- Senate panel approves Dr. Robert Califf as FDA commissioner (hosted.ap.org)
President Obama's choice for commissioner of the Food and Drug Administration won easy approval from a Senate panel Tuesday, but two senators - a Republican and Democratic presidential candidate Bernie Sanders - threatened to block the nominee...Sen. Lisa Murkowski said she will hold up a vote on the Senate floor until she has reassurances from the agency that it will write rules for labeling genetically modified salmon. The Alaska Republican has said the engineered salmon approved by the FDA last year could be harmful to her state's wild salmon industry...Sanders has said the country needs an FDA commissioner who will stand up to the pharmaceutical industry and that Califf is "not that person." He said he is also considering a hold on the nomination...Califf's nomination does have the support of the Republican chairman of the Health, Education, Labor and Pensions Committee. Tennessee Sen. Lamar Alexander said Califf has been thoroughly vetted, and he is confident that Califf can lead the agency "fairly and impartially."
- NIH asked to fight price gouging by overriding drug patents (statnews.com)
A group of 50 congressional lawmakers wants the Obama administration to develop guidelines that would require drug makers to license their patents to others in a bid to end “price gouging.”...In their letter, they argue that the National Institutes of Health has the ability to issue so-called march-in rights, which refer to overriding a patent. Under federal law, this allows an agency that funds private research to require a drug maker to license its patent to another party in order to “alleviate health and safety needs which are not being reasonably satisfied” or when the benefits of a drug are not available on “reasonable terms.”...the lawmakers argue that “reasonable guidelines can discourage price gouging.” The letter was released...by the Affordable Drug Pricing Task Force...their reasoning, the lawmakers emphasized that march-in rights should only be used when “wrongdoing occurs” and that “innovation should not be threatened.” By issuing guidelines, they argue the NIH would help drug makers make “better-informed pricing decisions.”
- Retail Pharmacist MTM Roles Supported by US House (pharmacytimes.com)
More than 40 members of the House of Representatives have expressed support for greater pharmacist roles in improvements made to Medicare Part D’s medication therapy management program...CMS announced plans to improve MTM with its Part D Enhanced MTM model in September 2015. The enhanced model aims to look at additional incentives and flexibilities to achieve the goals of the program...Some of those goals include increased communication with pharmacists, prescribers, and patients; improved patient knowledge; reduced medication problems; and improved compliance with medication protocols...The enhanced MTM model test will launch in January 2017...Some of the medication adherence concerns that the Congressional members noted were:
- Nonadherence costs the United States $290 billion annually and makes up 13% of total health care expenditures.
- Patients with several chronic conditions comprise two-thirds of all hospital admissions and are 100 times more likely to have a preventable admission.
- These patients with several chronic conditions visit many different physicians in a year and receive around 50 prescriptions annually on average.
- MTM is currently poorly integrated into health systems.
Congressional leaders called for retail pharmacists to be included in the enhanced MTM models that will be tested, citing how pharmacists have been shown to improve patient health, reduce costs through fewer hospitalizations and readmissions, and increase patient involvement in their own medication management...Our seniors deserve the most robust and effective MTM program possible—one that includes the utilization of the most trained and highly skilled providers medication management services: local retail community pharmacists...
- Indiana bill encourages sale of meth-resistant PSE products (drugstorenews.com)
Community Pharmacies of Indiana...announced the organization's unanimous decision to support Senate Bill 80, also known as the Pharmacist Legitimization Bill...as a method to control the sale of pseudoephedrine products and decrease meth manufacturing in Indiana without requiring a prescription and unfairly penalizing law-abiding customers...Under the bill, cold medicines containing single-ingredient PSE, such as Sudafed, will remain available for behind-the-counter sales without a prescription. The bill would enable pharmacists to briefly consult with customers seeking products containing single-ingredient PSE, inquiring about symptoms and potentially recommending effective, non-prescription PSE products that contain meth-resistant safeguards, such as Nexafed and Zephrex-D…The bill would also grant pharmacists the legal protection to decline potentially illegitimate sales of PSE products that lack meth-resistant features where appropriate...Pharmacist Legitimization Bill represents common-sense legislation that balances efforts to help curtail the proliferation of meth labs throughout our state while also preserving the customer's ease-of-access to effective cold medicines for legitimate use without the burden of obtaining a prescription every time they have a head-cold…
- English doctors strike for first time in 40 years (reuters.com)Industrial action: junior doctors provide emergency-only care (bma.org.uk)
English doctors staged their first strike in 40 years on Tuesday over government plans to reform pay and conditions for working anti-social hours, in a move health chiefs have warned could put patients' lives at risk...Junior doctors, or doctors in training, who represent just over half of all doctors in the state-funded National Health Service, said they would only deliver emergency care during the 24-hour walkout..."This strike is not necessary, it will be damaging," Prime Minister David Cameron said on Monday. "We will do everything we can to mitigate its effects but you cannot have a strike on this scale in our NHS without real difficulties for patients and potentially worse."...Most people in England are supportive of the strikes, as long as emergency care is still provided...The doctors' union the British Medical Association said the contract does not provide proper safeguards against doctors working dangerously long hours.
