Background
The objectives of this study were to determine if clinical trials in breast cancer, with an investigational drug, created direct drug cost savings for the healthcare system related to cost ...avoidance of the best standard of care treatments used in these studies. The aim was to quantify this potential drug cost avoidance.
Methods
We conducted a retrospective observational study of the drug cost avoidance during the study period (2014–2016). We included clinical trials with investigational drug, managed by pharmacy department and provided by the sponsor. The patients included had a therapeutic alternative defined as standard treatment that should have been received in case of not participating in the clinical trial. Direct cost savings, to national healthcare system, associated to clinical trials were calculated.
Results
Thirty-seven clinical trials with a total of 89 breast cancer patients were included in the study. A total of 62.2% were phase III and 75.7% belonged to the pharmaceutical industry. They provided a total cost avoidance of 957,246€ (1,130,028$), an average cost avoidance per patient of 10,756€ (12,697$).
Conclusions
Our study suggests that those clinical trials in which investigational drug are provided or refunded by the sponsor provide substantial cost savings. Due to the shortage of published articles that calculate the cost avoided in medication, we cannot compare directly the results obtained in the different institutions.
Background and ImportanceMultiple myeloma (MM) is an incurable and chronic disease, so the quality of life (QoL) of patients with MM is an important criterion to consider. The patient-reported ...outcomes (PROs) are a fundamental tool to know the success of a treatment in clinical practice.Aim and ObjectivesAssessing QoL as a PROs in adult with MM treated with daratumumab.Material and MethodsRetrospective observational study which included patients with MM treated with daratumumab between 01/2019 and 04/2023 in a second-level Hospital.The electronic medical record were used to search patients and treatments variables. QoL was analysed using a standardised questionnaire (EORTC QLQ-C30 v3) and the MM-specific questionnaire (QLQ-MY20) to be answered by the patients themselves. The items to be answered were the presence of symptoms classifying as ‘not at all’, ‘a little’, ‘quite’ and ‘a lot’. The general health and the QoL were assessed with a score of 1 to 7, being 1 terrible and 7 excellent.ResultsOf the 39 patients (58.97% men, median age 70 years) treated with daratumumab in the study period, 11 completed the questionnaires. In 5 of them, the questionnaire was completed on two occasions: before starting and during treatment. In the remaining 6, only during treatment. The average of treatments received at the time of completing the form was 23.25 months (SD:7.39). In active treatment, 58.17% of the responses were symptoms ‘not at all’. In 30.29% were ‘a little’, in 10.10% ‘quite a bit’ and a 1. 44% ‘a lot.’ General health was assessed with an average of 4.2 points before treatment and 4.89 points during treatment. The QoL was assessed with 4.4 points before treatment and 5 points during treatment.Conclusion and RelevanceIn general, the presence of symptoms or problems related to the disease were mostly considered by the patients themselves as null. In addition, general health and QoL improving in the patients who were given the questionnaire at the beginning and during treatment with daratumumab.References and/or AcknowledgementsConflict of InterestNo conflict of interest.
The failure mode and effects analysis (FMEA) has been used as a tool in risk management and quality improvement. The objective of this study is to identify the weaknesses in processes in the clinical ...trials area, of a Pharmacy Department (PD) with great research activity, in order to improve the safety of the usual procedures.
A multidisciplinary team was created to analyse each of the critical points, identified as possible failure modes, in the development of clinical trial in the PD. For each failure mode, the possible cause and effect were identified, criticality was calculated using the risk priority number and the possible corrective actions were discussed.
Six sub-processes were defined in the development of the clinical trials in PD. The FMEA identified 67 failure modes, being the dispensing and prescription/validation sub-processes the most likely to generate errors. All the improvement actions established in the AMFE were implemented in the Clinical Trials area.
The FMEA is a useful tool in proactive risk management because it allows us to identify where we are making mistakes and analyze the causes that originate them, to prioritize and to adopt solutions to risk reduction. The FMEA improves process safety and quality in PD.
4CPS-058 Management of the hospitalised patient with flu Mañes Sevilla, M; Santiago-Gallego, B; Soto-Baselga, I ...
