Keeping you updated on the latest Medicare and Part D news

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Opioid prescription patterns linked to likelihood of long-term use

A recent study has found that opioid days supply and the number of prescriptions in the first episode of opioid use can greatly affect the likelihood a patient will become an opioid chronic user.  The study examined a random sample of opioid-naive adults without cancer that received a prescription for opioid pain relievers.  Starting with the third day, the risk of becoming a chronic opioid user grows with each day additional day supply provided to patients.  Prescribing opioids is increasingly becoming a complicated decision for doctors to make.

FIGURE 1. One- and 3-year probabilities of continued opioid use among opioid-naïve patients, by number of days’ supply* of the first opioid prescription — United States, 2006–2015

	The figure above is a line chart showing 1- and 3-year probabilities of continued opioid use among opioid-naïve patients, by number of days’ supply of the first opioid prescription in the United States during 2006–2015.

* Days’ supply of the first prescription is expressed in days (1–40) in 1-day increments. If a patient had multiple prescriptions on the first day, the prescription with the longest days’ supply was considered the first prescription.


FIGURE 2. One- and 3-year probabilities of continued opioid use among opioid-naïve patients, by number of prescriptions* in the first episode of opioid use — United States, 2006–2015

	The figure above is a line chart showing 1- and 3-year probabilities of continued opioid use among opioid-naïve patients, by number of prescriptions in the first episode of opioid use, in the United States during 2006–2015.

* Number of prescriptions is expressed as 1–15, in increments of one prescription.



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Questionable Prescriptions for Dementia Patients

Last week, CMS announced a new goal to reduce antipsychotic medication use in nursing homes by 25 percent by the end of 2015 and 30 percent by the end of 2016. Antipsychotic medications come with black box warnings, the FDA’s most serious alert, notifying users that the medication can have fatal risks for the elderly and people with dementia. Currently, around 20 percent of long-stay nursing home residents receive antipsychotic medications. Past studies conducted by the OIG and Boston Globe found widespread inappropriate use of antipsychotic medications in nursing homes, including regimens with high dosages and excessive durations, and prescriptions for off-label conditions.

CMS Announcement

A recent study published in the Journal of American Medicine found other questionable prescriptions for nursing home patients with advanced dementia. Within the sample studied, almost 54 percent of patients received a drug that was deemed never appropriate for people with advanced dementia receiving palliative care (e.g., cholesterol medication). Not only do these medications provide little benefit to patients, they also come with a high cost and potential side effects.



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FDA Approves Hand-Held Opioid Overdose Treatment

Yesterday, the FDA approved Evzio, a hand-held device that delivers a single dose of naloxone, which reverses the effects of opioid overdose such as stopped breathing and lost consciousness. When used during the one to three hour window after someone has overdosed, naloxone can reverse the binding of the opioid drug to certain receptors in the brain that control breathing. The approval took a short 15 weeks, and the product is expected to be available this summer. Currently, naxalone treatment is available mostly in hospitals and other medical settings, and naxalone treatment outside of a medical setting can require assembly (e.g., syringes, vials, nasal spray attachments). The hand-held device is the shape of a credit card and the thickness of a cellphone, small enough to fit in one’s pocket or a medicine cabinet. It provides verbal instructions on how to administer the drug and uses a retractable needle, no assembly needed. Evzio also created a training device people can use to practice using the product.

Those in favor of the FDA’s decision believe that the new device, when widely disseminated, can help prevent the growing number of fatal opioid overdoses. The most recent data shows that in 2010, 16,651 people died from opioid overdoses in the US.  Others have criticized the FDA for not focusing on the bigger issues, e.g., preventing inappropriate prescribing or the controversial approval of Zohydro, and instead approving an device that could encourage opioid abusers act  irresponsibly.


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FDA Releases Draft Guidance On Use of Scientific and Medical Literature for Drug Promotion

The new FDA guidance on the use of scientific and medical literature to promote drug products enters a grey area between upholding the First Amendment right to free speech and ensuring drug safety. The FDA already regulates company-sponsored or generated studies that include information that has not been specifically approved by the FDA or fail to meet scientific standards. However, when rigorously-conducted, independent studies that are driven by scientific rather than promotional purposes recommend drug uses that are not approved by the FDA, should companies be allowed to distribute them? The FDA’s guidance outlines what qualifies as independent and scientifically sound literature, and what sort of disclosures companies should include when distributing such literature.


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OpenFDA and the Future of Drug Safety Information

The FDA has collected millions of records on adverse drug events since 1998, amounting to the world’s largest catalog of how drugs interact with the human body. The FDA publishes bulk files on a quarterly basis; however, it takes a great deal of expertise and software to understand the data. Also, the information is extremely inaccessible for anyone outside the FDA (e.g., viewing a report on a specific drug requires a Freedom of Information Act request), making it almost impossible for everyday citizens and physicians to make informed decisions about prescription drugs.

In January 2014, the FDA began the openFDA project to release datasets covering adverse drug events, recalls, and drug documentation. Beta access to the database is expected by this summer, followed by a full launch in the fall. 

Startups have tried to use the FDA’s bulk files to provide information for consumers and clients in the health care industry. For example, AdverseEvents creates reports based on the FDA’s bulk files for insurers and hospitals. DrugCite allows users to search for side effects by medications online. Founders from both organizations have expressed frustrations with the current FDA data, citing challenges such as duplicate records, misspelled drug names, and piecemeal files. Once openFDA is launched, more entrepreneurs and software developers will likely create websites and applications to satisfy the public demand for drug safety information.