- Britain set for first mass strike by doctors in 40 years (reuters.com)Junior doctors strike: Talks with BMA lasted less than an hour, says Jeremy Hunt (dailymail.co.uk)
The British government said it was seeking to hold talks with doctors in its state-funded health service in a last-ditch bid to avert a series of mass walkouts, potentially the first such strikes for four decades…Junior doctors, or doctors in training who represent just over half of all doctors in the National Health Service, said…they would stage a 24-hour stoppage next week, followed by two further 48-hour strikes…It will affect non-emergency care and lead to the cancellations of many operations… Ninety-eight percent of more than 37,000 junior doctors had voted to take part in industrial action, including strikes, in protest against the new employment contract proposed by Health Secretary Jeremy Hunt…The BMA and doctors have criticized the contract, which changes the way they are paid for anti-social hours, saying it does not provide proper safeguards against doctors working dangerously long hours…The government says the new contract is part of measures to ensure patients get the "same quality of care across the week"…"Our absolute priority is patient safety and making sure that the NHS delivers high-quality care 7 days a week – and we know that's what doctors want too, so it is extremely disappointing that the BMA have chosen to take industrial action which helps no-one," Hunt said in a statement.
- Getting the Pill Without a Doctor: The Revolution Begins (bloombergview.com)
Oregon is making hormonal birth control legally available without a doctor's prescription, and California is set to follow suit. This is great policy, and the rest of the country should follow this example...Before I explain why they should, we should dispense with the policy hopes that easier access to birth control won’t fulfill:
- It won’t end the political fight over the contraception mandate.
- It won’t end the political fights over abortion, either. Easier access to birth control is a great thing. But there is surprisingly weak evidence that making birth control easier to get substantially reduces abortion rates.
- It won’t save the health-care system any significant amount of money.
There are still very good reasons to make birth control available without a doctor visit, starting with the fact that women like it...Absent a compelling reason that women need to see a doctor, it should be as easy as possible for them to get any form of birth control they might like to have...Advocates for keeping doctors involved in dispensing birth control have historically used two arguments.
- The first is that the drugs have side effects -- which is true, but of course, also true of over-the-counter medications...
- The second argument is that we need to keep doctors involved so that women will keep coming to the gynecologist to get their annual exam and pap smear.
- How much are junior doctors paid, and why are they threatening to strike? (telegraph.co.uk)Junior doctors row: David Cameron asks doctors to call off strike (bbc.co.uk)
As the British Medical Association prepares for industrial action, ending in the first 'all out' strike by medics in the history of the NHS, we examine the issues...Junior doctors are on the verge of their first day of industrial action, marking the first of three days that ends next month with the first "all out" strike by medics in the history of the NHS...Under the plans, junior doctors will provide "emergency care only" action for Tuesday 12 January, and Tuesday 26 January, followed by a full walk out from 8am to 5pm on Wednesday 10 February...What's caused such ire in the medical community? Is it all about pay? How justified is their anger? Read on for all you need to know.
- Why are they so cross?
- What do the current proposals look like?
- What will strike action involve?
- Is the dispute all due to the 7-day NHS idea?
- Why won't the two sides talk?
- Weren't doctors meant to strike in December?
- How much do junior doctors get paid?
- How does this compare to other starting salaries?
- But what about cuts to their pay?
- Would doctors be put off certain specialities?
- How will their pay supplements change?
- What about working hours?
- When would these new contracts come into force?
- What happens next?
- Complaint alleges McKesson shipped nearly 100 million doses of highly addictive RX drugs to WV, fueled drug epidemic (wvillustrated.com)Morrisey files suit against nation’s largest drug distributor (wvgazettemail.com)
Prescription drug distributor McKesson Corporation is the target of a complaint alleging it fueled West Virginia's prescription drug addiction problem by "failing to identify, detect, report and help stop the flood of suspicious drug orders into the state," Attorney General Patrick Morrisey said…the...complaint…alleges McKesson flooded West Virginia with highly addictive prescription medications, delivering roughly 99.5 million doses of hydrocodone and oxycodone…McKesson…"made no efforts to determine whether the volume of prescription pain killers it was shipping ...was excessive and whether any of the orders it filled qualified as suspicious orders, which should have been refused."…Sales agents and managers received commissions and bonuses based on sales numbers, and made "little to no effort to visit pharmacies" to ensure shipments weren't being diverted to illegal use…"In the near future, the office will seek to join this case with the ongoing matter in Boone County involving 12 other drug wholesaler defendants," he said in a prepared statement…in order to coordinate the Amerisource and McKesson cases and to ensure adequate resources are available to prosecute the McKesson case, the state has awarded an outside counsel appointment...Morrisey also announced Jan. 8 he will be handing off the management of both the Amerisource and McKesson cases to...Anthony Martin and...Vaughn Sizemore and will voluntarily step aside, going further than the rules require. Morrisey has had ties to Cardinal Health, one of the nation's largest drug distributors.
- HHS And CVS Health Partner To Promote Consumer-Centered Preventive Services (healthaffairs.org)
The Department of Health and Human Services’ Office of Disease Prevention and Health Promotion and CVS Health recently formed a public-private partnership. This partnership aims to increase awareness of the availability of convenient, consumer-centered, recommended preventive services using healthfinder.gov. Healthfinder.gov is a source of easy-to-use prevention and wellness information, designed using health literacy and usability principles...CVS Health, recognizing the important role of informing and engaging patients about preventive care...integrated the myhealthfinder API into the MinuteClinic website in a pilot project conducted jointly with the healthfinder.gov team at the ODPHP...we expect individuals to become more informed and active consumers of clinical preventive services...To extend the reach of federal programs that improve health literacy, and encourage prevention and healthy behaviors...the HHS and CVS Health collaboration could be a model for other retail clinics…Because of retail pharmacies’ consumer and convenience focus, and their important role in connecting patients to and sustaining their relationships with primary physicians, retail pharmacies add valuable perspective and insight to the assessment of preventive care.









