Utilization and Costs of Compounded Medications for Commercially Insured Patients, 2012 – 2013

Background: Although compounding has a long-standing tradition in clinical practice, insurers and pharmacy benefit managers have instituted policies to decrease claims for compounded medications, citing questions about their safety, efficacy, high costs, and lack of Food and Drug Administration (FDA) approval. There are no reliable published data on the extent of compounding by community pharmacists nor the fraction of patients who use compounded medications. Prior research suggests that compounded medications represent a relatively small proportion of prescription medications, but these surveys were limited by small sample sizes, subjective data collection methods, and low response rates. Objective: To determine the number of claims for compounded medications, on a per user per year (PUPY) basis, and the average ingredient cost of these claims among commercially insured patients in the United States (US) for 2012 and 2013. Methods: This study used prescription claims data from a nationally representative sample of commercially insured members whose pharmacy benefits were managed by a large pharmacy benefit management company. A retrospective claims analysis was conducted from January 1, 2012 through December 31, 2013. Annualized prevalence, cost, and utilization estimates were drawn from the data. All prescription claims were adjusted to 30-day equivalents. Data mining techniques (association rule mining) were employed in order to identify the most commonly combined ingredients in compounded medications. Results: The prevalence of compound users was 1.1% (245,285) of eligible members in 2012 and 1.4% (323,501) in 2013, an increase of 27.3%. Approximately 66% of compound users were female and the average age of a compound user was approximately 42 years throughout the study period. The geographic distribution of compound user prevalence was consistent across the US. Compound users’ prescription claims increased 36.6%, from approximately 7.1 million to approximately 9.7 million prescriptions from 2012 to 2013. The number of claims for compounded medications increased by 34.2% from 486,886 to 653,360 during the same period. PUPY utilization remained unchanged at 2 prescriptions per year from 2012 to 2013. The most commonly compounded drugs were similar for all adult age groups, and represented therapies typically indicated for chronic pain or hormone replacement therapy. The average ingredient cost for compounded medications increased by 130.3% from $308.49 to$710.36 from 2012 to 2013. The average ingredient cost for these users’ non-compounded prescriptions increased only 7.7%, from $148.75 to$160.20. For comparison, the average ingredient cost for all prescription users’ claims was $81.50 in 2012, and increased by 3.8$84.57 in 2013. Conclusions: Compound users represented 1.4% of eligible members in 2013. The average ingredient cost for compound users’ compounded prescriptions ($710.36) was greater than for non-compounded prescriptions ($160.20). The one-year increase in average compounded prescription costs (130.3%) was also greater than for non-compounded prescriptions (7.7%). Although prevalence of compound users and the PUPY utilization for compounded prescriptions increased only slightly between 2012 and 2013, the mean and median cost of compounded medications increased dramatically during this time. Text mining revealed that drug combinations characteristic of topical pain formulations were among the most frequently compounded medications for adults

Is it time US dentistry ended its opioid dependence?

Background. In 2017, 11.4 million US citizens misused prescription opioids, resulting in 46 overdose-deaths daily and a $78.5 billion burden on the economy. Dentists are one of the most frequent prescribers of opioids and there is concern that dental prescribing is contributing to the opioid crisis. Methods. A recent study showed 22.3% of US dental prescriptions were for opioids compared to 0.6% in England, where nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen accounted for most analgesic prescriptions. This observation prompted a review of international analgesic prescribing habits and of the advantages and disadvantages of opioids and NSAIDs for treating dental pain. Results. US opioid prescribing far exceeded that in other countries where NSAIDs accounted for the vast majority of dental analgesic prescribing. Furthermore, recent reviews confirm NSAIDs, and NSAID-acetaminophen combinations are as or more effective than opioids for controlling dental pain and cause significantly fewer side-effects. Conclusions. In light of the potential for misuse, and evidence that NSAIDs are as effective as opioids and have fewer side effects, there is clear patient benefit in avoiding opioids for the prevention or management of dental pain. Practical Implications. A growing preponderance of evidence shows that opioids are not needed for routine dental care. This article provides an overview of the evidence and outlines possible pain management models to minimize opioid use in dentistry. The purpose is to stimulate debate on this important topic and encourage the development of definitive guidance by professional bodies, health providers, and state and federal agencies

Generic drug competition: The pharmaceutical industry “gaming” controversy

Among American adults 20 years and older, 59 percent take at least one prescription drug on a regular basis. Unlike most branded drugs, which are generally drugs that have a trade name and are protected by a patent, off‐patent generic drugs make up approximately 90 percent of prescriptions annually filled in the United States; yet in 2017, generic drugs made up only 23 percent of total drug costs in the U.S. The U.S. Food and Drug Administration has taken the lead in encouraging increased competition in the nation’s prescription drug marketplace, most recently with its release of the agency’s Drug Competition Action Plan, but also with its regulatory guidance and enforcement efforts to eliminate “gaming” of the regulatory process by both branded and generic pharmaceutical manufacturers. Such “gaming” activities include “pay‐for‐delay” agreements involving financial compensation between branded and generic pharmaceutical manufacturers to forestall the emergence into the market of generic pharmaceuticals to compete against a formerly patent‐protected branded drug. A combination of new enabling legislation, federal judicial guidance, and agency regulatory activities show promise in encouraging increased competition in the prescription drug marketplace, with the American consumer the ultimate beneficiary of lower health care costs and improved overall personal health.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/152498/1/basr12186_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/152498/2/basr12186.pd