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Access, watch, reserve: WHO committee advises when to use common antibiotics
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For the first time in its 40-year history, WHO’s Model List of Essential Medicines includes advice on when and when not to use certain antibiotics — a significant change that health officials said was aimed at containing the global threat of antimicrobial resistance, optimizing treatment and preserving last-resort antibiotics.
Eighteen WHO committee members and advisors grouped 39 essential antibiotics into three groups called “access,” “watch” and “reserve” and made recommendations on when medicines in each group should be used.
Initially, the categories apply only to antibiotics used to treat 21 of the most common infections, WHO said. But the recommendations could be broadened in the future to include more drugs.
“From an antimicrobial resistance perspective, this is really a very important day,” Marc Sprenger, MD, PhD, director of WHO’s secretariat for antimicrobial resistance, said during a teleconference.
The essential medicines list, which is updated every 2 years, is fundamentally an international blueprint laying out medicines that should always be available in health systems around the globe, according to Marie-Paule Kieny, PhD, WHO assistant director-general of health systems and innovation. Medicines are chosen based on safety, efficacy and public health relevance, and many countries use it to create their own lists at a national level, which, among other things, can increase access to the drugs and provide the basis for reimbursement lists for health insurance.
In addition to revising the section on antibiotics, WHO experts added 55 medicines — 30 for adults and 25 for children — including 22 antibiotics, and specified new uses for nine drugs that had been included in past lists. The experts met at WHO headquarters in Geneva, Switzerland, in March. Drugs for hepatitis C virus, HIV, tuberculosis and cancer were added to the list, bringing the total to 433.
“Essential medicines should be available in health systems everywhere at all times,” Kieny said.
Medicines added to the list this year include Epclusa (sofosbuvir/velpatasvir, Gilead Sciences), the once-daily tablet treating all six major forms of HCV; Tivicay (dolutegravir, ViiV Healthcare) for HIV infection; pre-exposure prophylaxis (PrEP) with tenofovir alone or in combination with emtricitabine or lamivudine to prevent HIV infection; multidrug-resistant TB medicines Deltyba (delamanid, Otsuka) for children and adolescents and Lamprene (clofazimine, Novartis) for children and adults; and child-friendly fixed-dose combination formulations of ethambutol, isoniazid, pyrazinamide and rifampicin for treating pediatric TB.
The list now includes oral cancer medicines Sprycel (dasatinib, Bristol-Myers Squibb) and Tasigna (nilotinib, Novartis) for chronic myeloid leukemia resistant to standard treatment; and fentanyl skin patches and methadone for pain relief in cancer patients.
“I would like to stress that currently many of these medicines are sold at very high prices and may be unaffordable for health systems irrespective of the country,” Suzanne Hill, BMed, PhD, WHO director for essential medicines and health products, said. “The fact that they are now included on the essential medicines list sends a strong message to all public health actors that these medicines provide true public health benefits and really should be made available when needed. But obviously, for health systems to do this, the price must be affordable.”
Antibiotics listed under the “access” group — the largest of the three categories — include drugs like amoxicillin with lower resistance potential that should be available at all times. The “watch” group contains first- or second-choice drugs like ciprofloxacin that have a higher potential for resistance and should be used sparingly, according to the group.
Drugs in the “reserve” list include last-resort antibiotics like colistin, Zyvox (linezolid, Pfizer) and new-generation cephalosporins used to treat life-threatening infections due to multidrug-resistant bacteria.
“These medicines should be protected and prioritized as key targets in stewardship programs to preserve their effectiveness,” Kieny said.
It is the first time the list has specified when and when not to use certain antibiotics, according to Kieny, who said she does not expect the change to be a “quick-fix solution” to antimicrobial resistance. Previous efforts to address antibiotic resistance have mostly been aimed at changing the behavior of prescribers, yielding modest results, Kieny said.
“We hope that this new categorization of antibiotics — emerging at a time when political awareness of the issue is high — will increase countries’ commitment to address the problem in targeted ways,” she said. “We think the political will is there, but this needs to be followed by strong policies.” – by Gerard Gallagher
Reference:
WHO. Technical report series – The selection and use of essential medicines. 2017. http://www.who.int/medicines/publications/essentialmedicines/EML_2017_EC21_Unedited_Full_Report.pdf?ua=1. Accessed June 6, 2017.
Disclosure: Hill, Kieny and Sprenger report no relevant financial disclosures.
Perspective
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Richard A. Murphy, MD, MPH
Unexpectedly, the new edition of the WHO essential medicines list — a critical document that helps countries prioritize key medicines — included for the first time much-needed basic guidance on antibiotic stewardship aimed at low- and middle-income settings. This welcome guidance addresses the reality that antimicrobial resistance (AMR) has the potential to do the most harm in developing world settings among vulnerable patients who rarely benefit from key tools such as microbiology and second-line antibiotics. In the 20th WHO Model List of Essential Medicines, WHO placed antimicrobials in tiers according to how permissive or restrictive their use should be. Such tiering serves as a welcome signal that WHO is becoming more deeply engaged in antibiotic stewardship, an activity which has barely been on the radar in most of the world.
Unfortunately, the actual implementation of stewardship — at the hospital and country level — will not be simple and will require far more than this initial advice. One key concern is that, in the developing world, bacterial infections have a much greater impact on human health and overly restrictive antibiotic policies could place lives at risk. For example, in rural Africa, far more children still die from lack of access to simple antibiotics — for bloodstream infections, for example — than from antibiotic resistance and zealous stewardship should not be done at the expense of the most vulnerable. Therefore, stewardship must be introduced very carefully and not limit the availability of antibiotics to patients requiring urgent antimicrobials. So, beyond the simple tiered antibiotic groupings that were proposed in the new essential medicines list, WHO must do far more to provide nuanced guidance, tools and communication on stewardship that is geared toward the concerns and needs of the developing world. It is hinted in the executive summary that such guidance is a priority for WHO, and it would be welcomed.
At this time, there are very few published experiences with antibiotic stewardship in the developing world, and more practical experiences need to be shared in international meetings and journals. This will help WHO in its process. Models that have been adopted in the U.S. and Europe — premised on the existence of high-quality microbiology labs and infectious diseases/pharmacist specialists — will not be applicable. The truth is that in the development of specific guidance on stewardship strategies for low- and middle-income countries, WHO is late to the game. But huge opportunities exist in the next few years, and WHO is well-positioned and trusted to be the source of such critical material. The grouping of antibiotics into tiers to guide more appropriate use represents an important step in this process and an important step for global public health.
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