Survey of workflow and cost implications of decommissioning regarding the Falsified Medicines Directive in Hungarian hospital pharmacies.
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ABSTRACT: Objectives, setting and participants
In July 2011, the EU adopted the Falsified Medicines Directive (FMD) primarily aiming to prevent the infiltration of falsified medicines into the legitimate supply chain. Our aim was to measure the cost elements of FMD implementation and operation using an internationally adaptable tool among Hungarian hospital pharmacies.Design
A 41-item questionnaire was developed to evaluate the implementation process and associated cost consequences leading up to February 2019, and the stabilisation period.Results
Our representative data are supported by the high response rate, as 44.8% of the Hungarian hospital pharmacies have completed the survey. Human resource requirements related to decommissioning activities were measured as working hours and were expressed in full time equivalent (FTE). We have found an increased workload with extra 0.25 pharmacist and 0.75 technician FTE/institution at the end of the stabilisation period. The entire infrastructural and IT implementation costs were determined as €2173, on average (SD: €3366) and the median was €1506 (range: €0-€20 723). The total IT investment cost per institution was valued at €1410 (SD: €335). We identified a positive correlation (R=0.663) in consideration of the costs, the number of beds and the number of hospital locations with a multivariate linear regression model. At the time of our survey, 76.7% of the respondents experienced drug shortages, 58.1% reported suspected increase in drug costs regarding serialised medications, and 53.5% noticed an increase in packaging size.Conclusions
Notably, our research is the first complex study depicting FMD cost implications in the hospital pharmacy sector in Central Europe, indicating decommissioning significantly impacted workflow referencing human resources and IT.
SUBMITTER: Vajda P
PROVIDER: S-EPMC8611447 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveTo assess the variation in price among different brands of anticancer medicines available in hospital pharmacies at Nepalese cancer hospitals.MethodsThe price of different brands of the same anticancer medicines available in the hospital pharmacies of two cancer hospitals was assessed. Prices of different dosage forms such as a single tablet, capsule and vial were calculated. The difference in the maximum and minimum price of the same drug manufactured by different pharmaceutical industries was determined, and the percentage variation in price was calculated. The prices of medicines (brands) were also compared with the price determined by the government where available.ResultsPrice variation was assessed for 31 anticancer medicines belonging to six broad categories. Prices were found to vary maximally among the following medicines, each belonging to separate categories: among alkylating agents, the price of temozolomide 100 mg capsule varied 308%; among antimetabolite agents, the price of pemetrexed 500 mg injection varied 134%; among hormonal drugs, the price of letrozole 2.5 mg tablet varied 200%; among antibody class, the price of trastuzumab 440 mg injection varied 73%; among natural products, the price of irinotecan 100 mg injection varied 590%; and among miscellaneous agents, the price of bortezomib 2 mg injection varied 241%. There was a significant difference in the mean MRP of the alkylating agents with the antimetabolites (p-value 0.006) and the monoclonal antibody (p-value <.001). Antimetabolites, natural products, hormonal therapy all had significant mean differences in their MRPs with the monoclonal antibodies. (p-value <.001) and the monoclonal antibodies had a significant mean difference in the MRP with the miscellaneous agents. (p-value <.001).ConclusionsThere was a considerable variation in the price of different brands of anticancer medicines available in the Nepalese market. The Government of Nepal has regulated the prices of some medicines, including anticancer medicine. However, it is not enough as prices of the majority of anticancer medicines are still not regulated. Therefore, further strategies are needed to address the variation in the prices of anticancer medicines available in the Nepalese market.
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Project description:The World Health Organization and others warn that substandard and falsified medicines harm health and waste money, especially in low- and middle-income countries. However, no country has measured the market-wide extent of the problem, and no standardized methods exist to estimate the prevalence of either substandard or falsified medicines. This is, in part, because the task seems overwhelming; medicine markets are huge and diverse, and testing medicines is expensive. Many countries do operate some form of postmarket surveillance of medicine, but their methods and goals differ. There is currently no clear guidance on which surveillance method is most appropriate to meet specific public health goals. In this viewpoint, we aimed to discuss the utility of both case finding and risk-based sentinel surveillance for substandard and falsified medicines, linking each to specific public health goals. We posit that choosing the system most appropriate to the goal, as well as implementing it with a clear understanding of the factors driving the production and sale of substandard and falsified medicines, will allow for surveillance resources to be concentrated most efficiently. We adapted principles used for disease outbreak responses to suggest a case-finding system that uses secondary data to flag poor-quality medicines, proposing risk-based indicators that differ for substandard and falsified medicines. This system potentially offers a cost-effective way of identifying "cases" for market withdrawal, enhanced oversight, or another immediate response. We further proposed a risk-based sentinel surveillance system that concentrates resources on measuring the prevalence of substandard and falsified medicines in the risk clusters where they are most likely to be found. The sentinel surveillance system provides base data for a transparent, spreadsheet-based model for estimating the national prevalence of substandard and falsified medicines. The methods we proposed are based on ongoing work in Indonesia, a large and diverse middle-income country currently aiming to achieve universal health coverage. Both the case finding and the sentinel surveillance system are designed to be adaptable to other resource-constrained settings.
