Trumm Drug

January 2012 Drug News

New Baby Acetaminophen Strength Prompts FDA Warning.

FDA issued a new warning about the potential for dosing errors with liquid acetaminophen products for infants, after the introduction of a new strength, 160 mg/5 mL, marketed for infants. The change in concentration can affect the amount of liquid given to an infant, according to the agency, which advised consumers to read the product’s Drug Facts label before administering. FDA Press Release

About 12 Million Motrin Bottles Pulled From Shelves.

Johnson & Johnson is voluntarily asking retailers to remove about 12 million bottles of Motrin pain relievers from store shelves. The coated caplets may not dissolve as quickly as intended when they near their expiration dates, the company found when testing product samples, according to a statement posted on a website of J&J’s McNeil Consumer Healthcare Division. “There is no safety concern if consumers continue taking the product in accordance with its label; however, it is possible there may be a delay in experiencing relief,” the statement claimed. MSNBC.com, Statement

Public Support For Healthcare Law Rebounds: Kaiser Poll.

A steep October dip in the proportion of Americans with a favorable view of the health reform law reversed itself in December, according to the latest Kaiser Health Tracking Poll. The poll found 41% of respondents had a favorable view of the law (compared with 34% in October) and 43% expressed unfavorable views (compared with 51% in October). Partisan division persists, with 64% of Democrats backing the law and 69% of Republicans opposing it. KFF Press Release, Poll

New York law stops mail-order pharmacy mandate.

Independent pharmacies in New York can breathe a sigh of relief with the passage of the Anti-Mandatory Mail Order Bill, which allows consumers the choice of where to fill their prescriptions.

This bipartisan bill (5502-B), introduced by Assemblyman Carl E. Heastie (D-Bronx) and State Senator George D. Maziarz (R-62nd Senate District), was signed into law by New York Governor Andrew Cuomo (D), enabling prescriptions to be filled at a local pharmacy or through mail-order without any added copayments or fees.

The National Community Pharmacists Association (NCPA) praised the passage of the legislation and the leadership of Governor Cuomo, the original sponsors, and the efforts of Pharmacists Society of the State of New York (PSSNY). PSSNY stated that the requirement to use mail-order pharmacies had resulted in more than $5 billion leaving the state every year, according to an NCPA statement.

“Enactment of this bill into law is a signal to community pharmacists across the country as to what can be accomplished nationally and in their own states by working together through grassroots activism. In this instance, legislation that protects patient choice and helps to align the interests of the patient, payer, plan, and the pharmacist is now state law,” according to NCPA.

Primatene Mist inhaler: Gone after December 31.

As reported earlier this year in Pharmacy Today, Primatene Mist, the only FDA-approved OTC inhaler for temporary relief of occasional symptoms of mild asthma on the U.S. market, is being withdrawn after December 31 of this year.

FDA is concerned that current users of the product may be self-treating their conditions. Since all other currently available products for asthma require a prescription, Primatene Mist users need to act now to see a prescriber and obtain the medications they need. In addition, the agency is concerned that many of these patients are likely uninsured and may have financial difficulties in seeing a prescriber and paying for prescription products.

Primatene Mist uses chlorofluorocarbon (CFC) as its propellant, and the U.S. is phasing out CFC use because of obligations made under the Montreal Protocol on Substances that Deplete the Ozone Layer. The phaseout of CFC-containing inhalers was announced by FDA in 2008, and many manufacturers of prescription inhalers have already converted their propellants to environmentally friendly hydrofluoroalkane (HFA).

FDA said during a September 22 news conference that two prescription inhalers will be withdrawn from the market on December 31, 2013, if they are not reformulated with HFA or another acceptable propellant. They are Combivent Inhalation Aerosol (albuterol/ipratropium—Boehringer Ingelheim) and Maxair Autohaler (pirbuterol—Graceway Pharmaceuticals).

Pharmacists should advise patients currently using OTC inhalers to contact their health provider to have symptoms evaluated and obtain prescription asthma medications if needed. FDA has provided several helpful counseling tips for patients currently using OTC epinephrine inhalers. These include telling patients to ask a family member, friend, or co-worker about a doctor they use and would recommend, helping patients with payment options and company assistance plans, and educating patients on use of their new prescription inhalers once they are transitioned to these products. The last point is especially important, an FDA official said, as the replacement products may taste and feel different.

