Browsing by study line "Socialfarmaci"
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(2020)Tiivistelmä – Referat – Abstract 15D is a generic, 15-dimensional instrument for measuring health-related quality of life (HRQoL). 15D instrument has been used in multiple studies evaluating the effectiveness of medical interventions in Finland and abroad. 15D-instrument is a self-administered questionnaire traditionally administered in a paper-and-pencil format. With the emergence of novel technologies, electronic modes of delivery of the 15D instrument are becoming increasingly common as methods for data collection. However, there are no previous studies evaluating electronic modes of delivery of the 15D instrument. In previous studies, electronic instruments measuring patient-reported outcomes have shown strong measurement equivalence and high acceptability. The aim of this study is to evaluate acceptability and measurement equivalence of electronic delivery modes of the 15D instrument. A repeated measures, randomized cross-over study was conducted in the Department of Otorhinolaryngology at Helsinki University Hospital during April, May and June of 2019. A total of 160 outpatients who participated in the study were randomized into four groups of 40 patients. Every participant filled two delivery modes of the 15D instrument: a single paper-and-pencil questionnaire and one out of two electronic questionnaires provided in the study. The two electronic delivery modes delivered in the study were a web-based questionnaire and a mobile app-based questionnaire. The order and the mode of the administration varied between the groups. The patients filled the first questionnaire before the doctor’s appointment at the study site. The patients were then asked to fill the second questionnaire after the doctor’s appointment at home within 3 days after the first administration. Information about acceptability concerning different delivery modes were collected using an end-of-study questionnaire. As a part of determining patient acceptability, response rates for different delivery forms and mode preferences were examined. Measurement equivalence was assessed by intra class correlation coefficients (ICCs) and comparison of mean and median for 15D scores and weighted kappa for item scores. Paired observations were also visually analysed with Bland-Altman plots. Subgroup analyses were conducted for identifying differences in observed patient characteristics (age, sex, base-line HRQoL). 86 participants (females 53.5 %; males 46.5 %) aged 18 to 80 (mean ± SD: 48.2 ± 15.7) filled both questionnaires of the 15D instrument resulting in an overall response rate of 54.1%. Response rates for filling both questionnaires were lower in both groups that filled electronic forms at home (41.0 % for mobile app-based and 52.5 % for web-based questionnaires) than in the paper-and-pencil groups (60.0 % and 62.5 %). Overall 74.1 % preferred the electronic delivery mode compared to 16.5 % preferring the paper-and-pencil mode. Statistically significant differences favouring the web-based form over the paper-and-pencil form were observed in the speed of use (p = 0.002) and in the possibility to edit answers (p = 0.018). Similarly, mobile app-based form was favoured over paper-and-pencil group in the possibility to edit answers (p = 0,041). In terms of measurement equivalence for 15D index scores, high association across paper-and-pencil and web-based questionnaires (ICC: 0.910 [Cl 95 % 0.794-0.962] and ICC: 0.935 [Cl 95 % 0.862-0.971]) and high to moderate across paper-and-pencil and mobile app-based questionnaires (ICC: 0.949 [Cl 95 % 0.883-0.978] and ICC: 0.928 [Cl 95 % 0.601-0.980]) were observed. A clinically important and a statistically significant difference in mean 15D scores was identified in the paper-mobile app group. A statistically significant but not clinically important difference in medians was observed in mobile app-paper group with participants returning the second delivery form in time. This study provides strong evidence supporting the use of electronic delivery modes of the 15D instrument regarding measurement equivalence and patient acceptability. However, differences in electronic delivery modes may have an impact on measurement equivalence and representativeness of study participants. In this study, a small sample size and limited data on study participants limit the generalizability of the results. Most effective ways of collecting data electronically concerning all age and patient groups must be identified in future studies. Electronic data collection methods offer many opportunities for utilising HRQoL data. For example, it is important to assess whether HRQoL-instruments can be used as clinical tools in the future.
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(2021)Abstract Faculty: Faculty of Pharmacy Degree programme: Master of Science in Pharmacy Study track: Social pharmacy Author: Laura Toivonen Title: Deficiencies and risks related to medication use management in nursing homes identified by Regional State Administrative Agencies during their inspection visits Level: Master´s thesis Month and year: November 2021 Number of pages: 94+7 (appendice) Keywords: Medication safety, medication use process, nursing home, older adult, risk management, guidelines for safe medication practices Supervisor or supervisors: M.Sc. Pharm, PhD student Suvi Hakoinen, University of Helsinki, Keusote; Professor, PhD Marja Airaksinen, University of Helsinki Where deposited: ethesis.helsinki.fi Additional information: Abstract: Nursing home residents are often characterized by older age, multimorbidity and polypharmacy. Medication safety has become an issue as part of client/patient safety in nursing homes in Finland. Still, little is known about medication safety risks and their management in this care context. The aim of this study was to identify deficiencies and risks associated with medication use management in nursing homes using inspection visits by the Regional State Administrative Agencies (AVIs) as a data source. In addition, the aim was to evaluate what issues the AVI-authorities pay attention to in the medication use management during their inspection visits in nursing homes. The data consisted of the latest inspection reports (n = 24) prepared by the Regional State Administrative Agencies (n = 6) on the basis of their nursing home visits (nursing homes for older people). The data were analysed by deductive content analysis methods. In addition to qualitative documentary analysis, quantitative indicators were used to illustrate the frequency of the risks and deficiencies -observed in different phases in the medication use process to identify phases posing risks most commonly. Reason´s system-based risk management theory was applied as a theoretical framework for the study. A total of 372 deficiencies and risks related to medication use process were identified from the inspection reports (n = 24) of Regional State Administrative Agencies. The largest proportion (58,9 %, n = 219) of the deficiencies and risks concerned the management and quality management of the medication use process. Particularly, deficiencies and risks related to lack and competence of personnel were emphasized. Deficiencies and risks were also identified in the self- assessment guidelines for safe medication practices used in the inspected nursing homes. The second highest number of risk observations (26,9 %, n = 100) was reported for ordering, delivery and storage of medicines. In particular, the deficiencies and risks were reported for the storage and warehousing practices. Reported risk observations in other phases of the medicines use process were rare. This study showed that the medication use process in Finnish nursing homes includes deficiencies and risks endangering the safety of the older nursing home residents. In order to manage the risks, both self-assessment and inspection practices by the authorities need development. One way to improve and harmonize both self-assessment and inspection practices could be use of a comprehensive checklist covering of all the relevant issues required for the safe medication practices in nursing homes. Increasing collaboration with pharmacists could also be a way to improve medication safety in nursing homes.
