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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.

A judge ruled...that the Department of Corrections must reveal the name of the attending physician in the planned execution of Scott Dozier, but the name may be revealed only to the attorneys who represent the makers of drugs in the state’s lethal injection protocol...Assistant Solicitor General Jordan Smith, who represents the prison system, told District Judge Elizabeth Gonzalez that publicly revealing the name could lead to death threats...Todd Bice, an attorney for Alvogen Inc., which makes the sedative midazolam, said the company’s lawyers wanted to ensure that the doctor who is expected to oversee capital punishment is a licensed physician...Gonzalez is expected to hear further arguments...in the fight over the use of the three drugs in Nevada’s lethal injection cocktail.

With less than a year left for the UK to leave the EU, ensuring an undisrupted flow of medicines in between the UK and the EU following Brexit is a growing concern among drug developers and regulatory agencies...On 23 August the UK’s Department of Health and Social Care has asked pharmaceutical companies that supply drugs to National Health Service patients to ensure a minimum of six weeks of additional supply of medicines over and above their usual buffer stocks, due to a potential disruption of medicine imports from the EU in the event of a no-deal Brexit. While the UK still may remain part of the EU’s drug approval system following Brexit, the uncertain regulatory environment post-Brexit is urging drugmakers to prepare for the worst...The actions that will need to be implemented by the pharmaceuticals industry, such as stockpiling of medicines, duplicating facilities in both the UK and the EU area, and establishing alternative trade routes are expected to be highly costly measures...drugmakers are on their own to implement these changes, and recent survey results reported by the EMA indicate that some drugmakers have not taken sufficient steps to maintain the continuous supply of their products following Brexit.

A Canadian province has launched a proposed class-action lawsuit against the opioid industry, targeting companies from the nation’s biggest grocer Loblaw Cos. to Oxycontin-maker Purdue Pharma Inc., marking a new front of international action against the industry...British Columbia filed its claim...against more than 40 manufacturers, wholesalers and distributors of opioids, seeking to recover “millions of dollars in opioid-related health care costs incurred by the provincial government,” Attorney General David Eby said in a statement...The suit accuses companies of contributing to “an epidemic of addiction”...in Canada. The class action is probably the first such lawsuit outside of the U.S...If the court certifies British Columbia’s claim as a class action, other Canadian provinces and territories will be able to join...

A doctor has been disciplined by Nevada state pharmacy regulators after he was accused of improperly looking up prescription records of the dead gunman in last October's mass shooting in Las Vegas...Attorney E. Brent Bryson said Thursday that Dr. Ivan Goldsmith has to pay $26,000 in fines and attorney fees but keeps his license to prescribe medicines if he completes a year of probation...Goldsmith was accused of improperly looking up gunman Stephen Paddock's patient profile and disclosing to the Las Vegas Review-Journal that Paddock had been prescribed diazepam, an anti-anxiety drug better known as Valium.

IBM and CDC experts are hopeful that using a blockchain could help streamline long-running surveys that track patient symptoms and treatments...The Centers for Disease Control and IBM are collaborating on a blockchain-based system that could track public health issues like the ongoing opioid crisis...The new system, which IBM and the CDC’s National Center for Health Statistics have tested using simulated data, could make it easier for the CDC to survey medical providers about data like the reasons patients visit and the symptoms they display...Using the blockchain approach could make it easier to automatically collect the data, keep it secure, and log who’s accessed which parts of it...“There’s a lot of transparency that blockchain seems to offer to us,”...Blockchains are perhaps still most commonly associated with cryptocurrencies, where the secure digital ledgers are used to track who owns each unit of currency, with copies of the ever-growing chain of records automatically duplicated to anyone who wants them. But companies like IBM and Microsoft are exploring how the technology can be used in more traditional industries to sync up data like logs and transaction records between business associates, like health providers and the CDC. The automatic data replication can help maintain a reliable audit trail for more than just digital currency, they say...

We have previously written about pharmacy benefit managers and the way states are trying to regulate them through legislation and other means. With just one week left of the California session, it is possible that the state will become the most recent to regulate PBMs...California Assembly Bill 315, simply titled Pharmacy benefit management...was recently...revived with an amendment on August 20, 2018...The legislation, if passed, would require PBMs to be licensed by the California Department of Managed Health Care; require that a PBM exercise a duty of good faith and fair dealing in the performance of its contractual duties to a purchaser, and would require the PBM to disclose to a purchaser any conflict of interest that would interfere with the discharge of that duty; require a PBM to periodically disclose to a purchaser, at their request, certain information such as drug acquisition cost, rebates received from pharmaceutical manufacturers, and rates negotiated with pharmacies; require PBMs to notify pharmacy network providers of certain material contract changes at least 30 days before those changes take effect; prohibit PBMs from including in a contract with a pharmacy network provider provisions that prohibit the provider from informing consumers of alternative medication options or from dispensing a certain amount of prescribed medication; and would also create a toll-free provider line for pharmacies to report any PBMs who are in violation of the law.

Nevada officials have filed an emergency request with the state Supreme Court seeking to block a lower court’s decision to release the identity of the attending physician scheduled to oversee the delayed execution of Scott Raymond Dozier...In an emergency motion...the attorney general’s office, representing the Nevada Department of Corrections, is seeking to block a...decision by District Court Judge Elizabeth Gonzalez. The judge said the state must reveal the name of the physician set to oversee Dozier’s execution to attorneys representing one of the drug manufacturers whose product will be used in the execution...Although Gonzalez’s order would limit disclosure of the physician’s identity to the attorneys for drug manufacturer Alvogen, the state wrote in its emergency request that the attending physician would only oversee the execution “to the extent their anonymity is protected from disclosure” and that even a limited disclosure of individuals involved in the execution wasn’t relevant and would limit the state’s ability to carry out the execution...“The drug manufacturers should not be permitted to go on a fishing expedition for information that can be used to harass individuals who assist the State in carrying out lawful executions,” attorneys with the state wrote in the filing. “The intended effect is to scare people away from assisting the State. This tactic is well-documented and, unfortunately, has been effective in stopping executions.”

The Food and Drug Administration’s “black box” warnings and advisories give important safety information about drugs. But they can sometimes go too far and harm more people than they help...Take the FDA’s highly publicized warnings that taking antidepressants increases the risk of suicidality...among children, adolescents, and young adults. We have evidence, as do many others, that these warnings have decreased youths’ access to mental health care and increased suicide attempts...In October 2004, the FDA required a so-called “black box warning” of this risk to be printed on the labels of all antidepressant drugs. It was implemented in January 2005. Two years later, the FDA extended the same warning to include young adults, again based on industry studies...There’s no question that antidepressants can cause harm if used inappropriately. But the FDA failed to recognize — and still won’t acknowledge — that the harms of its public advisories and black box warning on antidepressants for young people more than outweigh the benefits...

As the US Food and Drug Administration continues to navigate a bumpy road toward modernization, a new data enterprise will aim to enhance regulatory decisions on products...The growing number of novel medical products in the US prompted FDA to “refashion” the approaches to drug and device regulations and “create more modern platforms that are better suited to the efficient evaluation of these advances,” said FDA Commissioner Scott Gottlieb...The initiatives already underway...will help “fund the creation of a cross-cutting data enterprise for the generation of evidence, and a more modern and integrated approach to the evaluation of this information,”...Modernization is intended to make regulatory premarket reviews more consistent and predictable to ultimately increase competition among firms and allow for more timely patient access to a greater number of drugs and devices in the US market that are more affordable and of higher quality. This culture shift could also lead to reduced burden and potential cost savings...