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A Korean patient taking Hanmi’s cancer drug olmutinib died from a rare case of Stevens-Johnson syndrome a full 14 months before it was reported to the country’s health authorities, triggering a scramble that ultimately caused its partner Boehringer Ingelheim to abruptly withdraw from their $730 million partnership on the drug…Korean officials determined that Hanmi broke two medical laws related to monitoring and reporting clinical trials…the case dates back to the death in July 2015, when a patient taking olmutinib and two other drugs died from the lethal skin condition...the case dates back to the death in July 2015, when a patient taking olmutinib and two other drugs died from the lethal skin condition. The physicians involved in the case...reported the case to a monitoring agency...it was not reported as an unexpected serious adverse event...Hanmi and the monitoring agency finally reported the death to health officials in September, 2016...only after Hanmi said it first became aware of the incident...The case spurred accusations...that the influential Hanmi...had intentionally delayed reporting the death so it could get the drug approved in Korea.

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

• Newsletter Goes Electronic
• More on Opiate Addiction
• DEA Changes Registration Renewal Process
• ISMP Medication Safety Self Assessment for Community/Ambulatory Pharmacy
• CDC Publishes Resource to Foster Use of JCPP Pharmacists’ Patient Care Process
• FDA Issues Final Guidance on Repackaging Drugs by Pharmacies and Registered
• Outsourcing Facilities
• CriticalPoint Launches QP503A CertificationProgram for Sterile Compounding in 2017
• PTCB Suspends Implementation of Planned 2020 Accredited Education Requirement for Pharmacy Technicians
• ASOP Global Spreads Awareness About Illegal Online Drug Sellers and Counterfeit Medications
• New Interactive Map Tracks Pharmacist Vaccination Laws
• PMP Data Submission Accuracy
• Attention Pharmacy Managers!

There are a lot of health insurance bills at state legislature this session, as there is great concern about what will happen if Congress does "Repeal and Replace" ObamaCare...After 7 years of the Affordable Care Act, we’re all kind of used to the bill that has provided subsidized insurance to about 80,000 Nevadans and expanded Medicaid coverage to about 300,000...Chair of the Assembly Health and Human Services Committee, Mike Sprinkle of Sparks, has a bill that would remove the income limits on the state’s Medicaid program and open it up to Nevadans who want to buy. People would be able to buy insurance on the Silver State exchange for a certain amount, while current Medicaid recipients could continue to receive government assistance through the program...I was opposed to expanding Medicaid in Nevada, as I was concerned about the cost to taxpayers. But maybe its expansion is actually helping lower costs for all of us. I’m not totally sold, but I’m more open to ideas like Assemblyman Sprinkle’s after a few years of seeing it actually enacted...By doing what is "morally" right — helping low-income and working class families access healthcare — may turn out to be fiscally right. But if you disagree, bring it on!

CRISPR that favored the Broad Institute…Jennifer Doudna of the University of California...and Emmanuelle Charpentier of the University of Vienna were first to apply for patent in 2012 after discovering how the primitive bacterial system...could be used to edit genomes in simple pieces of DNA…A team at the Broad Institute led by...Feng Zhang applied for a separate patent six months later, but paid for a fast-track review process, which landed them the first CRISPR patent in 2014. The Broad's patents were for showing that the CRISPR system could be used to edit more advanced, eukaryotic cells, including animal and human cells...In its...decision, an appeals board...determined that the Broad's CRISPR patents "did not interfere" with those awarded to the UC because they were sufficiently different, allowing them to stand...In the appeal...UC is seeking a reversal of the decision, which ended before actually determining who invented the use of CRISPR in eukaryotic cells. Major commercial applications of CRISPR are expected to be in eukaryotic cells...geneticist George Church said he expects the disputes will end in cross-licensing...I'm not that interested in the details of who pays who what. We're all going to do very well, including the patients. That was evident from the very beginning…

Maryland lawmakers have passed a first-in-the-nation measure that lets the state attorney general sue generic drug makers that sharply raise prices in a move aimed at fighting what legislators call "price-gouging."...The bill overwhelmingly was approved by the Democratic-controlled legislature on Monday and hailed by Maryland Attorney General Brian Frosh as a way to check sharply higher prices for crucial generic drugs…Governor Larry Hogan, a Republican, has not said whether he would sign the legislation...The bill allows Maryland's state authority on Medicaid...to let the attorney general's office know when it sees patients being charged an "unconscionable increase" for essential generic drugs...The attorney general could then seek an explanation from the manufacturer and sue to protect consumers, with a fine of up to $10,000 for each violation. A judge could order the company to reverse its price increase.

‘Next steps on the NHS five year forward view’ outlines progress made so far and highlights priorities for the next few years, including plans for 900 clinical pharmacists in GP surgeries by 2018 and over 1,300 by 2019...according to plans announced on 31 March 2017 by Simon Stevens, chief executive of NHS England...it expects GP surgeries to work in "hubs" or networks enabling them to share community nursing, mental health and clinical pharmacy teams and also work more closely with community pharmacists to make "fuller use of the contribution they make"...Sandra Gidley, chair of the Royal Pharmaceutical Society’s English Pharmacy Board, welcomes the document but says that the clinical skills of pharmacists are still an untapped resource...The National Pharmacy Association, the trade association for independent community pharmacies in the UK, shared this view in a statement. "Local pharmacies can do far more in urgent care and the management of long-term conditions, and take pressure off other parts of the system including GPs and hospitals...We will need to make sure that pharmacists have a significant role in clinical care, regardless of where they practice as the forward view is implemented."...

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

A surgeon told a federal court in Arkansas...that a sedative the state plans to use in its lethal injection mix is not suitable for surgery and should be prohibited when Arkansas holds an unprecedented series of executions later this month...Arkansas plans to kill eight prisoners in dual executions...Death penalty opponents have said the rushed schedule is reckless and increases the chance of errors...The convicted murderers scheduled to die have asked U.S. District Judge Kristine Baker in Little Rock to halt their executions, saying the state's rush to the death chamber was unconstitutional...Lawyers for Arkansas, have told the court that the drug in question, midazolam, has been used in executions in other states and its lethal injection protocols pass constitutional muster...Arkansas Governor Asa Hutchinson...set the schedule, saying the state's midazolam supply expires at the end of April and it was in the interest of justice to hold as many executions as possible while Arkansas has the difficult-to-obtain drug.

Health Canada plans to increase transparency into its regulatory process for drugs and medical devices by publicly releasing clinical information submitted by companies who receive market authorization...Opening access to clinical information used to support the authorization has widespread health system benefits and can help Canadians make informed decisions about their health…Under the proposed transparency policy, the information will be kept confidential during the regulatory process but disclosed if the drug or medical device is approved for sale. According to Health Canada, this information is "far more comprehensive" than data available in sources such as medical journals and clinical trial registries...Companies will be able to request, however, that certain parts of the clinical information they submit be exempt from public release...Health Canada states that this transparency initiative will increase public confidence in the drug and medical device review process; help patients and health care providers make more informed decisions about drugs and medical devices; avoid duplication in clinical trials; and make clinical trial data available for secondary analysis to advance medical science...