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NCPA reiterates stance on compounding to House Energy and Commerce Committee

BY Michael Johnsen

ALEXANDRIA, Va. — The National Community Pharmacists Association on Thursday reiterated its stance on compounding to the House Energy and Commerce Committee of the U.S. House of Representatives. 

The House committee has conducted an investigation and held several hearings into how the meningitis outbreak was handled by the Food and Drug Administration and state regulators and, as Congress returns from its August recess, the panel is actively considering what policy or legislative changes may be necessary to avoid a similar public health crisis from happening again, NCPA reported. 

“Compounding is the backbone of pharmacy practice and for many decades independent community pharmacists have provided millions of adults, children and animals with access to safe, effective and affordable medications through compounding services,” Hoey wrote to committee chairman Reps. Fred Upton, R-Mich., and ranking member Henry Waxman, D-Calif. “Compounding can help bridge the gaps during times of drug shortages. Drug shortages have nearly tripled, according to the FDA, and their impact can be devastating.”

NCPA expressed its dissent of a Senate proposal (S. 959) as currently written because it would inadvertently “create unnecessary federal regulatory burdens, hamper independent community pharmacies from providing medications to patients with unique health needs, and far exceeds a targeted approach to prevent another tragedy such as NECC.” Specifically, S. 959 would require community pharmacies to report directly to the FDA when they are compounding medications to alleviate a drug shortage. In addition, S. 959 would jeopardize patient access to vital medications by directing the FDA to maintain a “do not compound” list which could potentially be used by the agency to prevent compounding in response to a doctor’s prescription for medications such as hormone medications, thyroid preparations, promethazine gels and medications to treat autism, NCPA suggested. 

Instead, NCPA supports the efforts of Rep. Morgan Griffith, R-Va., to develop bipartisan House legislation based on the “discussion draft” legislation posted on the committee’s website. The proposal “rightfully maintains state board of pharmacy oversight of traditional compounding pharmacies while strengthening badly needed two-way communications between the FDA and state boards of pharmacy.” Poor coordination and communication between FDA and state boards of pharmacy were a vital factor that prevented regulators from stopping or mitigating the impact of the meningitis outbreak, NCPA noted. Other provisions in the legislation would protect patient access to essential medications from pharmacies at hospitals and physician’s offices, yet clarify the authority of FDA and other regulators to go after any bad actors, such as the New England Compounding Center.


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BACtrack launches ‘police-grade’ breathalyzers into retail

BY Michael Johnsen

SAN FRANCISCO — BACtrack on Thursday announced multiple partnerships with retailers — including Best Buy, Costco, Urban Outfitters and Walgreens — to begin selling "police-grade" breathalyzers.

“We’ve built a strong online presence through BACtrack.com, Breathalyzer.net and Breathalyzer.com and have forged partnerships with Amazon as well as respected multichannel retailers like Best Buy,” stated Keith Nothacker, CEO BACtrack. “But many consumers still prefer and need the immediate convenience of the in-store experience. Through agreements with Walgreens, Best Buy and Costco … we’re working to put BACtrack on every street corner in America.”

Reflecting the need for publicly available tools to gauge intoxication, a July 2013 consumer survey organized by BACtrack showed 7-out-of-10 adult American drinkers think owning a breathalyzer would allow them to estimate when they’ve had enough to drink. Two-thirds of adult drinkers also believe owning a breathalyzer would lower their risk of getting a DUI.

The National Transportation Safety Board recently proposed that American states reduce the legal blood alcohol content drinking limit from the current .08% BAC to .05% BAC. If states adopt this recommendation, drinkers will be responsible for complying with the new law and will need tools to stay safe and legal, the company noted. 


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Addressing prescription drug abuse and access issues — every day

BY Steve Anderson

Two recent developments demonstrate the complexity of the prescription drug abuse issue. Perhaps ironically, August 31 is International Overdose Awareness Day, while the month of September is National Pain Awareness Month.

Timed with the recognition of International Overdose Awareness Day, the White House Office of National Drug Control Policy announced the release of an Opioid Overdose Toolkit. This resource is designed to help raise awareness of overdose prevention, treatment and recovery for first responders, prescribers and patients.

Meanwhile, as part of National Pain Awareness Month, organizations like the U.S. Pain Foundation are raising awareness of the challenges faced by millions of Americans each day, including their need for medications to help them confront severe pain and illness. The Foundation created a special “30-Day Challenge” to help redefine perceptions surrounding pain issues.

These issues deserve the focus that they receive during this commemorative day and month, and every day. And it also makes sense to think about these issues from a more unified perspective. In fact, NACDS has made it a priority to simultaneously address prescription drug abuse and legitimate prescription drug access. As we say, there needs to be a 100-percent commitment to patient care and a zero tolerance for drug abuse and diversion.

Opinion research conducted for NACDS this past August found that nearly eight-out-of-ten respondents agreed with NACDS’ positioning on this issue, as reflected in this statement: “Pharmacies have a dual role when it comes to battling prescription drug abuse. They have to be part of the solution by working with law enforcement officials to stop prescription drug abuse, but they also have to maintain their responsibilities to patients by making sure they receive the medications they legitimately need.”

The necessity of this dual focus also is reflected in legislation backed by NACDS that would create a commission of federal and state governmental agencies, law enforcement and healthcare professionals to collaborate on solutions for drug abuse and drug access alike. As NACDS noted in an op-ed column in the Capitol Hill newspaper Roll Call, the “Combating Prescription Drug Abuse Act” (S. 1277) by Senator Barbara Boxer (D-CA) deserves support and action.

The existence of a special day to raise awareness of overdoses and the existence of a special month to raise awareness of chronic pain demonstrates the complexity of these issues. Hopefully, this dialogue also will demonstrate the need to address drug abuse and legitimate medication access in a coordinated fashion that benefits all Americans.


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