Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements. Final rule.
Fed Regist. 2016 Sep 27;81(187):66191-6
Authors: Substance Abuse and Mental Health Services Administration (SAMHSA), HHS
This final rule outlines annual reporting requirements for practitioners who are authorized to treat up to 275 patients with covered medications in an office-based setting. This final rule will require practitioners to provide information on their annual caseload of patients by month, the number of patients provided behavioral health services and referred to behavioral health services, and the features of the practitioner's diversion control plan. These reporting requirements will help the Department of Health and Human Services (HHS) ensure compliance with the requirements of the final rule, "Medication Assisted Treatment for Opioid Use Disorders," published in the Federal Register on July 8, 2016.
PMID: 27726319 [PubMed - indexed for MEDLINE]
Activated Carbon-Based System for the Disposal of Psychoactive Medications.
Pharmaceutics. 2016 Nov 07;8(4):
Authors: Song Y, Manian M, Fowler W, Korey A, Kumar Banga A
The misuse and improper disposal of psychoactive medications is a major safety and environmental concern. Hence, the proper disposal of these medications is critically important. A drug deactivation system which contains activated carbon offers a unique disposal method. In the present study, deactivation efficiency of this system was tested by using three model psychoactive drugs. HPLC validation was performed for each drug to ensure that the analytical method employed was suitable for its intended use. The method was found to be specific, accurate and precise for analyzing the drugs. The extent and rate of deactivation of the drugs was determined at several time points. After 28 days in the presence of activated carbon, the extent of leaching out of the drugs was evaluated. Deactivation started immediately after addition of the medications into the disposal pouches. Within 8 h, around 47%, 70% and 97% of diazepam, lorazepam and buprenorphine were adsorbed by the activated carbon, respectively. By the end of 28 days, over 99% of all drugs were deactivated. The desorption/leaching study showed that less than 1% of the active ingredients leached out from the activated carbon. Thus, this deactivation system can be successfully used for the disposal of psychoactive medications.
PMID: 27827989 [PubMed - in process]
Preparation and in vitro evaluation of thienorphine-loaded PLGA nanoparticles.
Drug Deliv. 2016;23(3):787-93
Authors: Yang Y, Xie XY, Mei XG
Poly (d,l-lactic-co-glycolide) nanoparticles (PLGA-NPs) have attracted considerable interest as new delivery vehicles for small molecules, with the potential to overcome issue such as poor drug solubility and cell permeability. However, their negative surface charge decreases bioavailability under oral administration. Recently, cationically modified PLGA-NPs has been introduced as novel carriers for oral delivery. In this study, our aim was to introduce and evaluate the physiochemical characteristics and bioadhesion of positively charged chitosan-coated PLGA-NPs (CS-PLGA-NPs), using thienorphine as a model drug. These results indicated that both CS-PLGA-NPs and PLGA-NPs had a narrow size distribution, averaging less than 130 nm. CS-PLGA-NPs was positively charged (+42.1 ± 0.4 mV), exhibiting the cationic nature of chitosan, whereas PLGA-NPs showed a negative surface charge (-2.01 ± 0.3 mV). CS-PLGA-NPs exhibited stronger bioadhesive potency than PLGA-NPs. Furthermore, the transport of thienorphine-CS-PLGA-NPs by Caco-2 cells was higher than thienorphine-PLGA-NPs or thienorphine solution. CS-PLGA-NPs were also found to significantly enhance cellular uptake compared with PLGA-NPs on Caco-2 cells. An evaluation of cytotoxicity showed no increase in toxicity in either kind of nanoparticles during the formulation process. The study proves that CS-PLGA-NPs can be used as a vector in oral drug delivery systems for thienorphine due to its positive surface charge and bioadhesive properties.
PMID: 24870204 [PubMed - indexed for MEDLINE]
[Trend in buprenorphine and methadone shopping behavior in France from 2004 to 2014].
Presse Med. 2016 Nov 4;:
Authors: Kernisant M, Delorme J, Kabore JL, Brousse G, Laporte C, Zenut M, Chenaf C, Authier N
INTRODUCTION: The opioid maintenance treatments (OMT) are widely misused and diverted in many countries. Doctor shopping represented the main way to obtain high quantities of opioids in abuse/diversion. The aim of this study was to assess the trends in the prevalence of doctor shopping for high dosage buprenorphine (HDB) and methadone (MTD) from 2004 to 2014 by using the French Health Insurance claims.
METHODS: This was a cross-sectional study of patients treated by OMT (High Dosage Buprenorphine or Methadone) between 2004 and 2014 from a representative sample of the French Health Insurance claims. Doctor shopping was defined as at least 1 day of overlapping prescriptions, written by at least 2 different prescribers and filled in at least 3 different pharmacies.
RESULTS: HDB patients were more likely men (77.9 % in 2014) with a mean age ranged from 33.4±7.6 years in 2004 to 39.5±9.3 years in 2014, P<0.001. MTD patients were also more likely men (73.9 % in 2014) with a mean age ranged from 33.5±6.9 years in 2004 to 37.1±8.5 years in 2014, P<0.001. In 2014, 35 % of HDB patients and 36 % of MTD patients presented a long-term disease which was most frequently a mental health disorders. The prevalence of doctor shopping for HDB decreased from 2004 to 2014 (12.6 % versus 3.9 %, P<0.001). The prevalence of doctor shopping for MTD was very low during the period study (0.2 % to 0.5 %). Overall, the prevalence of doctor shopping was higher for HDB than for MTD whatever the year (P<0.001) of the study.
CONCLUSION: Doctor shopping for HDB decreased significantly during the last decade while doctor shopping for MTD remained nearly inexistent even if it could be underestimated because of dispensations in specialized centers and in hospitals not comprised in the insurance claims. The low rates of doctor shopping reported in these last years could result from the guidelines for good practices in OMT use made in 2004 and the adjustments of ANSM (French National Agency for Medicines and Health Products Safety) for HDB best use made in 2011.
PMID: 27823911 [PubMed - as supplied by publisher]