PHARMACY

CVS Caremark launches national medication disposal program

BY Antoinette Alexander

WOONSOCKET, R.I. — In recognition of National Prescription Drug Take Back Day being held Oct. 26, CVS/pharmacy has launched the CVS/pharmacy Medication Disposal for Safer Communities Program.

The new program is designed to provide police departments across the country with an easy way to team up with CVS/pharmacy locations in their area to hold National Drug Take Back Day events or to help raise community awareness of local drug disposal programs managed by law enforcement.

"We recognize the importance of removing unused, unwanted and expired medications from our communities in a safe and environmentally responsible manner in order to prevent abuse and misuse of these drugs," stated Josh Flum, SVP of retail pharmacy at CVS/pharmacy. "Many CVS stores across the country will be hosting local police at Drug Take Back Day events this Saturday. As part of our new Medication Disposal for Safer Communities Program, we are making our store sites available nationwide to law enforcement agencies to hold Drug Take Back events. Additionally, our stores are well positioned to help promote awareness of permanent collection site programs run by law enforcement agencies at their police stations and other facilities."

CVS/pharmacy has established a toll-free phone number, (866) 559-8830, and a website, cvs.com/safercommunities, for its Medication Disposal for Safer Communities Program. Law enforcement agencies can use these channels to arrange future National Drug Take Back Day events at their local CVS/pharmacy locations. Law enforcement agencies that operate their own ongoing collection site programs can also arrange to have the address and hours of operations posted in local CVS/pharmacy locations.

National Prescription Drug Take Back Day was established in 2010 by the Drug Enforcement Administration, in conjunction with local law enforcement agencies across the country. The events are held twice each year, in the spring and fall, at thousands of locations in the United States. Since inception, more than 2.8 million pounds of unneeded medications have been collected and destroyed, helping to prevent diversion, misuse and abuse.

CVS/pharmacy’s participation in National Prescription Drug Take Back Day and the new CVS/pharmacy Medication Disposal for Safer Communities Program is part of the company’s ongoing commitment to combat prescription drug abuse. This commitment also includes:

  • Being the only retail pharmacy sponsor of the Medicine Abuse Program, a multi-year initiative of The Partnership at Drugfree.org with the goal of preventing a half million teenagers from abusing prescription medication by the year 2017;
  • The Sharps Compliance Takeaway Environmental Return program available at all CVS/pharmacy locations, providing customers with the ability to safely dispose of their unused, expired or unwanted drugs using affordable medication disposal envelopes. The postage-paid envelopes allow customers to mail their unwanted prescription and OTC medications through the U.S. Postal Service to a licensed, secure facility for safe destruction. (Controlled substances cannot be disposed of using this program.);
  • Ongoing identification of physicians who exhibit extreme patterns of prescribing such high-risk drugs as pain medications and suspending the dispensing of controlled substance prescriptions they write; and
  • Working at the federal and state levels to implement policy changes to curb prescription drug abuse, such as mandatory electronic prescribing of controlled substances and improved prescription drug monitoring programs.

"Our efforts to prevent medication abuse are helping our communities on their path to better health, but we realize that our initiatives are not a comprehensive solution," Flum said. "Defeating the epidemic of prescription drug abuse will require the active involvement of stakeholders throughout the healthcare community, as well as law enforcement and regulatory agencies. CVS/pharmacy is committed to being part of the solution to this problem."

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PHARMACY

FDA to recommend rescheduling of opioid painkiller hydrocodone from CIII to CII

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration plans to recommend stronger regulations for a commonly used opioid painkiller.

In a statement Thursday, FDA Center for Drug Evaluation and Research director Janet Woodcock said the agency would formally recommend to the Department of Health and Human Services that products containing 15 mg or less of the drug hydrocodone’s be reclassified as Schedule II controlled substances, from the current Schedule III. The higher scheduling would impose tougher regulations on hydrocodone, which is an active ingredient in products like AbbVie’s Vicodin, among other products. The Drug Enforcement Administration, which regulates controlled substances, proposed the change in 2009, and the FDA will submit its recommendation in December.

