[Translated article] Current situation and evolution of the availability of drugs in the pediatric population in Spain.

OBJECTIVE: To analyze the characteristics of the new medicines approved in the pediatric population in the last 3 years, both those with studies only in the pediatric population and those that extend their indication in this population group, as well as the current situation in relation to their marketing and financing. METHODS: Descriptive observational study of all drugs that include an indication in the pediatric population in Spain (by extension of the indications of drugs already authorized or because they are new drugs that already include an indication in this population group), from January 2019 to March 2022. RESULTS: During the study period, 129 drugs included their indication in the pediatric population. 13.9% of them are not marketed, 46.5% are in a situation of non-financing, under study or without a request for financing, and 4.6% are financed for a specific pediatric subpopulation. 52.7% are original drugs, 4.7% are generic, 38.8% are biological, 3.8% are biosimilar, and 17.8% are orphan drugs. 57.36% of these medicines obtain the pediatric indication due to extension of the indication and 42.64% obtain it because they are new medicines that already include their studies in the pediatric population. CONCLUSIONS: Drugs with authorized indications are increasingly available in the pediatric population and the trend is to extend the indication of authorized drugs to the adult population. However, barriers in terms of financing and marketing need to be expedite and overcome to facilitate access to them.

Medication reconciliation on admission in paediatric chronic patients: A multicentre study.

INTRODUCTION: Medication reconciliation (MC) is one of the main strategies to reduce medication errors in care transitions. In Spain, several guidelines have been published with recommendations for the implementation and development of MC aimed at the adult population, although paediatric patients are not included. In 2018, a study was carried out that led to the subsequent publication of a document with criteria for selecting paediatric patients in whom CM should be prioritised. OBJECTIVES: To describe the characteristics of paediatric patients most likely to suffer from errors of reconciliation (EC), to confirm whether the results of a previous study can be extrapolated. METHODOLOGY: Prospective, multicentre study of paediatric inpatients. We analysed the CE detected during the performance of the CM on admission. The best possible pharmacotherapeutic history of the patient was obtained using different sources of information and confirmed by an interview with the patient/caregiver. RESULTS: 1043 discrepancies were detected, 544 were identified as CD, affecting 317 patients (43%). Omission of a drug was the most common error (51%). The majority of CD were associated with drugs in groups A (31%), N (23%) and R (11%) of the ATC classification. Polymedication and onco-haematological based disease were the risk factors associated with the presence of CD with statistical significance. CONCLUSIONS: The findings of this study allow prioritisation of CM in a specific group of paediatric patients, favouring the efficiency of the process. Onco-haematological patients and polymedication are confirmed as the main risk factors for the appearance of CD in the paediatric population.

Current situation and evolution of the availability of drugs in the paediatric population in Spain. / Situación actual y evolución de la disponibilidad de medicamentos en la población pediátrica en España.

OBJECTIVE: To analyze the characteristics of the new medicines approved in the pediatric population in the last three years, both those with studies only in the pediatric population and those that extend their indication in this population group, as well as the current situation in relation to their marketing and financing. METHODS: Descriptive observational study of all drugs that include an indication in the pediatric population in Spain (by extension of the indications of drugs already authorised or because they are new drugs that already include an indication in this population group), from January 2019 to March 2022. RESULTS: During the study period, 129 drugs included their indication in the pediatric population. 13,9% of them are not marketed, 46,5% are in a situation of non-financing, under study, or without a request for financing, and 4,6% are financed for a specific pediatric subpopulation. 52,7% are original drugs, 4,7% are generic, 38,8% are biological, 3,8% are biosimilar and 17,8% are orphan drugs. 57,36% of these medicines obtain the pediatric indication due to extension of the indication and 42,64% obtain it because they are new medicines that already include their studies in the pediatric population. CONCLUSIONS: Drugs with authorised indications are increasingly available in the paediatric population and the trend is to extend the indication of authorised drugs to the adult population. However, barriers in terms of financing and marketing need to be expedited and overcome to facilitate access to them.

Does the use of new cephalosporins follow the authorised, financed and approved indications? A study of their use in routine clinical practice in a tertiary hospital.

