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The International Society of Pharmaceutical Engineering announced...that it is field-testing the design principles of a comprehensive industry-led program of self-evaluation of pharmaceutical quality program with industry colleagues, senior leaders, and regulators. The vision for the program is to evolve the focus from submission of harmonized quality metrics as given in recent FDA guidance documents to establishing a framework for advancing the state of pharmaceutical quality, while at the same time continuing to align with the purpose outlined by FDA...ISPE believes this approach will deliver on the objectives outlined by FDA and will increase the value to industry...

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

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...

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

Kelly Davio, welcome to This Week in Managed Care from the Managed Markets News Network

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.

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...

Kelly Davio, host, the Pharmacy Times News Network's Pharmacy Week in Review.

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...

Samantha DiGrande, Welcome to This Week in Managed Care from the Managed Markets News Network