Market Pressures Hinder Access to Essential Antibiotics

A commentary published in Elsevier explains that several older antibiotics that are used to treat common bacterial infections are exceedingly becoming more difficult to access, mostly since manufacturers are finding them less profitable to produce and market. The authors stress that the lack of availability of these antibiotics may have serious repercussions.

Lack of available antibiotics might force physicians to use alternative broad-spectrum antibiotics that may be less optimal, have more adverse effects, and “drive the selection of resistance,” the authors write. One example that they share is having to use amoxicillin instead of penicillin to treat a sore throat. They stress, “The limited access to these old antibiotics is a threat to antibiotic stewardship.”

In fact, in 2011, the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Antimicrobial Stewardship found that out of 33 “old but potentially useful antibiotics,” 22 were marketed in less than 20 out of 38 countries. The reason these antibiotics weren’t being marketed boiled down to economics.

The survey was updated in 2015, and showed that the situation had grown even worse—even fewer antibiotics were available in the countries that had been included in the survey. “High registration costs and small market size (limited volume sales and low prices)” had been the central reasons why the antibiotics were not marketed. Pharmaceutical companies felt that these factors led to a “lack of return on investment.” Lack of demand, lack of awareness, or “low prioritization of the problem by health authorities,” were among other cited reasons. The authors note that in low- and middle-income countries, the situation could be even worse, but right now, there’s no published data available on the subject.

In addition to the lack of marketing of these antibiotics, the authors also note “repeated and prolonged shortages” of these antibiotics occurr on a global scale in different settings. In fact, the authors cite one study that found that between 2001 and 2013 in the United States, 148 antibiotics experienced supply shortage, while 22% “experienced multiple shortages.” Furthermore, a notable rise in these shortages was occuring since 2007, “with an increase of 0.35 additional antibiotics experiencing shortage every month.”

Another study conducted in 2011 found that shortages resulted in negative patient outcomes due to the use of alternative antibiotics that were “less effective, more toxic, or more costly.” The authors warn that these shortages may also negatively impact patients’ “confidence in the public health system and in national and supranational organizations’ abilities to provide adequate healthcare and supply systems.” Although there are several associated concerns that the authors have mapped out, they report that a coordinated response to address this issue has not yet been taken.

Therefore, they call for “standardized monitoring systems” to better “estimate the scale of the problem.” They also suggest that a dialogue be started between “providers, national agencies, and international organizations,” with the focus being the search for adequate ways to address availability and pricing of antibiotics.

The last issue that the authors highlight is the lack of availability of pediatric formulations of old antibiotics. The fact that there is limited pediatric pharmacokinetic data pertaining to old antibiotics makes appropriate dosage in these patients even more challenging.

“There are additional challenges for treating babies and children. With these patients, doctors often need much smaller doses and different formulations, for example a liquid medicine rather than a tablet. In many cases, no pediatric formulation is available,” Celine Pulcini, Professor of Infectious Diseases at Nancy University Hospital and University of Lorraine, France, and Secretary of the ESCMID Study Group for Antibiotic Policies (ESGAP), explained in a recent press release. “Bacterial infections can be particularly dangerous for premature babies. But their medical teams have to contend with adult-sized vials when only a fraction of the dose is needed.”

To address this issue, the authors call for “economic incentives tied to pre-defined Target Product Profiles” and for “academic collaborations” to promote production of pediatric formulations.

Dr. Pulcini concluded, “The availability of these essential medicines must be made a priority globally. International organizations, such as the WHO, should take the lead here, working with Member States to ensure sustainable global access to all essential antibiotics, in their optimal formulation, quality and cost, to everyone everywhere.” She warned, “If no action is taken, we will lose these excellent and relatively cheap antibiotics that are needed on a daily basis to treat common bacterial infections worldwide. Instead, we will end up using less efficient antibiotics, leading to worse clinical outcomes for patients, and adding to the problem of antibiotic resistance.”