European journal of hospital pharmacy. Science and practice,
03/2020, Volume:
27, Issue:
Suppl 1
Journal Article
Peer reviewed
Open access
Background and importanceClinical practice guidelines recommend oseltamivir in hospitalised patients with influenza but its use in clinical practice is limited.Aim and objectivesTo determine the ...criteria for use of oseltamivir in hospitalised patients and to analyse the prescription of concomitant antibiotics.Material and methodsAn observational, descriptive, retrospective study was conducted in patients treated with oseltamivir (November 2018–February 2019) in a second level hospital. Electronic medical history was used as the source of information. Variables collected: date of admission/discharge, clinical service, polymerase chain reaction (PCR), age, risk factors, dosing regimen/adjustment, duration of treatment, complications, return to hospital and concomitant antibiotics prescribed. SPSS was used for statistical analysis.ResultsOseltamivir was prescribed in 160 patients, mostly from the internal medicine service (58.1%) and pneumology (22.5%), with an average entry duration of 8 days.PCR was performed in 111 patients (69.4%) and confirmed the diagnosis in 103 (64.37%), such as flu A. In eight patients with negative PCR, oseltamivir was discontinued. Cases confirmed by age range were: 3 (<18 years), 31 (18–65 years) and 69 (>65 years). The most common pathological history was high blood pressure (HTA) (27.7%), dyslipaemia (19.3%), cardiovascular disease (18.5%), lung disease (14.7%), diabetes (10.1%), immunosuppression (6.3%) and chronic kidney disease (CKD) (7.8%). As risk factors, 21.4% were active smokers, 14.6% were obese and there were no pregnant women. Regarding complications, 8.7% required the intensive care unit, 3.9% died and 11.7% returned to hospital.The most common oseltamivir dosing regimen was 75 mg/12 hours. In 13 patients with CKD, 75% who had a ClCr 10–30 mL/min had the dose adjusted to 30 mg/24 hours. In contrast, 11.11% of patients with ClCr 30–60 mL/min, the dose was adjusted to 30 mg/12 hours. Duration of treatment in 52% was 5 days. Seventy-three patients received empiric levofloxacin, 67 ceftriaxone, 35 amoxicillin/clavulanic and 11.8% received no antibiotic.Conclusion and relevancePCR was not performed in all patients suspected of flu virus infection. The population >65 years of age was the most affected by the virus, with HTA and smoking being the main risk factors. Oseltamivir was used at the correct dose, but treatment duration greater than or less than 5 days was not warranted. Adjustment for CKD was not always taken into account. Overuse of antibiotics was confirmed in patients where an antiviral might have been sufficient to treat the influenza.References and/or acknowledgementsNo conflict of interest.
6ER-005 Drug wastage: a hidden cost of cancer care Pousada Fonseca, AB; García Martinez, D; Vázquez Castillo, MJ ...
European journal of hospital pharmacy. Science and practice,
03/2024, Volume:
31, Issue:
Suppl 1
Journal Article
Peer reviewed
Open access
Background and ImportanceOur country’s legislation bans the return of dispensed drugs to Pharmacy Services, potentially leading to increased costs for the National Health System.Aim and ObjectivesTo ...estimate the cost of pill wastage due to dose modifications and discontinuation for oral anticancer drugs.Material and MethodsRetrospective economic evaluation carried out in an intermediate complexity hospital. Using the electronic medical record, dispensations of oral anticancer drugs between July 2022 and July 2023 were identified.The following variables were collecteddrug, date of dispensing, tablets dispensed, date the patient needs to return to the pharmacy, treatment interruption and cause, date of interruption and leftover tablets.The laboratories’ sales prices were used to calculate the costs. We calculated the potential number of dispensations that the wastage could have covered by dividing the total wastage by the median price per dispensation.Dose modifications were not taken into account in drugs which had pill strengths divisible at each dose-reduction level.Unmarketed drugs in our country were excluded.Results1239 dispensations were identified. The most dispensed drugs were enzalutamide 40 mg with 308 dispensations (25%) ribociclib 200 mg with 219 (18%), niraparib 100 mg with 143 (12%) and lenvatinib 10 mg with 66 (5%). The median number of days for which medication was dispensed was 30 IQI 28–35. The median price per dispensing was €3,173 IQI 1,866–4,445 and the total annual expenditure was €3,759,172.63 (5%) dispensations were interrupted. The most frequent causes were disease progression for 33 drugs (52%) and toxicity for 19 (30%). The median price per dispensing was €3,173 IQI 1,155–4,445 and the total price was €186,327.In 34 of the interruptions (54%) patients had tablets remaining. The median wastage per patient was €1,393 IQI 645–2,503 and the total wastage was €56,459 (1.5% of the annual expenditure and 30.3% of the discontinued treatments).Seventeen dispensations (1.4%) could have been covered with the total cost of pill wastage.Conclusion and RelevanceAlthough few treatments were discontinued, significant economic wastage occurred due to drug prices. To minimise it, it has been suggested that companies refund money for unused tablets and manufacture appropriate pill strengths¹. Additionally, hospital pharmacists could be empowered to decide on the return of medications.References and/or Acknowledgements1. https://pubmed.ncbi.nlm.nih.gov/37471095/Conflict of InterestNo conflict of interest.