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(2021)Medication errors due to infusion pump programming errors are common in neonatal intensive care units and often lead to overdoses of medicines. Medication errors can be prevented with dosing limits set into the smart infusion pump drug library. However, alert fatigue caused by unnecessary alarms has been identified to hinder their use. To ensure the benefit of dosing limits as a defence of intravenous medication process, the aim of this study was to define the dosing limits to the drug library for certain high alert medications, and to pilot them in the neonatal intensive care unit. The study was based on the theoretical framework of preventive medication risk management. Based on the results, the suitability of the dosing limits for the use of the unit and the patient group was assessed. This mixed method study employed register-based research methods. The research data consisted of the infusion rate related medication errors (n=21) reported to the HUS HaiPro-system between January 2018 and December 2019 in the HUS Neonatal Intensive Care Unit. The data was analysed qualitatively and quantitatively to describe the infusion rate related errors, and to identify their mechanisms and contributing factors. Based on the identified mechanisms of the errors, simulated test patient cases were developed. Dosing limits were defined by a multidisciplinary expert group for certain high alert medications, and their suitability for preventing medication errors was investigated by programming infusion pumps according to the test patient cases and analysing the pump alerts. Based on the identified mechanisms of infusion rate-related medication errors (n=21) in the HaiPro-reports, 2-, 5-, and 10-fold infusion rates as well as mixing of infusion rates between medicines were established as test patient cases. As a result of the tests (n=226), the infusion pumps did not alert when programming normal infusion rates (n=32) and 73% (n = 70/96) of the erroneous 2-, 5-, and 10-fold infusion rates were prevented. 10-fold infusion rates were inhibited in all cases (n=32). Interference of infusion rates between medicines was prevented in 24% (n=24/98) of the cases. According to this study, significant infusion rate related medication errors can be prevented in the neonatal intensive care unit with the multidisciplinarily defined dosing limits set in the infusion pump drug library. However, they do not prevent all the infusion rate related medication errors alone, and therefore additional defences are needed. In addition to the neonatal intensive care unit, the method used in this study to define and test the dosing limits may be applied in other pediatric units in the future. By using this method, the suitability of the dosing limits for the use of the unit and the patient group can be ensured before integration of the barrier and thereby promote the benefits of its use. The suitability of the dosing limits set into the infusion pump drug library should be assessed again after implementing the defence into the neonatal intensive care unit.
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(2024)Alzheimerin taudin riskiä lisää monet tekijät sekä mahdollisesti tietyt lääkkeet. Näiden riskien monitoroinnilla saattaa olla suotuisa vaikutus ennusteeseen. Näin ollen riskiä lisäävät lääkkeet olisi erityisen tärkeää tunnistaa ja lopettaa tai rajoittaa käyttöä korvaamalla muilla lääkeryhmillä tai lääkkeettömillä keinoilla. Pitkäaikaisesti käytössä olleiden lääkkeiden hallittu lopettaminen eli annosten pienentäminen tai lopettaminen vaatii varovaisuutta ja tarkkaa harkintaa, jotta vältytään lopetusoireilta eikä heikennetä elämänlaatua. Tämän Tutkielman tavoitteena oli tutkia, kuinka kognitiivisia haittoja aiheuttavia lääkeaineita voidaan lopettaa hallitusti, jotta vältytään irreversiibeleiltä kognitioon kohdistuvilta haitoilta. Tämä toteutettiin tutkimalla lääkevalmisteiden lakisääteisistä valmisteyhteenvedoista (SmPC), pakkausselosteista ja muista keskeisistä terveydenhuollon ammattilaisille suunnatuista tietolähteistä̈ löytyvää tietoa trisyklisten masennuslääkkeiden ja bentsodiatsepiinien hallitusta lopettamisesta. Tutkimusta varten tarkasteltiin kaikkia Suomessa huhtikuussa 2024 markkinoilla olleita lääkeaineita, joilla on merkittäviä antikolinergisia vaikutuksia. Lisäksi tarkasteltiin tuolloin markkinoilla olleita unilääkkeinä käytettyjä bentsodiatsepiineja. Näistä tutkimukseen sisällytetyt lääkeaineet valittiin sen perusteella, että niiden lopettamisessa tulisi noudattaa varovaisuutta (valittiin trisykliset masennuslääkkeet ja bentsodiatsepiinit). Tutkimus toteutettiin laadullisena sisällönanalyysinä, jossa aineistona käytettiin tutkimukseen valittujen lääkkeiden (amitriptyliini ja nortriptyliini, diatsepaami, oksatsepaami ja loratsepaami) valmisteyhteenvetoja (n = 5), pakkausselosteita (n=5), kansainvälisesti merkittävää hoitosuositusta: 1) American Psychological Association APA: Practice Guideline for the Treatment of Patients with Major Depressive Disorder, Yhdysvallat, 2) National Institute for Health and Care Excellence NICE: Depression in Adults: Treatment and Management, 3) NICE: Medicines Associated with Dependence or Withdrawal Symptoms: Safe Prescribing and Withdrawal Management for Adults, 4) The Maudsley: Deprescribing Guidelines Antidepressants, Benzodiazepines, Gabapentinoids and Z-drugs, Iso-Britannia sekä yhtä kansallista hoitosuositusta (Suomalainen Lääkäriseura Duodecim: Unettomuus Käypä̈ hoito -suositus). Tiedon määrä, sisältö ja laatu vaihtelivat tietolähteiden välillä. Trisyklisten masennuslääkkeiden hallitusta lopettamisesta löytyi selkeästi vähemmän tietoa kuin bentsodiatsepiinien hallitusta lopettamisesta. NICE:n hoitosuositukset täydensivät toisiaan lääkityksen hallitusta lopettamisesta. APA- ja käypä hoito -ohjeistukset sisälsivät tietoa yleisellä tasolla, mutta eivät sisältäneet yksityiskohtia lääkityksen hallitusta lopettamisesta. Muistin ja kognition kannalta huomattiin, kuinka trisyklisten masennuslääkkeiden valmisteyhteenvedoista ja pakkausselosteista puuttui kokonaan tietoa mahdollisista muistiin tai kognitioon kohdistuvista haitoista. Bentsodiatsepiinien mahdollisista muistiin tai kognitioon kohdistuvista haitoista taas löytyi jonkin verran tietoa, mutta tieto oli suhteellisen rajallista ja epätarkkaa.
