Background The recent development of highly effective interferon free drug regimens has dramatically changed the therapeutic landscape of hepatitis C virus (HCV). An intensive pharmaceutical care programme is necessary, due to their recent commercialisation, the limited available data on their effectiveness and safety in clinical practice and their high cost.
Purpose Our purpose was to evaluate, in terms of safety and efficiency, pharmacists´ interventions on patients starting treatment with new antiviral drugs (NAD).
Material and methods Design: observational, prospective study.
Inclusion criteria: patients who began treatment with NAD between April and September 2015. Drugs were dispensed at the outpatient pharmacy after a clinical interview on a monthly basis.
A pharmaceutical care programme was developed: a protocol was elaborated by a multidisciplinary team describing the selection criteria and duration of treatment according to National Health System recommendations. It includes a checklist with demographics, pharmacologic (drug schedule, drug interactions), laboratory (haematologic, hepatic, renal) and clinical data (virological response, adverse events) to be monitored at each clinical visit to the outpatient pharmacy.
The primary outcome was pharmacists’ interventions classified according to Overhage et al. and severity of medication errors according to NCC MERP.
Results 694 patients were included (63.4% men), mean age 56.2 years, 52.9% fibrosis F4 and 24.6% co-infected. 50.1% of patients were naïve. Regarding prescription profile, 54.5% were treated with ombitasvir/paritaprevir/ritonavir with or without dasabuvir, 40.6% with sofosbuvir/ledipasvir, 3.1% with sofosbuvir+dacltasvir and 1.8% received other combinations. 31.3% followed a 24 week schedule.
194 pharmaceutical interventions were made, with 99% acceptance rate. According to the severity, 7 (3.6%) errors were severe (G/H: 1 interaction with primidone and 3 with salmeterol and 3 ribavirin high dose); 157 (80.9%) were serious D/E/F and 30 (15.5%) were classified as not causing harm (A/B/C).
Medication errors detected: 75 (38.7%) drug interactions requiring close monitoring or treatment modification, 67 (34.5%) errors in the administration technique and 12 (6.2%) errors in dosage.
Selection and duration were adjusted to the protocol in 99.6% of patients with 98.2% of virological response. 10 pharmacists’ interventions concerning selection and 4 concerning duration were made, resulting in cost savings of 121.194Euros.
Conclusion The role of the pharmacist in HCV patients has been fundamental in detecting relevant drug interactions and in providing accurate information on drug administration, improving safety. Pharmacists have also participated in the selection of the most cost effective treatment.
No conflict of interest.
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