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Become a member and receive career-enhancing benefits
Our top priority is providing value to members. Your Member Services team is here to ensure you maximize your ACS member benefits, participate in College activities, and engage with your ACS colleagues. It's all here.
Surgeon prescribing patterns for postoperative opioid drugs may contribute to ongoing opioid overuse and increased risk for drug addiction by certain patient groups. Despite implementation of various methods for educating surgeons and reminding prescribers to avoid overprescribing (for example, email reminders when an opioid prescription exceeds the 75th percentile of opioid consumption), this problem persists.
This study evaluated opioid prescribing patterns and investigated reasons for overprescribing. An email survey was provided to study participants and responses were analyzed. Data were available on 10,672 patients, and 29.4% of opioid prescriptions exceeded institutional guidelines (outlier prescriptions). Survey responses were completed by 20.6% of prescribers.
When patient consumption data and surgeon survey data were available, the analysis showed that despite provision of opioids in amounts that exceeded institutional guidelines, 35.2% of patients consumed none of the provided drug and 21.5% consumed less than 50% of the provided drug. Less than 40% of patients who received outlier prescriptions were outlier consumers. Providers cited assessment of patient characteristics as a common driver of their prescription decisions, but the data showed that this did not align with usage in 50% of patients.
In the editorial that accompanied this article, Neha Nimmagadda, MD, and Virginia O. Shaffer, MD, FACS, noted that 5% of opioid-naïve patients continue using the drug after their surgical care is completed. Other data they cited indicate that 75% of heroin users reported using opioids prior to using heroin. Additional data support the conclusion that overprescribing contributes to the ongoing problem of drug addiction.
It is worth noting that multidisciplinary interventions have been shown to improve opioid prescribing practices; these efforts should be supported. Additional research is necessary for determining ways to improve provider prescribing practices and to predict which patients will require larger opioid prescriptions.
FDA Approval Is Sufficient for Determining Safety of Animal-Derived Wound Care Devices, but Effectiveness Validation Is Needed
Wound care is commonly needed in older patients; according to Medicare data, 15% of patients are currently treated for at least one wound. Wound care products are needed to facilitate care of this patient group, and animal-derived wound care products are determined to be “safe” according to evaluations conducted via the US Food and Drug Administration (FDA) Class II 510 (k) pathway.
Of note is the observation that this pathway can approve the safety of a device if it is “similar” to a previously approved device. The pathway does not assess the effectiveness of the wound care device. The study reported in this article used PubMed literature searches to determine whether effectiveness studies had been performed for 132 wound care devices approved by the FDA.
The data analysis showed that biocompatibility testing was performed for 74.6% of devices but was referenced in published reports in only 8.8% of these devices. Preclinical wound healing testing was done in 14.9% of devices, and only 7.9% of the devices underwent clinical safety testing.
The authors concluded that FDA approval was sufficient for determining product safety, but clinical effectiveness validation is often lacking.
In the editorial by Vic Velanovich, MD, FACS, that accompanied this article, he noted that the FDA is focused on protecting patients from risks and facilitating timely access to new devices. Dr. Velanovich encouraged surgeons and patients to demand evidence of effectiveness so that improved choices of wound care devices can be made.
Secondary Analysis Suggests BCS and Mastectomy Have Similar Locoregional Recurrence after Chemotherapy
Available evidence has shown that breast conserving surgery (BCS) may be safe following neoadjuvant chemotherapy (NAC), but this treatment approach is underutilized because of older data that suggested higher rates of local-regional recurrence (LRR) in patients who were treated with BCT.
Because of this conflicting data, the authors performed a secondary analysis of a recent randomized prospective trial (I-SPY 2 trial, n = 1,462) to determine rates of LRR and locoregional recurrence-free survival (LRFS) according to treatment received; the relationship between residual cancer burden, measured by pathologist examination of excised breast tissue using and accepted grading scale, was also assessed. In addition, the investigators determined whether the extent of surgery changed the risk of LRR according to patient age and clinical stage of breast cancer.
The data analysis showed that in patients treated with BCS or mastectomy, LRR (5.4% vs 7.0%) and LRFS were not different. Tumor receptor subtype and residual cancer burden were associated with LRFS regardless of the type of surgery performed.
The authors hypothesized that use of contrast-enhanced MRI imaging in the I-SPY 2 trial may have led to improved detection of multicentric and multifocal disease and more precise selection of BCS versus mastectomy. The authors concluded that careful evaluation of imaging, tumor characteristics, and residual cancer burden can facilitate patient selection and lead to similar outcomes for BCS and mastectomy.