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(2021)Antidepressant use among children and adolescents has become more common in many countries. The prevalence of antidepressants is higher for boys but during adolescence girls’ have a higher antidepressant prevalence. In previous studies, the prevalence of selective serotonin re-uptake inhibitors (SSRI) has increased. The aim of this study was to investigate antidepressant use among Finnish children and adolescents aged 1–17 years during 2008–2019. The differences of antidepressant use in different age groups and genders were investigated. Furthermore, the secondary objective was to examine the trends in prevalence and costs of the five most commonly used antidepressant agents. This was a nation-wide register study. The data for this study was from Kelasto which is a statistical database maintained by the Social Insurance Institution of Finland. The extracted data was from 2008–2018 and included each persons’ age, gender, dispensed drug and costs. The data extracted was for 1–17-year-olds who had been dispensed reimbursed antidepressants from community pharmacies. The data was analyzed with Microsoft Office’s Excel program. The results were transferred in to tables and reported as prevalences by age groups, genders, antidepressants and costs. The prevalence of antidepressant use among children and adolescents was 5,0 per 1000 in 2008 and it increased to 10,3 by 2018. In the youngest age group of 1–6-year-olds, antidepressant use decreased. Antidepressant use increased slightly among 7–12-year-olds. Antidepressant use increased the most among 13–17-year-olds. 13–17-year-old girls had the higher antidepressant use prevalence throughout the study. The same group had a 2,4-fold increase in prevalence during the study period which accounted for the biggest increase in the study. The most used group of antidepressants was SSRIs. The total cost for antidepressants among children and adolescents increased by 73,7 % during the study period. The most commonly used antidepressant agents were fluoxetine, sertraline, escitalopram, mirtazapine, and venlafaxine, respectively. Fluoxetine was the most used agent throughout the study. In 2014, sertraline surpassed escitalopram and became the second most used antidepressant agent. Escitalopram and venlafaxine’s cost per user decreased during the study. The cost per user stayed stable for mirtazapine. Fluoxetine and sertraline’s cost per user increased. The Kelasto database does not include data on indications for prescriptions. The prevalence of antidepressants does not necessarily correlate directly to depression among children and adolescents because antidepressants can be used to treat other diseases. More studies need to be conducted on different off-label uses for antidepressants among children and adolescents. This study only investigated the trends on cost for the five most commonly used antidepressants. Further studies on antidepressant costs among children and adolescents are needed. Additionally, it is essential to investigate the reasons for the increase in antidepressant use among children and adolescents.
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(2024)Lääkityspoikkeamat aiheuttavat maailmanlaajuisesti eniten vältettävissä olevia potilashaittoja terveydenhuollossa. Vaaratapahtumista raportoiminen on tärkeää lääkitysturvallisuuden edistämiseksi, sillä raportoinnin avulla saadaan tietoa lääkehoitoprosessin riskikohdista, jota voidaan puolestaan hyödyntää kehitettäessä lääkehoitoprosessien suojauksia. Tutkimuksen tavoitteena oli selvittää, millaisia sosiaali- ja terveydenhuollossa tapahtuneita lääkehoidon vaaratapahtumia apteekeissa on havaittu ja estetty sekä millaisiin kehittämistoimenpiteisiin apteekkien vaaratapahtumailmoitukset johtivat tapahtumayksiköissä. Tutkimus toteutettiin retrospektiivisenä rekisteripohjaisena tutkimuksena avoapteekkien sosiaali- ja terveydenhuollon yksiköihin lähettämistä HaiPro-vaaratapahtumailmoituksista sekä tapahtumayksiköiden seurantalomakkeista. Tutkimusaineisto oli kerätty Pohjanmaan, Kanta-Hämeen ja Keski-Uudenmaan hyvinvointialueilla 1.2.2022-31.12.2023. Alkuperäinen aineisto sisälsi 457 vaaratapahtumailmoitusta. Aineiston esikäsittelyssä poistettiin ilmoitukset, jotka eivät olleet sosiaali- ja terveydenhuollossa tapahtuneita vaaratapahtumia (n=11). Ilmoitukset, jotka koskivat useampaa kuin yhtä lääkeainetta tai potilasta (n=15) jaettiin erillisiksi tapauksiksi. Strukturoitujen kohtien valintojen oikeellisuus tarkistettiin tapahtumakuvausten perusteella ja tarvittaessa valinta korjattiin. Lopulliselle tutkimusaineistolle (n=461) suoritettiin kuvaileva määrällinen analyysi (frekvenssit ja prosenttiosuudet) Microsoft Excel ohjelmistolla. Aineistosta laskettiin vaaratapahtumien määrä, luonne, havaitsija, tyyppi sekä asiakkaalle ja apteekille aiheutuneet seuraukset, yleisimmin esiintyneet lääkeaineet, lääkeaineryhmät sekä suuren riskin lääkkeiden osuus. Terveydenhuollon yksiköiden kehittämistoimenpiteille suoritettiin laadullinen sisällönanalyysi aineistolähtöisesti sekä tarkasteltiin kehittämistoimenpiteiden jakautumista yksilö- ja järjestelmänäkökulmiin. Lähes kaikki (94 %) aineiston vaaratapahtumista (n=461) oli apteekin havaitsemia. Valtaosa tapauksista oli läheltä piti -tapahtumia (71 %). Vaaratapahtumat olivat lähes aina lääkehoitoon liittyviä (98 %). Yleisimmin kyseessä oli määräyspoikkeama (93 %), jossa oli väärä annos tai vahvuus (26 %), epäselvä tai puutteellinen annosohje (13 %) tai SIC-merkintä puuttui (11 %). Eniten vaaratapahtumailmoituksia oli hermostoon vaikuttavista lääkeaineista (23 %) sekä systeemisesti vaikuttavista infektiolääkkeistä (19 %). Suurin osa sosiaali- ja terveydenhuollossa ehdotetuista kehittämistoimenpiteistä (n=470) oli tapahtuman käsittelyä ja siitä keskustelua (63 %). Yleisimmin ehdotettiin asian käsittelyä tai siitä keskustelua ylilääkärin ja lääkäreiden kanssa (15 %) tai moniammatillisessa palaverissa (14 %). Tämä tutkimus osoittaa apteekin roolin keskeisen merkityksen sosiaali- ja terveydenhuollon toimijana ja lääkitysturvallisuuden varmistajana. Tutkimuksen perusteella apteekkien vaaratapahtumailmoittaminen voi tukea muun sosiaali- ja terveydenhuollon lääkehoitoprosessien turvallisuuden kehittämistä, mutta kehittämistoimien vaikuttavuutta lääkehoidon vaaratapahtumien ilmaantumiseen tulisi tutkia lisää.