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Project description:Background Community pharmacy services play an important role in controlling some factors related to medicine use and patients can benefit from these services to improve the adherence and knowledge of their medications, besides to reduce medicine-related problems. Objective The aim of the REVISA project is to carry out a study on preliminary implementation of the medicines use review service in Spanish community pharmacies. Setting Sixty-four community pharmacies from all regions of Spain. Method A preliminary implementation, cross-sectional multicentre study was conducted using a convenience sample of voluntary community pharmacies. A structured interview enabled to pharmacists to obtain a better understanding of patient's medicines use. Main outcome measure Medicines use review-related time and cost, satisfaction and willingness to pay. Results A total of 495 patients were enrolled. The mean age of the patients was 66.1 years, with the majority females (56.4%) and a mean consumption of 5.7 medicines. A total of 2811 medicines were evaluated and 550 referral recommendations were made (29.8% to Primary Care). The mean time employed by the pharmacists in the medicines use review service was 52.8 min (medicines use review-related cost of €17.27). Most patients expressed a high level of satisfaction with this service (98.5%) and a willingness to pay for it (84%). Conclusion Medicines use review service in community pharmacies in Spain can be delivered, that it appears to be acceptable to patients and that most patients said they would be willing to pay for it. This service may offer an opportunity to promote inter-professional collaboration between pharmacists and general practitioners.
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Project description:BackgroundThe use of herbal medicines is on the increase globally and they are usually supplied in pharmacies as non-prescription medicines. Pharmacists are, therefore, responsible for educating and informing the consumers about rational use of herbal medicines.ObjectiveTo evaluate the knowledge of pharmacists in Lagos, Nigeria with regards to the herbal medicines they supplied by their pharmacies.MethodsPharmacists in charge of randomly selected 140 community pharmacies from 20 Local Government Areas in Lagos were required to fill out a self-administered questionnaire. We gathered information on their knowledge of the indications, adverse effects, potential drug-herb interactions and contraindications of the herbal medicines they supply in their pharmacies.ResultsOf the 140 questionnaires distributed, 103 (72.9%) participants completed the questionnaire appropriately. The majority (74; 71.8%) of the participants were males and 36-50 years (56; 54.4%). The pharmacies supplied mostly Yoyo cleanser bitters® (101; 98.5%), ginseng (97; 98.5%), Jobelyn® (91; 88.3%), Ciklavit® (68; 66.6%), gingko (66; 64.1%), herbal tea (66; 64.1%), and Aloe vera (57; 55.3%). The pharmacists self-rated their knowledge of herbal medicines mostly as fair (39%) and good (42%), but they exhibited poor knowledge with regards to the indications, contraindications and safety profiles. Seventy participants consulted reference materials such as leaflet insert in the herbal medicines (56%) and internet (20%) before supplying herbal medicines. The information most frequently sought was herb-drug interactions (85%), contraindications (75%) and adverse effects (70%).ConclusionsCommunity pharmacists need to be informed about the indications and safety profiles of herbal medicines.
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Project description:ObjectiveTo determine the extent of substandard and falsified medicines in the UK.DesignA retrospective review of drug alerts and company-led recalls.SettingThe Medicines and Healthcare Products Regulatory Agency (MHRA) website search for drug alerts issued between 2001 and 2011.Eligibility criteriaDrug alerts related to quality defect in medicinal products.Main outcome measureRelevant data about defective medicines reported in drug alerts and company-led recalls, including description of the defect, type of formulation, year of the alert and category of the alert.ResultsThere were 280 substandard medicines of which 222 were recalled. The two most frequent problems were contamination (74 incidents) and issues related to packaging (98 incidents). Formulations for parenteral administration (117 incidents) were the formulation most frequently affected. There were 11 falsified medicines, as defined by the MHRA, reported over the 11-year period. The number of defective medicines reported by the MHRA increased 10-fold from 5 in 2001 to 50 in 2011.ConclusionsSubstandard medicines are a significant problem in the UK. It is uncertain whether the increasing number of reports relates to improved detection or an increase in the number of substandard medicines.
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Project description:Substandard and falsified medicines have severe public health and socioeconomic effects, especially in low- and middle-income countries. The WHO has emphasized the need for reliable estimates of the prevalence of such medicines to efficiently respond to this problem. In the present study, we used 601 medicine samples collected in Cameroon, the DR Congo, and Malawi to assess the rates of substandard and falsified medicines based on different criteria. Based on the specifications of the U.S. Pharmacopoeia for the amount of the active pharmaceutical ingredients, the rate of out-of-specification medicines was 9.3%. By contrast, this rate ranged from 3.3% up to 35.0% if the tolerance limits of other pharmacopoeias or recently published medicine quality studies were used. This shows an urgent need for harmonization. Principal methods to assess the rate of falsified medicines are packaging analysis, chemical analysis, and authenticity inquiries. In the present study, we carried out an authenticity inquiry for the aforementioned medicine samples, contacting 126 manufacturers and 42 distributors. Response rates were higher for samples stated to be manufactured in Asia (52.4%) or Europe (53.8%) than for samples manufactured in Africa (27.4%; P < 0.001). One sample had been identified as falsified by packaging analysis by the local researchers and two additional ones by chemical analysis. Notably, seven additional falsified samples were identified by the authenticity inquiries. The total rate of falsified medicines resulted as 1.7%. Considerations are discussed for assessing the rates of "substandard" and "falsified" medicines in future medicine quality studies.
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