WHO Essential Medicines Update Adds Antibiotic use Framework and new HCV & HIV Drugs

Regulatory NewsRegulatory News | 06 June 2017 |  By 

The World Health Organization (WHO) on Tuesday announced updates to its essential medicines list (EML), including new recommendations for antibiotic use and the addition of new drugs to treat hepatitis C, HIV and leukemia.

The list, which is intended to serve as a model for the most crucial medicines for ensuring public health, is updated every other year based on recommendations from WHO's Expert Committee on the Selection and Use of Essential Medicines.

"These medicines are chosen according to evidence of safety, efficacy and public health relevance. Essential medicines should be available in health systems everywhere, at all times," said WHO Assistant Director-General for Health Systems and Innovation Marie-Paule Kieny.

For the 2017 list, WHO says it is adding 30 new medicines for adults and 25 new medicines for children, bringing the total number of medicines on the list to 433.

Notably, WHO says it is recommending Gilead's Epclusa (sofosbuvir and velpatasvir) as the first pan-genotypic hepatitis C treatments to make the list.

"Countries without sophisticated diagnostic equipment can actually have an option to move straight to a one treatment approach, even without knowing what types of hepatitis C virus they are dealing with," said Suzanne Hill, director of essential medicines and health products at WHO.

The list also includes a recommendation for tenofovir, either alone or in combination with emtricitabine or lamivudine for pre-expore prophylaxis (PrEP) to prevent HIV, and both Sprycel (dasatinib) and Tasigna (nilotinib) to treat chronic myeloid leukemia.

However, Hill cautioned that some of the drugs added to the list are currently priced out of reach for many health systems.

"Currently, many of these medicines are sold at very high prices, and may be unaffordable for health systems, irrespective of the wealth of the country. The fact that they're not 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," she said.


For this revision, WHO says it carried out the "biggest revision of the antibiotics section in the EML's 40-year history," in an effort to curb antimicrobial resistance.

Now, WHO says it will group the 39 antibiotics on the list according to three categories—"access," "watch" and "reserve"—based on their use in treating 21 common infections.

"The aim is to contain antibiotic resistance, to optimize antibiotic treatment and to preserve last resort antibiotics," Kieny said.

According to WHO, antibiotics in the "access" group should be available at all times for first- or second-choice options for common infections.

For the "watch" group, WHO lists antibiotic classes that are recommended for first- or second-choice treatments, but in a more limited range of indications, as they have a higher resistance potential. In total, seven classes of antibiotics were selected for the watch group, including quinolones and fluoroquinolones, third-generation cephalosporins, macrolines, glycopeptides, anti-pseudomonal penicillins with beta-lactamase inhibitors, carbapenems and penems.

Lastly, the "reserve" group includes last-resort antibiotics that WHO says should only be used when "tailored to highly specific patients and settings, and when other alternatives would be inadequate or have already failed." This group includes four antibiotics classes and four other specific antibiotic drugs.

WHO, Model List of Essential Medicines, Model List of Essential Medicines for Children


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