Medication Dosing Error
Conditions
Keywords
Electronic Prescriptions (e-Rx), Pharmacy Dispensing Practices
Brief summary
The study objective is to assess the impact of an automated electronic health record (EHR)-based intervention that leverages e-prescriptions to support pharmacist adherence to recommended dispensing practices, with the goal of reducing parent dosing errors. Specifically, the study aims are to: 1) Examine the efficacy of the EHR-based intervention in improving pharmacy dispensing practices, including a) adherence to mL-only dosing and b) provision of optimal dosing tools; 2) Examine the efficacy of the EHR-based intervention in reducing parent dosing errors. The study will also explore whether implementation of the EHR-based intervention will reduce disparities in dosing errors by parent health literacy and LEP, and explore the efficacy of the EHR-based intervention in reducing ADEs. A pre-/post-implementation study will be performed with English- and Spanish-speaking parents of children prescribed oral liquid medications in the pediatric emergency room, outpatient general pediatric clinic, and pediatric subspecialty clinics of 2 New York City hospital systems (NYU Langone Health - Brooklyn and NYC Health+Hospitals - Bellevue Hospital). Prior to implementation, e-Rx's will be generated by the EHR in the usual fashion; after implementation, e-Rx's will be generated by the EHR with instructions to the dispensing pharmacy to: 1) keep the dosing instructions in mL-only, and 2) dispense a specific dosing tool based on the amount prescribed. The proposed project is consistent with a growing national focus on promoting the adoption of evidence-based strategies to improve disease management that address the needs of those with low health literacy and LEP from groups like the Joint Commission and the AHRQ.
Interventions
OTHEREHR-Based Approach
The intervention will be built directly into the EHR. E-prescriptions will be generated with pharmacy instructions for all prescription medications. The intervention will impart: 1) inclusion with e-Rx request for pharmacy to keep metric-only (mL-only) dosing on Rx label and 2) inclusion of guidance on the e-Rx requesting that the pharmacy give an optimal tool based on an algorithm. Algorithm for dosing tool recommendation: 1) for a prescribed dose of \<= 1mL, optimal tool is 1 mL syringe, 2) for \>1 mL to 5 mL, use a 5 mL syringe, 3) for \>5mL to 10mL, use 10 mL syringe.
Sponsors
NYU Langone Health
Food and Drug Administration (FDA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Single (Outcomes Assessor) Two raters will independently assess dosing errors. Raters will be kept blinded to each other's estimated dose volumes and dosing error assessment in order to minimize bias.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Caregiver/Child 1. English or Spanish-speaking 2. Parent or legal guardian of a child prescribed a liquid medicine in the NYU Langone Health - Brooklyn or Bellevue ED, general outpatient pediatric clinic, or specialty care clinics 3. 18 years of age or older 4. Child ≤8y discharged home with a Rx for ≥1 daily liquid medication dose ≤10mL, for use as a chronic or short course (≤14 days) medication 5. Primary person who will administer child's medications 6. Access to a smartphone that can take photos and send/receive text messages 7. Willingness and ability to participate Pharmacy staff 1\. Works at a pharmacy that dispensed index medicine to one of our study participants.
Exclusion criteria
Caregiver/Child 1. Does not have a working phone number 2. Not able to return for in-person follow-up visit 3. Was told to stop medication by provider after doctor/ED visit 4. Parent no longer having index medication bottle 5. Uncorrected hearing impairment 6. Self-reported poor visual acuity Pharmacy staff 1\. Staff with no responsibility in determining unit of measure to include on Rx's or type/capacity of the dosing tool to dispense for pediatric oral liquid medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Dosing Error | Within 8 weeks of index visit (Visit 2) | Dosing error will be defined as \>20% deviation from the prescribed dose |
| Caregiver Large Dosing Error | Within 8 weeks of index visit (Visit 2) | Large dosing error will be defined as \>40% deviation from the prescribed dose |
| Pharmacy Use of mL-only on Rx Label | Within 4 weeks of index visit (Visit 1) | — |
| Pharmacy Provision of Optimal Dosing Tool | Within 4 weeks of index visit (Visit 1) | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORH. Shonna Yin, MD, MS
NYU Langone Health
Outcome results
None listed