Anti-microbial stewardship

About one third of hospital patients are prescribed antibiotics and up to 50% of their use is unnecessary or inappropriate.  Whilst some EU countries have made significant strides in the control of drug-resistant infections, overuse and the spread of Antimicrobial Resistance (AMR) urgently need to be addressed in others. As drug-resistant infections are not contained by national borders, the approach must be strict, consistent and coordinated at European and international level.

Antimicrobial stewardship (AMS) was a topic at the 21st Congress of the European Association of Hospital Pharmacists in Vienna where great emphasis was placed on the importance of establishing well-trained, multidisciplinary teams supported by committed leadership. As medicines experts with knowledge of infection control, hospital pharmacists play an important role as educators of other healthcare workers and patients.

AMS can be described as a series of multi-professional interventions across all care settings. Alongside infection control and decontamination action it has become an essential strategy deployed in hospitals across Europe to fight multi-drug resistant ‘superbugs’.

Efficient AMS programmes hinge on first-rate management skills across hospital and community settings, and the availability of local guidance. This must go hand in hand with surveillance data on antibiotics use and occurrence of resistance so that compliance with guidance can be measured, and its impact evaluated.

To read more about Antimicrobial Stewardship on the epha.org website

Orphan medicinal products

The European Commission has published an inventory of Union and Member State incentives to support research into, and the development and availability of, orphan medicinal products.
To date, the Commission has authorised 117 orphan medicines for the benefit of patients suffering from rare diseases, 82% of which are new active substances. Around 25 of the orphan marketing authorisations are from SMEs. The number of products authorised has grown over the years but remains limited bearing in mind the existence of 5,000 to 8,000 distinct rare diseases, only 1 % of which are currently covered by authorised medicinal products in the EU. The incentives of the orphan drug legislation are therefore essential to facilitate pharmaceutical development. The most frequently authorised medicinal products are treatments for pulmonary arterial hypertension, acute myeloid leukaemia, cystic fibrosis, multiple myeloma and acute or chronic lymphoblastic leukaemia.

This paper also includes information about the European expert group on rare diseases, the EU funded research on rare diseases and examples of national measures to support R&D and the availability of orphan medicinal products (e.g. reduction of taxes, pilot project on joint procurement, direct reimbursement after marketing authorisation).

To download the inventory on the ec.europa.eu website

Priority medicines

The European Medicines Agency has launched the PRIME (PRIority MEdicines) scheme, which offers early, proactive and enhanced support to medicine developers to optimise the production of robust data on a medicine’s benefits and risks and enable accelerated assessment. To support earlier access to patients, the Commission has shortened the timeframe for adopting decisions that authorise medicines for unmet needs that have been evaluated under an accelerated assessment procedure.

According to the EU Commissioner for Health and Food Safety, “The launch of PRIME is a major step forward for patients and their families that have long been hoping for earlier access to safe treatments for their unmet medical needs. Through enhanced scientific support this scheme could help, for example, to accelerate the development and authorisation of new classes of antibiotics or their alternatives in an era of increasing antimicrobial resistance. It is also a potential godsend for those suffering from diseases for which there are currently no treatment options, such as rare cancers, Alzheimer’s disease and other dementias. Furthermore, it optimises the use of the current regulatory framework that can contribute to the European Commission’s priorities in terms of boosting innovation, jobs, growth and competitiveness.

For more information on PRIME and the European Medicines Agency, on the ema.europa.eu website

New business model for antibiotics

Revenues for pharmaceutical companies need to be delinked from sales of antibiotics to avoid their over-use and avert a public health crisis, according to a new report from the Centre on Global Health Security, Chatham House.
The main recommendations of the report are:
  1. A new business model needs to be developed in which the return on investment in R&D is delinked from the volume of sales.
  2. Increased public financing of a broad menu of incentives across the antibiotic life-cycle is required, targeted at encouraging the development of antibiotics to counter the greatest microbial threats.
  3. The assessment of current and future global threats arising from resistance should be updated periodically in order to identify which classes of product are a priority for incentives.
  4. The delinkage model should prioritize both access and conservation.
  5. Domestic expenditures on the model need to be globally coordinated, including through the establishment of a secretariat, and global participation in the model is the ultimate goal.

The report “Towards a new global business model for antibiotics: delinking revenues from sales” on the chathamhouse.org website

Health at a glance 2015

According to this report, pharmaceutical spending reached around USD 800 billion across OECD countries in 2013, which is about 20% of total health spending on average.

It also believes that health care is improving too slowly to meet the rising strains of chronic diseases. Through the most recent comparable data on the performance of health systems in OECD countries and a new set of dashboards, Health at a Glance 2015 shows that all countries have wide scope for improving the quality of health care and tackling unhealthy lifestyles. This edition includes a special focus on the pharmaceutical sector, chapters on health care resources, health expenditure and outcomes as well as new indicators on health workforce migration.

To read the full report on the oecd.org website

Harmonising pharmaceuticals for human use

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has been reconfigured to transform it into a truly global initiative with robust and transparent governance mechanisms.

The ICH will promote public health through international harmonisation of technical requirements for the authorisation and regulatory oversight of medicinal products. This will help with the timely introduction of new medicines, the prevention of unnecessary duplication of clinical trials, and the development, registration and manufacture of safe, effective and high quality medicines in an efficient and cost-effective manner.

For more information about the changes to the ICH, click here on the ich.org website

Pharmaceutical pollution across the world

According to the global consumer watchdog SumOfUs.org, the improper disposal of pharmaceutical waste by polluting factories in China, and their links with some of the world’s biggest pharmaceutical companies, is creating a looming public health disaster. These polluting Chinese factories supply some of the world’s best known pharmaceutical brands including Pfizer and some of the biggest generic drug manufacturers (McKesson, Teva) are also sourcing products from factories violating environmental and safety standards.

The report’s findings are based on customs data, import licenses, databases and company financial and legal documents, reports from regulatory bodies in several countries and first-hand evidence obtained from an undercover investigation in China. They reveal a ‘complex and murky’ web of commercial relationships between Chinese producers, Indian middlemen, and trusted global brands. The need to clean up the global production and supply chain is urgent since the disposal of large quantities of antibiotic effluent in the environment and the proliferation of resistant bacteria in land and waterways surrounding production sites is contributing to an aggravation of the global Anti-Microbial Resistance crisis.

By dumping antibiotic waste into the environment, these factories create huge breeding grounds for superbugs, and the concentrations of antibiotics in polluted waterways can be as high as in the bloodstream of someone on a full strength dose of antibiotics. The report calls on pharmaceutical companies to embrace transparency throughout their supply chains and to immediately stop purchasing active pharmaceutical ingredients (APIs) from polluting factories. 

To read the full report, click here on http://sumofus.org

To read the executive summary, click here on http://sumohere