NACDS expresses to FDA cautious optimism on the ‘new paradigm’ for third class of drugs
ALEXANDRIA, Va. — The National Association of Chain Drug Stores submitted on Monday comments to the Food and Drug Administration regarding its position on the “new paradigm” for a third class of drugs.
The comments were submitted to the FDA in conjunction with the agency’s hearing titled, “Using Innovative Technologies and Other Conditions of Safe Use to Expand Which Drug Products Can Be Considered Nonprescription.”
In its comments, NACDS emphasized the value of community pharmacies as high-quality and accessible health-and-wellness centers. NACDS also emphasized the importance of current and future collaboration among healthcare professionals for the ultimate benefit of patient care and to reduce healthcare costs.
“In recent years retail community pharmacies have played an increasingly important role in providing patient care,” NACDS said in its comments. “Activities, such as the increased number of health screenings provided by pharmacists help educate patients and give them a better understanding of their health status and potential needs. Pharmacists also provide vital patient care through their participating in collaborative practice agreements and their expanding role in providing immunizations. Pharmacists are uniquely positioned and qualified to take on these expanded roles.”
NACDS noted that arrangements already exist in 34 states that allow pharmacists to engage in collaborative practice agreements with physicians. Such written agreements foster collaboration between a pharmacist or pharmacy and a physician or group of physicians to manage patients’ drug therapy. Under this type of arrangement, pharmacists serve as physician extenders and help to monitor and carry out physicians’ drug therapy plans for their patients.
Overall, NACDS also cited cautious optimism regarding the creation of a “new paradigm,” and indicated that it is eager to work with FDA to prevent unintended consequences of a “new paradigm” of third class drugs.
“Structured properly, this new paradigm has the potential to increase access, improve patient compliance, and reduce healthcare costs. However, a flawed structure could result in a group of drugs with limited access, reduced compliance, and lacking in a clear compensation policy for pharmacies, despite the additional clinical and administrative responsibilities that it would impose,” NACDS said.
One of the most critical unintended consequences is the impact on consumers — and their wallets — regarding what may occur when prescription-only medications become over-the-counter medications and potentially may not be covered by insurance or other third-party payers, according to NACDS.
“Costs for some of their medications that were previously covered by their third party payer might no longer be covered if dispensed under this new paradigm and would therefore be an out of pocket cost to them. This may be viewed as a positive for decreasing costs to healthcare system, but if the patient no longer can afford the product and adherence decreases, the costs associated with poor outcomes and increased hospitalizations and emergency room visits could increase,” NACDS said.
NACDS also expressed the importance of clear guidance on what types of drugs would qualify for this new status, so as not to disrupt medication regimens for patients, as well as medication management counseling between pharmacists and patients for these regimens.
“Consistency and predictability are needed to train pharmacists and other pharmacy staff, determine formulary placement and reimbursement policy, and ensure uninterrupted availability for patients. Consequently, NACDS advocates that this new paradigm should be a permanent class for drugs that require special counseling, monitoring, screening, lab testing, or other clinical intervention,” NACDS said.
NACDS has stated that it will continue to work with the FDA to address these issues and challenges as to ensure that patients benefit from community pharmacy’s care and services to help improve their health and reduce healthcare costs across the board.
NCPA lobbies for bills that would help mitigate market dominance of new super-PBM ESI
WASHINGTON — The battle for public opinion and legislative sway was in full swing Monday as executives from the National Community Pharmacists Association lobbied congressional leaders regarding several pieces of "pro-patient, pro-pharmacist legislation." To counter that effort, the Pharmaceutical Care Management Association issued some marketing firepower of its own.
To support NCPA’s Legislative Conference in Washington May 7 to 9, the association of independent pharmacies took out advertisements in support of "pro-patient, pro-pharmacist legislation."
The first ad makes the case for how NCPA-backed legislation can empower community pharmacists to help reduce costs and improve health outcomes while supporting local jobs. According to the ad copy, community pharmacy supports 340,000 jobs all told, including some 63,000 neighborhood pharmacists. And nearly 80% of NCPA members offer free, same-day delivery to patients.
A second ad, “Why PBM Reform is Needed,” describes the heightened need for reforming pharmacy benefit managers in the wake of the Express Scripts-Medco merger. "When the merger of two of three largest pharmacy benefit managers — Express Scripts and Medco — was announced, the question was would the Federal Trade Commission rubber-stamp it? We got our answer," the ad reads. "[This] despite concerns being raised by more than 80 members of Congress and outright opposition from consumer, business and pharmacy groups."
The PCMA fired back with a public message of its own, specifically targeting Walgreens and the NCPA. "Employers know what mega-chain Walgreens and its ‘independent’ drug store surrogates want," the ad reads in an attempt to reframe the battle as between the retail pharmacy industry and employers.
"This agenda is promoted by local drug stores, but it raises costs for every other business in town and mostly benefits Walgreens — a $70 billion company that doesn’t need the help," stated PCMA president and CEO Mark Merritt.
According to the advertisement, PCMA suggests the retail pharmacy industry is attempting to stop the redirection of pharmacy patients into a pharmacy benefit manager’s own mail-order pharmacy program; is attempting to force plans to include drug stores that "overcharge"; and is demanding higher payments (relative to prescription drug costs) from the government and employers.
Responding to that ad, NCPA spokesman John Norton noted that none of the legislation supported by industry would prevent employers and plan sponsors from offering mail-order pharmacy. And the NCPA’s support of H.R. 1971 would mandate that community pharmacy accept any terms applied to the entire pharmacy network.
Norton responded to the final PCMA assertion, that community pharmacy is demanding higher payments, with this: "As pharmacist Joe Lech … testified before Congress: Drug costs are up, PBM profits are up, co-payments are up, premiums are up, while pharmacy reimbursement is down — so where is the money going?"
Over the next few days, the NCPA will be lobbying support for the following legislation:
H.R. 1971/S.1058, the Pharmacy Competition and Consumer Choice Act, to preserve patient choice of pharmacy and bring transparency to pharmacy benefit managers;
H.R. 4215, the Medicare Pharmacy Transparency and Fair Auditing Act, to clarify Medicare Part D generic drug reimbursements and prevent abusive audits of pharmacies;
H.R. 1946, the Preserving Our Hometown Independent Pharmacies Act, to allow pharmacies to negotiate contracts with PBMs; and
H.R. 1936, the Medicare Access to Diabetes Supplies Act, to protect seniors’ access to needed testing supplies and face-to-face advice at local pharmacies.
Purdue Pharma launches free educational resource to combat drug abuse
STAMFORD, Conn. — Drug maker Purdue Pharma has introduced a new educational resource for healthcare professionals designed to curb the abuse of prescription drugs, the company said Monday.
Purdue announced the launch of the free "Patient Evaluation Resources for Opioid Risk Management," abbreviated "Perform." The company has been active in efforts to prevent misuse of prescription drugs as one of its lead products, the opioid painkiller OxyContin (oxycodone), is a frequent target for abuse.
"Substance abuse can impede medical care and may even be life-threatening," Albany Medical College neurology professor and Albany Medical Center Comprehensive Pain Center director Charles Argoff said. "I helped developed Perform because it is important for healthcare professionals to be able to recognize and address substance abuse in order to address medication therapy adherence and to intervene when appropriate."
Perform combines an interactive CD-ROM and resource binder and includes case vignettes to illustrate patients at various risk levels of abuse; patient-screening tools; documentation and monitoring information; and links to other resources.