The FDA is using a “big data” approach to monitoring the safety of marketed drugs. The Mini-Sentinel, which took 5 years to create, can look through the billing records of nearly 180 million Americans to find connections between drugs and health complications. The program now runs hundreds of queries a year.
The FDA recently approved Targiniq ER, a painkiller that contains both oxycodone, a powerful opioid, and naloxone, which is used to prevent fatal opioid overdose. When swallowed intact, the naloxone component of Targiniq ER stays dormant. However, when the pill is crushed, the naloxone component is activated and prevents the oxycodone from binding to brain receptors to provide pain relief. Though people could still become addicted or overdose when using the drug as intended, Targiniq ER limits the common abuse delivery routes such as injecting or snorting crushed pills.
Currently 48 states operate prescription drug databases, and New Hampshire will become the 49th later this year. Missouri is the only state resisting the trend due to a group of lawmakers and citizens who view a prescription drug database as a violation of personal privacy. As a result, Missouri has attracted people from neighboring states looking to stockpile and deal prescription drugs.
As discussed in a previous blog post, CMS released guidance to prevent duplicate payments for drugs that Part D beneficiaries receive while in hospice. The new rule, which required Part D plans to place prior authorizations on all drugs for beneficiaries in hospice, received strong criticism. Those against the rule argued that prior authorizations would delay and reduce access to necessary drugs for beneficiaries in hospice care.
Last week, CMS revised the rule so that prior authorization is only required for pain relievers, anti-nauseants, laxatives, and anti-anxiety drugs. These drugs are generally associated with hospice treatment and should be covered by the fixed rate payments made to hospices. Part D plans will cover other drugs without additional prior authorization so that beneficiaries can have access to their medications.
A new study analyzes the impact of changes in the shape and color of pills on patient adherence to drug regimens. Following a group of patients who were hospitalized with heart attacks and began a cardiac drug regimen upon discharge, the study calculated instances of medication non-persistence and changes in pill color and size. Overall, the authors found that the odds of non-persistence increased by 34% after a change in pill color and 66% after a change in pill shape. For patients taking drugs that have multiple generic versions, these findings could have serious implications for medication adherence and health outcomes.
As discussed in a previous blog post, the FDA has issued draft guidance recommending that generic drug manufacturers adopt similar dimensions and volume as the reference listed drug (the guidance does not cover pill color). Urging generic manufacturers to use similar physical attributes as the brand could help patients adhere to drug regimens, but could could also lead to trademark disputes that would delay generic competition.
Using 2012 data, the CDC calculated opioid pain reliever prescription rates at the national and state level. Nationally, there were 82.5 opioid pain reliever prescriptions for every 100 Americans. But, the opioid pain reliever prescription rate varied 2.7 fold at the state level, with the highest rates in the South. In Alabama, which had the highest rate, there were 143 painkiller prescriptions for every 100 people.
Unlike its neighbors, Florida’s opioid pain reliever prescription rate was on the low end of the spectrum. Florida was once considered the center of illegal prescription drug sales, but its aggressive measures against prescription drug abuse demonstrate how state policy can reduce improper prescribing. In 2010, Florida began requiring pain clinics to register with the state, and taking action against “pill-mills” and inappropriate prescribers. In 2011, the state banned doctors from dispensing narcotics from their offices and clinics, though with a few exceptions, and started a prescription drug monitoring system. Between 2010 and 2012, the rate of fatal overdoses fell by 23 percent, and the rate of fatal oxycodone overdoses declined more than 50 percent.