Study: Almost half of all narcotic prescriptions written by 5% of opioid prescribers
SAN DIEGO — As many as 40% of U.S. narcotic prescriptions in 2011-2012 were written by only 5% of opioid prescribers, according to a study Express Scripts presented Monday at AcademyHealth’s annual research meeting.
The study identifies prescribers who prescribe opioids at a much higher rate than peers who are in the same specialty, treat patients of similar age and practice in the same geographic region. Express Scripts’ multivariate approach to identifying high prescribers is the first of its kind, the company noted.
According to the analysis, high prescribers wrote an average of 3.5 times more opioid prescriptions — 4.6 prescriptions per patient compared to 1.3 in their peer group. Opioid cost per patient per day of therapy was nearly five times higher, on average, for patients treated by high prescribers.
Internal medicine and family practice are among the specialties with the highest prevalence of high prescribers, even after accounting for the volume of prescribers in these two specialties. Nearly 20% of the high prescribers were only prescribing opioids to one patient.
"While narcotics provide needed pain relief to many patients, high prescribing patterns are a potential area of concern," stated Glen Stettin, SVP clinical, research and new solutions at Express Scripts. "The findings of this study could indicate the need for better education about prescribing guidelines or tighter controls on narcotic prescribing."
This research, when applied to prescriber databases, can help identify potential issues with the prescription of narcotics and can be incorporated into efforts to help plan sponsors fight prescription drug fraud and abuse, Express Scripts noted.
This research also highlights the value of clinical specialization. Of the more than half million prescribers analyzed for this study, only 385 were identified as pain specialists.
"The rise in opioid abuse-related deaths has coincided with increased prescribing of narcotics," Stettin said."Because nearly all of these prescribers specialize in an area other than pain management, the specialist pharmacists within our neuroscience Therapeutic Resource Center can help assure appropriate use of these potent medications and close critical gaps in care."
FDA publishes interim final rule regarding cGMPs for infant formula
SILVER SPRING, Md. — The Food and Drug Administration last week published an interim final rule to further safeguard the health of infants fed infant formula in the United States. The rule, which sets standards for manufacturers to produce safe infant formula that supports healthy growth, is accompanied by two draft guidance documents for industry.
“Many families rely on infant formula as either the sole source of nutrition or an integral part of an infant’s diet through 12 months of age,” stated Michael Taylor, the FDA’s deputy commissioner for Foods and Veterinary Medicine. “The FDA sets high quality standards for infant formulas because nutritional deficiencies during this critical time of development can have a significant impact on a child’s long-term health and well-being. This rule will help to prevent adulteration in infant formula and ensure infant formula supports normal, physical growth.”
While breastfeeding is strongly recommended and many mothers hope to breastfeed, only 75% of infants in the United States start out being breastfed. By age 3 months, two-thirds, or 2.7 million U.S. infants, rely on infant formula for some portion of their nutrition. The interim final rule applies only to infant formulas represented for use by healthy infants without unusual medical or dietary problems.
The interim final rule amends the FDA’s quality control procedures, notification and record and reporting requirements for manufacturers of applicable infant formula products. The rule, in part, will ensure that infant formula contains all federally required nutrients. The interim final rule also establishes current good manufacturing practices specifically designed for infant formula, including required testing for microbial contamination from cronobacter or salmonella.
The interim final rule also establishes quality factor requirements to support healthy growth.
Companies currently manufacturing infant formula in the United States already voluntarily conduct many of the current good manufacturing practices and quality control procedures included in the interim final rule. Following publication of the rule, the FDA will be accepting and reviewing comments on issues or information not previously considered.
The two draft guidance documents published last week provide industry with additional information related to the interim final rule. One draft guidance document addresses the manufacture of infant formula products made for infants with unusual medical or dietary problems. For example, these infant formulas might be made for infants who are born extremely premature and have special dietary needs. This type of formula is not the subject of this interim final rule. The draft guidance provides information about the manufacture of such formulas in relation to the requirements for current good manufacturing practices, quality control procedures, the conduct of audits, and records and reports that apply to the infant formulas covered by the interim final rule.
The other draft guidance document explains how manufacturers of currently and previously marketed infant formulas can demonstrate that their products meet the quality factor requirements of the interim final rule.
Amgen taps former 3M exec as new CFO
THOUSAND OAKS, Calif. — Amgen on Monday appointed David Meline as EVP and CFO, effective July 21. Meline will be responsible for the company’s finance and investor relations operations. He succeeds Michael Kelly, who has been acting CFO since January.
Meline joins the company from 3M, where he served as SVP and CFO, overseeing finance activities for the company across 70 countries. His other leadership roles include positions at General Motors.
"David’s leadership talent and broad international experience will be invaluable to Amgen as we execute our strategy for long term growth and bring our pipeline of medicines toward commercialization in a number of new markets. I am delighted to welcome him to the team," said Robert Bradway, chairman and CEO of Amgen.
Meline received an MBA in finance from the University of Chicago, a MS in economics from the London School of Economics and a BS in mechanical engineering from Iowa State University.