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(2023)Medication safety is an important target of development in health and social services systems internationally. Medication errors are one of the biggest risk factors in medication safety. Majority of the medication incidents could be avoided by improving the medication treatment process. Patient safety incident reporting systems enable health and social services to collect systematic data from risk factors within the medication treatment process. This study was conducted as a retrospective registry-based study where medication incidents that occurred in health and social care units reported by community pharmacies to the incident reporting system HaiPro from 21st of September 2021 to 31st of October 2022 were analysed. Cases that did not meet the criteria for this study (n=55) were removed from the original data (n=3841). If needed, the nature and type of the reported error were corrected. A descriptive quantitative analysis was conducted for the final data (n=3786) using Microsoft Excel. The number, natures, types, observers, and prescription types of medication errors were investigated from the data. In addition, the most common groups of medicinal substance and high risk medicines were identified. A qualitive content analysis was performed to near miss cases involving high-risk medications (n=446) using the Atlas.ti program. Interventions, measures following the interventions and risks prevented by the measures were identified from the open description in the incident reports. The qualitative analysis was performed as an abductive content analysis. Of the medication errors included in the study (n=3786) 91% were detected by community pharmacies and the majority (68%) of the reported incidents were near misses. Most (96%) of the safety incidents (n=3786) were associated with the patient’s medication treatment and had occurred mostly during the prescribing process (92%). As a result from the prescribing errors, patients were most commonly prescribed wrong dose or strength of the medicine (26%) or the prescription lacked SIC marking (26%). High-risk medications occurred in 16% (n=591) of the incidents (n=3786). Most frequently detected high-risk medications were opioids (35 %). Three quarters (76 %) of safety incidents associated with high-risk medications were near misses (n=446). The majority (92 %) of interventions (n=471) made to prevent safety incidents associated with high-risk medications were made by community pharmacies. The most frequent intervention was community pharmacies contacting the doctor. Based on the HaiPro incident reports made about medication errors in health and social care units reported by community pharmacies, it can be concluded that community pharmacies are a central barrier in primary care medication treatment process. Community pharmacies detect and report medication errors that have occurred in other health and social care units. Safety incidents reported by pharmacies systematically accumulate important information that can be used in the development of medication safety in primary care at a unit, wellbeing services county and national levels.
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(2022)The operation of community pharmacies has developed extensively over the past decades, with special emphasis on medication counselling services. In addition to dispensing, pharmacies can offer various kinds of clinical pharmacy services, such as medication reviews, automated dose dispensing and other services to support rational use of medicines. All this activity requires patient information, which is currently available in pharmacies only from prescriptions, reimbursement information, and by asking the customer. Because of this, a need to increase the availability of patient information in pharmacies has come up. The aim of this study was to determine what kind of patient information should be available in community pharmacies for 1) the statutory dispensing of medicines, the medication counselling and treatment monitoring, and 2) other services related to promotion of health and well-being and prevention of diseases. Furthermore, the study investigated experts' experiences of the sufficiency of patient information in pharmacies, as well as in what form and from what period the information should be available in pharmacies. The study was conducted as a 3-round Delphi study with an expert panel consisting of 20 pharmacists specialized in clinical pharmacy. Consensus was formed with the help of a preliminary patient information list which had been compiled based on the literature and the expertise of the research group (a total of 39 patient data items). The limit of the experts' consensus was set to ≥80%. The Delphi-rounds were conducted as electronic surveys during the spring and summer of 2022. The responses were analysed using quantitative and qualitative methods. Most of the expert panellists (n=20) perceived that the patient information available in community pharmacies was insufficient. This study reached a strong consensus that pharmacies should have quite a large set of patient information available both for dispensing medicines and medication counselling, and for providing services supporting rational use of medicines. Of the patient data items, nine reached the consensus line concerning dispensing of medicines and 31 measures concerning other services. From both points of view, information about the client's diagnoses, blood pressure, and the GFR value indicating kidney function were rated as the most important to be available in community pharmacies. However, the panellists also reported challenges to overcome in the access and utilization of the patient information, for example, related to current legislation, resources, and competences of pharmacists. These aspects should be considered in the development of community pharmacy practice and electronic patient information (e.g., Kanta services).
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(2020)The pharmacy operations are strictly regulated in Finland and the operation of a pharmacy business requires a licence. Number of community pharmacies has stayed quite steady for the past 10 years. At the end of the year 2019 there were 817 pharmacies or their subsidiaries in Finland. The number of pharmacies is expected to increase, since 29 new pharmacies has been established since 2016. The inspection of pharmacies is a part of the legal duties of the Finnish Medicines Agency. In Finland, pharmacies are inspected based on a risk assessment, as often as it is necessary to ensure appropriate operations of a pharmacy. During a pharmacy inspection, the focus is on operations that are critical to drug safety and medication safety. The aim of an inspection is to make sure that pharmacy operations comply with the regulations. There are only few studies made on remote inspection of the pharmacies. The Finnish Medicines Agency hasn’t made remote pharmacy inspections before. The aim of this study was to develop, validate and test a questionnaire, which could be used to inspect community pharmacies remotely and to develop and test a process for remote inspections. The study was done in two parts. In the first part, a draft of the questionnaire was developed by studying the regulations and laws regulating the operations of a pharmacy and by using a content analysis. The material for the content analysis was a pre-inspection questionnaire form, answers to the pre-inspection questionnaires and defect lists of the inspection reports of those pharmacies (n=37), which had answered to the pre-inspection questionnaire before pharmacy inspection in 2019. Content of the pre-inspection questionnaire and the answers of pre-inspection questionnaire were compared to the content of the defect lists of inspection reports. The aim of the comparison was to find out how the existing pre-inspection questionnaire could be utilized when developing the questionnaire for the remote pharmacy inspections. In addition, the listed defects of the inspection reports were categorized to explore what were the most common defects observed during pharmacy inspections. In the second part of the study, the content of the developed questionnaire was validated by using a three round modified Delphi survey. Seven experts with good knowledge of the pharmacy inspections were chosen to the Delphi panel. The aim of the Delphi rounds was to achieve full consensus among the experts about the content of the questionnaire. Alongside the Delphi rounds, a process to remote inspect a pharmacy was developed. The remote inspection questionnaire and the process were tested internally in the Finnish Medicines Agency at the end of the second stage of study. The draft of the questionnaire included 15 sections and 164 questions. Based on the comments received during the Delphi rounds, the content of the questionnaire was modified. On the third Delphi round a full consensus of the content of the questionnaire was achieved among the experts. The final questionnaire for the pharmacy remote inspection included 14 sections and 184 questions. The process of the remote pharmacy inspection follows the procedure of an on-site pharmacy inspection. In the internal test, the process of the remote inspection was found to be a good way to inspect pharmacies remotely. The remote inspection process is a new way to inspect pharmacies. With the remote inspection, it is possible to find out the most common defects on the pharmacy operations by using the questionnaire and contact calls. The remote inspection questionnaire and the process need to be further tested to ensure that the process is optimal from the perspective of the authority and the pharmacies.
