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.
Integration of PharmaSmart technology improves pharmacist-patient counseling at Astrup Drug, companies say
ROCHESTER, N.Y. — Health kiosk maker PharmaSmart International and a drug chain that operates stores in Minnesota and Iowa have integrated PharmaSmart’s technology into the chain’s software system.
PharmaSmart and Astrup Drug said Friday that the integration of PharmaSmart’s interoperable biometric screening technology with Astrup’s Rx30 system allows timely patient interventions, counseling sessions and increases medication therapy management case recruitment for patients with hypertension, ultimately improving outcomes.
"With chronic diseases, such as hypertension, drug therapy is complex, and medication adherence is a major challenge," Astrup COO Tim Gallagher said. "This creates a costly care gap that the pharmacists can help address, if they have the right tools."
Astrup pharmacists see color-coded icons within the patient health record to alert them to the patient’s specific biometric screening status. Icon status is based on average readings, and in the most severe cases, flashing red icons trigger immediate interventions. Ultimately, it initiates a referral to the pharmacist for followup care with the patient when indicated, and pharmacists can access an advanced clinical portal to view the patient’s biometric history.
"This investment helps our pharmacists obtain a higher quality cognitive assessment, which supports the objectives of the patient, the physician and the health plan," Gallagher said. "Unlike traditional health screening kiosks or promotions, PharmaSmart creates a real-time, permanent ‘bridge’ between the health kiosk and our pharmacist."
National MS Society invests $7 million in research for nerve-repair treatments
NEW YORK — The National Multiple Sclerosis Society is putting $7 million toward research into ways to speed repair of the nervous system in patients with MS, the organization said Friday.
The society said the money would support 15 new research projects focusing on innovative approaches to repairing the coating of myelin that protects nerve fibers; the coating is destroyed in patients with MS, leading to nerve damage, and finding ways to restore and protect it is a key research priority for the group. The new investments, in commercial and academic research, total $37.8 million.
"The idea of rebuilding the nervous system and protecting it from ongoing MS damage was just a dream a few years ago," National MS Society chief research officer Timothy Coetzee said. "Now, because of efforts by the research community as well as focused investments by the society, we can see a future where people with MS will have treatments that could restore what’s been lost."
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