Related Experiment Video

Updated: Jan 3, 2026

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
10:17

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry

Published on: April 23, 2019

10.1K

Rescheduling hydrocodone combination products: Impact on patients receiving long-term HCP therapy in a large chain

Brian L Winbigler, Michael G O'Neil, Jeremy Crain

    Journal of the American Pharmacists Association : Japha
    |November 30, 2019
    PubMed

    Insights

    The rescheduling of hydrocodone combination products (HCPs) from schedule III to schedule II significantly reduced dispensing and use in chronic opioid patients. This change led to a 45% decrease in dispensed tablets and morphine milligram equivalents (MME).

    Area of Science:

    • Pharmacology
    • Public Health
    • Health Policy

    Background:

    • Hydrocodone combination products (HCPs) were previously classified as Schedule III (CIII) controlled substances.
    • Chronic opioid therapy often involves the use of HCPs for pain management.
    • Regulatory changes can impact medication dispensing patterns and patient treatment.

    Purpose of the Study:

    • To evaluate the impact of rescheduling HCPs from CIII to CII on dispensing and usage patterns.
    • To analyze changes in the quantity of HCPs dispensed to patients on chronic therapy.
    • To assess the effect of the schedule change on overall opioid exposure.

    Main Methods:

    • Retrospective cohort analysis of administrative pharmacy data from 118 retail pharmacies in Tennessee.
    • Analysis of HCP filling histories for patients meeting enrollment criteria between July 1, 2014, and October 1, 2015.
    • Comparison of dispensed tablets, daily tablet averages, and monthly morphine milligram equivalents (MME) before and after the schedule change using a pooled t test.

    Main Results:

    • A total of 4536 patients were included in the study.
    • Total hydrocodone tablets dispensed decreased by 45.5% (467,217 to 259,327) post-rescheduling (P < 0.001).
    • Total MME decreased by 45.3% (4.11 to 2.29 million) (P < 0.001), and the number of patients receiving HCPs dropped by 40%.

    Conclusions:

    • Rescheduling HCPs from CIII to CII resulted in a significant reduction in dispensing and use among patients on chronic opioid therapy.
    • Statistically significant decreases were observed in total tablets dispensed, average daily tablets, MME, and average daily MME.
    • The schedule change effectively curtailed the overall volume of HCPs dispensed in this large community pharmacy cohort.
    Abstract

    More Related Videos

    Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System05:10

    Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

    Published on: December 11, 2016

    10.1K
    Tracking Drug-induced Changes in Receptor Post-internalization Trafficking by Colocalizational Analysis07:48

    Tracking Drug-induced Changes in Receptor Post-internalization Trafficking by Colocalizational Analysis

    Published on: July 3, 2015

    9.1K

    Related Concept Videos

    Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment01:08

    Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment

    Hepatic impairment, characterized by decreased liver function, does not uniformly mandate adjustments in drug dosage. Whether dosage modifications are necessary depends on various factors related to the drug's metabolism and elimination pathways. If a drug is primarily excreted via the kidneys and bypasses significant hepatic processing, if it undergoes minimal metabolic transformation in the liver, or if it is volatile and primarily expelled through the lungs, dose adjustments may not be...
    216
    Drug Dosing: Geriatric Patients01:15

    Drug Dosing: Geriatric Patients

    Elderly individuals encompass a diverse population with varying degrees of age-related physiological changes. Defining the elderly presents challenges, as the geriatric population is often arbitrarily categorized as individuals older than 65. However, many individuals in this group lead active and healthy lives, with an increasing number surpassing 85 years and falling into the older elderly category. Physiological changes associated with aging impact performance capacity and homeostatic...
    189
    Chronopharmacokinetics: Circadian Rhythms and Influence on Drug Response01:15

    Chronopharmacokinetics: Circadian Rhythms and Influence on Drug Response

    Circadian rhythms are cyclic changes that are crucial in plasma drug concentrations. Various standard circadian parameters, including core body temperature, heart rate, and other cardiovascular factors, directly impact disease states and the therapeutic response to drug therapy.
    The time of drug administration is an important factor to consider, as it can influence the toxic dose of a drug. For example, a study conducted by Prins et al. in 1997 examined the effects of the timing of...
    316
    Opioid Analgesics: Synthetic and Semisynthetic Opioids01:15

    Opioid Analgesics: Synthetic and Semisynthetic Opioids

    Synthetic and semisynthetic opioids are pivotal in pain management and tackling opioid addiction. Semisynthetic opioids, including morphinans (morphine derivatives), oxycodone, oxymorphone, hydrocodone, and hydromorphone, have improved pharmacokinetic profiles compared to morphine. Additionally, heroin and 6-MAM (6-Monoacetylmorphine) show better CNS penetration than morphine due to heightened lipid solubility. Hydromorphone, a potent opioid, undergoes hepatic metabolism to form the active...
    848
    Drug Dosage Regimen: Overview01:15

    Drug Dosage Regimen: Overview

    A drug dosage regimen describes the specific instructions and schedule for administering a drug to a patient. It considers factors such as drug dosage, frequency, route of administration, and duration of treatment. Designing an appropriate dosage regimen for a patient aims to achieve a target drug concentration at the site of action.
    Typically, the starting dose and dosing interval are guided by the manufacturer's recommendations based on clinical trials conducted during and after drug...
    4.3K
    Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

    Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

    Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
    152