CC March 2016 Risk Evaluation and Mitigation Strategy (REMS)

echoecho's version from 2016-04-19 04:25


Question Answer
A 2011 report by the Institute of Medicine estimated that more than ____ million Americans suffered from chronic pain each day?100
Since 1990, US utililzation of opioids for treatment of ___-______ chronic pain has exponentially increased?non-cancer
Sales of opioids from 1997 to 2007 increased between ____% and ____% depending on the type of opioid?280%; 1,293%
Along with increased consumption of these drugs, the incidence of what 4 conditions rose to the level of a national epidemic?1) misuse 2) abuse 3) diversion 4) accidental overdose fatality
In 2012, it was estimated that nearly ____ million Americans 12 years or older had used a prescription opioid for nonmedical use?37
Since 2004, there has been a ____% increase in emergency department visits attributed to misuse or abuse of prescribed opioids?183%
Among the 20,044 deaths in 2008 related to prescription drugs, almost ____% were overdose deaths caused by prescription opioids?75%
Opioids are portent and effective for relief of moderate to severe pain and can be helpful to patients who have a favorable benefit/risk ratio for opioid use, however, all opioid analgesics have serious adverse effects and potential for what?misuse and abuse
The most serious concern is what?respiratory depression and death (especially in certain vulnerable populations such as the elderly and children)
Opioid-induced respiratory suppression is also increased in the presence of what other medications?1) alcohol 2) benzodiazepines 3) other drugs that may alter opioid metabolism
Both immediate-release (IR) and extended release (ER/longacting (LA) opioid analgesics share the same risk of respiratory depression, but the which opioid products contain a larger amount of drug than immediate-release formullations, lasting longer in the event of an overdose and are more often associated with adverse effects and fatalities?extended release (ER) / long-actiing (LA) opioids
To lessen the societal and personal costs of this current public health crisis, the FDA and ONDCP (Office of National Drug Control Policy) and the DEA have been working with other stakeholders (manufactueres, healthcare providers, patients and parents) to develop a national action plan called what?Risk Evaluation and Mitigation Strategy (REMS)
What does the REMS program require manufacturers of ER / LA opioid analgesics to do?fund independent Accreditation Council for Continuing Medical Education (ACCME)- accredited continuing education (CE) providers to develop and offer education programs for healthcare providers, as well as education programs (medication guide and patient counseling document on ER/LA opioid analgesics) for patients
*** The FDA has a goal of having ____% of all opioid prescribers complete these education programs within 3 years of implementing the programs?60%
Currently, participation in REMS traiing is voluntary, but the FDA strongly favors future ______ requirement of opioid education to achieve the goal of ensuring that each prescriber uses evidence-based best practices in treating chronic pain?mandat general drug information for ER/LA opioid analgesic productsory
In 2012, the FDA approved a new REMS for ER/LA opioid analgesics that must comply with a ____ developed blueprint that specifies the content of the training?FDA
Each CE provider then develops its education probrams adhering to the FDA ________ available at its website?blueprint
To promote access, the REMS programs ar available in multiple learing formats (live presentation, online or monograph) and prescribers can obrtain updated information of available REMS programs from what web site at no cost to the participant?
According to the FDA REMS blueprint, each program must cover what 6 areas?1)assessing patients for treatment with ER/LA opioid analgesic therapy 2) initiating therapy, modifying dosing and discontinuing use of ER/LA opioid analgesics 3) managing therapy with ER/LA opioid analgesics 4) counseling patients and caregivers about the safe use of ER/LA opioid analgesics including safe disposal 5)general drug information for ER/LA opioid analgesic products 6) specific drug information for ER/LA opioid analgesic products
Each program requires at least ____ hours to complete. An extended ___ hour program is optional?2; 3
AT the end of the program, each participant is required to complete an evaluation and assessment form in order to receive CME credits, true or false?true
*** SUMMARY = Sales of opioids from 1977 to 2007 increased between ____% and ___% depending on the type of opioid? 280%; 1,293%
*** SUMMARY = Along with this increased consumption of opioids, the incidence of what due to prescription opioids rose to the level of national epidemic?misuse, abuse, diversion and accidental overdose fatality
*** SUMMARY = Both immediate-release (IR) and extended-release (ER)/long-acting (LA) opioid analgesics share what?the same risk of respiratory depression
*** SUMMARY, which opioid formulation (IR vs. ER/LA) contain a larger amount of the drug than the other and last longer in the event of an overdose?ER/LA (extended-release/ long-acting)
*** SUMMARY = The new REMS (Risk Evaluation and Mitigation Strategy) program requires manufacturers of ER/LA opioid analgesics to do what?fund continuing education (CE) providers to develop and offer education programs to healthcare providers, as well as education programs for patients