Opioid analgesics are usually used to relieve moderate to severe pain. There are many common side effects such as constipation, drowsiness and sedation. The severe and life-threatening side effects are related to abuse and addiction.
Increased rates of opioid prescribing and the associated serious health consequences have been a national crisis in the US. By 2014, the US had the highest opioid consumption in the world; and deaths related to opioid overdose have increased dramatically in recent years. In the UK, a similar trend of increasing opioid prescriptions has been observed; however, there was no obvious increase in overdose death related to opioids.
The aim of this study is to evaluate the overall prescribing trend of opioid analgesics, in both pediatric and adult patients over 20 years. We will also estimate potential factors associated with new opioid prescribing, e.g. age, gender, health status, alcohol and smoking histories. In addition, we will investigate if benzodiazepines and gabapentinoids were prescribed together with opioid analgesics, which may increase the risk of serious adverse events. We also plan to identify the most common pain-related diagnoses in the period preceding treatment with opioid or other analgesics. In addition, we will compare prescribing patterns for (1) opioid versus non-opioid analgesics; (2) strong-opioids versus weak-opioids; and (3) long-term versus short-term opioid analgesic therapy.
Opioid analgesics are usually used to relieve moderate to severe pain. Despite many common side effects, the major fear concerning opioid analgesics is related to life-threatening side effects of abuse and addiction.
Increased rates of opioid-related misuse and overdose death have emerged as a national crisis in the US recent years. In the UK, a similar trend of increasing opioid prescriptions has been observed, while the increase in overdose death related to opioids was obviously less significant.
Our overall objective for this project is to evaluate the prescribing trend of opioid analgesics, in both pediatric and adult patients over more than two decades. We have three specific aims. Aim (1), we will evaluate prevalent opioid analgesics prescribing patterns and the trend changes over time. For Aims (2) and (3), we will establish incident prescribing cohort, also called new user cohort. Aim (2), we will first evaluate incident opioid analgesics prescribing patterns and the trend changes over time. For the new pediatric and adult patient cohorts, we also propose to estimate opioid analgesicsÂ’ refill patterns, treatment duration, and concomitant medications. For specific aim (3), we propose to estimate potential risk factors associated with incident opioid prescribing, e.g. age, gender, health status, social economic status, alcohol and smoking histories, concomitant medications, and related pain diagnoses. In addition, we will compare prescribing patterns for (1) opioid versus non-opioid analgesics; (2) strong-opioids versus weak-opioids, and (3) long-term versus short-term opioid analgesic therapy.
We will use a retrospective cohort study design for the time-period from January 1, 1995 through December 31, 2018, using the CPRD GOLD data. The exposures are analgesics. The outcome measures are proportions and prescribing rates of analgesic prescriptions. To estimate potential factors associated with incident opioid prescribing, logistic regression will be utilized.
The main study outcome is analgesics prescribing rate by year. We will estimate opioids refill patterns, treatment duration, and concomitant medications in incident prescribing cohort. Refill patterns are featured by patterns of allowable gaps and overlaps between prescriptions. Treatment duration is defined by total quantity and number of days.
We will also evaluate the concomitant medications prescribed together with opioids over the years. Drugs of interest include benzodiazepines and gabapentinoids. Concomitancy is defined as any medication overlapped at least one day with opioid analgesics.
Esther Zhou - Chief Investigator - Food and Drug Administration - FDA
Esther Zhou - Corresponding Applicant - Food and Drug Administration - FDA
Grace Chai - Collaborator - Food and Drug Administration - FDA
Jana Mcaninch - Collaborator - Food and Drug Administration - FDA
Judy Staffa - Collaborator - Food and Drug Administration - FDA
Rose Radin - Collaborator - Food and Drug Administration - FDA
Xiaoqing Huang - Collaborator - Food and Drug Administration - FDA
Zhou Feng - Collaborator - Food and Drug Administration - FDA
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