RESUMO
In recent years, the number of drug shortages has risen alarmingly both in Belgium and internationally. Between 2010 and 2020, the number of reported shortages is almost 27 times higher, according to the French Agency for the Safety of Medicines and Health Products. A recent survey conducted by the European Association of Hospital Pharmacists showed that 95 % of hospital pharmacists consider drug shortages to be a major problem. The drug classes most affected include anti-infectives, analgesics and anaesthetics. The sudden and unpredictable occurrence of drug shortages has a negative impact on the daily lives of healthcare professionals and patients. Doctors are sometimes forced to prescribe alternative treatments that are considered less effective or even less well tolerated. These alternatives make it more difficult for patients to adhere to their treatment and generate an additional risk of medication errors. There are several possible solutions to minimize these shortages: relocating production sites to Europe, imposing penalties on offending companies, adopting a common European policy for managing shortages of medicines of major therapeutic interest,... As a corollary to these proposals, legal texts have been adopted to regulate and guarantee the supply of medicines in Belgium.
Depuis ces dernières années, le nombre de médicaments indisponibles a augmenté de manière inquiétante, tant en Belgique qu'au niveau international. Entre 2010 et 2020, le nombre de pénuries signalées sont près de 27 fois plus élevées, selon l'Agence Française de Sécurité du Médicament et des Produits de Santé. Une récente enquête réalisée par l'Association Européenne des Pharmaciens Hospitaliers a montré que 95 % des pharmaciens hospitaliers considèrent ces pénuries médicamenteuses comme un problème majeur. Parmi les classes médicamenteuses les plus touchées se retrouvent, notamment, les anti-infectieux, les analgésiques et les agents anesthésiques. De survenue soudaine et imprévisible, les ruptures entachent le quotidien tant des professionnels de la santé que des patients. Les médecins sont, parfois, contraints de prescrire des traitements alternatifs jugés moins efficaces, voire moins bien tolérés. Ces alternatives complexifient l'adhérence thérapeutique du patient en générant un risque supplémentaire d'erreur médicamenteuse. Pour pallier ces indisponibilités, certaines pistes de solutions peuvent être dégagées : relocaliser en Europe les sites de production, sanctionner les firmes fautives, adopter une politique européenne commune de gestion des pénuries de médicaments d'intérêt thérapeutique majeur, En corollaire de ces propositions, des textes juridiques ont été édictés afin d'encadrer et de garantir l'approvisionnement en médicaments en Belgique.
Assuntos
Indústria Farmacêutica , Farmacêuticos , Humanos , Bélgica , Europa (Continente) , Inquéritos e QuestionáriosRESUMO
OBJECTIVES: Based on recent pharmacokinetic/pharmacodynamic (PK/PD) evidence, continuous-infusion (CI) ß-lactam administration is increasingly recommended for serious infections. Since 2016, the combination ceftazidime/avibactam (CAZ/AVI) is administered as per the manufacturer's instructions as an intermittent infusion of 2.5 g every 8 h. Thus, CI has not yet been evaluated in clinical trials. METHODS: We aimed to evaluate the use of CI of CAZ/AVI in a retrospective case series from December 2016 to October 2019. All isolates displayed in vitro susceptibility to CAZ/AVI according to EUCAST definitions. Patients were initially given CAZ/AVI as CI of 5 g every 12 h, and dosages were adjusted according to therapeutic drug monitoring of ceftazidime with a therapeutic goal of ≥4-5 × MIC in plasma and/or at the site of infection. RESULTS: CAZ/AVI was administered by CI in 10 patients with infections mainly caused by multidrug-resistant Pseudomonas aeruginosa (54.5%) and Klebsiella pneumoniae (36.4%). Bacteraemia occurred in 30% of cases. Sepsis or septic shock was present in 20% of cases. CAZ/AVI was used as monotherapy in 60% of cases. Clinical cure and microbiological eradication were achieved in 80% and 90% of cases, respectively. The 30-day mortality after CAZ/AVI treatment onset was 10%. The therapeutic goals of ≥4-5 × MIC in plasma and/or at the site of infection were achieved in 100% and 87.5% of cases, respectively, without adverse events. CONCLUSION: Despite a limited number of patients, CI of CAZ/AVI provided promising results after optimisation of PK/PD parameters both in plasma and at the site of infection.
