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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face new drug development requirements before they can sell copycat versions of abuse-deterrent opioids, according to a draft guidance released today by the Food and Drug Administration...the agency is recommending that generic drug makers run a variety of studies and provide data analyses to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can achieve that goal, especially since these are generally lower-cost alternatives to brand-name medicines...The draft guidance, however, won’t be finalized until after a 60-day comment period and the agency digests the reactions...The greater concern is whether the tamper resistance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...

One in six seniors in the U.S. regularly uses potentially dangerous combinations of prescription and over-the-counter medications and dietary supplements, according to new research...This is a major public health problem...Many of these potentially deadly drug interactions involve prescription and non-prescription medications and supplements that are not only commonly used, but are increasingly being used by older adults. While it is not known how many older adults...die of drug interactions, the risk seems to be growing and public awareness is lacking...study authors identified 15 potentially life-threatening drug combinations...health care providers should carefully consider the potential adverse effects of commonly used prescription and nonprescription drug combinations...and counsel their patients about the risks...Improving safety in the use interacting medication combinations has the potential to reduce preventable, potentially fatal, adverse drug events...We need to create systems that support an ongoing process of monitoring medications...Such systems would help us periodically assess the benefits, harms and ongoing need for each of a patient's medications, as well as the reasonableness of the medication regimen as a whole. These systems could also help physicians with deprescribing, for example by supporting gradual down-titration of a medication and monitoring patients for adverse drug withdrawal reactions after a drug is stopped...

If a drug does a good job of treating lung cancer, but is less effective at combating pancreatic cancer, you might think that the price should be lower for pancreatic cancer patients. But it doesn’t work that way in the convoluted world of pharmaceutical pricing, where a one-size-fits-all approach is generally used...Now, though, a new drug pricing scheme is gaining traction that would base payments on how well a medicine actually works...The concept, which is known as indication-specific pricing, would set different prices for the same drug to reflect the extent to which a medicine is effective for multiple purposes. The goal is to calibrate spending with performance and, in turn, lower overall health care costs.

...Anthem Inc said it had sued pharmacy benefit manager Express Scripts Holding Co to recover damages from drug pricing it believes was too high...latest development in a months-long dispute over Anthem's contract with Express Scripts...The lawsuit also seeks to recover damages from operational issues and for a declaration of Anthem's right to terminate its contract with Express Scripts…Anthem, which has been seeking $3 billion in annual cost savings through a repricing provision in its 10-year contract with Express Scripts, said it had not yet decided whether to end the contract...The latest news has taken a very unhealthy turn and we see it unlikely that Anthem renews its contract with Express Scripts past 2019, and is likely to leave sooner to the extent it can manage the transition for consumers smoothly...Express Scripts...said in a statement that it believed the lawsuit to be without merit. The company has consistently acted in good faith and in accordance with the terms of its agreement with Anthem…

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...

Aprecia Pharmaceuticals announced the U.S. availability of its Spritam (levetiracetam) tablets...The epilepsy medication is the first tablet made using the company’s ZipDose 3D printing technology to be approved by the Food and Drug Administration. It is designed to dissolve with a sip of liquid, easing the process of taking medication for patients with difficulty swallowing...

Last week, Express Scripts released its new 2015 Drug Trend Report...For the first time, the Express Scripts data account for rebates—a meaningful and welcome improvement in reporting methodology. After accounting for rebates, the 2015 report reveals that drug spending growth is comparable to growth in other parts of the healthcare system. For some payers, utilization (script growth) was a bigger driver of spending than drug prices...So much for the myth of exploding drug costs! Our politicians may not believe it, but Martin Shkreli et al. are the exception in the pharmaceutical industry. Below, I review the four key highlights about traditional and specialty drug spending, trend patterns for different payers, and a red flag from upcoming biosimilar launches.

FOUR TAKEAWAYS

1. Commercial payers were better able to control costs.
2. More people are getting access, which is “good” spending.
3. Specialty growth continues.
4. Hunker down for the biosimilar formulary wars.

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...

American Associated Pharmacies, a member-owned cooperative comprised of over 2,100 independent pharmacies located in 49 states, announced...that it has reached an agreement to acquire the assets of Partners in Pharmacy Cooperative, an independent pharmacy cooperative with more than 300 members in 19 states...The acquisition of PIPCo fits within AAP's growth strategy and solidifies its position as a leader in the independent pharmacy cooperative market... AAP has a successful track record of business consolidation, helping to strengthen independent pharmacy's influence in the marketplace...In addition, AAP realizes additional cost synergies through its recently announced joint venture, Arete Pharmacy Network, the fourth largest nationwide Prescription Service Administrative Organization.

Centers for Disease Control and Prevention...issued a new guideline for prescribing opioids...for chronic pain that is not related to cancer or end-of-life care. The document’s goal is to curb...a doctor-driven prescription overdose epidemic...Of the guideline’s 12 recommendations, the top one states that non-drug or at least non-opioid drug approaches should be tried before opioids...the Office of the Assistant Secretary for Health at the Department of Health and Human Services released a national pain strategy that emphasized the need to treat chronic pain with a variety of well-tested approaches, not just medication...Non-drug approaches to relieving chronic pain, such as exercise, weight loss and talk therapy, have the advantage of not needing warning labels, and research suggests that they can be as effective as NSAIDs. But they take more time and effort than swallowing a pill.