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Last Updated
November 20, 2015
NEWSROOM > Latest News > Current
Current | 2014 News | 2013 News | Prior to 2013

August 25, 2015
FDA's MedWatch Safety Alerts for Consumers: July 2015
FDA is warning consumers about children's cough-and-cold medicine with codeine, the risks of nonsteroidal anti-
inflammatory drugs (NSAIDs), unapproved prescription ear products and drugs from Moses Lake Professional 
August 21, 2015
Team Against Opioid Abuse Site Launched
The website, launched by Purdue Pharma, LP, aims to educate healthcare providers and patients about abuse-
deterrent opioid-based painkillers. Purdue markets two of the three opioid formulations available with the abuse-
deterrent properties.  The site features sections about why it’s critical to deter abuse and how all the members on 
the healthcare team can make a difference. It also outlines the 2015 Food & Drug Administration’s Guidance on 
Abuse-Deterrent Opioids — Evaluation and Labeling, which informs drug developers about FDA’s current thinking on 
what kinds of testing potentially abuse-deterrent opioids should undergo. Because FDA states that having 
information about an opioid’s abuse deterrence available for healthcare professionals and patients, the website also 
reviews how Section 9.2 of a drug product’s Full Prescribing Information is the key to identifying opioid formulations 
with FDA-approved abuse-deterrent properties. "We dev eloped this website to inform everybody who influences 
how drugs are prescribed, taken, stored, and destroyed when no longer needed," stated Dr. J. David Haddox, vice 
president of health policy at Purdue. 
August 20, 2015
Pharmacists Help Heart Patients With Medication Adherence
Pharmacists in one study made a significant impact in helping heart patients stick to their medication regimens, 
report researchers. A multidisciplinary team at the US Department of Veterans Affairs talked to patients from a 
previous study who adhered to their medications after suffering an acute coronary syndrome, or an episode when 
blood is blocked from the heart, reports Pharmacy Times. These patients cited “supportive and concerned” 
pharmacists who called to remind them to take their medicine as a key factor in actually doing so. The study 
researchers “suggested that training health care providers to respect patients’ views about their medications could 
be the next step toward improving adherence,” reports Pharmacy Times. The research can be found in the latest 
issue of Patient Preference and Adherence, published in 
June 2015.
August 18, 2015
Flow Restrictors for OTC Pediatric Oral Liquid Drug Products Containing Acetaminophen
In a Guidance to industry document issued August 4, the FDA endorsed the use of flow restrictors for over-the-
counter (OTC) pediatric oral liquid drug products containing acetaminophen. "OTC pediatric oral liquid drug products 
containing acetaminophen have been associated with overdoses due to medication errors that resulted in serious 
adverse events, including severe liver damage and death, the FDA notes in the Guidance. This guidance is designed 
to help "drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver 
damage" associated with use of these products.

Specifically, the FDA recommends adopting "container features designed to improve safety by potentially 
contributing to more accurate dosing and helping to reduce the incidence and magnitude of accidental 
acetaminophen ingestion by children, such as an appropriate flow restrictor contained in the opening of the 
immediate container." "If a flow restrictor is included, it should be attached to the container in a way that prevents 
it from being pushed into the bottle or easily removed. Firms are encouraged to discuss innovative 
containers/packaging features with FDA before introduction into the market," the FDA says.

Related:  See Know Your Dose.
August 13, 2015
Pathways to Safer Opioid Use eLearning Course Announced
Adverse drug events (ADEs) are the largest contributor to hospital-related complications and account for more than 
3.5 million physician office visits each year. The U.S. Department of Health and Human Services (HHS) recently 
released the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan), which targets opioids as a 
significant contributor to ADEs.

The new, interactive training, “Pathways to Safer Opioid Use,” teaches health care providers how to implement 
opioid-related recommendations from the ADE Action Plan, and patient-centered strategies to communicate the safe 
use of opioids in managing chronic pain. Continuing medical education (CME) is available to participants who 
complete the course.