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The US Food and Drug Administration offered a sneak peek...into a new report on the impact of opioid use disorder (OUD) from the perspectives of about 155 patients...Preliminary results highlighted...offer insights into the impact of OUD on patients’ day-to-day lives to aid industry and FDA staff in the push for patient-focused drug development...The input can serve FDA and others in identifying specific areas of unmet needs for patients with OUD, support advice on medical product development programs and facilitate greater appropriate use of approved medications and how these are evaluated...The results highlight the impacts of OUD, a sensation called “craving,” treatment goals, as well as benefits and downsides of and the current barriers to medication-assisted treatment (MAT)...Benefits to MAT that patients reported include reducing the “euphoric rush,” as well as being able to “arrest the cravings and compulsiveness” and regain control of their life. In contrast, downsides relate to “intolerable or bothersome” side effects and the need to stay on MAT long-term. MAT also reportedly fails to address underlying issues, such as anxiety and pain...On challenges to MAT, participants cited a lack of access due to long wait times to obtain medication and strict requirements to remain in a program, among other issues. They also cited unpleasant experiences at MAT facilities, stigma, the intensity of withdrawals, addressing comorbid pain or mental health needs and a self-recognized need to come to terms with OUD.

California’s insurance regulator is suing AbbVie Inc., alleging that the pharmaceutical giant gave illegal kickbacks to health-care providers in order to keep patients on its blockbuster rheumatoid arthritis drug Humira...The company “engaged in a far-reaching scheme including both classic kickbacks -- cash, meals, drinks, gifts, trips, and patient referrals -- and more sophisticated ones -- free and valuable professional goods and services to physicians to induce and reward Humira prescriptions...AbbVie paid for registered nurses that it called ambassadors to help doctors with patients who were taking Humira. While the nurses were represented to patients as an extension of the doctor’s office, they were trained to tout the drug while downplaying its risks...The allegations “are without merit,”...The company complies with state and federal laws governing interactions between health-care providers and patients...Its services help patients and “in no way replace or interfere with interactions between patients and their health-care providers...

Are rural hospitals properly tracking and reporting healthcare-associated infections like clostridium difficile? What about screening their patients in ambulatory clinics for alcohol use and abuse?...Those quality measures are among a set of suggested measures the National Quality Forum released...in an effort to put rural providers “on a pathway” to improvement...The measures are part of the NQF’s Measure Applications Partnership, created under the Affordable Care Act to provide input to the U.S. Department of Health and Human Services on the best performance measures for public reporting and performance-based payments...MAP singled out 20 measures that to fit the unique needs of rural providers and address their key concerns, such as access to care...The forum has recommended that the Centers for Medicare & Medicaid Services adopt the measures in Medicare first, and then potentially expand them to Medicare Advantage...Ensuring that rural hospitals and providers can participate in quality improvement is crucial...

The FDA's latest round of testing has revealed an additional impurity, N-nitrosodiethylamine (NDEA) in three lots of Torrent Pharmaceuticals' recalled valsartan products. NDEA is a known animal carcinogen and a suspected human carcinogen...The source of the impurity was the valsartan active pharmaceutical ingredient from Zhejiang Huahai Pharmaceuticals. Not all products made from Zhejiang Huahai's valsartan contain the impurity, however...More than half of valsartan products are now under recall and FDA said last month more are likely...The story has now escalated. Once the FDA and EMA learned that Zhejiang Huahai discovered an additional impurity, NDEA, the authorities retested all valsartan API and products. Like NMDA, NDEA appears to be formed as a result of a specific sequence of steps in manufacturing.

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.

Medical errors of all kinds, including medication errors, are now the third highest cause of death in the United States and may be responsible for 10% of all deaths in the country, according to a 2016 study by Johns Hopkins Medicine. According to the National Academy of Medicine, preventable medication errors harm 1.5 million Americans annually and cost hospitals an additional $3.5 billion each year...“I think the problem is becoming worse because this is a complex medical system that we have,”...Strategies to prevent medication errors in recent years include a move to electronic prescribing and adding barcodes to drug products. But experts say these efforts have not eliminated the need for vigilance among pharmacists, technicians, and other healthcare professionals in the community and hospital setting. Here’s more on the actions pharmacists need to take to avoid some of the most common medication errors.

• Processing Errors
• Dosage Errors
• Care Transition Errors
• Alert Fatigue Errors
• Other Errors
• Technology on the Horizon

Pharmaceuticals is one of the highest value industries globally..Any contamination in the drugs manufacturing process can have a substantial financial impact, not to mention possible safety implications...Drug manufacturer Genzyme was forced to temporarily close its Massachusetts plant in 2009, halting production of the Fabrazyme and Cerezyme drugs that were at the time used by 8,000 patients globally, after a virus was found to have contaminated a bioreactor...At the time it was estimated that the incident could cost Genzyme up to $300m in lost revenue...The company was later fined $175m by the US Food and Drug Administration and wrote off more than $28.4m worth of product...

The landmark legislation would disburse nearly $8 billion to HHS, CMS, CDC and state governments, with big goals for population health, care coordination and patient safety...The Opioid Crisis Response Act of 2018...It's a massive bill comprising a wide array of proposals drawn from five Senate committees, and has many implications for the use and funding of health IT...It contains funding for stopping the flow of illegal opioids from other countries, and for supporting local programs for prevention, treatment and recovery...spur research and development of new non-addictive painkillers and stem "doctor shopping" by boosting prescription drug monitoring programs...has funds to give behavioral and mental health providers the tools they need to offer treatment and recovery – including potential electronic health record incentives – and for hospitals to better care for infants with neonatal abstinence syndrome.

The Department of Justice has given the green light to insurance giant Cigna Corp.'s planned $67 billion acquisition of pharmacy benefit manager Express Scripts...The move terminates the applicable waiting period..The transaction still remains subject to certain state regulatory approvals and filings, including clearances from certain departments of insurance...Cigna and Express Scripts have obtained clearances from departments of insurance in 16 states. The companies are working with regulators in the remaining jurisdictions to obtain clearance for the merger...

Almost half of all European-registered clinical trials - in which scientists test drug treatments, interventions or therapies in humans - have breached EU rules by failing to report results...The analysis also found that while most major pharmaceutical companies are coming close to complying with EU reporting rules for trials in people, most major academic institutes are not...European Union guidelines say that funders of clinical trials must ensure all studies entered on the EU Clinical Trials Register since 2004 have posted results there within a year of concluding...Advocates for transparency in science say enforcing the rule is necessary to ensure researchers do not bury results they consider unfavorable...We cannot make informed choices about which treatments work best, as doctors and patients, unless all results are reported...