Quality Of Medicines A Key Focus Of Antimicrobial Resistance Fight 05/10/2017 by William New, Intellectual Property Watch Leave a Comment Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)NEW YORK — Assuring the quality of medicines all the way to the consumer is a key component of the global antimicrobial resistance action plan now beginning to be implemented around the world, a panel of experts said during the recent United Nations General Assembly. There are a number of reasons why patients develop resistance to antimicrobials, said Ramanan Laxminarayan, director and senior fellow, Center for Disease Dynamics Economics & Policy (CDDEP), the moderator of the panel. Examples are that people do not take the full course of treatment, or that they buy substandard medicines over the counter from local shops. (l-r) Darko, Piervincenzi, Kerr, Inoue, Koek, Nwokike, Taher, Laxminarayan The panel, “Quality Medicines: Critical underpinnings of all AMR strategies,” was hosted by several organisations including USP, and held on 19 September at the Harvard Club in New York. Laxminarayan said the lack of access to antibiotics continues to kill more people globally than antibiotic resistance does, “that will change over time for sure.” And resistance itself will become the biggest barrier to access to antibiotics. Quality Institute, and Exploiting Africa’s Natural Resources The event also saw the launch of the USP Quality Institute, focused on doing research on issues related to quality medicines. The first topic of the institute will be AMR. Ameenah Gurib-Fakim, President of Mauritius, a highly trained medical researcher, spoke at the launch of the institute, after the panel. “There’s nothing more noble than the commitment to ensuring that essential and quality assured medicines are made available to the people who need them,” Gurib-Fakim said. ” To see that goal realized will require the combined efforts of policymakers, NGOs, industry, academia, and the public. But where do we start? Our individual and joint efforts must be focused on the things that really matter and understanding what really matters depends on getting our facts straight. Thus, rigorous research is needed to understand the impacts of quality medicines.” Africa should be open for business to exploit its natural resources for drug development, she said. “More must be done to responsibly exploit the unique natural resources of Africa to contribute to drug development,” the president said. “I find it concerning that while about 25 percent of all plant genetic resources reside in Africa, just 83 of the 1100 plant-derived blockbuster drugs marketed globally are synthesized by African species.” “On our continent, 45,000 plant species are still unexplored for their potential to serve as the molecular basis of pharmaceuticals,” she continued. “And African species unfortunately are disappearing at almost twice the global rates, driven by climate change, habitat loss, and development.” But, she noted, “Africa accounts, unfortunately, for just two percent of world research outputs, 1.3 percent of world research spending, and hang on to your, not chair anymore, you’re standing, so 0.1 percent of patents. So the challenges are fundamental from education to economic development, to climate change. And all these factors may more bear upon our ability to contribute to the SDG of access to healthcare for all.” Problems in the System Kicking off the panel, Delese Mimi Darko, CEO, Food and Drugs Authority, Ghana, emphasised the “big problem” sub-Saharan Africa has with storage of medicines. So, she said, they have an accredited laboratory and have attained ISO certification, so the country is ensuring medicines coming in have the right quality and in addition to the registration procedure, they ensure their borders are secure. They are also training the storage facilities and the importers, and have used public education to ensure patients know how to store their medicines. Darko also said the pharmacovigilance system has helped in detecting poor quality drugs. When a medicine does not have the desired effect on a patient, they have a way to report it. Last year, some 80 percent of the substandard products reported were through this system. These were brought to the regulatory authority and tested, and some 70 percent of them were found to be substandard, she said. The bad actors, they understand where you are watching and they change their practices and their games – Mirfin Mpundu, on trying to stop sales of poor quality medicines Ronald Piervincenzi, CEO, US Pharmacopeial Convention, said quality is a priority for addressing antimicrobial resistance (AMR) because low-quality medicines have been proven to contribute to AMR, and because there are so many contributors to AMR “it is nearly impossible to parse out one from the others” and they tend to be coincidental in populations or geographies. So places that have high degrees of substandard medicines are also places with problematic supply chains or a lack of prescribing to create gatekeeper to proper use of medicines. This can make the case for investment in quality of medicines, which is needed, he said, as the answer to whether to make the investment “has been up to now lacking enough power to drive change.” Piervincenzi also said while challenges are there to ensure proper use by patients, the tools and abilities to assure quality of medicines already exist. Larry Kerr, director, Pandemics and Emerging Threats Office, Office of Global Affairs, US Department of Health and Human Services (HHS), said the agency views the concept of ensuring access to quality medicines as an important part of AMR. He said the US Food and Drug Administration (FDA) has developed a global strategic framework for counterfeit and substandard medical products to help consumers by reducing their exposure to such products. The framework is based on the pillars of prevention, detection and response. “The FDA has the legislative and regulatory authority to play the critical role in preventing substandard or counterfeit products from ultimately reaching the patients,” he said. “That is why the FDA works very, very closely with technical partners overseas to assist other and foreign national regulatory authorities to help raise the standards and raise awareness of this issue.” To keep such products from entering the US market, the FDA is “focusing on good manufacturing, distribution and pharmacy practices and leveraging global standards to create a more level playing field for legitimate supply chains,” Kerr said. The FDA is working with foreign counterparts to strengthen the foreign supply chains to reduce the emergence and spread of antimicrobial drug resistance and ensuring products meet quality standards, he added. In the question period, Kerr said the Office of International Affairs is “expanding its global presence,” recognizing that it can expand FDA technical assistance to individual countries. Right now it’s only a