Aurobindo gets OK from FDA for Zyrtec generic
DAYTON, N.J. — Aurobindo Pharma Limited announced Tuesday that it had received approval from the Food and Drug Administration for its over-the-counter cetirizine hydrochloride in 5- and 10-mg dosage strengths. The drug is a generic version of Zyrtec.
The cetirizine hydrochloride tablets are indicated for temporarily relieves runny nose, sneezing, itchy, watery eyes and itching of the nose or throat caused by hay fever or other upper respiratory allergies.
The product has an estimated market size of $264MM for the twelve months ending January 2014, according to IRI.
Advocating pharmacy: A Q&A with NACDS’ Tom O’Donnell
Leading up to NACDS Total Store Expo, Drug Store News had an opportunity to sit down with Tom O’Donnell, VP federal government affairs at the National Association of Chain Drug Stores, to discuss pharmacist provider status and the latest pro-pharmacy legislative initiatives in the U.S. House and Senate.
DSN: The pharmacy profession and retail pharmacy industry continue to struggle for full provider status recognition, and a fair and standardized reimbursement model for an expanding menu of patient-care services. How would you describe the role of NACDS in advancing those efforts?
Tom O’Donnell: Even as we work to accomplish these goals, it’s worth noting that advocating for this legislation has given pharmacy a tremendous opportunity to build recognition of pharmacy’s value. That already has proven effective.
For example, when the U.S. House Energy and Commerce Committee considered the 21st Century Cures legislation in June, there was a proposal on the table to help pay for the legislation in a way that would have reduced pharmacy Medicaid reimbursement. Based on the elevated awareness of pharmacy, NACDS successfully made the case that this move would have hurt beneficiary access to medications, and the proposal was dropped.
In addition, we continue to push the proactive legislation that you mentioned. The Pharmacy and Medically Underserved Areas Enhancement Act (H.R. 592/S. 314) has 185 cosponsors in the U.S. House (82 Democrats; 103 Republicans) and 28 Senate cosponsors (16 Democrats; 12 Republicans). Certainly, we would love to see this legislation enacted this year, yet we have prepared for a multiyear campaign to achieve this goal — similar to the approach of the nurses in the late 90s.
NACDS is working as a Steering Committee member of the Patient Access to Pharmacists’ Care Coalition (PAPCC), which is waging a Washington, D.C., advertising campaign and other strategies to help advocate for the legislation.
The Medication Therapy Management Empowerment Act of 2015 (S. 776) also is gaining traction in the Senate with 13 cosponsors (10 Democrats and 3 Republicans). This legislation would allow Medicare Part D beneficiaries to become eligible for MTM services, if they suffer from a single chronic condition that has been shown to respond well to improved medication adherence such as diabetes, cardiovascular disease, COPD and high cholesterol. NACDS is working to gain support for introduction of similar legislation in the U.S. House, again emphasizing the role of pharmacists in advancing patient care.
DSN: And how would it change the practice and business model of retail pharmacy?
O’Donnell: The provider-status legislation would make available to underserved Medicare patients the services that state laws allow pharmacists to administer.
Pharmacists are highly educated and trained healthcare professionals who now must earn a doctor of pharmacy degree (Pharm.D.) to graduate — which takes a minimum of six years to complete and reflects the evolution of pharmacy practice to a more patient-centered focus.
This legislation would reflect this positive advancement of pharmacy practice, and would keep the momentum moving forward in terms of the ability of pharmacists to improve access to healthcare services.
DSN: Briefly, can you describe the basic elements of H.R. 592 v. 314 that impact the role of pharmacists serving the medically underserved?
O’Donnell: H.R. 592/S. 314 would amend The Social Security Act of 1935 to enable pharmacists to provide to Medicare patients in underserved communities services that pharmacists already are providing for other patients under state law.
Specifically, Medicare patients would have enhanced access to pharmacists’ expertise and pharmacy services, including immunizations, diabetes screenings and self-management education, cardiovascular screenings and behavioral therapy — in states in which pharmacists are allowed to provide these services.
These bills would enable all licensed pharmacists to care for Medicare patients to the full extent of state scope of practice laws, elevating pharmacists’ ability to improve patient health.