Background and importanceMedication errors (ME) are especially frequent in hospital emergency departments (ED). To minimise these ME, medication reconciliation programmes are established, which ...analyse and resolve the discrepancies detected in the medication regimen of the patient.Aim and objectivesTo evaluate implementation of the reconciliation programme in the ED of a second level general hospital.Material and methodsAn observational retrospective study was conducted. Records from patients admitted to the observation area of the ED from 1 January 2018 to 31 March 2019 and whose chronic medication was reconciled were studied. Information related to their chronic medication was collected from the hospital medical records, the primary care prescriptions and/or through an interview with the patient. Discrepancies were classified according to the SEFH consensus document, and categorisation of the potential harm associated with these ME was based on the NCCMERP index; the pharmacotherapeutic groups involved in these ME were also analysed.Results26.7% of patients admitted to the ED during the study period were reconciliated (780/2921), with a mean of 10.14 medications per patient. A mean of 1.6 discrepancies per patient were detected; 40.52% were ME, two thirds of which resulted from the omission of chronic medication and 72.15% of errors reached the patient but did not cause harm. The drugs involved in a higher proportion of ME were drugs to treat cardiovascular disorders. From the total amount of pharmaceutical interventions performed, 49.25% were accepted by physicians.Conclusion and relevanceDue to the high average chronic drug intake of patients attending the ED and, therefore, the potential risk of ME, collaboration between physicians and pharmacists is crucial to ensure reconciled medication of patients, as a patient safeguard strategy and a standard of quality within the health system.References and/or acknowledgementsNoConflict of interestNo conflict of interest
2SPD-026 Management of drug shortages Bernias Domínguez, MI; Mañes Sevilla, M; Martin Cruz, B ...
European journal of hospital pharmacy. Science and practice,
03/2020, Volume:
27, Issue:
Suppl 1
Journal Article
Peer reviewed
Open access
Background and importanceDrug shortages (DS) are a current global health issue facing pharmacists, prescribers and patients. To deal with DS, pharmacists are forced to resort to different suppliers ...and manufacturers, or to seek supplies abroad, in order to guarantee treatment of patients.Aim and objectivesTo analyse DS that affected a second level hospital over 1 year (March 2018 to March 2019) and to describe measures taken by the hospital pharmacist to deal with them.Material and methodsThis was a descriptive, observational, retrospective study of DS over a 1 year period. A list of all DS that affected our hospital was obtained from the Spanish Agency for Medicines and Health Products (AEMPS) webpage and from calling laboratories when medications were delayed. Variables collected were: drugs involved, therapeutic group according to the anatomic, therapeutic, chemical (ATC) classification system and pharmaceutical actions to solve DS.ResultsDuring the study period, 172 DS affected our hospital. Eight (4.7%) were not notified to the AEMPS. According to the ATC classification system, the main groups affected were: antimetabolites (7%; ATC-L01B), corticosteroids for systemic use (4.7%; ATC-H02A), antiarrhythmics, classes I and III (4.1%; ATC-C01B), antipsychotics (2.9%; ATC-N05A) and all other therapeutic products (2.9%; ATC-V03A). The strategies for management of these DS were changing the supplier (37.8%), buying a different packaging (11%), foreign medicine importation through AEMPS authorisation (8.7%), using a therapeutic alternative (4.1%), restricting use of available stock according to clinical criteria (2.9%) and performing a magistral formula (1.2%). In the remaining 34.3% of cases, no action was needed.Conclusion and relevanceCurrently, we are forced to deal with a large number of DS. Antimetabolites, systemic corticosteroids and class I and III antiarrhythmics were the main ATC groups affected. In most cases, it was possible to change laboratory and change the packaging. DS affect every level of the healthcare system, compromising standards of care. Because of this, it is important to coordinate different health services in order to take adequate measures to face shortages, without risking patient safety.References and/or acknowledgementsNo conflict of interest.
