- Audit offers bevy of regulations for Nevada medical marijuana program (reviewjournal.com)
Tweaking the system...Nevada’s legislative audit division issued nine recommendations for the state’s medical marijuana program:
- Better verification of authenticity of physicians who recommend marijuana
- More monitoring of physicians who write those recommendations
- Ensure patients reason’s for growing at home are legitimate
- Eliminate the background check for medical marijuana card applicants
- Develop controls so dispensaries do not sell to patients with expired cards
- Better safeguard sensitive information
- Develop a cleaner and more organized record keeping system
- Report: Hanmi’s failure to report patient death in olmutinib study broke South Korea’s medical laws (endpts.com)
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.
- Health Canada to increase transparency (cmaj.ca)
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...
- Sanofi Pasteur coughs up $19.8M to settle claims it overbilled the VA (fiercepharma.com)
Sanofi Pasteur agreed to pay more than $19.8 million to settle allegations that it overcharged the Department of Veterans Affairs for its products...The French pharma’s vaccines unit voluntarily reported the "calculation and reporting error" with the VA in 2012, and has since "cooperated fully and negotiated in good faith with the government,"...Sanofi Pasteur based its first disclosure to the U.S. government on products sold to the VA from 2007 to 2011. A follow-up investigation by the VA's Office of Inspector General found the overcharging error dated back to 2002, the DOJ said…This is not the first settlement in a pharma overpricing case. A range of drugmakers have paid settlements to wrap up improper billing allegations, which often fall under the False Claims Act, which governs overcharging for Medicare, Medicaid and other government programs. The most prominent recent case was Mylan’s $465 million deal to settle allegations that it overcharged Medicaid for EpiPens...
- Nation’s First ‘Budtender’ Certified In Sacramento (sanfrancisco.cbslocal.com)
A Sacramento woman was recently certified as California’s and the nation’s first cannabis pharmacy technician or "budtender."...Shayna Schonouer isn’t just an expert on all things cannabis-related when it comes to using marijuana products to treat a medical condition. She is now the only person in the nation to hold the state-sanctioned title of "budtender."...Schonouer has just wrapped-up a two-year program making her the first graduate apprentice in the field of pharmacy cannabis technician..."She’s not a doctor, she’s not a pharmacist — but she has in this industry enough expertise to help people make informed decisions on their choices to self-medicate," explained Don Merrill, who works for the state’s Department of Industrial Relations and helps run the program...She will now work with pharmacists who offer cannabis products to patients coping with cancer or any chronic condition...It will also be her job to make sure the cannabis products coming in to shops and pharmacies are properly tested...
- Doctor tells U.S. court drug not suitable for Arkansas executions (reuters.com)
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.
- Uruguay gives pharmacies green light to start selling marijuana (reuters.com)
Uruguay's three-year process of legalizing recreational cannabis consumption reached its final stage...when the government said it would authorize pharmacies to begin selling the substance as of July...Sixteen pharmacies have registered with the government of the tiny South American country to be able to sell marijuana for recreational purposes. That number is expected to increase to 30 in the coming months, said Juan Roballo, head of the National Drug Board...The government hopes the formalization process will "guarantee the quality and the purity of the product" citizens consume, Roballo said. The cannabis sold in pharmacies will be grown by producers licensed by the state...The process will be heavily regulated by the government...Interested Uruguayans 18 or older must enroll in a government registry...and are limited to purchasing 40 grams per month…
- WFI System Meets European Requirements (pharmtech.com)
Bosch’s new system for the production of water for injection, which is used in solutions for injection and infusion, uses membrane processing and ultrafiltration. Previously, it was only possible to produce WFI for the European market using distillation...the revised European Pharmacopeia monograph allows, for the first time, WFI to be obtained using other comparable processes...Pharmatec designed a WFI production unit using membrane processes that meets the requirements...from the European Medicines Agency...The generation unit employs cold membrane processing methods (i.e., reverse osmosis and electrodeionization), with an additional ultrafiltration step...Monitoring all the processes in the production chain is essential to guaranteeing the microbial quality of the water, which is why we fitted the unit with various sensors and measuring devices to monitor the water quality throughout the process and to check the individual steps...
- NHS report promises ‘over 1,300’ pharmacists in GP surgeries by 2019 (pharmaceutical-journal.com)
‘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."...
- Failure to Reauthorize User Fee Programs Would Result in About 3,000 FDA Layoffs (raps.org)
Representatives from the biotechnology, medical device and generic drug industries told members of the Senate Committee on Health, Education, Labor & Pensions...that if the five-year user fee programs are not reauthorized, the US Food and Drug Administration would likely see more than 3,000 job cuts...Those layoffs...would significantly curtail new medical product approvals for pharmaceutical, biotech and medical device companies and likely delay research...Senators on both sides of the aisle also criticized Trump’s budget proposal on Tuesday, which would cut billions from the National Institutes of Health and replace congressional appropriations at FDA with more user fees...Representatives from industry groups BIO, AdvaMed and AAM reiterated to the committee what FDA officials told the House Energy & Commerce Committee late last month: that a failure to act on the already-agreed-to reauthorizations would be devastating...