Validation of a novel Artificial Pharmacological Intelligence (API) system for the management of patients with polypharmacy.

OBJECTIVE: Medication management of patients with polypharmacy is highly complex. We aimed to validate a novel Artificial Pharmacological Intelligence (API) algorithm to optimize the medication review process in a comprehensive, personalized, and scalable way. MATERIALS AND METHODS: The study was conducted on anonymized retrospective electronic health records (EHR) of 49 patients. Each patient's file was reviewed by the API system, a clinical pharmacist, and a judging committee. Validation was assessed by comparing the overall agreement of the judging committee (as the gold standard, blinded to the identity of the analyzer) to both the API system and clinical pharmacists' conclusions. Five medication-related problem (MRP) categories were assessed: duplication of therapy, age-related issues, incorrect dose, current side effects and future side effects' risk. For each category the overall validity parameters, agreement, positive predictive value (PPV), negative predictive value (NPV), sensitivity and specificity were analyzed. RESULTS: The agreement between the API system and the judging committee was 93.5 % (95 % CI 92.7-94.4), while the agreement between the clinical pharmacists and the judging committee was 73.9 % (95 % CI 72.5-75.3). The PPV was 92.2 % (90.9-93.5) and NPV was 94.2 % (93.1-95.2) for the API system and 76.3 % (69.8-82.8) and 73.5 % (72.3-74.8) respectively for the clinical pharmacists. DISCUSSION: AI systems can equip clinicians with sophisticated tools and scale manual processes such as comprehensive medication reviews, thus reducing MRPs and drug-related hospitalizations related to multidrug treatments. The API system validated in this study provided comprehensive, multidrug, multilayered analysis intended to bridge the innate complexity of personalized polypharmacy treatment. CONCLUSIONS: The API system was validated as a tool for providing actionable clinical insights non-inferior to a manual clinical review of a clinical pharmacist. The API system showed promising results in reducing MRPs.

Transimplant antral lavage as minimally invasive treatment of chronic rhinosinusitis: Preliminary report of 11 consecutive cases.

OBJECTIVE: The present article reports how a dental implant with an internal port dental implant valve approach (DIVA) can be utilized as oroantral port to treat chronic rhinosinusitis (CRS) in a minimally invasive manner. METHOD AND MATERIALS: Eleven patients (age mean 68.1 years) with CRS were subjected to the transimplant lavage technique. For three patients the CRS treatment was performed via previously installed dental implants, and for another eight patients the implantation procedure was combined with the CRS treatment. The moment the implant was fully installed, the sinus membrane was punctured via the implant channel. Upon completion of the pus drainage the sinus was irrigated with normal saline, followed by the injection of a steroid solution (100 mg hydrocortisone). RESULTS: Patients began to report symptomatic improvement from the first day after the first-session procedure. Nine patients had complete relief of most of their symptoms (nasal obstruction/discharge, anosmia/hyposmia) at day 30. The follow- up nasal endoscopy demonstrated no evidence of active sinus disease. All the implants used were found to be well-osseointegrated and still in use for prosthetic purposes. Clinical and radiologic results showed stability and no recurrence in the follow-up period. CONCLUSION: The dental implant with an internal central port and integral dedicated sealing screw may be used for irrigation, observation, and further treatment of the maxillary sinus in cases of CRS.

Fatal and Near-Fatal Non-allergic Reactions in Patients with Underlying Cardiac Disease Receiving Benzathine Penicillin G in Israel and Switzerland.

Benzathine Penicillin G (BPG) is commonly used for treatment of penicillin-susceptible infections and secondary prevention of rheumatic fever. Death following administration of BPG is extremely rare-only a handful of cases have been described in the literature since the 1950's. In this case series from Israel and Switzerland, we describe nine cases of serious adverse reactions-six fatal reactions and three near-fatalities-occurring within minutes of receiving intramuscular BPG. Allergic reactions or faulty administration were not implicated in any of the cases; however, all patients had cardiac risk factors. This case series describes a relatively rare risk that should be borne in mind when prescribing BPG.

Pharmacovigilance in Israel - tools, processes, and actions.

BACKGROUND: Due to the limited safety data available at the time that a new medication is first marketed, it is essential to continue the collection and monitoring of safety data about adverse drug reactions (ADRs) during the medication's life cycle. This activity, known as pharmacovigilance (PV), is performed worldwide by the pharmaceutical industry as well as by regulatory agencies. In 2012, the Israeli Ministry of Health (MOH) established a Pharmacovigilance and Drug Information Department. The Department is tasked with identifying, monitoring, and initiating activities aimed at minimizing risks associated with medication utilization. To enable this, the MOH has devised procedures for PV and promoted extensive legislation in this area that require marketing authorization holders (MAHs) and medical institutions in Israel to report ADRs and new safety information to the MOH. A computerized database was created to support the reporting process. The objective of this article is to characterize the PV tools and activities implemented in Israel. METHODS: Since September 2014, The Israeli Pharmacovigilance and Drug Information Department receives ICSRs at a central computerized database developed for this purpose. The data were analyzed by Department personnel and ICSRs were characterized according to their seriousness, source, categories of drugs involved, and the reporting format. Additionally, the Department reviewed signals detected from ADR reports and from other sources and assessed the resulting regulatory actions. RESULTS: An analysis of the Individual Case Safety Reports (ICSRs) submitted to the MOH's ADRs central database reveals that during the review period, a total of 16,409 ICSRs were received by the Department and 850 signals were identified, resulting in the following PV activities: inquiry and enhanced follow-up (430, 50.6%), prescriber's and patient's leaflets updates (204, 24%), recall of products/batches (6, 0.7%), alerts for health care professionals (63, 7.4%). Eighty five (10%) of the signals required a comprehensive investigation involving external specialist and 1 (0.1%) resulted in initiation of epidemiologic study. Additionally, in 2015 the Department incorporated comprehensive framework for risk minimization of marketed medicinal products, also known as risk management plans (RMPs). CONCLUSIONS: As practiced by other health authorities, the Israeli MOH effectively implemented various PV tools to ensure the safety of the Israeli health consumer.