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The top two Democrats in the Nevada Legislature are calling on U.S. Sen. Dean Heller to explain how Republicans in Congress will replace key provisions of the Affordable Care Act if they repeal it...Aaron Ford and Jason Frierson...sent a letter...posing...questions to Nevada’s senior senator in Congress...the state leaders asked what steps will be taken to ensure people who purchased coverage through the state exchange and those who receive federal tax credits will still be able to buy affordable insurance...what will be done to ensure more than 217,000 Nevadans receiving coverage under expanded Medicaid eligibility will remain covered; guarantees for women’s health care; and continued mandates to cover people with pre-existing conditions and allow parents to keep children on their policies until age 26...“I would anticipate nobody’s going to lose their health care for the next two or three years until the replacement is put in place,” Heller said...

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

...Indian drug manufacturer Wockhardt is in trouble again with the US Food and Drug Administration, this time for destroying current good manufacturing practice documents, among a list of other major violations...FDA sent a warning letter to the company following an eight-day inspection...of its Ankleshwar...manufacturing site that uncovered “torn and shredded equipment maintenance documents, raw material labels, and change control work orders” in the site’s scrap yard awaiting incineration...The site was banned from shipping products to the US in August...This is the latest in a series of failures by Wockhardt to meet the standards of not just FDA but other regulators...

1. FDA announces major change in pharmacy inspections - In July, FDA issued a notice announcing that they are changing procedures for inspections of human drug compounders. FDA only gave about a month from the announcement—August 1—for the notice to be effective. APhA government affairs identified troubling language in the notice as follows: FDA will still undertake inspections of 503A facilities, rather than complying with current statute; FDA still intends to include CGMPs on Form FDA-483s, potentially for 503A pharmacies.
2. New sleep recommendations for most age groups - Good sleep is a must. In March, the National Sleep Foundation revised all recommended sleep ranges, which are age-specific and based on a systematic review of the current scientific literature. Overall, wider appropriate sleep ranges for most age groups are recommended by NSF.
3. CDC releases updated vaccine recommendations for 2016–17 influenza season - Updated vaccine recommendations for the 2016–17 influenza season included the continuation to have everyone aged 6 months and older without any contraindications receive a routine annual influenza vaccine. In addition, only injectable inactivated influenza vaccine and recombinant influenza vaccine should be used. In the recommendations, two new influenza vaccines were approved since last season and finally, a few of the recommendations for administering influenza vaccine in those with a history of egg allergy have been modified.
4. Zika virus disease: Frequently asked questions for pharmacists and their patients - Zika virus disease was on everyone’s minds this year, including pharmacists. Here were some frequently asked questions from February as the disease was beginning to emerge.
5. Newer antihistamines can cause adverse reactions in children - In a study published in the Archives of Disease in Childhood, Dutch researchers found that adverse reactions from second-generation antihistamines can occur in children—a finding that gave many pause since these second-generation antihistamines were developed in an attempt to decrease adverse effects from first-generation antihistamines.
6. FDA: Antibacterial soaps should be avoided - In October, FDA put out a striking announcement to ban 19 active ingredients in antibacterial soaps and body washes, including triclosan and triclocarban—the two most commonly used ingredients. The reason: These active ingredients have little science to back up their effectiveness and could actually do more harm than good.
7. New federal overtime rules likely to have implications for pharmacy residents - The Department of Labor issued a final rule that took effect on December 1. It stated that employers must increase minimum salary for certain employees to keep them exempt from wage regulations, such as those related to overtime pay. The final rule does not exempt pharmacy residents, meaning they could see a bigger paycheck going forward.
8. FDA approves brand-name change for vortioxetine - FDA decided to change the brand name for vortioxetine. Starting in June, Brintillex switched its labeling to Trintellix in order to avoid errors associated with the similar-sounding name of the medication Brilinta.
9. CDC issues health advisory on beginning of severe flu season - Back in February when flu season was just beginning to hit, CDC issued a health advisory stating that severe influenza illnesses were reported. They also took the opportunity to encourage clinicians to continue with efforts to vaccinate patients against the influenza virus.
10. With Obama’s signature, expansive opioid policies become law - President Barack Obama signed legislation in July to provide a much-needed framework for opioid abuse prevention and treatment. The legislation, called the Comprehensive Addiction and Recovery Act of 2016, also recognized pharmacists as key players in the fight against the opioid epidemic.

