- Indian API maker Pan Drugs is reconstructing its manufacturing suite after holes in the wall and rusty equipment landed the facility a US FDA warning. (in-pharmatechnologist.com)
Pan Drugs received the Warning Letter…with the US Food and Drug Administration citing a number of deviations from GMP (good manufacturing practices) standards during an inspection of the Nandesari, Vadodara facility (India)…failed to maintain, repair, and keep clean its API manufacturing units,…holes in the walls and roof which allowed pigeons access near production equipment…gaps and holes in outside walls for piping and air ducts which allow contaminants to enter the building…We have given the commitment to stop all production while we renovate the facility,…
- Pharmacists Hit the Hill on Legislative Day (ashp.org)
As pharmacists from across the nation gathered in Washington, D.C., for meetings with their congressional representatives, ASHP President John Armitstead reminded his colleagues that they are not alone in advocating for the profession's priorities…referring to Georgia Representative Buddy Carter, the only licensed pharmacist in Congress…"Provider status is very important," emphasized Carter,..cosponsor of the Pharmacy and Medically Underserved Areas Enhancement Act, which would recognize pharmacists as healthcare providers under Medicare in specific circumstances…Legislative Day is part of ASHP's annual Policy Week activities, which include council meetings and a trip to Capitol Hill for attendees to talk pharmacy with their elected officials.
- Pharmacy accidentally gave man chemo (radionz.co.nz)Patient given cancer drugs rather than immunosuppressant (mp3) (radionz.co.nz)Decision 14HDC00439 (hdc.org.nz)
Deputy Health and Disability Commissioner (New Zealand) has found a man wrongly took a chemotherapy drug (cyclophosphamide) for three weeks because a pharmacy dispensed the wrong medication…The 79-year old man was supposed to be taking an immuno-suppressant (cyclosporine), following a kidney transplant…He took the chemotherapy drug for about three weeks before asking the pharmacist why his tablets had changed…The pharmacist checked the records and found a technician had filled the prescription, but that he had signed it off... he did nothing further, he didn't complete an incident form, he didn't alert the owner of the pharmacy…the pharmacist was also remiss for not offering any counselling to the patient…pharmacist has been ordered to apologise to the man in writing, and further action could follow.
- Health district reports year’s first human West Nile case (reviewjournal.com)
Clark County man has become the first documented West Nile virus patient of 2015 in Southern Nevada…The man over the age of 50 has the more serious form of the illness, according to the Southern Nevada Health District… Environmental health specialists routinely survey known breeding sources for mosquitoes and trap them for identification and disease analysis…The health district has collected West Nile positive mosquitoes this year in 22 local ZIP codes: 89011, 89012, 89014, 89025, 89027, 89029, 89031, 89074, 89107, 89113, 89117, 89118, 89119, 89123, 89128, 89129, 89130, 89131, 89134, 89143, 89146 and 89147.
- Researchers said a popular antidepressant was safe for teens. It was actually deadly. (vox.com)Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence (bmj.com)
For years,…GlaxoSmithKline was illegally persuading doctors to prescribe paroxetine (Paxil),…as an antidepressant for children and teenagers…citing…Study 329…research...claiming to show that Paxil is "well tolerated and effective" for kids…A…new analysis of the raw data behind Study 329, published in BMJ (British Medical Journal), suggests that the original conclusions were…wrong. Not only is Paxil ineffective, working no better than placebo, but it can actually cause serious side effects, including self-injury and suicide…New York State Attorney General…sued GSK,...pleaded guilty...paying out $3 billion in fines. Drug companies are pushing to market more drugs for off-label uses…
- Taking the opioid crisis to the boardroom – Gloucester police chief urges dialogue with pharmaceutical executives (bostonglobe.com)
Gloucester police, taking an unconventional approach to fighting the state’s opioid epidemic, are imploring people to contact chief executives at five pharmaceutical companies and ask what they’re doing to curb the drug scourge…In a Facebook post this week that was shared more than 500 times, Police Chief Leonard Campanello listed names and contact information…exhorted the department’s....followers to reach out directly to the corporate chiefs to start a conversation about drug abuse prevention… Campanello said he believes that the executives could play a key role in finding a solution to the epidemic, but they "might need a little push" in the form of phone calls and e-mails.
- NIH takes next steps in Obama’s Precision Medicine plan (reuters.com)
National Institutes of Health…approved a blueprint for President Obama's Precision Medicine Initiative and named an NIH insider as interim director of the project (Francis Collins)…sweeping study,…goals of the study are to develop better estimates on individuals' risk for developing disease...
- Las Vegas judge won’t be removed from medical malpractice case (reviewjournal.com)
Chief District Judge David Barker today denied a request to disqualify the judge assigned to a medical malpractice case against Summerlin Hospital…Ruben White, who claims malpractice led to the tuberculosis-related deaths of his wife and twin daughters at the hospital, had asked District Judge Joe Hardy Jr. to withdraw from the case because of an appearance of impropriety…. The court finds that a reasonable person, knowing all the facts, would not harbor doubts about Judge Hardy's impartiality…White argued in a motion for recusal that Hardy's father, Republican state Sen. Joe Hardy, has an economic interest in the outcome of the case. White indicated he plans to file a motion in the case asking that the state's cap on medical malpractice damages be declared unconstitutional, and he argued that the judge's father has been "an active opponent" of removing the cap.
- HELP Committee chairman calls for flexibility in implementation of Stage 3 EHR rules (modernhealthcare.com)AMA urges hitting Stage 3 pause button (healthcareitnews.com)
Sen. Alexander, chairman of the Senate Health, Education, Labor and Pensions Committee,…called for a delay and a phased-in implementation of Stage 3 of the electronic health-records program…we should delay until Jan. 1, 2017, making of the final rules for Stage 3 of the federal government’s program to require doctors and hospitals to create electronic health-record systems…should be phased in at a rate that reflects how successfully the program is being implemented…about a quarter of a million physicians and about 200 hospitals face Medicare penalties if the current Stage 2 rules are not revised. Only about 12% of physicians and 40% of hospitals have been able to comply thus far …
- Carson Tahoe Health partners to unveil Sierra Pediatric Blood and Cancer Consortium (nevadaappeal.com)
Three Northern Nevada hospitals along with area provider groups are ganging up on childhood cancer…Renown health, Saint Mary’s, Carson Tahoe Health, Washoe County and the Access to Healthcare Network joining forces to establish the first full-time clinic in Northern Nevada to provide complete services to child cancer patients… the Sierra Pediatric Blood and Cancer Consortium...






