Category:

Shortages of some life-saving antibiotics are putting growing numbers of patients at risk and fuelling the evolution of “superbugs” that do not respond to modern medicines...The non-profit Access to Medicine Foundation said there was an emerging crisis in the global anti-infectives market as fragile drug supply chains - reliant on just a few big suppliers - come close to collapse...Global demand for antibiotics has grown by two-thirds since 2000, driven by population growth and the need for medicines to fight infectious diseases in low- and middle-income countries...Most antibiotics are cheap, off-patent generic medicines, which is good for affordability. But that also means they have very low profit margins - particularly compared to modern drugs for diseases like cancer - offering manufacturers little incentive to invest in new production facilities...antibiotic shortages can have especially dire consequences, since doctors have to resort to sub-optimal treatments that are less efficient at killing specific pathogens, leading to the rise of resistant bacteria or so-called superbugs...

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

High-priced prescription drugs will soon become 5% cheaper, thanks to simplification of the mechanism that controls their maximum permitted prices. This will lead to savings of NIS 150m. to NIS 200m., the Treasury and Health ministries announced...“This is an additional step to reduce the cost of living and make health more accessible to the public,” Finance Minister Moshe Kahlon said. “This change is part of a series of steps we have taken in the past three years to strengthen the public health system”...ministries have been working on implementing a reform in the mechanism for determining the maximum prices of prescription drugs...The committee carried out international reviews and consultations with representatives of health funds and the pharmaceutical companies. It decided to revise the drug price-control model to bring down the prices of expensive prescription drugs and increase the supply of inexpensive medications...

Bayer AG and Elsevier studied more than 1.6m adverse events to show how big data can be used to reduce animal testing and design trials "altered to potential risks," says researcher...The entire life sciences industry is committed to reducing animal testing, and all organizations are looking at how this can be done effectively...The study analyzed 1,637,449 adverse events (AEs) reported for both humans and the five most commonly used animals in US Food and Drug Administration and European Medicines Authority regulatory documents for 3,290 approved drugs and formulations...published in the Journal of Regulatory Toxicology and Pharmacology...We already know that animal testing has some predictive capabilities for humans but there has never been a study on this broad scale before to look at the level of exact concordance...Of the study’s key results...the species most frequently used in toxicology (rat and dog)...are performing well with regard to identifying adverse events in humans...also...the negative predictive value is low for many adverse events...no findings in animal often does not mean that no adverse events will occur in humans...some effects observed in some animal species do not imply high risk for humans...The analysis allows a researcher to estimate the human risk implied by a given observed effect in an animal...With access to this kind of information, researchers can design safer clinical trials in the future...

Officials are considering adding an “export manufacturing waiver” to the Supplementary Protection Certificates that extend patent protection. The waiver would allow companies to manufacture drugs covered by SPCs at sites in Europe, provided the products are destined for export to markets in which patent protection has lapsed or never existed...The Commission is proposing the waiver to enable companies based in the European Union to meet demand for biosimilars and generics in emerging markets and other overseas territories. Currently, SPCs can prevent manufacturers from using their European operations to supply drugs for export, potentially making them less competitive than their foreign peers...This will help create growth and high-skilled jobs in the EU. It could generate €1bn ($1.2bn) net additional sales per year and up to 25,000 new jobs over 10 years...the European Federation of Pharmaceutical Industries and Associations questioned whether the policy will achieve its objectives and said it may create friction between the EU and its trading partners...EFPIA...perceives clear downsides to a policy it sees as devaluing the European intellectual property framework and deterring investment in the region...

Alibaba will place some of its online pharmacy business into a listed unit in a deal valued at $1.35 billion....Alibaba Health Information Technology will buy Ali JK Nutritional Products, which controls sales of medical devices, health-care products, adult products, and health-care services on Alibaba's Tmall platform...The deal will see parent Alibaba receive newly issued shares in Ali Health, taking its economic interest in the firm to 56.2 percent from 48.1 percent currently. Alibaba will also have a 67.5 percent voting interest in Ali Health after the deal...The deal should bolster business for Ali Health amid a broader push into a fast-growing health-care technology market...Alibaba CEO Daniel Zhang said in a statement that health care was a "strategically important" business area for the firm and that the deal would help turn Ali Health into the country's "best health-care ecosystem."...Chinese health-care spending is set to hit $1 trillion by 2020, up from $357 billion in 2011...with technology firms increasingly looking to break into a growing private health-care market.

President Trump signed a bill...allowing terminally ill patients access to experimental medical treatments not yet approved by the Food and Drug Administration...Dubbed "right to try," the law's passage was a major priority of Trump and Vice President Pence, as well as congressional Republicans..."Thousands of terminally ill Americans will finally have hope, and the fighting chance, and I think it's going to better than a chance, that they will be cured, they will be helped, and be able to be with their families for a long time, or maybe just for a longer time," Trump said at a bill signing ceremony at the White House, surrounded by terminally ill patients and their families...Most Democrats and public health groups oppose the bill, arguing that it could put patients in danger...FDA oversight of access to experimental treatments exists for a reason — it protects patients from potential snake oil salesmen or from experimental treatments that might do more harm than good...Opponents also argue it gives “false hope” to patients, since drugmakers aren’t required to give unapproved medicines to patients who ask for them...Supporters say, however, it will provide new treatment opportunities for terminally ill patients who have exhausted existing options...

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

...the Business, Energy and Industrial Strategy Committee released a report detailing the consequences of the UK leaving the EU without a deal for the pharmaceutical industry...UK-headquartered pharma companies generated a total of $87.5bnin global sales...A small reduction in the size of the sector could therefore have significant effects on the UK economy...Findings in the BEIS report suggest that if the UK fails to reach an agreement with the EU for the industry during Brexit negotiations, there is a risk of the UK becoming a second-tier state in pharmaceuticals...The UK’s future role in the European Medicines Agency...is expected to significantly impact the UK’s pharmaceutical sector post-Brexit. If the UK government does not negotiate regulatory parity with the European Economic Area, the UK will no longer have access to the single marketing authorisation for EU and EEA countries, requiring companies to submit a separate UK application for any new drug...This would require duplication of staff and facilities to conduct clinical trials and submit regulatory applications in both the UK and the EU, costing pharmaceutical companies millions of dollars. BEIS warns these consequences will make the UK an unattractive small market and result in complete loss of access to certain drugs, particularly specialised therapies...

King's Daughters Medical Center...found it challenging to provide an accurate, verifiable home medication record for its providers to trust as they made important decisions about existing medications both during an inpatient visit and after discharge...King's Daughters now uses external medication history from pharmacy fill data as well as insurance claims data, provided by vendor DrFirst, to complement verification and push the information to the providers...While it is not intended as a replacement for the patient/family interview, its integration into the electronic health record greatly augments the conversation and can prompt a patient to include easily forgotten information...This reduces the risk of prescription loss and makes the process more efficient for the patient while ensuring the health record is updated in advance of future visits...King's Daughters is required to report its performance on both medication reconciliation (with a threshold goal of 50 percent) and e-prescription (10 percent) to the Centers for Medicare and Medicaid Services...most recent reporting period, Q4 2017, our stats were 77 percent and 52 percent, respectively...integrating medication management tech into the EHR also helped King’s Daughters more effectively retrieve historical data and deliver that information to providers to facilitate new prescriptions in a trustworthy manner that both reduces errors and the abuse of controlled substances...