In a sign of improving cooperation between the U.S. and China to fight the global drug trade, the Drug Enforcement Administration will open a new office there...acting administrator Chuck Rosenberg will visit Beijing, Guangzhou and Hong Kong...at the invitation of China's Ministry of Public Security...DEA maintains that China is the top source country for synthetic opioids like fentanyl and its precursors, which have been fueling the deadliest drug abuse epidemic in U.S. history. China is also emerging as a laundering destination for drug money... Beijing has taken significant steps to crack down on the production and export of synthetic drugs, even though these substances are not widely abused within China...

Greek officials announced Tuesday that they are investigating Novartis for bribery in the wake of local media reports raising questions about the company. It is the fourth set of bribery allegations…to go public in the past year…Greek authorities have interviewed scores of sources and raided Novartis offices in Greece, according to multiple local news outlets. Justice Minister Stavros Kontonis ordered the inquiry after "denunciations concerning bribes paid to functionaries by Novartis" appeared in the press… Greece’s investigation follows a similar probe launched in South Korea last February and corruption allegations leveled by a Turkish whistleblower…South Korean prosecutors indicted a half-dozen Novartis executives for issuing improper rebates to local doctors…last year, Novartis agreed to pay $25 million to settle an SEC investigation into bribery allegations in China…Novartis offered Chinese doctors lavish entertainment…and other inducements to boost prescriptions of its drugs in the country.

The roll out of the pilot will see a further 1,500 pharmacists working in general practice by 2020-2021...NHS (National Health Service) England has announced an additional £112m ($137m) investment to roll out a pilot scheme embedding clinical pharmacists in GP surgeries...a commitment set out in the ‘General practice forward view’...The expansion...follows a “successful” pilot that involved 490 clinical pharmacists working in approximately 650 general practices across 90 sites...The goal of the scheme is to ease pressure on the NHS by increasing capacity in general practice, which will free up GP time as well as ensure safer prescribing by offering specialist advice and support for patients with chronic diseases…The success of the initial pilots has shown the benefits of having more clinical pharmacists in general practice, reducing GP workload and helping ensure patients are seen by the right professional in a more convenient and timely way...the scheme was welcomed by the Royal Pharmaceutical Society, which says it is a “significant step” towards its shared vision with the RCGP ( Royal College of General Practitioners) that every GP practice should have access to the expertise of a pharmacist...

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

The Food and Drug Administration is ironing out new rules for how drug companies can electronically submit medications for approval, and on Dec. 28 unveiled a draft of what they have planned so far…The draft largely focused on manufacturing establishment information (MEI) — things like a production facility's address, what it's manufacturing, how to reach the person in charge of scheduling inspections, as well as a unique facility identifier, which the agency uses to keep track manufacturing plants…The FDA is requiring companies to electronically submit MEI for each facility, but all in a single list. Companies must provide those lists for new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and any other supplemental materials… Once the final version of the guidance gains approval, drugmakers will have 24 months before the new rules become mandatory…The agency noted several reasons for the push toward electronic MEI submissions. The primary one was the convenience of having all the information on a single file versus non-electronic applications, where it can be scattered.

Community pharmacist sentenced for dispensing the wrong medicine spoke of ‘cramped working’ conditions and problem of similar packaging...An “overworked” community pharmacist, who pleaded guilty to dispensing the wrong drug to a patient who later died, has been sentenced to four months imprisonment suspended for two years...Martin White of Belfast Road, Muckamore in Northern Ireland, mistakenly dispensed propranolol instead of prednisolone, having told investigators that the two packages were “side by side on the shelf and have similar branding”...White admitted at an earlier hearing...to an offence under section 64 of the Medicines Act 1968, that he had “supplied a medicinal product in pursuance of a prescription given by a practitioner, which was not of the nature or quality specified”, to the prejudice of Ethna Walsh...(her) death has had a devastating effect on her family and said the damage and injury caused by the pharmacist could not be higher...The pharmacist’s degree of culpability was the result of “poor professional performance, but not professional misconduct”...adding that there was “no evidence of intentional negligence”...given the cumulated effect of White’s guilty plea, previous good character, loss of reputation and career and permanent financial loss, (Judge Gordon Kerr) said he did not feel an immediate custodial sentence was necessary...