The change is being recommended in light of Vicodin being a common target for abuse and misuse, which itself feeds the problem of pharmacy robberies and can have potentially fatal consequences for people taking the drug improperly or recreationally.

Abuse and misuse of opioids has become a growing problem across the country in recent years. According to the Centers for Disease Control and Prevention, more than 36,000 people died from drug overdoses, most of them from prescription drugs, and three-fourths of prescription drug overdoses are caused by opioid painkillers. The rise in overdose deaths in the United States has run parallel to the 300% increase since 1999 in the sale of opioid painkillers, which were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined. They were further responsible for more than 475,000 emergency department visits in 2009.

To combat abuse, some drug makers have sought to make opioid painkillers tamper-resistant to prevent them from being ground or dissolved for snorting or injection. Examples of drugs that have been changed in this way include Purdue Pharma’s OxyContin (oxycodone) extended-release tablets and Endo’s Opana ER (oxymorphone).

Nevertheless, pharmacy groups say rescheduling hydrocodone could have the unintended side effect of making it harder to get for patients using it for legitimate purposes. In a statement Friday, the National Community Pharmacists Association, while supporting the FDA’s intent, said the move to restrict the drug could be harmful to patients. In the past, the NCPA has suggested that the federal government instead use such strategies as electronic prescription drug monitoring programs and tracking systems.

"The FDA’s reported decision will likely pose significant hardships for many patients and delay relief for vulnerable patients with legitimate chronic pain, especially those in nursing home and long-term care settings," NCPA B. Douglas Hoey said. "Community pharmacists support aggressive efforts to combat the abuse and diversion of prescription drugs. Such abuse has ruined lives, devastated families and fostered dangerous crimes against pharmacies. At the same time, there are more practical means available to reduce prescription drug abuse."

The National Association of Chain Drug Stores echoed the NCPA’s views.

"Pharmacies have a zero tolerance for prescription drug abuse and a 100% commitment to patient care," the NACDS’ statement read. "This proposal is not the best avenue to address abuse and would negatively impact access to needed medications for those who suffer from chronic pain. In the interest of patient care, we have worked with patient advocacy groups in opposition to this recommendation as we support and advance workable solutions."

 

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APhA, NACDS, NCPA join biosimilar naming debate

BY Alaric DeArment

NEW YORK — Three pharmacy groups are petitioning the World Health Organization to uphold common generic names for biosimilars and their branded reference products.

In a letter to the WHO sent in conjunction with the 57th Individual Nonproprietary Name Consultation, which ended Thursday, the American Pharmacists Association, the National Association of Chain Drug Stores and the National Community Pharmacists Association said they were "concerned" about efforts to give biosimilars different generic names from their branded counterparts.

"The proposal surrounding a word identifier plus a fantasy suffix, or a two-part name, is concerning to our organizations," read the letter, addressed to INN program manager Balocco Mattavelli and signed by APhA SVP pharmacy practice and government affairs Stacie Maass, NACDS VP public policy and regulatory affairs Kevin Nicholson and NCPA VP policy and regulatory affairs Ronna Hauser. "To avoid a naming convention that may create confusion, our organizations have previously recommended that biosimilar products maintain the same name as their reference biologic counterparts and not use suffixes."

The generic names used for biosimilars have emerged as a contentious issue as the Food and Drug Administration prepares to implement the abbreviated regulatory approval pathway for them, as mandated by the Patient Protection and Affordable Care Act of 2010. Biotech companies, which stand to lose billions in sales when cheaper biosimilar versions of their products enter the market, maintain that because biosimilars will be made using separate cell lines from their branded counterparts, there is a risk that they will be different in terms of safety and efficacy, but generic drug makers reject these claims, pointing to the six years in which biosimilars have been available in the European market.

Also, in a paper recently presented to the WHO, Hospira SVP and chief scientific officer Sumant Ramachandra noted that European regulators had approved biosimilars with the same generic names as their reference biologics for more than six years in a system that had proved effective.

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