NACDS, NCPA, GPhA express support for Drug Quality and Security Act
WASHINGTON — A bill designed to strengthen the security of the drug supply chain by creating an electronic track-and-trace system and national standards for sterile pharmacy compounding has attracted support from trade groups representing retail pharmacies and generic drug makers.
In letters to legislators Friday, the National Association of Chain Drug Stores, the National Community Pharmacists Association and the Generic Pharmaceutical Association expressed support for the Drug Quality and Security Act, which would tie together "patchwork" state-level prescription drug supply chain laws under one federal law.
In its letter, addressed to members of both houses of Congress, the NACDS touted the contributions that chain pharmacy retailers have made to strengthening the pharmaceutical supply chain.
“We believe [the agreement] will help guarantee patient safety through a more secure supply chain and appropriate and improved oversight of compounding activities,” the NACDS letter read. “We believe that the reforms contained within the legislation meet the overarching goal of protecting patients while allowing chain pharmacies to operate effectively and efficiently in dispensing needed medications.”
"As you know, the current patchwork of State prescription drug supply chain laws has left our nation’s pharmaceutical supply vulnerable to the entry of counterfeit and adulterated prescription drugs, which threaten the health of patients and the integrity of our industry," GPhA president and CEO Ralph Neas wrote in a letter to members of the House and Senate. "That is why GPhA has worked with Congress to enact a single, uniform, and national pharmaceutical distribution supply chain law."
Meanwhile, the NCPA highlighted the law’s goals of improving the safety of pharmacy compounding.
"This compromise proposal provides a balanced and effective approach to address critical and complex issues surrounding compounded medications, as well as strengthening our nation’s pharmaceutical supply chain," NCPA CEO B. Douglas Hoey wrote in a letter to members of the Senate.
FlavoRx to honor independents with annual award
COLUMBIA, Md. — FlavoRx will start recognizing independent pharmacies that have implemented its program next month, the company said Friday.
FlavoRx, which makes flavorings that pharmacists can add to drugs, announced the inaugural FlavoRx Independent Pharmacy of the Year award, to be presented every October.
"Our roots are in independent pharmacy, so we’re excited to recognize the great achievements of our best independent pharmacy partners," FlavoRx VP marketing Chad Baker said. "This award is one way we can thank pharmacists and pharmacy technicians for the enthusiasm and dedication they put into improving pediatric adherence with FlavoRx."
The award recognizes those pharmacies that have successfully implemented the company’s program, shown a commitment to improving patient care and a willingness to go "above and beyond" to develop their pharmacy business.
Federal government should take wise approach to compounding regulations
Congress is expected to pass the Drug Quality and Security Act, which would subject sterile compounding pharmacies to stronger federal regulations and has attracted support from an independent pharmacy trade group, compared with a previous effort at federal regulations of compounding, Senate Bill 959, which many pharmacists feared would threaten their businesses and patients’ access to compounded drugs. The efforts to place compounding pharmacies under federal regulations stem from last year’s scandal in which many patients died and more were sickened after taking injected steroids contaminated with fungus.
The bills’ purpose is simple enough: protecting the safety of patients. But the older bill attracted opposition from independent pharmacies because, despite its good intentions, it forced them to make costly changes to their business models or force them out of compounding altogether.
Since the NECC scandal last year, the Food and Drug Administration has been inspecting sterile compounding pharmacies around the country, finding many problems with sterilization and lab cleanliness, and with numerous compounding pharmacies shipping their drugs across state lines, it’s no secret that some kind of federal oversight is needed.
But as a recent survey of pharmacists conducted by compounding supply company PCCA regarding S. 959 showed, it’s important that regulations be applied carefully. The survey found that more than 40% of compounding pharmacies would fit the bill’s criteria as "manufacturers," forcing them to make "painful" adjustments or to give up their business altogether. The National Community Pharmacists Association likewise expressed opposition to the bill, saying it would "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 like NECC."
By contrast, however, the NCPA is supporting the Drug Quality and Security Act, saying it would enhance safety while preserving patients’ access to compounded drugs and also creating a uniform standard for security in the country’s drug supply chain.
Another important aspect of the bill is that it would distinguish between sterile and traditional compounding — a distinction that was often lost in media reports about the NECC scandal. Traditional compounding would continue to be regulated by state boards of pharmacy.
Compounding is a highly important part of pharmacy practice. It’s as old as the profession itself, historically being the norm before the rise of the modern drug industry. Today, many independent pharmacies have gotten into compounding because it provides a competitive niche. But while regulations of compounding, especially sterile compounding, are necessary, they also must be done wisely so that protecting patients’ safety doesn’t mean depriving them of access to needed drugs altogether.