presence of five country offices, he said. Kerr spoke at length about the “deeply personal” commitment to the issue of now-former Health and Human Services Secretary Tom Price, who since has stepped down under scandal. It is uncertain how his departure will affect the AMR focus. In his panel remarks, Hajime Inoue, senior advisor to the director-general and special representative for antimicrobial resistance at the World Health Organization, said more than 130 member states have completed a national action plan on AMR or in the process, covering more than 90 percent of the global population. Inoue’s remarks at the event are the subject of a separate IP-Watch story, available here (IPW, WHO, 5 October 2017). The UN adopted a political declaration on AMR last year, and in 2015 WHO adopted a global action plan and World Health Assembly resolution on AMR. In one year, WHO and the UN Interagency Coordination Group on AMR (IACG) will have to report back the assembly on progress. USAID’s View Irene Koek, acting assistant administrator, US Agency for International Development (USAID), said the agency has been working on AMR for years, including the problem of poor quality drugs and counterfeit drugs. USAID has been supporting the WHO in its database on counterfeit drugs, she said. “The more information about which drugs are poor quality or counterfeit drugs become incredibly important pieces for both communities and individuals when they go to a pharmacy or they go to buy a drug – but also for ministries of health and practitioners as well,” she said. USAID also has tried to ensure that good drugs are available, Koek added. Working with manufacturers and WHO there are now at least two suppliers of quality-assured products for every NVR (tuberculosis) drug available, which “can really change the landscape” at country level as patients do not go to other sources for their drugs. In questions, Koek noted that the issue is probably less looked at from a pathogen perspective and more from an economist’s perspective. Later, Koek navigated around budget questions since large cuts were proposed by the Trump administration, and Congress is still in the process of going through it. “It may have been a reduction in some of the resources but it doesn’t mean an elimination of them,” she said. Koek also noted the new head of USAID, Administrator Mark Green, who speaks about the agency’s work on health and development. Laxminarayan noted that “there is no other country stepping up to pay for these things either.” Mauritius President Ameenah Gurib-Fakim makes remarks Promoting Quality Jude Nwokike, director, Promoting the Quality of Medicines Program, US Pharmacopeial Convention, was asked about medicines regulatory authorities and best practices or innovative solutions. He said he works with the Promoting the Quality of Medicines program funded by USAID and implemented by USP. He said in countries where they work on quality issues, policies on product quality is usually overlooked. There is some incongruence between national medicine policy, national actions plans and even the global antimicrobial surveillance system, so-called WHO Glass, he said, as “it doesn’t adequately highlight the place of product quality surveillance which should be a subset of the overarching efforts.” An example he gave is when a national quality control laboratory is not aware that the public health program includes a drug in their standard treatment guideline, so the regulatory authority is asked to support or grant a waiver and the product is then in the country. The problem then is that the system is not positioned to continue follow-up on the quality of the product, “shortchanging the opportunity to be proper stewards,” Nwokike said. Their program addresses surveillance, supply and systems issues. They have gotten close to 26 manufacturers to become pre-qualified, and have more than 20 internationally accredited or prequalified labs that can test quality and produce reliable resource which are used for regulatory actions, he said. Government Emphasis, Prioritisation, Regional Differences Prof. Akmal Taher, special advisor to the Minister of Health, Indonesia, said the country has been working on its national action plan, which is more comprehensive than its pre-existing plan, but that the problem with the plans in his view is that the role of government is “too heavy” and should be addressed in the implementation period. He also said the Indonesian government collected 15,000 samples, with antibiotics just 30 percent of the samples, and found 90 percent of all to be above the quality standard. “For us it’s too good to be true,” he said. Another problem with the national action plan is that it has no prioritization, so they don’t know what is the first or second priority for implementation. And finally he noted that with wide variations in priorities across countries, national action plans need to be translated into each province and district. Costs and Bad Actors Mirfin Mpundu, head, Action on Antibiotic Resistance (ReAct) Africa, and executive director, Ecumenical Pharmaceutical Network, Nairobi, Kenya, said in Africa, quality of medicine has been missing in national action plans. Mpundu joined the meeting remotely from Nairobi where he was participating in a ReAct meeting. That could be because only two areas in the global action plans addresses that issue: surveillance and stewardship. Surveillance is focused on pathogens, and the consumption of antimicrobials. Stewardship relates to the best use of antimicrobials and making sure they are not overused. At the ReAct meeting, he said issues of transportation and storage came up, as well as issues of falsified medicines as some 10 percent of medicines sampled did not reach quality in Africa. And of the substandard and falsified medicines, the “number one on top of the list” is antibiotics, number two is anti-malarials, Mpundu said. So countries are going back and trying to add quality of medicines to their action plans, he said. He noted that there should probably be a move away from the term quality medicines to “quality-assured medicines. Another weakness Mpundu pointed to was cost surveillance, in that countries tend to stop when the medicine is registered and do not do cost marketing surveillance. Meanwhile, during the questions Mpundu said in the quality database at USP with some 15,000 records of products that were tested and sampled across more than 30 middle-income countries, they found a consistent drop in the proportion that fails, and “that’s not surprising because … the bad actors, they understand where you are watching and they change their practices and their games.” Rocio Alatorre Eden-Wynter, commissioner of evidence and risk management, Federal Commission for the Protection against Sanitary Risk (COFEPRIS), Mexico, was not able to join the panel due to the massive earthquakes occurring there around the time of panel. 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