Pediatric drug development is hampered by biological, clinical, and formulation challenges associated with age-based populations. A primary cause for this lack of development is the inability to accurately predict ontogenic changes that affect pharmacokinetics (PK) in children using traditional preclinical animal models. In response to this issue, our laboratory has conducted a proof-of-concept study to investigate the potential utility of juvenile pigs to serve as surrogates for children during preclinical PK testing of selected rifampin dosage forms. Pigs were surgically modified with jugular vein catheters that were externalized in the dorsal scapular region and connected to an automated blood sampling system (PigTurn-Culex-L). Commercially available rifampin capsules were administered to both 20 and 40 kg pigs to determine relevant PK parameters. Orally disintegrating tablet formulations of rifampin were also developed and administered to 20 kg pigs. Plasma samples were prepared from whole blood by centrifugation and analyzed for rifampin content by liquid chromatography-tandem mass spectrometry. Porcine PK parameters were determined from the resultant plasma-concentration time profiles and contrasted with published rifampin PK data in human adults and children. Results indicated significant similarities in dose-normalized absorption and elimination parameters between pigs and humans. Moreover, ontogenic changes observed in porcine PK parameters were consistent with ontogenic changes reported for human PK. These results demonstrate the potential utility of the juvenile porcine model for predicting human pediatric PK for rifampin. Furthermore, utilization of juvenile pigs during formulation testing may provide an alternative approach to expedite reformulation efforts during pediatric drug development.
Background Prescribing for the elderly is challenging. A previous observational study conducted in our geriatric psychiatry admission unit (GPAU) using STOPP/START criteria showed a high number of potentially inappropriate drug prescriptions (PIDPs). A clinical pharmacist was added to our GPAU as a strategy to reduce PIDPs. Objective The objective of the present study was to assess the impact of a clinical pharmacist on PIDPs by measuring acceptance rates of pharmacist interventions (PhIs). Setting This study was conducted at the GPAU of Lausanne University Hospital. Method The clinical pharmacist attended four GPAU meetings weekly. Complete medication reviews were performed daily. The clinical pharmacist conducted standard analyses based on clinical judgment and STOPP/START criteria assessment. A PhI was generated when a PIDP was detected. When a PhI was accepted, the PIDP was considered as eliminated. Acceptance rate of PhI was calculated (number of PhI accepted/total number of PhI). Main outcome measure PhIs acceptance rates. Results In a cohort of 102 patients seen between July 2013 and February 2014, a total of 697 PhIs (average 6.8/patient) were made based on standard evaluation (n = 479) and STOPP/START criteria (n = 243). The global acceptance rate was 68% (standard, 78%; STOPP/START, 47%). Conclusion Good PhIs acceptance rates demonstrated that a clinical pharmacist can reduce PIDPs in a GPAU. PhIs based on standard evaluation had a higher acceptance than those based on STOPP/START criteria, probably because they are better adapted to individual patients. However, these two evaluation approaches can be used in a complementary manner.
In order to improve patient care, OMEDIT (Observatory of drugs, medical devices and therapeutic innovation) Alsace, conducted a study to develop a Preferential list of Drugs adapted to the Elderly (PDE list) in nursing homes. The study conducted from December 2011 to June 2012 was organized in 4 phases: 1) creation of a preliminary list of drugs from those currently used in nursing homes in Alsace, 2) application of a two-round Delphi process to evaluate the preliminary list involving mobilization of experts from different backgrounds (geriatricians, general practitioners, pharmacists …), 3) identification of molecules considered in literature as potentially inappropriate, 4) generation of a final PDE list, including information concerning proper use of drugs for prescription and administration. 53 experts participated in the study. In the first round, 338 drugs were on the preliminary list, 246 were considered as appropriate by experts and 28 as inappropriate. 64 drugs without consensus were submitted to a second round. 32 of them were considered as inappropriate and 32 others remained on the list with no consensus. These last 32 were evaluated by OMEDIT and 3 were considered as appropriate drugs for the elderly. Totally, 252 drugs constitute the final PDE list from our study. The PDE list constitutes a new guide for optimization of both prescription and administration of drugs in nursing homes and could help reduce misuses and poly-medication, which are constant preoccupations to avoid adverse drug reactions in elderly.Key points● The study was carried out with the aim to create a Preferential list of Drugs adapted to the Elderly (PDE list) in nursing homes using a modified Delphi method.● The PDE list constitutes a new guideline to harmonize practices in nursing homes and to help physicians and nurses to achieve best possible care management.
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