Pharmacoepidemiology and drug safety
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Increasing use of tramadol for chronic non-cancer pain is concerning since tramadol users may be at risk of developing recurrent opioid use with increasing opioid consumption and co-medication. Therefore, we investigated a complete national cohort of tramadol users. ⋯ Many patients who developed recurrent opioid use received prescriptions which substantially conflicted with existing guidelines and might lead to problematic opioid use.
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Pharmacoepidemiol Drug Saf · Jan 2019
Scoring the best deal: Quantity discounts and street price variation of diverted oxycodone and oxymorphone.
Diverted prescription opioids are significant contributors to drug overdose mortality. Street price has been suggested as an economic metric of the diverted prescription opioid black market. This study examined variables that may influence the street price of diverted oxycodone and oxymorphone. ⋯ Street prices for diverted oxycodone and oxymorphone are influenced by multiple factors including potency, dosage, formulation, and bulk purchasing. Buyers who purchase large quantities of low potency, large dosage, crush-resistant formulation prescription opioids can expect to achieve the lowest price.
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Pharmacoepidemiol Drug Saf · Jan 2019
Opioid tolerance and clinically recognized opioid poisoning among patients prescribed extended-release long-acting opioids.
In recognition of potential for increased overdose risk, drug labels for extended-release and long-acting (ER/LA) opioids emphasize the need for established opioid tolerance prior to initiating high dosages. ⋯ Over one-third of patients initiating ≥90 MME ER/LA opioids did not have evidence of opioid tolerance. The 7 days following high dose ER/LA initiation may represent a high-risk period for clinically diagnosed opioid poisoning in patients who do not have prior opioid tolerance.
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Pharmacoepidemiol Drug Saf · Dec 2018
Significance of data mining in routine signal detection: Analysis based on the safety signals identified by the FDA.
Data mining has been introduced as one of the most useful methods for signal detection by spontaneous reports, but data mining is not always effective in detecting all safety issues. To investigate appropriate situations in which data mining is effective in routine signal detection activities, we analyzed the characteristics of signals that the US Food and Drug Administration (FDA) identified from the FDA Adverse Event Reporting System (FAERS). ⋯ Data mining was shown to be effective in the following situations: (1) early detection of safety issues for newly marketed drugs, (2) continuous monitoring of safety issues for old drugs, and (3) signal detection of nonserious AEs, to which little attention is usually given.
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Pharmacoepidemiol Drug Saf · Sep 2018
What is the quality of drug safety information for patients: An analysis of REMS educational materials.
Poor-quality patient drug information has been identified as a major cause of preventable medication errors in the United States. The US Food and Drug Administration (FDA) has the authority to require marketing authorization holders of medicinal products to implement risk evaluation and mitigation strategies (REMS) to ensure that the benefits of a drug or biological product outweigh its risks. Aside from medication guides, no research has been conducted to assess the quality of patient-targeted REMS materials, including whether, and to what extent, patients find these materials understandable and actionable. ⋯ Currently approved REMS patient materials fell short in terms of recommended reading level, and over half did not meet recommended standards for actionability. Developers of these materials should apply plain language principles when design these materials to improve their readability and to assess both understandability and actionability in order to increase the effectiveness when distributed to patients.