Advertisement

Topics

A Survey to Eval the Relation Between Doctor/Pharmacy Shopping and Outcomes Suggestive of Misuse, Abuse and/or Diversion

2016-01-28 16:53:22 | BioPortfolio

Summary

To evaluate the reasons patients go to more than one prescriber or more than one pharmacy to obtain prescriptions opioids and assess whether the percentage of patients reporting misuse, abuse and/or diversion increases across defined categories of doctor/pharmacy shopping as defined in Study 4A.

Description

Based on a review of the literature, the Food and Drug Administration (FDA) concluded that more data are needed regarding the serious risks of misuse, abuse, addiction, overdose, and death associated with the long-term use of extended release/long acting (ER/LA) opioid analgesics. Thus, the FDA is requiring that ER/LA opioid analgesic drug sponsors conduct post-marketing studies to assess these risks. The four observational post-marketing requirement (PMR) studies are labeled Study #2065-1, Study #2065-2, Study #2065-3, and Study #2065-4.

The objective of PMR Study #2065-4 is to define and validate doctor/pharmacy shopping as outcomes suggestive of misuse, diversion, abuse and/or addiction.

Study #2065-4 consists of three sub-studies, Study 4A, Study 4B, and Study 4C. In the current study (#2065-4 sub-study, Study 4B), the association between doctor/pharmacy shopping behavior and misuse, diversion and abuse will be assessed by surveying patients within the a priori defined four categories of shopping behaviors. The four categories of shopping behaviors identified and defined in Study 4A will be applied to Study 4B. Asking patients directly about their behaviors related to misuse and abuse will provide us with the patient's perspective that is unavailable in Study 4A. Surveying patients regarding misuse and abuse requires the use of an instrument that has undergone a validation process to ensure that misuse and abuse are being measured. Study 4B will utilize the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) that will be validated in PMR Study #2065-2A. An administrative claims database will be used to identify the eligible patient population using their pharmacy claims for immediate release (IR) or ER/LA opioid analgesics to determine the number of prescribers and number of pharmacies they visit. Consenting patients will be asked to complete an online survey that includes the POMAQ to self-report their behaviors of misuse, abuse and/or diversion. It is hypothesized that as the likelihood of doctor/pharmacy shopping behavior increases the risk of misuse, abuse and/or diversion.

Study Design

Time Perspective: Retrospective

Conditions

Opioid-Related Disorders

Intervention

Survey to Eval Relation between Shopping and Misuse, Abuse

Status

Enrolling by invitation

Source

Member Companies of the Opioid PMR Consortium

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-01-28T16:53:22-0500

Clinical Trials [1195 Associated Clinical Trials listed on BioPortfolio]

Study to Eval Relation Btw Doctor/Pharmacy Shopping & Outcomes of Misuse, Diversion, Abuse, Addiction by Med Rec Review

To assess whether the percentage of patients with behaviors suggestive of misuse, diversion, abuse and/or addiction described in the medical record increases across pre-defined categories ...

A Qualitative Study to Assess the Content Validity of the Prescription Opioid Misuse and Abuse Questionnaire

The purpose of this study is to evaluate the patient usability and reliability of the POMAQ survey to evaluate opioid misuse and abuse among adults with chronic moderate to severe pain, in...

A Quantitative Study to Assess the Construct Validity of the Prescription Opioid Misuse and Abuse Questionnaire

The purposes of this study are to evaluate the validity and reproducibility of the POMAQ to identify opioid abuse and misuse behaviors among participants who have chronic pain which requir...

A Prospective Investigation of the Risks of Opioid Misuse, Abuse, and Addiction Among Patients Treated With Extended-release/Long Acting (ER/LA) Opioids for the Treatment of Chronic Pain

The purpose of this study is to quantify the serious risks of misuse, abuse, and addiction associated with long-term use of opioid analgesics for management of chronic pain, among patients...

Cross-Sectional Study to Define and Validate "Doctor/Pharmacy Shopping" as Outcomes Suggestive of Abuse and/or Addiction

The purpose of this study is to formulate definitions of doctor/pharmacy shopping and evaluate its association with abuse/addiction

PubMed Articles [6804 Associated PubMed Articles listed on BioPortfolio]

Barriers to accurately assessing prescription opioid misuse on surveys.

Surveys are the leading method of gathering data on prevalence and correlates of prescription opioid misuse. As the opioid crisis continues in the United States, reliable data on misuse have become in...

Doctor shopping of opioid analgesics relative to benzodiazepines: A pharmacoepidemiological study among 11.7 million inhabitants in the French countries.

The abuse of prescription opioids and its subsequent consequences is an important public concern particularly in the USA. The literature on opioid analgesic abuse is scarce.

Abuse of immediate-release opioids and current approaches to reduce misuse, abuse, and diversion.

Deaths from opioid overdoses have increased dramatically over the past few years. Given that immediate-release (IR) opioids account for most of the US market share, and that abusers generally prefer I...

Moving opioid misuse prevention upstream: A pilot study of community pharmacists screening for opioid misuse risk.

Prescription opioids are known to be highly addictive, contributing to the opioid epidemic which continues to besiege victims in the United States. Pharmacists are gatekeepers straddling the prescribe...

Associations between adolescent chronic pain and prescription opioid misuse in adulthood.

Prescription opioid misuse is a serious public health concern, yet antecedent factors are poorly described. Using data from the National Longitudinal Study of Adolescent to Adult Health (Add Health) (...

Medical and Biotech [MESH] Definitions

Abuse, overuse, or misuse of a substance by its injection into a vein.

Abuse, overuse, or misuse of a substance by ingestion.

The misuse of phencyclidine with associated psychological symptoms and impairment in social or occupational functioning.

Improper use of drugs or medications outside the intended purpose, scope, or guidelines for use. This is in contrast to MEDICATION ADHERENCE, and distinguished from DRUG ABUSE, which is a deliberate or willful action.

Disorders stemming from the misuse and abuse of alcohol.

More From BioPortfolio on "A Survey to Eval the Relation Between Doctor/Pharmacy Shopping and Outcomes Suggestive of Misuse, Abuse and/or Diversion"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Drug Approvals
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...


Searches Linking to this Trial