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.
Background and importanceDosing optimisation means therapeutic benefit with the lowest possible dose for each patient, improving patient adherence and reducing adverse effects.Aim and objectivesTo ...determine the impact of an implantation tool in the electronic medical history (ECHR) for rheumatology patients being treated with biologic drugs with or without optimisation.Material and methodsThe multidisciplinary team defined optimisation strategies based on dose reduction or dosing interval. The tool was designed to be incorporated as an alert in the ECHR (Selene): ‘B’ for patients with biologic drugs (etanercept, infliximab, adalimumab, certolizumab, golimumab, tocilizumab, abatacept, secukinumab, baricitinib, tofacitinib, ustekinumab) and ‘BO’ for patients with optimised biological drugs. Eight months post-implementation, the impact of these tools on optimisation of treatments was assessed.ResultsAt the beginning of the study, the ‘B’ alert was included in the ECHR of 236 patients and 8 months later the ‘B’ alert was visible in 279 patients, an increase of 18%. The distribution of the drugs at the beginning and post-intervention were: etanercept (23% vs 22%), adalimumab (19% vs 21%), golimumab (14% vs 14%), certolizumab (13% vs 13%), secukinumab (9% vs 12%), infliximab (8% vs 6%), abatacept (6% vs 6%), tocilizumab (4% vs 4%), baricitinib (3% vs 2%) and tofacitinib (2% vs 3%).For the ‘BO’ alert, at the beginning of the study it was included in 63 patients and in 91 patients at the end of the study, an increase of 44%. A total of 44% of patients were diagnosed with ankylosing spondylitis, 42% with rheumatoid arthritis and 14% with psoriatic arthritis. Drugs that were optimised were: adalimumab (54% vs 45%), infliximab (22% vs 14%), etanercept (21% vs 21%), certolizumab (2% vs 7%) and golimumab (3% vs 4%). This time, also optimised were: tocilizumab (3%), abatacept (1%), secukinumab (1%), tofacitinib (2%) and ustekinumab (1%). In 88% optimisation was performed by spacing of the dosing interval and in 12% by dose reduction.Conclusion and relevanceThis tool has been shown to be effective in monitoring patients receiving treatment with biologic drugs and it has had a high impact on optimising these treatments.References and/or acknowledgementsNo conflict of interest.
Background and importanceSelective cyclin dependent kinase (CDK) inhibitors, palbociclib and ribociclib, were recently approved to treat advanced or metastatic breast cancer. The hospital pharmacist ...plays an important role in the revision of the treatment at consultation, in order to ensure the safety and effectiveness of the treatment.Aim and objectivesTo analyse potential drug interactions (PDI) before starting palbociclib or ribociclib treatment and to evaluate physician acceptance of pharmacist recommendations.Material and methodsThis was a retrospective observational study including all patients who started treatment with palbociclib or ribociclib in a second level hospital until September 2019. At the beginning of treatment, the pharmacist interviewed patients and reviewed their medication in the pharmaceutical consultation. All PDI detected were analysed, making an intervention as therapeutic recommendations.PDI were identified using Lexicomp, Stockley’s Drug Interactions, Micromedex and CheckTheMeds. PDI were classified as moderate (pharmacological effects must be controlled) or severe (drug combination should be avoided). Follow-up of the recommendations was made 1 month after the beginning of treatment at the pharmaceutical consultation.ResultsTwenty-eight patients started palbociclib (50%) or ribociclib (50%) treatment in our hospital (95.9% women; mean age 63.6±9.8 years). Sixteen (57%) were polymedicated; the average number of medications per patient (not including endocrine and CDK inhibitors therapy) was 6.25. Thirty-one PDI were detected in 18 different patients (64.3%). There were 14 (45.2%) severe PDI and 17 (54.8%) moderate PDI. The most common types of drugs involved were statins (22.6%), proton pump inhibitors (22.6%), antidepressants (12.9%) and pyrazolones (16.1%).Eleven severe PDIs were accepted (78.6%). Moderate recommendations led to a reduction in antidepressant dosage (5.9%) and two change of drugs involved in the interaction (11.8%).Conclusion and relevanceThis study showed that more than half of patients that started treatment with CDK inhibitors has at least one PDI. Clinical pharmacists are essentials in detecting PDI, which is a positive influence on physician prescriptions and patient treatment outcomes, improving the safety and effectiveness of the oncological treatment.References and/or acknowledgementsNo conflict of interest.
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