Author: Peter

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.

...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...

Continuous manufacturing can help drugmakers save on development costs by reducing API waste...The continuous – as opposed to batch – method has been revered for its improved product quality and lower outlays, such as reduced good manufacturing practice areas, transport, and storage...The one thing that continuous manufacturing will definitely save you money on, is development..Commercial benefit?...It may look on paper that a batch method is going to be cheaper…but none of that cost will account for batches failing in commercial development, and then not being able to sell that product... The more complex the process it, the more susceptible you are to doing that...

The Stacie Mathewson Behavioral Health and Addiction Institute will focus on identifying the causes of mental illnesses and addiction at early ages. Thanks to a $6 million donation by Charles and Stacie Mathewson, parents and the medical community will have more resources to help battle addiction and mental health issues..."We don't have enough specialty providers that know how to treat children and adolescents in the community. It's a severe lack; we need more people to specialize in that population and those kids and being able to reach them early," said Kristen Davis-Coelho, psychologist at Renown Regional Medical Center...The Institute will also track babies who are born addicted and help provide individual case management to meet the medical needs of the babies, as well as parents working toward long-term recovery or support for foster and adoptive parents.

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...

A Las Vegas counseling and mental health care provider has been fined more than $1 million and placed on three years of probation after fraudulently billing Medicaid...We Care Behavioral Health Agency LLC was convicted on a gross misdemeanor charge of intentional failure to maintain adequate records...(the agency) didn’t keep documentation on when or which billed services it actually provided to Medicaid recipients

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...

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...