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(2021)Background and objectives: Documenting and processing of dispensing errors at both organizational and national levels is one of the basic preconditions for effective medication risk management. Since the most recently accomplished national register research of dispensing errors in Finland, there have been several changes in the medication dispensing process that advance medication safety. Thus, the previous study does not provide an up-to-date picture of the current situation. The primary objective of this study was to find out the trends in dispensing errors that were reported to the Finnish Pharmacy Association's registry of dispensing errors in 2015–2019. The secondary objective was to identify risk factors expository to dispensing errors in the dispensing process and to review the measures utilized by community pharmacies to prevent dispensing errors. Materials and methods: The retrospective registry study, in which the register of dispensing errors maintained by the Finnish Association of Pharmacists for the period from 1 January 2015 to 31 December 2019, was analyzed. Cases that did not fulfil the definition of a dispensing error (n=829) were removed from the original data (n=17763). In addition, clear errors (n=2130) were corrected in the data and cases (n=499) that were initially insufficiently entered in the register were added. 17433 dispensing errors were included in the study. The data was analyzed using Microsoft Excel. The number, qualities, prescription types, observers, therapeutic harms and contributory factors of the dispensing errors were investigated in the data. The most common groups of medicinal substance, high-alert medications and risk factors in the medication dispensing process were identified in the data. In addition, interventions reported by community pharmacies to prevent dispensing errors were collected from the data. Results: The number of cases reported to the dispensing error register has decreased annually (2015 n=3913, 2016 n=3795, 2017 n=3708, 2018 n=3578, 2019 n=2439). The most common types of dispensing errors are incorrect strength (51 % of all the reported dispensing errors) and incorrect quantity or package size (14 %). Slightly more than a half (51 %) of the reported dispensing errors were noticed by medicine users. The percentage of electronic prescriptions in dispensing errors has increased and is clearly the most common prescription type in dispensing errors (2015: 79 %, 2016: 84 %, 2017: 93 %, 2018: 96 %, 2019: 95 %). The majority of dispensing errors occurred with cardiovascular medicines (29 %) and medicines affecting the nervous system (26 %). 7 % of dispensing errors caused therapeutic harm to the medicine user. As a result of dispensing errors, 21 medicine users were hospitalized. 13 % of dispensing errors occurred with high-alert medications (n=2244). The high-alert medications were involved in one-third (n=7) of dispensing errors that led to hospitalization. Factors related to the employee (25 %), similar packaging (19 %), and similar medicine name (15%) were most commonly considered to be the main contributory factors for the occurrence of the dispensing errors. The risk factors identified in the medicine dispensing process were related to the pharmacy system, the characteristics of the prescription, the storage method of the medicine and the characteristics of the medicine packaging. In the automated dose dispensing process, the risk of dispensing error increased if changes had to be made to the dose dispensing order. The risk factors for automated dose dispensing were related to the pharmacy system and the characteristics of the prescription. The community pharmacies had mentioned taking measures to prevent dispensing errors in one-fifth (21 %) of the reported cases. In addition to developing their own operations, community pharmacies saw cooperation with other healthcare professionals as an important factor in preventing medication errors. In addition, community pharmacies reported exposing properties for dispensing errors of pharmaceutical products and systems to pharmaceutical companies and providers of pharmacy systems and automated dose dispensing. Conclusions: Trends, risk factors of the dispensing process and interventions to prevent dispensing errors can be identified in the dispensing errors reported to the Finnish Association of Pharmacists’ dispensing error registry. The dispensing error register provides valuable information on dispensing errors at the national level, but it is no longer able to fulfil completely the current medication safety needs. In the future, the role of the pharmacy as a promoter of medication safety should be perceived as more comprehensive. In the development of medication safety, special attention should be paid to the risk factors of the dispensing process, the high-alert medications and to new risks arising from the increase of electronic prescriptions and automated dose dispensing. In addition, cooperation between pharmacies and other healthcare professionals and the medication safety culture of pharmacies should be further strengthened.
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(2022)Operations of pharmaceutical supply chain and medication management practices will be evaluated as part of the ongoing social and health services reform in Finland. One of the goals is to develop digital medication management tools and services to meet the needs of both healthcare professionals and medicine users. The aim of this study was to examine population's willingness to use on new digital services by community pharmacies to promote rational pharmacotherapy and to support cooperation between those involved in the medication use process. The material for this study consisted of the national population survey conducted in 2020 for the VN TEAS report “Activation of price competition for pharmaceutical products and the population's expectations for pharmacy operations” (online survey for 18–79-year-old adults, n = 1650). The survey respondents represented well the target population expect those with higher educational level were over-represented. The current study focused on questions related to digital medication management services provided by community pharmacies, which were divided into the following 4 topics to form sum variables: 1) purchasing and dispensing process of medicines (4 items), 2) customer`s communication with pharmacy and health care personnel (2 items), 3) pharmacy and healthcare personnel`s communication with the customer (4 items) and 4) support services for medication self-management (12 items). The associations of the background variables to the sum variables were calculated using cross-tabulation and the Chi-Square test. Frequencies and percentages were used to present. The majority (85–90%) of the respondents were in favor of the possibility of sending messages electronically between the customer, the community pharmacy and other healthcare personnel by using a shared communication channel, such as My Kanta to update medication information online. Multimorbidity, medication use, and higher medication costs increased the respondent’s positive attitude towards the electronic communication channel. Three-quarters (76%) of respondents were willing to use electronic medicine purchasing and dispensing services. Younger respondents (18–34 years) were more interested in these services than older ones. The electronic medication self-management support services had more discrete opinions among respondents. More than half of the respondents indicated their strong willingness to use at least one of the medication self-management support online services listed in the survey instrument. Those aged 18–34 years (69%), those with higher education (62%), those living in the Province of Southern Finland (60%) and those living in the Helsinki Metropolitan Area (67%) were more positive than others. Of the respondents who opted for pharmacy's remote online services, 55% were willing to seek advice for reconciling their medication list. According to the survey, Finnish adults are willing to use new electronic services by community pharmacies. In particular, they were willing to use a shared electronic communication channel between the customer, the pharmacy and other healthcare personnel, such as MyKanta to update information related to their medication. The willingness to have support self-care support for medication self-management primarily from the pharmacy's online services was lower than the willingness to use online purchasing and dispensing services. Of the remote medication self-management services medication reconciliation had the highest demand. Future research should focus on enhancing use of electronic medication self-management services provided by community pharmacies. Further research should also be targeted to understand medicine user needs for support as it may vary between patient groups, requiring segmentation of services.
