BackgroundThe outpatient pharmacy unit (OPU), in consensus with the digestive service (DIG), held an intervention on selected chronic hepatitis B virus (HBV) infected outpatients. It consisted of decreasing the frequency of oral treatment from a monthly to a bimonthly basis. The aim was to reduce patient visits to the hospital and to diminish the healthcare burden in order to use human resources to improve pharmaceutical care.PurposeTo evaluate the impact on adherence and viral load (VL) after dispensing treatment on a bimonthly basis instead of a monthly basis to selected HBV outpatients.Material and methodsIn May 2014, patients were transversely selected by OPU following the criteria reached by consensus with DIG: age >18 years, receiving any oral drug (alone or combined) for HBV infection, HBV VL ≤100 copies/mL in their last analysis, on stable treatment for at least 6 months previous to the study and related adherence throughout that period >80%. All selected patients were informed about the importance of adherence, and bimonthly dispensation was offered to them. The next set of data was collected from the medical records: sex, age and VL. Adherence was measured by indirect methods from the dispensation programme registry (Farmatools). In May 2015, adherence since the intervention and VL values were revised for the selected patients to evaluate the effect of the intervention.Results94 patients met the criteria but only 73 wanted to change to bimonthly dispensation: 56.15% male, median (P50) age 52 (44–61). Results refer to 63 patients, as 8 patients had no analysis after the intervention and 2 were lost to follow-up. After the intervention, 6 patients still met the criteria. 35 patients maintained the same VL and 17 had decreased VL (13 to undetectable). 9 had increased VL but still met the criteria and 8 of them had adherence variation <10%. Causes of not meeting the criteria: 1 patient for changing treatment (simplification) and 1 patient for diminished adherence from 88.24% to 57.13%. This patient returned to monthly dispensation.ConclusionBimonthly dispensation is a safe tool for maintaining stable adherence and VL in selected patients and could be used to rationalise the use of the limited human resources of pharmacy services and reduce patient visits to hospital.References and/or AcknowledgementsIbarra O. Adherencia al tratamiento VHB. Grupo Hepatopatías Víricas. SEFH.2 junio 2010. BarcelonaNo conflict of interest.
Background Intravitreal dexamethasone implants (DEXi) were approved by the European Medicines Agency in 2010 to treat macular oedema following either branch or central retinal vein occlusion and inflammation of the posterior segment of the eye presenting as non-infectious uveitis. However, they have also been used to treat other forms of macular oedema and associated pathologies as an off-label use. Purpose To describe the off-label use of DEXi in our hospital and to evaluate the cost of DEXi compared to the standard treatment in diabetic macular oedema (DME), ranibizumab. Materials and methods A longitudinal, retrospective and descriptive study was carried out on patients treated with at least one DEXi from June 2011 to January 2013. The next set of data was collected from medical records:(1) sex, (2) age at first DEXi, (3) diagnosis, (4) number of injections and (5) re-injection interval period (months). (3), (4) and (5) were distinguished for each eye. Annual Costs For Each Eye Treated (ACFEET) with DEXi was estimated by multiplying the drug manufacturers’ price (Ozurdex, 950 € per implant) by the estimated annual number of implants. Estimated annual number of implants was calculated by dividing 12 (months) by the median re-injection interval period (months) in this study. ACFEET with ranibizumab was estimated regarding 2 scenarios: A) the use of 1 vial to obtain 1 injection or B) the use of the amount left over in each vial to obtain 3 doses (injections) from 2 vials (33% dose optimisation) under aseptic and controlled conditions in the pharmacy department. A minimum of 6 and a maximum of 12 injections of 0.5 mg per year were considered in both scenarios. The manufacturers’price for ranibizumab (Lucentis) is 857.21 € for each vial. Results 39 patients (43 eyes) were treated with at least one DEXi during the study period. DEXi was used off-label in 30 eyes and 26 patients [16 women, median (P50) age 74 years (57.75–78.75)] which means 69.77% of total DEXi prescriptions. The pathologies related to off-label uses were: DME (17 patients), Cystic Macular Oedema (CME) not following either branch or central retinal vein occlusion (7 patients), postsurgical CME (4 patients), CME secondary to Age-Related Macular Degeneration (4 patients), choroidopathy-associated choroidal neovascular membrane (1 patient). 12 eyes (40% of all off-label DEXi) received more than one DEXi. P50 re-injection interval was 5 months (4.5–6). 4 patients with DME received DEXi in both eyes. ACFEET with DEXi (2.4 implants) were 2,280.00 €. ACFEET with ranibizumab in scenarios A and B were 5,143.26–10,286.52 € and 3,429.01–6,858.02 € respectively. Conclusions A high proportion of DEXi prescriptions consisted of off-label use. DME was the most common off-label use. However, DEXi did not mean any incremental annual cost compared to ranibizumab (the standard drug treatment) in DME, even considering dose optimisation. Further studies that better determine efficacy and safety in these patients are needed. No conflict of interest.
Background In 2005, the Safe Use of Drug and Health Products website was launched by the Health Department of the Madrid Autonomous Community. Any health professional can communicate drug prescription errors detected through Functional Risk Management Units (UFR). Patient safety is a strategic guideline used. Considering that the drug treatment is one of the most widely used health services, and one of the most complex and effective, in terms of technology, attention needs to be given to this point and to its safe use. Purpose To analyse the medicines errors submitted from the Pharmacy Service to the UFR, to identify and prioritise actions for improvement. Materials and methods The submissions made through an online formulary to the Safe Use of Drug and Health Products website were analysed from September 2011 to September 2013. From all items of the formulary, we collected: error type, patient consequences, stage of the process and place where it happened. Error notification is anonymous and confidential. Results During the study, 159 errors were reported. Regarding the process stage: 135 (84.9%) during prescription, 13 (8.2%) while dispensing, 3 (1.88%) during manufacture, 3 (1.88%) during administration, 3 (1.88%) during labelling, 1 (0.63%) during validation and 1 (0.63%) during transcription. Concerning the type of error: 54 (33.96%) were due to a dose error, 25 (15.72%) to an administration frequency error, 22 (13.83%) due to a drug selection error, 12 (6.92%) due to a dispensing error, 8 (5%) due to a manufacturing error, 4 (2.5%) due to dispensing to the wrong patient, 3 (1.8%) due to a treatment length error and 3 (1.8%) due to a lack of drug quality. Regarding the consequences for the patient: 70 (44%) didn’t reach the patient; of the 69 (43.3%) events that could have caused an error, 17 (10.7%) reached the patient with no damage, 2 (1.2%) harm was done but was impossible to trace, 1 (1.72%) monitoring was required. Concerning the unit where the error took place: 111 (69.8%) in the hospital plant, 23 (14.5%) in the Pharmacy Service, 18 (11.3%) in the Urgency Service and 8 (5%) in other units. Conclusions Recording and categorising the drug errors provides the most accurate information about which points must be improved regarding the complex process of drug use. A lot of drug errors occur during the prescription but most of them do not reach the patients. The errors prompt us to continue improving the electronic validation of prescriptions, as well as future actions in other areas. No conflict of interest.
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