Supreme Court Sets Date For Healthcare Law Arguments.

The Supreme Court scheduled arguments for Mar. 26, 27 and 28 to decide the constitutionality of the Patient Protection and Affordable Care Act. The week’s worth of time alotted to arguments over the healthcare overhaul is unprecedented, and fills the court calendar with nothing but over five hours of debate over the law. The Supreme Court will begin with arguments on whether court action is premature because no one has yet paid a fine for not participating in the overhaul, and will also debate Congress’ authority in requiring coverage and if any other provisions can be implemented should the health insurance mandate be ruled unconstitutional. The Associated Press

Vitamin D Helps Bone Health Only With Calcium: Report.

Vitamin D cuts bone fracture risk in older adults, but only when taken with calcium supplements, according to a review of nearly 50 studies on vitamin D published in the Annals of Internal Medicine. Although the analysis by the U.S. Preventive Services Task Force found that it is too soon to tell if vitamin D supplements can help prevent cancer, the report’s author stated that a daily vitamin D regimen of between 300 international units (IUs) and 1,100 IUs combined with 500 mg to 1,200 mg of calcium reduces fracture risk in those over 65. HealthDay

PBM Settles Lawsuit, Rehired by Same Group It Was Accused of Defrauding.

CVS Caremark has agreed to pay nearly $20 million to settle claims that it defrauded three state pension systems from 2003 to 2006. Two former CVS pharmacists filed a whistleblowers lawsuit alleging that the PBM had falsified records, improperly switched patients to higher priced drugs, and dispensed drugs that had been returned to its warehouse. Caremark said it settled the case to “avoid the costs of continued litigation…There were no findings of wrongdoing or any admission of liability.”
CVS Caremark will pay CalPERS, the California state employees pension fund, nearly $7 million under the terms of the settlement. Illinois will get $4 million and Florida $3 million. The rest of the money will go to the plaintiffs’ attorneys. Usually the whistleblowers also receive some of the settlement funds.

Last June, CalPERS rehired CVS Caremark after its first PBM choice, Medco Health Solutions, became embroiled in a CalPERS bribery scandal. CalPERS said it had put new safeguards in place so that there would be no repeat of the earlier problem with CVS Caremark. During the saga, complaints were expressed in California over the lack of competition in the large PBM market and NCPA is bringing the episode to the attention of the Federal Trade Commission and Congress as they review the proposed Express Scripts-Medco merger which would further consolidate the market.

PBMs Bested in Oklahoma.

Community pharmacies won a clear cut victory over PBMs in the Sooner state last week when the Oklahoma State and Education Employees Group Insurance Board approved a proposal submitted by Pharmacy Providers of Oklahoma to level the playing field with mail order. The PPOk plan “provides savings to the [state employee health] plan, lowers total copayments and allows participants to choose the pharmacy of their choice without incurring copayment penalties,” said Lonny Wilson, DPh, PPOk executive director/CEO and NCPA president. “Allowing 90-day dispensing of maintenance drugs from hundreds of community pharmacies provides optimum convenience and access to the many additional services provided by Oklahoma pharmacies.”
Total savings are estimated at $13.1 million per year for the state, as well as a total of $19.8 million in total savings for the 163,000 thousand prescription drug consumers currently enrolled in Health Choice plans, said Gov. Mary Fallin, who praised the agreement.

For Ninth Consecutive Year, Pharmacists Ranked In Top Three In Gallup Integrity Survey.

The latest results of Gallup’s annual Honesty and Ethics survey reveal that pharmacists have ranked in the top three for the ninth consecutive year. In this year’s survey, pharmacists ranked second to nurses and ahead of doctors, moving up one place from last year’s survey. Among respondents, 73% rated the honesty and ethical standards of pharmacists as “very high” or “high.” “The Gallup survey reflects the unsurpassed value of community pharmacy in improving patient health and reducing healthcare costs across the board,” said National Association of Chain Drug Stores (NACDS) President and CEO Steven C. Anderson, IOM, CAE. “As the face of neighborhood healthcare, pharmacists are accessible healthcare providers, with nearly all Americans living within five miles of a community pharmacy.” NACDS News Release

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