- Transitional Chaos or Enduring Harm? The EHR and the Disruption of Medicine (nejm.org)
…complaints might be dismissed as growing pains, born of resistance to change. But transitional chaos must be distinguished from enduring harm…the EHR's limitations and why they've been largely ignored, one key barrier is that physicians who voice reservations are labeled "technophobic, resistant, and uncooperative." But in fact…most physicians recognize the potential of EHRs and appreciate such features as the ability to view data remotely. Nevertheless, the researchers found remarkable EHR-induced distress. They conclude, "No other industry, to our knowledge, has been under a universal mandate to adopt a new technology before its effects are fully understood, and before the technology has reached a level of usability that is acceptable to its core users."...What this surgeon and the rest of us need are patient records that communicate meaning and foster understanding of the particular patient in question. The blanks on our screens can be filled with words, but the process of understanding cannot be auto-populated. Perhaps life without the EHR will soon be unimaginable. But the technology will support and improve medical care only if it evolves in ways that help, rather than hinder, us in synthesizing, analyzing, thinking critically, and telling the stories of our patients.
- GNC Plunges After Oregon Says Unapproved Drugs in Supplement (bloomberg.com)
GNC Holdings Inc., the chain of health and wellness stores, plummeted as much as 21 percent after Oregon sued the company, claiming it sold supplements made with illegal ingredients…the company’s nutritional and dietary supplements were laced with unapproved drugs. One is picamilon, a Russian prescription medicine for neurological conditions, and the other is BMPEA, which was first synthesized in the 1930s as a replacement for amphetamines and never studied in humans, according to the state’s complaint.
- Court Records: Derby Nurse Pressured By Drug Company To Boost Sales (courant.com)
A…nurse who admitted taking kickbacks from a drug company that makes…Subsys (fentanyl sublingual) was pressured by sales representatives to increase her prescribing "so that the Subsys numbers would also increase,"…federal prosecutors charged that Heather Alfonso "continued to increase her prescribing of Subsys and to find more patients for whom she could prescribe the drugs" in exchange for a series of $1,000 kickbacks, totaling $83,000, from the company, Insys Therapeutics…the…narcotic is approved only for cancer patients, some of the patients given Subsys by Alfonso "did not have a cancer diagnosis,"...But "prior authorizations" submitted on behalf of patients falsely represented that they had cancer, misleading insurers into paying for the drug…She…was the highest prescriber in Connecticut in 2013, writing $2.7 million in prescriptions.
- CDC: State data shows opioid prescribing behavior needs to change (drugstorenews.com)
A new report from the Centers for Disease Control and Prevention is shining light on steps that can be taken to prevent opioid abuse and misuse… CDC found that prescribing practices between states vary drastically… demographic differences between states do not entirely explain the variation...the CDC notes that the real way to fix the issue is to improve prescribing practices…A more comprehensive approach is needed to address the prescription opioid overdose epidemic, including guidance to providers on the risks and benefits of these medications…One of the largest contributors to opioid abuse is overprescribing done by a small number of prescribers whose prevalence is different between states…
- The 21st Century Cures Act – To the Editor: (nejm.org)H.R.6 — 114th Congress (2015-2016) (congress.gov)
In their Perspective article…Avorn and Kesselheim argue that the 21st Century Cures Act, which is currently being debated in Congress, would lower the regulatory standards of the Food and Drug Administration by giving it greater discretion to approve drugs on the basis of less rigorous data…the legislation would authorize the FDA to "rely" on observational analyses, which are less rigorous than randomized controlled trials. But the Cures Act does not diminish the FDA's standards for requiring that new medical products are safe and effective. Rather, it recognizes that recent developments in genomics, systems biology, electronic data systems, and other fields can provide additional tools and resources to support better premarketing and postmarketing regulation and more efficient development of drugs and medical devices…Better evidence and up-to-date regulatory science are the best foundation for regulatory decisions and meaningful progress in biomedical innovation. They are also the best way to avoid turning back the clock on new opportunities to develop safe and effective treatments for unmet medical needs...
- Drug Firms Buy Pricey Vouchers to Speed Products to Market (wsj.com)
There is a new price surge in the pharmaceutical industry—for a limited number of government-issued vouchers that drug makers… are buying to speed products to market…vouchers require the FDA to shorten its decision deadline to six months… Because companies can also sell the vouchers, a lucrative secondary market has emerged. AbbVie agreed in August to pay $350 million for a voucher from United Therapeutics Corp. ,which received it for developing a pediatric cancer treatment…the voucher program is attracting…criticism…These programs allow sponsors to ‘purchase’ a priority review at the expense of other important public health work in FDA’s portfolio… such as reviewing applications for drugs that treat more serious conditions...Adding to the escalating prices: the vouchers have a scarcity value because only seven have been issued…
- Study: Outdated technology holding back retailers (drugstorenews.com)
Yesterday’s POS won’t cut it when it comes to providing a consistent experience across channels… retailers are struggling to unify their online and in-store experiences, with existing technology/infrastructure preventing them from moving forward with new omnichannel solutions… 77% of the surveyed retailers believe their legacy point-of-sale is preventing them from providing a consistent customer experience across channels…retailers…face significant challenges getting new technologies rolled out to stores and in helping employees respond to informed, smartphone-enabled shoppers. Key findings include:
- store and the digital experience must be brought together for a continuous, seamless experience
- getting new technologies rolled out to stores is a top challenge
- inventory insight across all channels is important
- real-time visibility into customer activity across all channels is important
- Drug shortages hit Tricare (militarytimes.com)
Tricare officials say the problem stems from drug shortages…shortages are exacerbated within the military system because by law, DoD is allowed to buy pharmaceuticals only from certain manufacturers… shortages peaked at about the time DoD began requiring Medicare-eligible retirees and military family members to fill their long-term prescriptions by mail or at a military pharmacy…GAO Health Care Director Debra Draper pointed out that, since Tricare did not specifically track the satisfaction of beneficiaries now required to use the mail-order system and did not monitor the availability of covered medications for these beneficiaries, DoD is "unable to assess availability."…"DoD does not know what, if any problems, beneficiaries may have experienced filling their prescriptions,"…
- Rite Aid, Rx orgs make case for expanded MTM (drugstorenews.com)
...House of Representatives’ Committee on Energy and Commerce Subcommittee on Health convened a hearing called "Examining Medicare Part D Medication Therapy Management Program."...aimed at figuring out the best ways to strengthen MTM model as the Centers for Medicare and Medicaid roll out an overhaul… Rite Aid’s director of field clinical services… spoke in favor of expanding MTM…and highlighted recent efforts...which include the introduction of a bill…the Medication Therapy Management Empowerment Act that would increase access to MTM for patients with such chronic conditions as diabetes, cardiovascular disease, high cholesterol and COPD…given community pharmacist’s unique role as an easily accessible healthcare provider, they could be at the center of the expansion of MTM programs.
- Obama announces massive push to curb opioid abuse, heroin use (drugstorenews.com)
two steps…the president detailed in a memo all federal departments and agencies…providing prescriber training among federal health care professionals, a move that addresses concerns raised recently by the Center for Disease Control and Prevention, which noted that prescribing behavior was one of the biggest contributors to opioid abuse…need for patients to have access to treatments…Obama has directed federal agencies and departments to…facilitate easy access to health benefits and to find barriers to treatment for those with opioid uses issues.








