Multicenter Observational/Exploratory Study Addressed to the Evaluation of the Effectiveness and Safety of Pharmacological Therapy in Opioid-Dependent Patients in Maintenance Therapy in Southern Italy

Abstract

A multicenter-observational study was performed to assess the effectiveness of rac-methadone, levomethadone, and buprenorphine in opioid-dependent patients in polytherapy in Southern Italy. The primary endpoint was the reduction of urinary positivity to the substances and the maintaining doses. Patients (N = 266, age = 44.80 ± 5.65, male = 79.70%, female = 20.30%) have been recruited. At recruitment, 75% of them were on treatment with rac-methadone, levomethadone, and buprenorphine/naloxone. The patients were grouped into three clusters. The levomethadone patients of Cluster A (N patients = 211), after 180 days, showed stability in urinary methadone positivity, with a marked decrease in heroin −53 ± 4%, cannabinol’s −48 ± 2%, and cocaine −37 ± 6% positivity, with no differences between treatments. A lower QTcF value of 426 ± 8.4 ms was recorded in the levomethadone patients (delta = −19 ms) vs. rac-methadone, at significantly lower doses of levomethadone (−34%, −50.2% in males) (p < 0.05). The Cluster B data were collected from 37 patients, with a high prevalence of comorbidity infections (HIV/HCV/HPV), monitored for 21 months during COVID-19. High doses of levomethadone (58.33 ± 31.58 mg/day) were needed to stabilize those that were negative for opioids and cannabinoids, in contrast to the rac-methadone and buprenorphine/naloxone patients that showed positive toxicology. Eighteen patients of the Cluster C in double diagnosis (major depressive 38.90%, bipolar 27.78%, and schizophrenia 16.67%) were stabilized with high doses of racemate 97.5 ± 8 mg/day, 51.8 ± 5 mg/day of levomethadone (−46.8% vs. rac-methadone; −71% in men), and 2.5 ± 1 mg/day of buprenorphine/naloxone. Three patients in remission were treated with tapering doses of levomethadone. Significantly reduced QTcF values were recorded with levomethadone (delta −32 ms vs. rac-methadone) in the bipolar patients, as well as the schizophrenia patients in remission (delta −45.19 ms vs. rac-methadone). Our patients were safely stabilized. Levomethadone, compared to the racemate, contributes to reducing the illicit use, especially of opioids and cannabinoids at significantly lower doses with cardiovascular safety, which, in bipolar patients, is clinically significant.

The Community Pharmacy as a Study Center for the Epidemiological Analysis of the Population Vaccination against SARS-CoV-2: Evaluation of Vaccine Safety and Pharmaceutical Service

“…Anamnestic data and data on post-vaccination adverse reactions were collected on an electronic C.R.F. (Excel Microsoft 10.00) for subsequent graphic and statistical processing under anonymity [32,[42][43][44][45] according to the guidelines indicated by Directives 679 and 680 of 2016 and the EU General Data Protection Regulation (GDPR) [46,47]. The person responsible for data privacy of the ASL BA was the lawyer Elisabetta Fortunato (privacy@sanita.puglia.it).…”

“…In a minority of cases, mid-dose low-molecular-weight heparin could also be considered [31]. In addition, a high-risk population is represented by the patients undergoing opioid treatments that, during the pandemic, received take-home therapy for addiction, with an enhanced risk of overdoses [32]. In this complex scenario, it is essential to consider some essential elements to develop effective communication strategies for COVID-19 vaccines, and the local pharmacist and the family doctor play a role in translating the messages directed to a large population into a patient-personalized message to reduce vaccine hesitancy [23,24]; vaccine campaigns are indeed often not personalized.…”

Community Pharmacy as a Study Center for the Epidemio-logical Analysis of the Population Vaccination Against SARS-CoV-2: Regulatory Rules and Prescriptions

“…Anamnestic data and post-vaccination adverse reactions were collected on electronic C.R.F. (Excel Microsoft) for subsequent graphic and statistical processing in anonymity [32,[42][43][44][45] according to the guide-lines indicated by Directive 679 and 680 of 2016, or the EU General Data Protection Regulation (GDPR) [46,47]. The responsibility for data privacy of the ASL BA is the lawyer Elisabetta Fortunato (privacy@sanita.puglia.it.).…”

“…In a minority of cases, mid-dose low-molecularweight heparin could also be considered [31]. In addition, a high-risk population is represented by the patients under opioid treatments that during pandemic enhanced they take home therapy for addiction with enhanced risk of overdoses [32]. In this complex scenario, it is essential to consider some essential elements to develop effective communication strategies on COVID-19 vaccines and the local pharmacist and the family doctor play a role in translating the messages directed to a large population into a patient personalized message to reduce the vaccine hesitancy [23,24], often vaccine campaigns are indeed not personalized.…”

Vaccines against Drug Abuse—Are We There Yet?

“…[3,9]. In the case of opioid-dependent patients, treatment options also extend to new, emerging drugs and psychological support [13].…”