OBJECTIVES: To evaluate the appropriateness of ceftazidime-avibactam (C-A), ceftolozane-tazobactam (C-T) and ceftaroline prescriptions according to European Medicines Agency (EMA)/Spanish Agency of Medicines and Medical Devices (AEMPS) approved indications, financed indications in the Spanish health system and hospital Infection Commission (IC) recommendations in a tertiary hospital. METHODS: Observational, descriptive and retrospective study of inpatients aged ≥18 years, who were prescribed the above-mentioned antimicrobials during the period January-December 2020. Variables obtained were demographic (sex and age), pharmacological (antibiotic, use - empiric or targeted, indication) and microbiological (sensitivity testing and antibiotic tested) data. RESULTS: A total of 79 patients were included. C-A (n=40): 67.5% of patients were male, with a mean age of 61 (range 22-87) years. Empiric treatment was applied in 30% of the cases (n=12). De-escalation in 33.33% of individuals. Sensitivity testing was done in 92.86% of patients, including C-A in 57.69% of them. C-T (n=19): 89.47% of patients were male, with a mean age of 65 (range 18-82) years. An empiric approach was followed in 5.26% of subjects; de-escalation was performed in all cases due to culture with multidrug-resistant (MDR) Pseudomonas aeruginosa. Sensitivity testing was carried out in 100% of patients, including C-T in 26.32% of them. Ceftaroline (n=20): 70% of patients were male, with a mean age of 55.5 (range 23-79) years. Empiric treatment was applied to 30% of cases. In 50% of these subjects de-escalation was done. Sensitivity testing was done in 92.85% of them, but in none with ceftaroline. Regarding the percentage of appropriateness: approved EMA/AEMPS indications: C-A: 100%; C-T: 84.21%; ceftaroline: 75%; financed indications in the Spanish health system: C-A: 85%; C-T: 100%; ceftaroline: 15%; IC: C-A: 60%; C-T: 57.9%; ceftaroline: 15%. CONCLUSIONS: Our results highlight the importance of stewardship programmes in the decision-making process and in the follow-up of patients with infections caused by MDR microorganisms.

Adherence of rheumatoid arthritis patients to biologic disease-modifying antirheumatic drugs: a cross-sectional study.

The aims of this study were to evaluate adherence of rheumatoid arthritis (RA) patients to biological disease-modifying antirheumatic drugs (bDMARDs), identify potential risk factors, and analyze the discriminative ability of the Morisky-Green test (MGT) to detect bDMARD nonadherence. One hundred and seventy-eight adult RA patients treated with bDMARDs were included. Adherence was measured using the medication possession ratio (MPR) of the previous 6 months. An MPR >80% was considered good adherence. Patient demographics, clinical characteristics, and MGT scores were assessed through a standardized clinical interview at the cross-sectional date. One-hundred and twelve patients (63%) were taking subcutaneous bDMARDs, while 66 (37%) were taking intravenous drugs. One-hundred fifty-eight (88.8%) showed good adherence to bDMARDs, while 79 (61.2%) also correctly took concomitant conventional synthetic DMARDs (csDMARDs). In logistic regression models, nonadherence to bDMARDs was associated with higher disease activity [odds ratio (OR) 1.45; 95% CI, 1.03-2.03; p = 0.032] and subcutaneous route (OR 3.70; 95% CI 1.02-13.48; p = 0.040). MGT accurately identified an MPR >80% of bDMARDs in 76.9% of the patients. A sensitivity of 78%, specificity of 70%, positive predictive value of 95.3%, negative predictive value of 28.5%, positive likelihood ratio (LR) of 2.6, and negative LR of 0.3% were obtained. Adherence may be good for bDMARDs but is low for csDMARDs. Low adherence for bDMARDs is associated with poorer disease control during the past 6 months and use of subcutaneous route. These findings should alert doctors to consider possible low adherence before declaring treatment failure.

[Dual therapy as an alternative treatment in HIV pretreated patients: experience in a tertiary hospital]. / Biterapia como alternativa de tratamiento en los pacientes VIH pretratados: experiencia en un hospital de tercer nivel.

OBJECTIVE: Dual therapy regimen might be an effective alternative to prevent the occurrence of side effects and comorbidities associated with prolonged treatment with antiretroviral (ARV) and a way of simplification of antiretroviral therapy (ART) to improve adherence in certain patients. It also represents a potential treatment option for patients who have failed previous TAR. METHODS: The aim of the study is to describe the effectiveness, adherence and costs of dual therapy regimen used in pretreated HIV patients in tertiary hospital. RESULTS: Thirty-eight patients were studied (eight were excluded). Reasons for simplification to dual therapy were previous treatment toxicity (40%), simplification (36.67%) and virological rescue (20%). The dual therapy regimens most used were: IP/r + INSTIs (26.67%), IP/r + NRTIs (23.33%), IP/r + NNR-TIs (23.33%), IP/r+ CCR5 (16.66%) e INSTIs + NNRTIs (10%). ARV more used were darunavir/ritonavir (DRV/r) + raltegravir (23.33 %); DRV/r + lamivudine (20%) y DRV/r + etravirine (16.67 %). Adherence was 86.79% before switching to dual therapy and 96.27% after switching. The cost savings of switching to dual therapy of these patients was € 3,635.16. CONCLUSIONS: Dual therapy with IP/r might be an effective alternative to selected treatment experienced patients compared with conventional therapy.