Category:

In the latest attempt to curb the spiraling opioid epidemic, generic companies will face new drug development requirements before they can sell copycat versions of abuse-deterrent opioids, according to a draft guidance released today by the Food and Drug Administration...the agency is recommending that generic drug makers run a variety of studies and provide data analyses to demonstrate that their medicines are no less abuse-deterrent than the brand-name products on which they base their own medications...We recognize that abuse-deterrent technology is still evolving and is only one piece of a much broader strategy to combat the problem of opioid abuse...encouraging generic alternatives can achieve that goal, especially since these are generally lower-cost alternatives to brand-name medicines...The draft guidance, however, won’t be finalized until after a 60-day comment period and the agency digests the reactions...The greater concern is whether the tamper resistance and abuse deterrence of the original formulation is sufficient. Many people abuse and misuse opioids orally, in which case tamper resistance will be essentially ineffective...

...small towns are looking to this corner of Story County for an answer to a chronic challenge: How can rural areas provide crucial pharmacy services, especially for elderly people who have trouble traveling?...Zearing leaders say the key is tucked in the corner of a former beauty parlor that has been transformed into a small drugstore. Next to the counter, organizers set up a video screen through which customers can interact with pharmacists working in larger towns...The pharmacists explain how patients should take medications and avoid interactions with other drugs. Customers can ask questions and raise concerns. The video conversations, which usually take a minute or two, could soon become more common around the state...Iowa legislators are considering a bill that would let state pharmacy regulators routinely approve tele-pharmacies instead of handling them as limited pilot projects.

Treatment cost for the average patient would go down by 16 to 20 percent, but for 40 percent of patients, the cost may go down by as much as 50 percent...Hepatitis C patients are often cured before completing a treatment regimen, suggesting patients require less of the drugs needed to fight the disease, according to a recent study...Researchers at Loyola University devised a mathematical model that predicts the length of time patients need direct-acting antiviral drugs, potentially limiting the cost of being treated with an expensive drug...Using more frequent blood testing, the researchers were able to determine hepatitis C levels and predict when the drug sofosbuvir, combined with one of three others, could be stopped...Treatment currently is standardized to be given for a set period of time, not tailored to the patient...In many cases, this may result in the prolonged use of expensive drugs with essentially no additional positive effect...

Less than two years after University Medical Center received $25.5 million in loans and eliminated hundreds of positions, the hospital is in the midst of a financial "rebirth," according to CEO Mason VanHouweling...At a meeting of the Clark County Commission...the county revealed UMC is expected to receive a $31 million subsidy — the same subsidy it received for the 2016 fiscal year and far less than it requested in years past...VanHouweling said the hospital has been able to "turn a financial corner"...As a facility that serves a large number of indigent patients, the hospital requires at least some funding from the county to function...It was never designed to generate the type of revenue that private hospitals today can generate...UMC is planning to modernize and remodel infrastructure at its main campus as well as at its primary and quick care facilities. The hospital also plans to move to a new electronic health records system and upgrade technology in operating rooms...the hospital is carefully watching for any possible reductions to disproportionate share hospital, or DSH payments, which help to offset the costs of care given to indigent patients. DSH payments are expected to be reduced nationwide, which would hurt UMC.

Poland's ruling conservatives plan to reinstate a prescription requirement for "morning after" emergency contraceptive pills, a move critics say reflects Catholic Church pressure and may lead to unwanted pregnancies...the...Law and Justice party has taken steps to redesign Poland's young democracy to reflect the country's traditional Catholic values...The party has already said it will end state funding for in-vitro fertilization, saying it is too expensive. The powerful Polish Catholic Church strongly opposes IVF, as well as morning after pills...There is now just one morning after pill available in Poland without a prescription to women 15 and over. It became available over the counter early last year, following a decision of the European Commission to authorize its prescription-free sale...Polish health ministry wants to reinstate the prescription requirement...

