory for Drug and Food in Jakarta in the second week of June. One workshop was focussing on sophisticated compendial drug analysis, for example liquid chromatography and dissolution testing, where as the other was more concerned about basic medicines testing using GPHF’s Minilab. Both organisations, USP and GPHF, brought in their experts to train thirty three member of staff recruited from governmental labs from East and West Java, South Sulawesi, North Sumatra, West Nusa Tenggara next to Bali and the national drug quality control lab itself. Indonesia rates as high burden tuberculosis country and in face of multi-drug resistance that challenges the Indonesian Government as a whole and the National Agency of Drug and Food Control in particular to do more to support and improve the good manufacturing practices compliance and monitor the quality and access to anti-tuberculosis medicines to support the National TB Control programme efforts in fighting the disease.