Groups push FDA for delay on Track and Trace regulations
ALEXANDRIA, Va. — Pharmacy organizations, including, The American Pharmacists Association, National Alliance of State Pharmacy Associations and National Community Pharmacists Association, called on Food and Drug Administration officials to delay enforcement of a July 1 electronic product-tracing deadline for prescription drug dispensers, to “help avoid any potential disruptions in the pharmaceutical supply chain,” the groups noted in a joint letter to FDA.
“With the December, 2014 FDA enforcement discretion delaying enforcement of the product tracing requirements until May 1, 2015, this implementation timetable has been compressed,” the groups wrote in a June 22 letter to FDA deputy director, office of compliance, Dr. Ilisa Bernstein.
“Our organizations remain concerned that despite the extensive efforts by pharmacy and wholesale distributor associations to educate dispensers, some trading partners will encounter challenges beyond their control, with the possible outcome of disruptions in the supply chain,” the letter said. “In order to forestall potential disruptions in the pharmaceutical supply chain, the undersigned organizations respectfully request that FDA utilize its enforcement discretion to delay the July 1 product-tracing deadline for dispensers. Our members fully intend to continue intense, concerted efforts toward full compliance, but by exercising its enforcement authority, FDA would allow progress to continue while minimizing the risk of product shortages or disrupting patient access to prescription drugs.”
To read the full letter, click here.
Oregon gov. signs legislation to expand access to pharmacists’ patient care services
WASHINGTON — Earlier this month, Oregon Governor Kate Brown signed landmark legislation into law that helps expand patient access to pharmacists' patient care services. The legislation, HB 2028, which passed with overwhelming bipartisan support, permits insurance carriers to add pharmacists to its network of providers and expands existing laws related to collaborative drug therapy management among other wins.
Through the legislation, patients will have access to the specialized care services pharmacists provide including medication management, disease prevention and wellness and post-diagnostic disease management. Pharmacists and doctors will now be able to work together to design and implement collaborative agreements to increase access to pharmacists’ patient care services and improve patients’ health.
“We applaud the state legislators in Oregon for recognizing that the future of health care is about access, quality and team-based care, and congratulate the Oregon State Pharmacy Association for their tireless work on this effort,” American Pharmacists Association EVP and CEO Thomas E. Menighan said in response to the move. ”This transformative legislation will improve patients’ access to patient care from pharmacists while also allowing for greater collaboration among health care providers, both of which will result in improved patient outcomes.”
Overt inclusion of pharmacists on the health care team continues to gain momentum across the country, as California and Washington recently passed similar legislation.
In late January, the Pharmacy and Medically Underserved Areas Enhancement Act was introduced in both the House of Representatives (H.R. 592) and Senate (S. 314). Passage of this legislation is a critical step in better utilizing pharmacists to positively impact patients and health care. Today, there are 145 bipartisan co-sponsors on the House bill and 19 co-sponsors on the Senate bill.
“APhA and the Patient Access to Pharmacists’ Care Coalition, a coalition of more than 30 organizations representing patients, pharmacists, and pharmacies, as well as other interested stakeholders, urges members of Congress to take steps now to improve Medicare beneficiary access to health care services through pharmacists and their services,” Menighan added. “As highly accessible and educated health care professionals, pharmacists are in a position to improve quality of care and patient outcomes, especially for those patients living in medically underserved areas.”
CVS Health inks clinical affiliations with four healthcare organizations
WOONSOCKET, R.I. — CVS Health has entered into new clinical affiliations with Sutter Health in California, Millennium Physician Group in Florida, Bryan Health Connect in Nebraska and Mount Kisco Medical Group, PC in New York. These new affiliations bring the total number of clinical collaborations for CVS Health and MinuteClinic to nearly 60 major health systems and healthcare providers across the country.
Through these clinical affiliations, CVS Health will provide prescription and visit information to the participating health care organizations by enabling communication between our secured electronic health record systems, which will help enhance clinical care for patients served by the partnering organizations. In addition, patients will continue to have access to clinical support, medication counseling, chronic disease monitoring and wellness programs at CVS/pharmacy stores and MinuteClinic, the retail medical clinic of CVS Health.
"In this era of health care reform, we are pleased to work with these health care organizations to develop collaborative programs that enhance access to patient care, improve health outcomes and lower health care costs in the communities they serve," stated Troyen Brennan, chief medical officer, CVS Health. "By allowing our electronic health records and information systems to communicate and share important information about the patients we collectively serve, we will have a more comprehensive view of our patients, which can aid in health care decision making and help ensure patients adhere to important medications for chronic diseases."
CVS/pharmacy currently has more than 7,800 retail pharmacy locations across the United States where CVS pharmacists provide counseling to patients to help them be adherent to their chronic disease medications. In addition, there are nearly 1,000 MinuteClinic walk-in medical clinics available at CVS/pharmacy retail stores. The clinics are staffed by nurse practitioners and physician assistants who provide treatment for common family illnesses and administer wellness and prevention services, including health condition monitoring for patients with chronic diseases.
Affiliates' health care providers will receive data on interventions conducted by CVS pharmacists to improve medication adherence for their patients. The affiliation also encourages collaboration between the health care providers and MinuteClinic providers to improve coordination of care for patients seen at MinuteClinic locations. Through this collaboration, the affiliate organizations and MinuteClinic practitioners will also work together on planning strategies around chronic care and wellness. If more comprehensive care is needed, patients can follow up with their primary care provider and have access to the services at the health care provider as appropriate. For those patients who do not have regular access to health care, MinuteClinic provides information to help patients in finding a primary care physician and a greater opportunity for continuity of health care services.
MinuteClinic, CVS/pharmacy and the participating healthcare organizations will begin to work toward streamlining and enhancing communication through their EHR systems. This will include the electronic sharing of messages and alerts from CVS/pharmacy to the health care organizations' physicians regarding medication non-adherence issues. In addition, MinuteClinic will electronically share patient visit summaries with the patient's primary care physician when they are part of an affiliate organization and with the patient's consent. MinuteClinic will continue its standard practice of sending patient visit summaries to primary care providers who are not affiliated with one of these participating healthcare organizations via fax or mail, with patient consent.