Cause and effect: Demystifying the Drug Quality and Security Act
In 2012, compounding made headlines when 64 people died as a result of fungal meningitis caused by contaminated compounded products.
In the fall of 2012, an outbreak of fungal meningitis was reported, and the Centers for Disease Control and Prevention tracked the outbreak to contaminated steroid injections, packaged and marketed by the New England Compounding Center in Framingham, Mass. The contaminated products had been distributed to 75 facilities in 23 states, and doses were given to approximately 14,000 patients. Of those, more than 750 fungal meningitis cases were reported, including 64 fatalities.
While pharmacists have long been mixing compounded products for patients with individual prescriptions, over the past several decades, mass compounding — with some pharmacies selling thousands of doses of regularly used compounded products for doctors to keep on hand for the future — had become increasingly popular.
The Drug Quality and Security Act
At the end of November 2013, President Barack Obama signed into law H.R. 3204, The Drug Quality and Security Act. The new law creates federal oversight for large volume compounding operations, but still allows pharmacists to provide traditional compounding services to individual patients. The idea was to give the Food and Drug Administration oversight for “outsourcing facilities,” a new class of compounding facility that is allowed to sell products in bulk to hospitals and physician practices without requiring individual prescriptions.
How much impact the new law will have is still largely unknown. The act allows traditional pharmacies to continue to be regulated by state boards of pharmacy; however, larger compounding facilities will be monitored via a system of voluntary registration. Once registered, these compounding facilities will be monitored by the FDA in much the same way as typical drug manufacturers are.
Who has registered so far?
As of the beginning of January 2014, only 11 compounding pharmacies had registered with the FDA. These pharmacies hope that registering with the FDA will give them a marketing advantage. Those who registered with the FDA are required to pay a fee, comply with good manufacturing standards, be subject to routine FDA inspections and report adverse events associated with their products.
The FDA hopes that healthcare organizations will prefer to purchase compounded medications from an FDA-regulated facility, and in early January, FDA commissioner Margaret Hamburg sent out hundreds of letters to hospitals urging them to buy compounded medications only from FDA-registered facilities.
“As a purchaser of compounded drugs, you can play an important role in improving the quality of compounded drugs by requiring compounding pharmacies that supply drugs to your facility to register as outsourcing facilities,” Hamburg wrote.
FDA draft guidance
Meanwhile, at the end of 2013, the FDA issued draft industry guidance about the new compounding law. The guidance suggests that compounding be done in accordance with U.S. Pharmacopeia chapters 795 and 797. While this would not be burdensome for non-sterile compounding, compliance with USP 797 could create implementation costs for compounding pharmacies. The second piece of guidance from the FDA would limit compounding pharmacies that do not have an agreement in place between the FDA and their state from shipping more than 5% of their compounded products outside of the state. Finally, the draft guidance also indicates that the FDA will regulate the bulk substances drug list. Comments to the guidance were due in early February.
Will the new law affect most pharmacists? No — particularly if the compounding is the typical mixing of a lotion in a mom-and-pop pharmacy. The new law really is targeting large operations compounding sterile — often injectable — medications, and selling them to hospitals, large physician practices and across state lines. As the year progresses and more compounding pharmacies register with the FDA, it will become clearer what the long-term effects of the new law will be.
Ann W. Latner, JD, a former criminal defense attorney, is a freelance medical writer in Port Washington, N.Y.
H1N1 virus returns at high levels this flu season
The same H1N1 virus to cause a pandemic in 2009 is by far the predominant influenza virus for the 2013-2014 season. This is the first season that the H1N1 virus has circulated at high levels since the pandemic.
However, the Northern Hemisphere quadrivalent and trivalent vaccines for the 2013-2014 season are well-matched to the H1N1 virus in circulation, according to the Centers for Disease Control and Prevention’s FluView report for the week ended Jan. 4.
Even though flu incidence started picking up later into the season, more people had gotten flu shots this season. “Overall, about 40% of the general population had reported getting a flu vaccine by mid-November,” noted Ann Schuchat, CDC’s director of the National Center for Immunization and Respiratory Diseases. “That is about three percentage points higher than last year at the same time, and most of the increase that we see is increases in adults getting vaccinated.”
“We estimate based on a conservative model that during last year’s flu season, … flu vaccination prevented at least 6.6 million people from getting sick with the flu, 3.2 million people from going to see a doctor or other healthcare professional and at least 79,000 hospitalizations,” said Tom Frieden, CDC director. “We’ve looked at the last few flu years going back with a similar model, all the way back to 2005, and this is by far the largest number of hospitalizations and other illnesses we’ve seen prevented. The high numbers prevented from last year were partly attributable to the fact that last year was a relatively severe season.”
As of Jan. 4, 35 states were experiencing widespread activity, and 20 states were reporting high levels of influenza-like illness. However, flu incidence this year is less pervasive than last year, running 5% to 10% below last year.
Nationwide for the week ended Jan. 4, 4.4% of patient visits reported through the U.S. Outpatient Influenza-like Illness Surveillance Network were due to influenza-like illness. This percentage is above the national baseline of 2%. Influenza-like illness is defined as a temperature of 100°F or greater, and cough and/or sore throat.
The neuraminidase inhibitors Tamiflu (oseltamivir) and Relenza (zanamivir) are currently the only recommended influenza antiviral drugs.
While the vast majority of the viruses that have been tested are sensitive to Tamiflu and Relenza, three additional 2009 H1N1 viruses proved resistant to Tamiflu during the week ended Jan. 4. So far this season, 13 (1.2%) 2009 H1N1 viruses have shown resistance to Tamiflu. No viruses have shown resistance to Relenza.
As in recent past seasons, high levels of resistance to the adamantanes — Symmetrel (amantadine) and Flumadine (rimantadine) — continue to persist among 2009 H1N1 and influenza A (H3N2) viruses. Adamantanes are not effective against influenza B viruses. Adamantanes are not recommended for use against influenza this season, the CDC noted.
Inaugural H. D. Smith & NAPPSA Scholarship award goes to University of Kentucky student
SPRINGFIELD, Ill. — H.D. Smith and the Nigerian Association of Pharmacists and Pharmaceutical Scientists in the Americas on Monday awarded the inaugural H. D. Smith & NAPPSA Scholarship to Oreoluwa Adedoyin.
Pharmacy students affiliated with the NAPPSA vied for a $1,000 scholarship as a part of an inaugural program sponsored by H. D. Smith for NAPPSA’s qualifying student members. “This scholarship program promotes a bright future for our young Nigerian pharmacists and brings our partnership with H. D. Smith to a new level,” stated Emmanuel Ezirim, NAPPSA board member and business to business coordinator.
“We are pleased to offer this program through our partnership with NAPPSA to recognize the efforts of promising and accomplished pharmacy students who will impact the future of community pharmacy,” Rob Meriweather, H. D. Smith director national accounts retail sales, said.
Eligible applicants were required to be enrolled in a Pharm.D. or graduate program relevant to pharmaceutical sciences in a university in the United States and had to be considered in good standing as defined by the educational institution. Applicants were asked to provide an essay reflecting on why the applicant believed he or she should be selected.
Oreoluwa Adedoyin of the University of Kentucky was awarded the scholarship. Oreoluwa is studying Pharmaceutical Sciences and holds a GPA above 3.85. She will use the funds towards school materials and to attend the 2014 NAPPSA meeting.
“We believe that Oreoluwa emulates all the desired aspects of the winner, and more importantly, that of a community pharmacist of the future,” noted Adeboye Adejare, chairman of the NAPPSA Scholarship Award Committee.