Misuse and Abuse of Loperamide in the United States

Study type

• Study topic:
  Human medicinal product

  Other
• Study topic, other:
  Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational database study

Population studied

• Short description of the study population:
  NPDS data represent loperamide exposures reported to US poison centers from 2012 through 2015. These include patients of all ages and may be contacts made by the public or healthcare professionals.; NMU-Rx data represent information captured via an ongoing online survey of the general adult population who have registered to participate in online surveys in exchange for modest compensation. The NMU-Rx survey was conducted in July/August 2016.
• Age groups:
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  40000

Study design details

• Main study objective:
  The objectives of this study are: 1) to describe abuse and misuse of loperamide as reported to the National Poison Data System (NPDS)2) to describe non-medical use of loperamide as reported via an ongoing online survey of Non-Medical Use of Prescription Drugs (NMU-Rx) by a general adult population sample.
• Outcomes:
  NPDS data source• Population-based rate of loperamide abuse• Sales-based rate of loperamide abuse• Population-based rate of loperamide misuse• Sales-based rate of loperamide misuseNMU-Rx data source• Population-based rate of loperamide non-medical use• Sales-based rate of loperamide non-medical use, • Describe the populations at-risk for the misuse and abuse of loperamide and associated outcomes as reported to NPDS.• Describe the populations at-risk for non-medical use of loperamide and potential risk factors as reported to NMU-Rx.
• Data analysis plan:
  Demographic characteristics for both NPDS and NMU-Rx will be summarized using descriptive analysis. Mean and standard deviation or median and interquartile range (IQR) will be calculated for continuous variables. Frequencies and proportions will be calculated for categorical variables.For NPDS, the main summary measures will be patient demographics, exposure characteristics, level of healthcare facility, and medical outcome.For NMU-Rx, the main summary measures will be respondent demographics, respondent characteristics, lifetime use and non-medical use of loperamide, frequency of recent non-medical use of loperamide, as well as reason and route of non-medical use.