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(2021)Pharmacy compounding involves the preparation of customized medications that are not commercially available for individual patients with specialized medical needs. The compounded preparations have many special features, such as the rapid/immediate need for the drug, the preparation of several pharmaceutical dosage forms, and the variation of batch sizes and manufacturing processes. Medicinal products prepared in hospital pharmacies may pose additional risks to patients compared to industrial products. These risks with limited evidence of quality, efficacy and microbiological purity can jeopardize patient safety. The aim of this study was to perform a product specific risk assessment of aseptically processed and terminally sterilized products belonging to the manufacturing range of the hospital pharmacy of Turku University Central Hospital. The study material contained 118 different products. The risk assessment was performed with the help of a risk matrix in which various quality and safety risks have been identified and assessed. The risk points obtained from the different areas of risks were multiplied together to obtain total risk points for each product. The products were qualitatively classified according to the total risk points into low-risk, medium-risk and high-risk products. All total parenteral nutrition (TPN) solutions of the study were classified as high-risk products. TPN solution prepared into a syringe without lipids and TPN solution prepared into an EVA bag without lipids had the highest risk points of the study (6561 points). Most of the eye drops (88 %) and patient controlled analgesia (PCA) pumps (68%) belonged to high-risk category. PCA pump containing morphine, clonidine, bupivacaine, ketamine and saline solution (1944 points) and autologous serum eye drops (1296 points) had the highest risk points of these product types. 60 percent of intraocular injections and half of pain products prepared into syringes were scored as high-risk products. Intravitreal bevacizumab had the highest risk points of intraocular injections (972 points). Medium-risk products were mainly different infusions. Infusions containing defibrotide, oxytocin and onasemnogene abeparvovec had the highest risk points in the medium-risk category. Liquid solutions and patient controlled analgesia (PCA) pumps were the second largest group in this category. All products used in allergy testing, all ointments and all inhalation solutions were in the low-risk category. The risk matrix used in the study can be used to identify high-risk compounded preparations in hospital pharmacies. Risk assessment enables targeting quality assurance more effectively to high-risk products. Risk assessment can be used to manage various risks in pharmaceutical compounding and reduce harm to patients. The results obtained in the study cannot be directly generalized to other hospital pharmacies because the products, manufacturing processes and the amounts of different products prepared vary among hospital pharmacies.
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Biologisiin lääkkeisiin ja biosimilaareihin liittyvä osaaminen suomalaisissa avohuollon apteekeissa (2024)Biological medicines are used, for example, in the treatment of diabetes, cancer, and autoimmune diseases. Biological medicines cause a significant part of the costs of prescription drugs in outpatient care. In Finland, automatic substitution of biological medicines will be introduced in 2024–2025 to promote the use of biosimilars and to increase price competition. When substituting biological medicines, pharmacists are required to counsel the customer and ensure proper use of the new administration device. The objective of this study was to study Finnish community pharmacists’ knowledge about biological medicines and biosimilars and the need for further training. Data was collected with an electronic questionnaire and analyzed using frequencies and percentages. Associations between background variables and readiness for automatic substitution were analyzed using crosstabulation and chi-squared test. Differences in drug-specific knowledge were compared using sum variables. Most pharmacists (n=899) answered that they understood at least the basics of what biological medicines and biosimilars are. The important role of biosimilars in reducing society's drug costs seemed to be well understood, but only one in four (25.0%) felt that they were ready for automatic substitution. Master’s degree in pharmacy, graduating as a pharmacist (BSc) between 2010 and 2022, and working in community pharmacy for less than 10 years after graduating as pharmacist (BSc) increased the experience of readiness for automatic substitution. Previous work in the pharmaceutical industry or wholesale trade, in official positions or in research and teaching positions also increased the experience of readiness for automatic substitution, as well as clinical expertise or additional training in the field of pharmacy. Drug-specific knowledge seemed to be best about enoxaparin and insulins. Further training was needed especially on the differences of administration devices and giving injection advice. The strength of this study was a representative sample of pharmaceutical personnel working in Finnish community pharmacies, although low response rate weakens generalizability of the results. The results give an indication of how Finnish community pharmacists assessed their knowledge about biological medicines and biosimilars before the introduction of automatic substitution in Finland. Further research is needed to monitor the development of knowledge about biological medicines and to examine customers’ experience on the quality of medication counselling related to biological medicines at pharmacies.
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(2021)Pharmaceutical costs have been rising globally every year. A significant portion of drug costs is caused by biological drugs, which are often very expensive, yet essential in the treatment of many chronic diseases. Biosimilars are clinically equivalent to biological originator products and are expected to alleviate the increase in drug costs. The biosimilar development process does not need to repeat the complete development process of the originator product, allowing the biosimilar to enter the market at a lower price than the originator after the patent and data protection period for the originator ends. The aim of this study was to find out what impact the market entry of biosimilars has on the prices of the reference products in outpatient care in Finland, and to investigate whether biosimilars create price competition for biological drugs. In addition, the study examined how the prices and market shares of outpatient biosimilars have developed in Finland. The study examined the development of price and market shares for adalimumab, etanercept, insulin glargine, insulin lispro, enoxaparin, filgrastim, pegfilgrastim, somatropin, follitropin alfa, teriparatide and epoetin biosimilars and their reference products. The data for the study was acquired from IQVIA and it covered pharmacy wholesale data between 1.1.2009–31.8.2020 for products under investigation. The weighted average wholesale price and monthly wholesale amounts were determined for each product, and the development of the price and market shares were analyzed. In addition, a linear segmented regression analysis was performed to examine the impacts of market entry of biosimilars on the prices of the reference products. According to the study, the prices of the reference products mainly decreased after the biosimilar entered the market. If the price of the reference product did not fall, it lost its reimbursement under the Health Insurance Act. The market shares of the reference products were marginal when they were no longer reimbursed. The prices of biosimilars did not change as much as the prices of reference products, and for most active substances biosimilar prices remained stable or decreased. The use of biosimilars varies widely between different biologics. The study found that prices of reference products were decreasing mainly as a result of various changes in drug policies. Therefore, biosimilars were not seen to generate genuine price competition between biological products. In many of the drug groups examined, the market shares of biosimilars had future growth potential.
