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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...

The state of Nevada’s government website has potentially exposed the personal data on over 11,700 applicants for dispensing medical marijuana in the state...each application, eight pages in length, includes the person’s full name, home address, citizenship, and even their weight and height, race, and eye and hair color. The applications also include the applicant’s citizenship, their driving license number, and social security number...A Google search done by a man in Dallas led to the discovery of the problem. Justin Shafer said he discovered the breach Tuesday night while he was looking to see if any government websites had errantly posted social security numbers online. Shafer said he noticed one of the completed applications pop up in the search results with a social security number in plain view...Many of the people affected are employed by members of the Nevada Dispensary Association…Riana Durrett, executive director of Nevada Dispensary Association...says she's been assured the state is focusing all of its efforts to fix the breach...The state disabled the website...as a precaution...

A drug distributor owned by Cardinal Health Inc has agreed to pay $10 million to resolve claims it failed to alert the U.S. Drug Enforcement Administration to suspiciously large orders of...painkillers by New York-area pharmacies...The settlement with Kinray LLC, a New York City-based pharmaceutical distributor, disclosed in papers filed...in federal court in Manhattan...Kinray shipped the drugs to more than 20 New York pharmacy locations in amounts that were many times greater than the distributor's average sales of controlled substances to all of its customers...Kinray ignored numerous "red flags" and did not report any suspicious orders to the DEA...latest agreement stemmed from a 2012 settlement with the DEA in which its facility in Lakeland, Florida, was suspended from selling painkillers and other drugs for two years...The 2012 deal only resolved administrative aspects of the case, not potential fines Cardinal Health faced in Florida or elsewhere...(Cardinal Health)...has set aside $44 million to cover those potential liabilities.

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.

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.

• Enact the Increasing Competition in Pharmaceuticals Act...to incentivize competition to address regulatory uncertainty, small market size, and other factors that serve as limitations to generic entry;
• Encourage generic competition by ensuring the right to obtain samples and simplifying Risk Evaluation and Mitigation Strategies;
• Consider allowing highly targeted, temporary prescription drug importation to provide prompt price relief for major price increases in off-patent drugs;
• Take steps to prevent the misuse of patient assistance programs and copay coupons;
• Reinvigorate the Federal Trade Commission to take greater enforcement action on drug company mergers, operations, and drug market dynamics; and
• Improve transparency in the health care system.

Biosimilars have already taken hold in Europe, with Celltrion's Remicade copy, for one, wreaking havoc on the branded med's sales. Whether they'll finally make their mark in the U.S., though, remains to be seen—and 2017 could be the year we find out...Over the next several years, billions of dollars in legacy drug sales could be ceded to an oncoming and rising wave of biosimilars, with much of the action set to kick off in 2017. All told, 7 of biopharma’s top 10 best-selling drugs next year face a near-term biosim threat, meaning fortunes will be made or lost as the field continues to take shape...Fundamental legal questions also remain surrounding biosims in the U.S...whether the biosimilar pathway will survive...a potential Affordable Care Act repeal...the Supreme Court will likely review the “patent dance clauses which are currently optional.” That could potentially throw a wrench in future launches...

From a healthcare fraud enforcement perspective, 2016 was nothing short of a dynamic year...It was punctuated by the arrival of several important trends within the addiction treatment, post-acute care and compound pharmaceutical industries…It also featured a Supreme Court ruling on a False Claims Act legal theory, and a changing enforcement landscape in the aftermath of the Yates memo...As 2016 comes to a close, let's look back at some of the fraud trends that emerged—or in some cases intensified—over the last 12 months.

• Impact of the Yates memo
• Government targets post-acute care providers
• Big healthcare fraud busts continue
• Compound pharmacies under fire
• OxyContin marketing concerns revisited
• Addiction treatment gains ground, raises concerns
• Data continues to influence fraud detection
• EpiPen price hikes lead to overpayment settlement
• Medicare Advantage overbilling resurgence
• Supreme Court rules on implied certification

Columbia University Medical Center researchers have created a computational tool that can rapidly predict which genes are implicated in an individual's cancer and recommend treatments. It is among the most comprehensive tools of its kind, and the first that incorporates a user-friendly web interface that requires little knowledge of bioinformatics...The researchers found that iCAGES identified personal cancer "drivers" 77 percent of the time when presented with a pair of randomly chosen driver genes and non-driver genes, compared with about 51 percent for other computational tools... Cancer "drivers" can vary from patient to patient, and there are no practical clinical tools for predicting which variants in an individual's genome are driving his or her disease and which are present but not causing disease...Dr. Wang...developed a computational tool called integrated CAncer GEnome Score…(it) analyzes the patient's entire genome, comparing it to the genomic sequence of the patient's tumor to identify possible cancer-causing variants. Next...cross-references these variants to databases of known cancer-causing genes, using statistical analyses and machine learning techniques to prioritize the most likely driver genes. Finally...matches the variants to FDA-approved and experimental drug therapies that specifically address those variants or genes. The entire process takes about 30 minutes...

An experimental Merck vaccine is showing 100% effectiveness against the Ebola virus, according to results of a trial in Guinea published in The Lancet...The vaccine was tested on people in West Africa from March 23, 2015 through Jan. 20, 2016, and has not been approved by the US Food and Drug Administration or any other agency, but is considered so effective than an emergency stockpile of 300,000 doses has already been created should there be another outbreak…the vaccine, called rVSV-ZEBOV is a recombinant replication competent vesicular stomatitis virus-based vaccine that expresses a surface glycoprotein of the Zaire strain of Ebola virus...