ABSTRACT
Background and Importance The Spanish Medicines and Health Products Agency (AEMPS) has developed criteria to adapt the prescription of sotrovimab1, due to the pandemic situation and the limited drug stock. Aim and Objectives To describe the patients' population on treatment with sotrovimab and to assess the adequacy of this prescription according to the criteria established by the AEMPS. Material and Methods Retrospective observational study analysing all sotrovimab prescriptions in patients with SARS-CoV-2 infection from 01/25/2022 to 08/31/2022. Demographic variables and data required by the AEMPS for sotrovimab prescription were collected: Omicron variant infection, SARS-CoV-2 vaccination status, serology [anti-S antibody< 260 BAU (binding antibody units)/mL]. Also, patients had to belong to one of the following groups: * Group 1: Immunocompromised, regardless of vaccination status. * Group 2: >80 years unvaccinated. * Group 3: >65 years (regardless of vaccination status) and >=1 risk factor for progression. Prescriptions for sotrovimab were collected and analysed to determine whether they met the criteria and whether they were accepted. Data collected from electronic medical records and processed using Excel2019. Results Fifty patients were included, 62% male;median age 69 years (IQR=60-76). 100% had the Omicron variant. Vaccination status: 84% complete, 6% incomplete and 10% unvaccinated. Serology: 96% (<260 BAU/mL) and 4% (>260 BAU/ ml). 92% belonged to group 1 (39% solid organ transplantation, 29% active myelotoxic chemotherapy, 13% non-cytotoxic onco-haematological treatments with neutropenia/lymphopenia, 13% treatment with biological immunomodulators, 2% Down's syndrome, 2% haematopoietic stem cell transplantation or CAR-T, 2% HIV infection (with <=200 cells/mL). Two per cent belonged to group 2. The remaining patients (6%) did not belong to any group. Ten per cent of the applications did not meet the criteria: four of them were not accepted (patients did not belong to any risk group);one was accepted, although it was a well-controlled HIV. Conclusion and Relevance The main profile of patients treated with sotrovimab is men with solid organ transplantation, vaccinated and with negative immunity to SARS-CoV-2. Although the appropriateness of the prescription is high, it is necessary to continue protocolising the use of this drug to ensure its rational use.
ABSTRACT
Background and importance Pharmaceutical validation of inpatient treatments is a fundamental activity in the clinical practice of the hospital pharmacist. Thanks to this, many prescription errors are detected, promoting patient safety. Aim and objectives To describe the interventions performed by a hospital pharmacy resident in the area of pharmaceutical validation, supervised by consultant pharmacists, and to evaluate their degree of acceptance. Material and methods Prospective interventional study conducted during September 2021. Adult inpatients, whose hospital treatment was reviewed, were included. Demographic (sex and age), clinical (clinical judgement (CJ) and inpatient clinical service) and pharmacotherapeutic (number of chronic medicines and polymedication (≥6 drugs)) variables were collected. Interventions were reported to the clinician via electronic prescribing software. They were classified as: Activity (reconciliation on admission/information to the clinician), Adequacy (detection of prescribing error/therapy reconciliation error), Change (therapeutic exchange), Initiation (usual treatment not prescribed/need for additional treatment), Modification Dosage Form (DF) or Posology, Suspension (duplicity/unnecessary medication/allergy). Patient lists and data were collected through medical records and electronic prescribing software, and processed using Excel 2020. Results Interventions were performed in 56 patients. 63.2% male;median age 73 years (IQR 61-80). The most frequent CJ were: heart failure (10.7%), COVID-19 (7.1%), liver dysfunction (7.1%). Services with most interventions: Internal Medicine (25.8%), General/Vascular Surgery (19.4%), Digestive (11.3%). Median number of chronic medicines: 8 (IQR 5-12). Polymedication in 71.4%. 62 interventions were performed (12.9% were 'not evaluable', reasons: discharge/death). Of the evaluable interventions, 77.8% were accepted. The percentages were: duplicity (30.9%), modification DF/posology (23.8%), usual treatment not prescribed (7.1%), therapeutic exchange (7.1%), discontinue medication due to allergy (7.1%), therapy reconciliation error (4.8%), reconciliation on admission (4.8%), information (4.8%), additional treatment (4.8%), prescribing error (2.4%), unnecessary medication (2.4%). Of the accepted interventions, 11.9% were related to high-risk medicines according to the Institute for the Safe Use of Medicines1- 2 (nonsteroidal anti-inflammatory drugs (NSAIDs), betablockers, heparin, immunosuppressants). Of the not-accepted interventions, 50.0% corresponded to errors in home treatment reconciliation. Conclusion and relevance The data obtained demonstrate that clinical interventions performed by the hospital pharmacy resident have a high degree of acceptance, increasing the quality and safety of healthcare and avoiding medication errors.