Infection Control Today

OCT 2018

ICT delivers to infection preventionists & their colleagues in the operating room, sterile processing/central sterile, environmental services & materials management, timely & relevant news, trends & information impacting the profession & the industry

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Page 22 of 40

22 ICT October 2018 The fndings demonstrate clear preferences from providers across specialties that can be used to ensure clinicians are more receptive to AU feedback: ✦ The vast majority (89 percent) of respondents preferred their own insti- tutions determining provider use attri- bution as opposed to external personnel. ✦ Most wanted to be compared to other providers within their service (64 percent) with feedback provided on a quarterly basis (69 percent) via email (73 percent). ✦ Surprisingly, the study found that providers agreed upon attribution of antimicrobial use early on in a hospital stay scenario but disagreed once care became more complex, with some teams deferring and others accepting responsibility. ✦ Providers generally shared concern a b o u t q u a n t i t a t i v e f e e d b a c k accounting for complexity of clinical care, severity of illness, and accuracy. ✦ Overall, 51 percent of providers anticipated changing practice based on AU feedback. "Data can help drive change, however to implement meaningful change, we must overcome barriers and use this data to improve the use of antibiotics," says Lines. "As current national reporting utilizes unit-based and facility-wide data, local antimicrobial stewardship programs will play a crucial role in examining provider- or service level data to identify and act on stewardship opportunities and to increase the acceptability of these programs." The authors note that since antimicrobial stewardship is a shared responsibility across the healthcare continuum through various roles including house staf f, physician assistants, nurse practitioners, pharmacists, nurses, and many others, future studies looking at all team members are needed. Industry has a signifcant role to play. A key strategy to fght back against AR has focused on the troublesome state of the pharmaceuticals pipeline. Earlier this year, Novartis announced its exit from the antibiotics development space, declaring that it made the decision to "prioritize our resources in other areas where we believe we are better positioned to develop innovative medicines that will have a positive impact for patients." Also making their exodus have been Allergan, AstraZeneca, Sanof and Bristol-Myers Squibb. As So and Shah (2014) observe, "Twenty new classes of antibiotics entered the market from 1940 through 1962. Since then, only two new classes of antibiotics, oxazolidinones (linezolid) and cyclic lipopeptides (daptomycin) have come on the market. More troubling is the foreseeable horizon of research and development (R&D) for novel antibiotics. An EMA–ECDC–ReAct study of the antibiotic pipeline identifed 90 antibacterial agents in clinical development. Of the 15 drug candidates that could be administered systemically, 12 showed in vitro activity against antibiotic-resistant Gram-positive bacteria, while only four had demonstrated in vitro activity against antibiotic-resistant Gram-negative bacteria, and not one of these acted via a novel mechanism of action." The researchers explain further, "Many have observed that as compared with other therapeutic areas, the antibiotic market is less proftable. In 2009, antibiotics generated global sales of $42 billion, representing 46 percent of sales of anti-infective agents (including antiviral drugs and vaccines) and 5 percent of the global pharmaceutical market. Over the past fve years, antibiotics showed an average annual growth of 4 percent as compared with an average annual growth of 16.7 percent and of 16.4 percent for antiviral drugs and vaccines, respectively. Pharmaceutical frms size up the opportunity costs of R&D investment by considering the risk-adjusted net present value (rNPV), that is, the return in future dollars after adjustment for the investment and any lost income. By comparison to other therapeutic categories, the rNPV of antibiotics is not high. The relative rNPV expressed as the number of millions of dollars for an antibiotic would be 100, compared with 160 for vaccines, 300 for an anticancer drug, 720 for a neurological drug, and 1,150 for a musculoskeletal drug. This difference stems, in part, from the nature of antibiotic treatment. Treating a bacterial infection requires days of therapy compared with potentially lifelong treatment for a chronic condition like hypertension or high cholesterol. Worse yet, there is an inherent tension between efforts to conserve the effectiveness of novel antibiotics and to generate revenues through increased marketing and sales." They add, "At the same time, antibiotics have also been described as the third most proftable class of drugs for pharmaceutical companies after central nervous system and cardiovascular drugs. However, a single antibiotic drug faces signifcant competition from other antibacterial agents, thereby commanding a smaller market share and realizing less proft than drugs from other therapeutic classes. For example, the best-selling antibiotic made $2.01 billion in 2003, while a lipid-lowering agent sold by the same company made $9.23 billion. However, few antibiotics coming on the market in recent years have been classifed as breakthrough treatments, and many are analogues of existing drugs. This has generated signifcant therapeutic competition that only exacerbates limited returns on novel antibiotics entering the market." Experts are calling for new business models to bring novel antibiotics to market. As So and Shah (2014) point out, "In recent years, policy-makers have applied a range of fnancial incentives to coax greater innovation from pharmaceutical frms. Pull-incentives that pay for the outputs of R&D have received greater attention than push-incentives that pay for the inputs of R&D. Pull incentives ensure return on investment through prizes or through higher drug prices protected by patents or extended data exclusivity. These incentives might be tied to requirements for effective stewardship and conservation of the novel antibiotic or delinked from returns on investment. By delinkage, returns on investment might be divorced from volume-based sales of the product. These incentives could be targeted to truly novel classes of antibiotics, with demon- strable activity against multidrug-resistant pathogens. Failing to target such incentives appropriately, more analogues of existing antibiotics might come forward, thereby creating greater therapeutic competition and further lowering the NPV for any new antibiotic." Ò Over the past fve years, antibiotics showed an average annual growth of 4% as compared with an average annual growth of 16.7% and of 16.4% for antiviral drugs and vaccines, respectively.

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