DSN: H.R. 592/S. 314 seems to be the primary focus right now for NACDS’ lobbying efforts on behalf of legislation to grant pharmacists full provider status. But NACDS is also weighing in on other issues that could impact retail pharmacy practice and business. Can you describe some of those other areas of focus?
O’Donnell: In addition to the provider status legislation, there are two other pieces of legislation that are important to highlight.
NACDS has worked with Sen. Pat Roberts, R-Kan., and Sen. Jeanne Shaheen, D-N.H., to expand beneficiary eligibility for MTM services. As previously discussed, their legislation — S. 776, the Medication Therapy Management Empowerment Act of 2015 — would provide access to MTM services for beneficiaries with diabetes, cardiovascular disease, COPD and high cholesterol.
NACDS is also working on efforts in the U.S. House to increase medication adherence and expand MTM criteria, including participating in the efforts of the House Energy and Commerce Committee’s “Better Use of Medicines” Working Group to draft medication adherence legislation.
NACDS has also been helping to advance legislation to fight prescription drug abuse and help preserve patient access to needed pain medication. The “Ensuring Patient Access and Effective Drug Enforcement Act of 2015” (H.R. 471/S. 483) was introduced in the U.S. House by Rep. Tom Marino, R-Pa., and in the U.S. Senate by Sen. Orrin Hatch, R-Utah.
This legislation would promote a comprehensive, collaborative approach to preventing prescription drug diversion and abuse bringing together all stakeholders — law enforcement, patient groups, pharmacy and government agencies — to work toward a solution.
H.R. 471 passed the U.S. House by voice vote earlier in the year, so it’s on to the Senate.
DSN: The NACDS RxImpact Day has been an effective way to tell pharmacy’s story on Capitol Hill, but it occurs one day each year. What should pharmacy operators around the country be doing throughout this year to elevate the status of pharmacists nationally and in their own communities — and to improve chances for passage of bills like H.R. 592?
O’Donnell: There is no doubt that NACDS’ grassroots advocacy program — NACDS RxImpact — can move mountains in advancing pro-patient, pro-pharmacy legislative initiatives. And it is a process that takes year-round diligence and commitment to deliver results.
The program empowers pharmacists, pharmacy students, pharmacy school faculty, pharmacy technicians and other pharmacy personnel and patients to engage in the political process.
The NACDS RxImpact program has several components, including the annual NACDS RxImpact Day on Capitol Hill; the Key Contact program, designed to build relationships with elected officials; training programs for pharmacy students; and more.
The most interactive opportunity for lawmakers to understand the value of pharmacists’ role in advancing patient health is the NACDS RxImpact Pharmacy Tour program. Through this program, lawmakers can see firsthand what pharmacists can do to help patients improve their health and manage chronic conditions.
To learn more about the NACDS RxImpact Pharmacy Tour Program and other grassroots advocacy opportunities, contact NACDS director of grassroots and advocacy Heidi Ecker at (703) 549-3001.
Sag Harbor Pharmacy, Southampton Hospital sponsor Rx disposal box
SOUTHAMPTON, NY — Sag Harbor Pharmacy and Southampton Hospital recently sponsored the creation of a local pharmaceutical collection receptacle to house unwanted, expired and unused medications.
The Big Red Med Disposal Box at the Sag Harbor Pharmacy, which was supplied by the Lloyd Magothy Water Trust, will promote responsible disposal of medications, according to Jeff Yohai, pharmacist and owner of Sag Harbor Pharmacy.
“Having the Big Red Med Disposal Box here in Sag Harbor Pharmacy is a great benefit for our community,” Yohai said. “We need to do our best to keep old prescription medications out of the hands of small children who might accidentally ingest them, and out of the hands of any teens who might seek to use medications for non-medical use.”
In addition to curbing prescription drug abuse, the receptacle is also designed to prevent water contamination from medication that’s improperly discarded.
“Water quality is a major concern for Long Island and we need to protect our drinking water from many kinds of potential contaminants, including unwanted medications that might otherwise be flushed into our groundwater,” Robert Chaloner, president and CEO of Southampton Hospital, said.
The Big Red Med Disposal Box meets the Drug Enforcement Administration’s regulations to implement the Secure and Responsible Drug Disposal Act of 2010, according to Southampton Hospital. The receptacle will collect only non-controlled medications until the New York State Bureau of Narcotics updates their regulations, the hospital said.