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Comparison of The U.S. and Finnish pharmaceutical markets and their impact on health care spending (2020)Theoretical framework: The consolidated pharmaceutical market is becoming increasingly global and the same international pharmaceutical companies operate around the world in different countries, responsible for drug development and production. The high costs of developing novel medicines and the motive for higher profits has led to elevating price level of pharmaceuticals and health care services. Finland and the U.S. offer two extremes at the pharmaceutical market. The pharmaceutical market field in Finland is very structural and rigid, and medicine prices are regulated by law. In the U.S. the prices are based on the laws of supply and demand and the prices differ by different states, retailers and insurance policies. A small-scale longitudal price comparison is also reviewed to showcase the effect of continuously rising medicine prices. Study objective: The idea of this study is to describe and compare pricing mechanisms of pharmaceuticals and price differences between two very different market structures and review how these might affect the cost-effectiveness of national health care spending. These divergences are also mirrored to survey recent global pharmaceutical market problems such as drug shortages, possibly due to less appealing markets of higher price regulation policies. Materials and methods: Price data were collected from national, official, open-source databases. National health care expenditure and comparison to GDP was collected from publications by the OECD. All monetary values have been presented in both currencies (EUR and USD) to present more comparable values. Results: When compared to other OECD-countries the U.S. spent distinctly the largest amount of funds on health care per capita. Finland’s national health care costs were thousand times minor in total spending and less than a half per capita when compared to those of the U.S. With lower expenditure Finland manages to offer access to public, government-funded health insurance program. Meanwhile the prices of prescription medicines in Finland have decreased significantly, the prices for have continuously elevated in the U.S. Conclusions: The outcome of this study is that free markets and a complex supply chain, compared to more regulated markets with more transparency, have higher overall price level in pharmaceuticals and health care services. Free markets and sufficient intellectual property rights are more enticing to pharmaceutical companies. They promote new innovations and developing of much-needed novel therapies to modern health problems, such as AIDS and the global threat of worsening situation of antibiotic resistance. More regulated markets may create problems such as drug shortages and are often considered complex and less appealing market systems due to high level of administrative work but conserve the cost-effectiveness of the use of public funds.
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(2023)Adequate vaccine coverage and vaccine refusal have been prominently featured in the media during the COVID-19 pandemic. The decision-makers have considered adequate vaccine coverage important for maintaining the capacity of healthcare. The purpose of this study is to produce population-based research data about the factors affecting the willingness to take the COVID-19 vaccine. With the help of that information, it is possible to identify the factors that influence individual’s decision-making about whether to take the COVID-19 vaccine. The data of the study is the first Kansalaispulssi-data of the year 2022. Kansalaispulssi is a survey, made by the assignment of the State Council, which is used to research Finnish citizen’s views of the current topics. The research design is cross-sectional. The analysis of the study is done by crosstabulation using the Chi-square test. Age and financial situation of the person were related to the willingness to take the COVID-19 vaccine and the person's view of the role of the vaccine in preventing severe corona disease and getting rid of the COVID-19 pandemic. Age also influenced the person's view of the importance of the vaccine in preventing the COVID-19 disease. Gender, province, or educational level had no effect on a person's vaccine views in this study. Based on the research, Finnish citizens are very pro-vaccine. They also understand well the role of the vaccine in preventing a serious illness caused by the disease.
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(2024)Tutkimuksen tausta: Avohuollon apteekit tekivät monia toimenpiteitä varmistaakseen apteekkipalveluiden jatkuvuuden ja lääkkeiden saatavuuden COVID-19-pandemian aikana. Kriisijohtamisen prosessiteoria antaa rakenteellisen viitekehyksen kriisien ymmärtämiseen ja hallintaan. Tavoite: Tutkimuksen tavoitteena oli tutkia suomalaisten avohuollon apteekkien kriisijohtamisprosessia COVID-19-pandemian aikana käyttäen kriisijohtamisen teoriaa teoreettisena viitekehyksenä. Menetelmät: Poikkileikkauskyselytutkimus kehitettiin kriisijohtamisen prosessiteorian pohjalta ja lähetettiin suomalaisille avohuollon apteekkareille sekä yliopistoapteekkien johtaville proviisoreille toisen pandemia-aallon aikana loka–marraskuussa 2020. Logistisen regressioanalyysin avulla tutkittiin, oliko johdon riskinäkemyksellä yhteyttä kriisivalmiuteen, ja miten kriisisuunnitelmat, tiimit ja yhteistyö ulkoisten sidosryhmien kanssa olivat yhteydessä pandemian vaikutuksiin avohuollon apteekeissa. Avoimista vastauksista saatu laadullinen aineisto ryhmiteltiin samankaltaisuuksien perusteella. Tulokset: Kyselyyn vastasi yhteensä 221 apteekkaria ja johtavaa proviisoria (vastausprosentti 36,7 %). Apteekeista 79,6 %:lla oli olemassa pandemiasuunnitelma ennen kriisiä. Pandemiakriisitiimi oli nimetty 35,3 %:lla apteekeista ja 33,5 % lisäsi tai paransi yhteistyötä muiden apteekkien tai lääkehuollon toimijoiden kanssa. Kollektiivinen päätöksenteko ja ulkoisen yhteistyön lisääminen tai parantaminen olivat yhteydessä vähäisempiin negatiivisiin vaikutuksiin johdon jaksamisessa. Lisäksi kollektiivinen päätöksenteko oli yhteydessä vähäisempiin negatiivisiin vaikutuksiin organisaation taloudessa. Kirjallisuudesta poiketen olemassa olevalla pandemiasuunnitelmalla oli enemmän negatiivisia vaikutuksia organisaatioiden resursseihin. Yhteyttä apteekkarin riskinäkemyksen ja apteekkien kriisivalmiuden välillä ei havaittu. Johtopäätökset: Apteekkien tekemät toiminnalliset muutokset ja infektion ehkäisy- ja torjuntakäytännöt mahdollistivat keskeisten palvelujen tarjoamisen pandemian asettamista haasteista huolimatta. Oppimista ja sopeutumista tapahtui reaaliajassa kriisin aikana. Kollektiivisen päätöksenteon kehittäminen ja yhteistyö kollegoiden ja muiden lääkehuollon toimijoiden kanssa voivat parantaa apteekkarien jaksamista ja apteekkien taloutta tulevissa kriiseissä. Jatkotutkimuksissa voitaisiin hyödyntää laadullisia tutkimusmenetelmiä ja tutkia tarkemmin kollektiivista päätöksentekoa sekä vaikuttavan kriisisuunnitelman sisältöä avohuollon apteekkien kontekstissa.
