Patients who use drugs containing hydrocodone as a pain reliever or cough suppressant are going to have to jump through more hoops to get them starting next month.
The Drug Enforcement Administration is reclassifying so-called “hydrocodone combination products” from Schedule III to Schedule II under the Controlled Substances Act, which will more tightly restrict access. Vicodin, for example, is an HCP because it has hydrocodone and acetaminophen.
The final regulation, which takes effect Oct. 6, will mean that patients generally must present a written prescription to receive the drug, and doctors will no longer be able to call in a prescription to the pharmacy in most instances. The regulation is a response to the widespread misuse of prescription pain killers.
In an emergency, doctors will still be able to call in a prescription, according to the new rule. And although prescription refills are prohibited, a doctor can, at his discretion, issue multiple prescriptions that would provide up to a 90-day supply.
These measures don’t satisfy consumer advocates or pharmacists who are opposed to the new rule.
While acknowledging that there has been an uptick in abuse and adverse events related to opioid painkillers, one patient advocate says the new rule restricts access indiscriminately.
“We certainly want steps taken to reduce adverse outcomes, but we don’t think this particular rescheduling was the appropriate way to go about doing that,” says Mark Fleury, a policy analyst at the American Cancer Society Cancer Action Network.
Many patients with painful chronic diseases, including cancer, take hydrocodone combination products.
Experts say they’re worried that patients may have trouble filling their prescriptions immediately after Oct. 6. Existing supplies of HCPs have to be relabeled as Schedule II drugs before they can be sold. “Starting Oct. 6, pharmacies won’t be able to sell their existing stock of products,” says Fleury.
Pharmacists say they’re anticipating confusion around refills of prescriptions written before the regulation takes effect, even though they’re permitted under the new rules.More From This Series Insuring Your Health
“We're hearing that because of discrepancies in state law, payers may not want to authorize refills,” says Stacie Maass, a senior vice president at the American Pharmacists Association.
In the long term, Fleury says, patients who don’t yet know there are new rules about refills will show up at pharmacies and likely be turned away.
“All of these patients are going to find out they don’t have a valid prescription, and have to go in and get a new one,” Fleury says. Adding insult to injury, they may get dinged with an office visit charge for their new prescription.
Massachusetts Attorney General Martha Coakley has submitted an amended agreement Thursday with Partners HealthCare over its proposed acquisition of Hallmark Health System.
The original agreement sanctioned Partners HealthCare to acquire South Shore Hospital and Hallmark Health System. Coakley says the amended agreement, which would cap prices at Hallmark for six and a half years, ensures the merger won’t increase health care costs in the state.
Under the re-negotiated agreement, Partners has also agreed to maintain the current level of psychiatric behavioral health services at Hallmark and North Shore facilities for five years.
Suffolk Superior Court Judge Janet Saunders is scheduled to consider the amended agreement at a hearing Monday. If approved, the settlement would resolve the attorney general’s anti-trust investigation into Partners and allow the merger and acquisition to go forward.
The agreement went back to the negotiating table after Massachusetts’ Health Policy Commission said the deal would raise the cost of medical spending in the region by an estimated $15.5 million to $23 million per year for three major commercial payers. Partners owns North Shore Medical Center and Hallmark Health System has two hospitals and about 400 physicians.
With reporting by State House News Service and the WBUR Newsroom
A new study published online in JAMA Pediatrics finds that a combination of aeorobic workouts plus resistance training offers the best hope for teenagers battling obesity.
From the abstract:
Aerobic, resistance, and combined training reduced total body fat and waist circumference in obese adolescents. In more adherent participants, combined training may cause greater decreases than aerobic or resistance training alone.
Here’s more from The New York Times coverage of the study, which found that “diet without exercise accomplishes little:”
Canadian researchers put 304 obese teenagers on a diet with a daily energy deficit of 250 calories (measured from their resting energy expenditure). Then they assigned them randomly to one of four groups for 22 weeks: aerobic training on exercise machines like treadmills, resistance exercise using weight machines and free weights, combined aerobic and resistance training, and a diet-only group with no exercise…
Aerobic exercise is usually recommended, but the lead author, Dr. Ronald J. Sigal, a professor of medicine at Calgary University in Alberta, said it is clear that “those who did both resistance and aerobic exercise had significantly more fat loss and decreased waist size than those who did aerobic exercise alone.”
The following is a guest post by Liah Caravalho, program specialist with the Office of Legislative and External Relations at the Law Library of Congress.
The Law Library hosted Yale Law School constitutional scholar Akhil Reed Amar in commemoration of Constitution Day on Tuesday, September 16. Professor Amar’s lecture, “Magna Carta and the United States Constitution,” celebrated the signing of the United States Constitution 227 years ago on Sept. 17, 1787 and served as the third lecture in the Magna Carta lecture series.
The lecture highlighted the ways in which the United States Constitution has drawn upon and broken with English constitutional precursors such as Magna Carta, the English Bill of Rights of 1689 and the Habeas Corpus Act of 1679. Professor Amar also gave a captivating account of how the United States Constitution evolved through the reconstruction amendments and later political movements such as women’s suffrage.
Professor Amar began his remarks by describing the unprecedented transformation that resulted from the drafting of the Constitution. We received the promise of freedom, self-governance and the open invitation of ordinary men to voice their opinions through freedom of speech and voter participation. All of these freedoms were granted at a time when monarchical governments ruled many other nations. As he stated “[f]ree speech is baked into our constitutional cake, unwritten, but it is part of the very process by which, We the People of the United States, in this year  that changed everything, did ordain and establish the Constitution, even before it is textualized in the first amendment.”
The original Constitution was revolutionary for the times, but Professor Amar also pointed out that it was “conciliatory toward slavery” by counting slaves as three-fifths of a person, which allowed Southern States to gain more power in the House and Electoral College. He reminded the audience that Thomas Jefferson wrote the phrase “all men are created equal” for the Declaration of Independence and that phrase did not appear in the Constitution until President Lincoln reinterpreted the language to abolish slavery with the 13th amendment.
Professor Amar also argued that later generations continue to reinterpret the Constitution through the prism of later constitutional amendments. Women suffragists, for example, would include women in Lincoln’s reinterpretation of “all men are created equal” to bolster their movement. Similarly, he described how this tradition of interpretation and even misinterpretation extends back to Magna Carta because later generations believe Magna Carta is about trial by jury. He argued that Magna Carta in 1215 was not about trial by jury as we know it because “peers” referred to lords and barons only and not the guarantee of the right to due process of law for ordinary men.
Professor Amar concluded his lecture stating that “today we are the product of many generations of constitutional advancement,” so perhaps it does not matter if Jefferson did not really mean “all men are created equal” or if Magna Carta did not truly represent trial by jury in 1215 because later generations were inspired to redefine their meaning. According to Professor Amar, what really matters is an understanding of our history and a realization that our Constitution has evolved as “We the People” have evolved. Our Constitution is both written and unwritten – the unwritten part is a reflection of how we act and what we believe as a nation. We get to decide what constitution we will give to future generations.
The exhibition “Magna Carta: Muse and Mentor” will celebrate the 800th anniversary of the first issuance of Magna Carta. Opening November 6, 2014 and running through January 19, 2015, the 10-week exhibition will feature the Lincoln Cathedral Magna Carta, one of four remaining originals from 1215, along with other rare materials from the Library’s rich collections to tell the story of Magna Carta’s influence on the history of the rule of law.
The Magna Carta lecture series is co-sponsored by the American Bar Association Standing Committee on the Law Library of Congress.