Summary
Background/objective
Pharmaceutical care is needed in hepatitis C virus (HCV)‐infected patients treated with direct‐acting antivirals (DAA). We describe the implementation of a comprehensive ...pharmaceutical care programme (CPCP) for HCV‐infected patients treated with DAA in a tertiary‐care hospital and provide data about health outcomes and costs.
Methods
Quasi‐experimental study between 1 April 2015 and 30 June 2016. A group of hospital pharmacists collaborating on HCV infection implemented interventional measures for validation of drug prescriptions, detection of clinically relevant drug‐drug interactions and adverse drug events (ADEs), and patient education. Quality, health and cost‐effectiveness outcomes were evaluated.
Results
A total of 1070 patients were enrolled. Pharmacists made 327 interventions that led to the prevention of 299 (91.4%) medication errors, 16 of which were grade G‐H (NCC MERP classification). The main reasons for the pharmacist's intervention were management of 143 drug‐drug interactions. The overall sustained virologic response at week 12 posttreatment (SVR12) rate was 93.0% (95% CI 91.4‐94.6). The SVR12 was higher than 90.0% in all populations, except in genotype 3 patients (86.0%, 95% CI 78.7‐93.9), decompensated cirrhotic patients (81.1%, 95% CI 69.7‐92.6) and transplant recipients (86.8%, 95% CI 76.7‐96.9). ADEs occurred in 85.5% of the study patients, but only 1.0% (11 patients) experienced an ADE that led to premature discontinuation. The total cost of treatment was €18 279 225 (€17 083 per patient). The most cost‐effective treatment was selected in 93.1% of patients.
Conclusions
The implementation of a CPCP developed by hospital pharmacists in patients treated with DAAs for HCV infection is an effective approach that improves patient safety and education. The active involvement of the pharmacist in improving adherence to local guidelines promoted the selection of the most cost‐effective treatment in the majority of cases.
BackgroundTo our knowledge, there is no pharmacy stratification model for patients in the oncology ambulatory setting.PurposeTo develop a tool to stratify oncology patients that helps us to implement ...ambulatory clinical pharmacy services.Material and methodsPhase I: a literature review was performed to identify risk factors for hospital admissions or emergency department (ED) visits in oncology patients and patients with care coordination requirements. Phase II: a panel of experts selected the variables of the model based on their impact on clinical pharmacy services and the feasibility of obtaining the data. Relative weight of each of the variables was assigned. Phase III: the stratification model was retrospectively tested on the population of patients that received care in the unit on a random day (13 June 2018). Three cut-offs were established to provide different levels of patient needs.ResultsThe variables were categorised under four domains (table 1).Abstract 4CPS-127 Table 1 Variable Weight Patient characteristicsAge >65 years1ECOG>11Body mass index <20.51Pregnancy/breastfeedingHighest priorityPatient included in the regional programme for complex chronic needs – PCC/NIAHighest priority Treatment-related variablesNumber of chronic medications >61Ambulatory high-risk drug2High-emetic risk chemotherapy1Oral antineoplastic agentHighest priority Clinical variablesGastrointestinal tumour1Chronic diseases2Treatment line >11 Previous utilisation of resourcesED visit or hospital admission in the previous 30 days1The model was tested on a population of 43 patients (48.8% were male; median of age: 64 (IQR:52–73) years; median of ECOG=1 (IQR:0–1)). Patients were on six (IQR: 3.5–10) drugs, and 20 (45.5%) patients took one or more high-risk ambulatory medications. Eleven (25.6%) patients had one or more chronic diseases. Only one patient was identified as PCC/NIA. Three patients were treated with oral antineoplastic agents. Five (11.6%) patients visited the ED or were admitted to hospital in the past 30 days, while 12 (27.9%) were in the following 30 days. The distribution by categories was as follows: high priority (12–8 points; four patients), medium priority (7–5 points; 12 patients) and low priority (4–0 points; 27 patients).ConclusionThe model can be a useful tool for detecting patients that could benefit from clinical pharmacy services, although it needs further validation.References and/or acknowledgementsNo conflict of interest.
BackgroundIn order to adapt Spanish regulations to the principles set out in the European Resolution CM/ResAP(2011)1 on quality and safety assurance requirements for medicinal products prepared in ...pharmacies, a guideline on pharmacy sterile preparations at hospital pharmacies (GPSP) was published by the Ministry of Health in June 2014. The guideline includes a risk based decision matrix to determine the potential risk of microbial contamination of pharmacy sterile preparations (PSPs) and sets beyond use dates (BUDs). According to the GPSP requirements, if recommended BUD limits are exceeded, each batch of PSP must be tested for sterility.PurposeTo determine the risk of microbial contamination of pharmacy sterile preparations according to current recommendations and to adapt beyond use dates.Material and methodsRisk of microbial contamination was determined for PSPs prepared in a grade C environment at our pharmacy in 2014. No batch was tested for sterility.PSPs were classified by dosage form. A database was created to evaluate the 6 risk based decision matrix criteria: preparation process, route of administration, drug safety profile, units per batch, microbial contamination susceptibility and distribution.According to the determined risk, GPSP recommended BUDs were set for each preparation and compared with the previous defined storage requirements.Results62 PSPs were evaluated: 18 individualised intravenous solutions, 11 standardised intravenous solutions, 6 subcutaneous preparations, 8 PSPs prepared from non-sterile components that were terminally sterilised, 15 ophthalmic preparations and 4 syringes for intravitreal injection.According to the risk based decision matrix, we obtained: 21 low risk (most individualised intravenous solutions, subcutaneous preparations), 18 medium risk (standardised intravenous solutions, intravitreal injections) and 23 high risk PSPs (ophthalmic solutions, PSPs prepared from non-sterile components).When comparing GPSP recommended BUDs and storage conditions with the previously defined BUDs, 21 (100%) low risk and 14 (78%) medium risk PSPs met the GPSP recommendations. BUDs of 4 (22%) medium risk preparations were shortened to comply with GPSP recommendations. In order to establish an extended BUD for 23 (100%) high risk PSPs, each batch must be tested for sterility.ConclusionThe GPSP proposed risk based decision matrix is a useful tool to determine the potential risk of microbial contamination of PSPs. Compliance with GPSP contributes to increased sterile compounding quality and protects the health of patients.No conflict of interest.