September 25, 2013
Legislative Response to Meningitis Outbreak Could Limit Community Pharmacies
Washington, D.C.—Will legislative efforts to avoid a recurrence of the fungal meningitis outbreak that killed 32 Americans also limit patient access to customized medications prepared by community pharmacists?
That is the concern expressed by a letter sent from the National Community Pharmacists Association (NCPA) to U.S. House Energy and Commerce Committee leadership.
According to the CDC, 428 cases of fungal meningitis and 10 cases of peripheral joint infection occurred across 19 states after a contaminated batch of compounded methylprednisolone acetate (MPA), a steroid injectable product, was distributed by a compounding center in New England last year.
“Compounding is the backbone of pharmacy practice and for many decades independent community pharmacists have provided millions of adults, children, and animals with access to safe, effective and affordable medications through compounding services,” NCPA CEO B. Douglas Hoey, RPh, MBA, wrote to Rep. Fred Upton (R-MI), the committee chairman, and Rep. Henry Waxman (D-CA), the committee’s ranking Democrat. “Compounding can help bridge the gaps during times of drug shortages. Drug shortages have nearly tripled, according to the FDA, and their impact can be devastating.”
NCPA’s letter urges legislators to avoid new regulations that interfere “with the triad relationship of patient-physician-pharmacist, and prevents patients from obtaining their necessary compounded medications.”
The letter also points out that the community pharmacy association does not support a Senate proposal (S. 959) as currently written, because it would inadvertently “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,” such as the one involving the New England Compounding Center.
The Senate bill would require community pharmacies to report directly to the FDA when they are compounding medications to alleviate a drug shortage, according to the letter, and also would direct FDA to maintain a “do not compound” list which could disallow some prescriptions for common compounded medications.
The NCPA instead came out in support of bipartisan House legislation introduced in September.
The Compounding Clarity Act, H.R. 3089, sponsored by U.S. Reps. Morgan Griffith (R-VA), Gene Green (D-TX), and Diana DeGette (D-CO), “would better enable regulators to protect the public from any entities like the New England Compounding Center (NECC) without harming patients or saddling independent community pharmacists with new red tape,” according to an NCPA press release.
In general, H.R. 3089 preserves state board of pharmacy oversight of independent community pharmacies that compound medications. A pharmacy only would fall under the legislation’s new category of “outsourcing facilities” subject to FDA regulation if more than 5% of the drugs it produces are shipped across state lines or are sterile medications prepared for office use—such as by a physician or hospital.
The NCPA praised the bill for also enabling better coordination and communication between FDA and state boards of pharmacy when it comes to compounding pharmacies.
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