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The FDA has tied the contamination of blood pressure drugs by probable carcinogens to an approved switch in manufacturing to a process that uses certain solvents. Now an online pharmacy says it has discovered the solvents are as bad as the impurities they have been creating and has criticized the FDA for not taking steps to limit their use...In a citizen petition...Valisure says the FDA has established acceptable limits for impurities such as those commonly known as NDMA and NDEA after they were discovered in heart drugs last year, leading to massive global recalls...But it claims the FDA has not lowered the acceptable level for the solvent DMF, although it “has become apparent that the switch in the manufacturing industry to the use of the DMF solvent may be largely responsible” for the appearance of the impurities in the U.S. drug supply...The petition says the FDA needs to investigate the use of the solvent N,N-Dimethylformamide in drug manufacturing since it is classified as a Class 2 carcinogen...READ MORE

Scott Gottlieb (Former FDA Commissioner) warns that health benefit claims about CBD have gotten well ahead of what science actually knows about the substance...“The idea that you can put it in dog food and it’s going to calm your dog ... I think that’s pretty hokey,” he says...CBD is not a “benign compound,” and regulations will be needed to protect people from possible unknown side effects, Gottlieb said...READ MORE

Using data from privately-insured adults, new findings from The University of Texas...revealed that there is a lower level of opioids prescribed in states that have allowed the use of medical marijuana...We found that the overall prescription opioid use increased by age, which we expected. But, when we looked at the results within different age groups, opioid prescription rates varied depending on the stringency of state cannabis laws. In particular, states that implemented medical cannabis laws had lower rates of opioid prescription in people aged 18 to 54...Initially, opioids were seen as a way to ease pain and their use became widespread over time, with little attention paid to possible side effects or the risk of addiction...READ MORE

Medical software company Allscripts has bought ZappRx, a start-up that aimed to modernize how people access prescription medicines...Allscripts’ core business is selling electronic medical record software to hospitals and other health providers...ZappRx specializes in helping people access the class of so-called specialty medicines, which includes expensive and high-complex or high-cost interventions...READ MORE

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.

The National Association of Chain Drug Stores today praised Texas’ enactment of a bill (HB 2174) to address opioid abuse and addiction, while providing key safeguards to address the needs of those suffering from chronic pain...the new law will require electronic prescribing for controlled substances, to help prevent fraud and abuse. It also will limit the supply of a patient’s first opioid prescription to 10 days, when that prescription is for temporary, or acute, pain. It is important to note that this limit does not apply to prescriptions for ongoing, or chronic, pain. It also does not apply to cancer care, treatment of other illnesses, or end-of-life care...READ MORE

A Canadian advisory council studying prescription drug coverage said...the federal government should create a C$15.3 billion ($11.5 billion) universal, single-payer public pharmacare system, and warned that the current system requires a major overhaul...Canada is the only country with a universal health care system that does not include universal coverage for prescription drugs. Most prescriptions are paid for through employer-funded drug plans, while some are covered by government programs for the elderly, or people with low incomes or very high costs...If implemented in full, the plan would likely cut into profits of insurers and drugmakers in Canada, while saving employers and patients money...READ MORE

A report from the EUIPO demonstrated that a shift in the focus of counterfeited goods to include pharmaceutical products has caused significant loss of sales and employment...The European Union Intellectual Property Office has released a report this month regarding 11 analysed sectors in the region, including the pharmaceutical industry...The European Union organisation found that all analysed sectors lost sales as a result infringement of intellectual property rights for a total of €92 bn ($106bn) between 2013 and 2916...the pharma industry suffered the second biggest loss of sales, at €16bn…READ MORE

...Sanofi has teamed up with Google to work on innovations, aimed at using emerging data technologies to change how medicines and health services will be delivered in future...Sanofi and Google will use data sets to improve their understanding of key diseases and extract patients’ insights and feedback...Combining Sanofi’s biologic innovations and scientific data with Google’s industry-leading capabilities, from cloud computing to state-of-the-art artificial intelligence...READ MORE

The Centers for Medicare & Medicaid Services approved a request...from Washington state to negotiate value-based drug rebate agreements with pharmaceutical manufacturers in its Medicaid program...The approval makes Washington the fourth state to test such an arrangement; similar policies have already been given the OK in Oklahoma, Michigan and Colorado, according to an announcement from CMS...Washington officials are aiming to test a “subscription” model for hepatitis C drugs...In this model, Medicaid would pay a fixed annual sum to a drug company for the hepatitis C medication, purchasing an unrestricted supply of the drug... CMS is committed to increasing states’ flexibility to develop policies that lower costs, increase the predictability of expenses and improve access for patients...READ MORE