The raging dispute between Anthem...and Express Scripts...is winning notice because the companies are battling over billions of dollars in prescription drug costs. Specifically, Anthem contends Express Scripts, which manages prescription drug benefits for health plans, failed to pass along rebates negotiated with drug makers...The battle, which is described in a lawsuit filed in federal court in New York...Anthem claims emphatically that Express Scripts has not been transparent because a third-party consultant conducted an audit and found the insurer was overpaying Express Scripts by about $3 billion annually...Anthem is seeking $15 billion in damages and wants out of its contract with Express Scripts...The outcome "could have far-reaching effects" on pharmacy benefits management..."The lawsuit challenges a fundamental aspect of PBM-insurer relationships: the value of a PBM’s negotiating power" with drug makers. The dispute could "embolden other (Express Scripts) clients to do the same" thing and claim they are not receiving rebates to which they are entitled...Another industry watcher...suggests that Anthem may have an additional motive for its lawsuit beyond recovering money. Anthem plans to merge with Cigna...which happens to have its own pharmacy benefits manager..."Anthem likely wants to bring its PBM function back in house as part of a combined Anthem-Cigna company,"..."Perhaps Anthem’s dispute with Express Scripts is in part a way to convince the FTC to approve the Anthem-Cigna merger because it would increase competition in the PBM market."...

India has defended its right to grant licenses allowing local firms to override patents and make cheaper copies of drugs discovered by big Western drugmakers, and said reports to the contrary were "factually incorrect"...The Commerce Ministry statement comes weeks after...media in India quoted the...U.S.-India Business Council, as saying India had given private assurances that it would not grant such "compulsory licenses"..."In this regard, it may be noted that India has a well-established TRIPS (Trade-Related Aspects of Intellectual Property Rights) compliant legislative, administrative and judicial framework to safeguard IPRs (intellectual property rights). Under the Doha Declaration on the TRIPS Agreement Public Health, each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted."...The USTR (U.S. Trade Representative) has placed India on its "priority watch" list for two years in a row, saying the country's patent laws unfairly favor local drug makers. A legal provision that allows granting of "compulsory licenses" has been a key bone of contention.

Patients who need to dispose of unwanted controlled substances and other medications are embracing the convenience of drug disposal kiosks managed by their local health-system pharmacies..."We've collected a little over two tons, in the last year, of unwanted medications," said Buck Stanford, community pharmacy operations director for Intermountain Healthcare...all 25 of Intermountain Healthcare's community pharmacies have a way for patients to dispose of their medicines...Kristina McGill...at Beth Israel Deaconess Hospital...fall became the second in Massachusetts to set up a drug disposal kiosk and the first to install one outside of the pharmacy...Both health systems obtained their kiosks, known as MedSafe units, from Sharps Compliance Inc....The steel kiosks are double padlocked and contain an inner receptacle consisting of sturdy inner and outer cardboard boxes plus plastic liners and absorbent pads. The inner boxes double as a shipping container for sending the medications away for incineration...The Drug Enforcement Administration in...2014 implemented a regulation that allows pharmacies and other healthcare entities to register as collection sites for controlled substances and other unwanted medications...as of February 29, a total of 882 DEA registrants had been designated as collectors...ASHP policy 0614, Safe Disposal of Patients' Home Medications, encourages pharmacists to develop patient-oriented medication disposal options that minimize the risk of accidental poisoning, drug diversion, and adverse effects on the environment...

Has Obamacare Reduced Costs?...Those family cost savings, of course, have not materialized...the health care cost curve is still on an upwardly mobile trajectory...Centers for Medicare and Medicaid Services data show that total per capita health insurance spending will rise from $7,786 in 2016 to $11,681 in 2024. Looking at the future of employer-based health insurance costs, the Congressional Budget Office (CBO) projects that job-based premiums are poised to increase by almost 60 percent between now and 2025...the Affordable Care Act...calls for sustained payment cuts to the popular Medicare Advantage program. It also has scheduled some big Medicare payment reductions over the next ten years for hospitals, nursing homes, home health agencies and even hospice care programs...Medicare trustees report that, if policymakers really go through with these Affordable Care Act provisions, 50 percent of America’s hospitals, 70 percent of the nation’s nursing homes and 90 percent of the nation’s home health agencies will be operating in the red in the next 24 years...This...will jeopardize seniors’ access and quality of care.

New safety warnings also added to all prescription opioid medications to inform prescribers and patients of additional risks related to opioid use...Food and Drug Administration...announced required class-wide safety labeling changes for immediate-release opioid pain medications...the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death...actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.