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(2022)Digitalization of health care and the corona pandemic have increased availability and use of online services provided by community pharmacies. In Finland, willingness to use online pharmacy services has been studied from population approach. Less is known about the user satisfaction with the core online pharmacy services such as dispensing and medication counseling services. This study aimed to investigate satisfaction with the University Pharmacy’s online services (ya.fi) from customers’ approach. Primarily, customer satisfaction with dispensing and medication counseling services was assessed. In addition, characteristics affecting customer satisfaction were analyzed. The conceptual framework of the study was Andersen's Model of Health Services Use. The data for this study was collected by a cross-sectional survey conducted in August 2020 among University Pharmacy’s online pharmacy customers who had made a purchase during the last three months. The survey instrument consisted mainly of structured Likert-scale questions, which were used to form two sum variables: satisfaction on online dispensing services (3 variables, Cronbach's alpha 0.803) and satisfaction on online counseling services (2 variables, Cronbach's alpha 0.883). Satisfaction on online dispensing services was studied through willingness to recommend and use the services in the future. Satisfaction on online counseling services was studied through a comparison of medication counseling on an online pharmacy and a conventional pharmacy. IBM SPSS (28) -software was used for statistical analysis consisting of bivariate (Kruskal-Wallis and Mann-Whitney U tests) and multivariate (generalized linear model) analyses to identify factors affecting satisfaction with dispensing and medication counseling services. Of 15 172 invitations sent to fill out the survey, 2555 eligible responses were received (16 %). Of the respondents, 92 % had concomitantly used the services of a conventional pharmacy. . The mean of satisfaction on online dispensing services on a scale from 1 to 5 (5 being the most positive option "completely agree") was 4.3 (SD 0.8). Similarly, the mean of satisfaction on online counseling services was 3.7 (SD 0.9). According to the multivariate analyses, significant characteristics affecting satisfaction on online dispensing services were age, form of living (alone/family with children/couple), purchase of prescription or OTC medicine, frequency of internet use and previous visits to a conventional pharmacy. Characteristics affecting satisfaction on online counseling services were education, purchase of prescription medicine, use of chat information service, frequency of internet use and previous visits to a conventional University Pharmacy outlet. The services on ya.fi online pharmacy rated most important by the respondents were services about medicine availabilities (in conventional University Pharmacy outlets and during a shortage) and information about medicines (prices, Kela reimbursements and information about customers' prescriptions). Customers were satisfied with online dispensing and counseling services. Online dispensing services received a higher satisfaction rate than online counseling services. Customers who had used the chat service and purchased a prescription medicine online were more likely to assess online counseling services to be equal or better than in a conventional pharmacy. Active use of internet and purchases of medicines online were factors connected to higher satisfaction with online dispensing services. Most online pharmacy customers had also visited conventional pharmacies. The results from this study can be utilized in the development of online and other pharmacy services.
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(2022)There is a growing need for antibiotic stewardship since antibiotic resistance is a global and increasing problem. One option would be outpatient parenteral antibiotic therapy (OPAT) which has evolved globally since 1970s. In Helsinki, it has been applied in hospital-at-home units since 2018 with elastomeric antibiotic infusion pumps that enable 24-hour continuous infusion and normal daily life for the patient. The continuous infusion via infusion pumps enables the use of first-line antibiotics whereas with intermittent infusions broad-spectrum antibiotics, that require doses less frequently, are a more likely choice. Thus, antibiotic therapy with elastomeric infusion pumps is likely to enhance antibiotic stewardship. The aim of the study was to analyse if treatment with elastomeric infusion pumps in hospital-at-home unit is cheaper than theoretical hospital stay and to compare the costs. An economic evaluation was performed with the assumption that hospital-at-home care and hospital stay are equal when it comes to the outcomes of the therapy. The economic evaluation was made with cost-minimization analysis. Data were collected manually by nurses in three hospital-at-home units in Helsinki between September 2021 and March 2022. Patients’ age, gender, indication and length of the antibiotic infusion pump therapy, distance from the hospital-at-home unit and problems with the therapy were collected. Cost information were received personally from City of Helsinki and taken from a paper of Finnish Institute for Health and Welfare. The data included 57 patients, of whom one had two treatment periods. The mean age was 60 years. Thirty-two percent of patients were female and 68% were male. The most common indications were bacteremia (n=24) and erysipelas (n=18). A total of 625 hospital bed days were saved, which is 10,8 days per patient on average. Cost savings with elastomeric infusion pump therapy were 89 000–116 000 euros compared to the theoretical treatment in a hospital ward depending on the cost information being used, which is 37–48% of the theoretical hospital stay costs. An economic evaluation was made separately for the treatment of bacteremia. The cost savings were 47 600–150 700 euros or 37–69% of the theoretical costs. Savings in travel costs were 2 300–3 800 euros when elastomeric pump therapy was compared to the conventional hospital-at-home intermittent infusion therapy of 4-6 nurse visits per day per patient. In conclusion, elastomeric infusion pump therapy in hospital-at-home units in Helsinki results in cost savings of 37–48% compared to theoretical hospital stay costs from the perspective of the entity responsible for the costs of the treatment.
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(2020)Lääkevaihto ja sitä täydentävä viitehintajärjestelmä ovat laskeneet lääkekustannuksia Suomessa. Epilepsialääkkeet eivät ole aiemmin kuuluneet lääkevaihdon piiriin, sillä epilepsian hoidossa eri valmisteet eivät välttämättä ole terapeuttisesti tarpeeksi samanarvoisia, ja pienikin muutos hoitotasapainossa voi altistaa epilepsiakohtauksille. Nykyisin epilepsialääkkeitä käytetään kuitenkin usein muihinkin käyttöaiheisiin, kuten psykiatrisiin sairauksiin ja kivun hoitoon. Vuonna 2017 lääkekorvausjärjestelmään tehtiin säästötoimenpiteitä, joiden yhteydessä epilepsialääkkeet sisällytettiin lääkevaihdon piiriin muissa käyttöaiheissa kuin epilepsian hoidossa. Lisäksi otettiin käyttöön poikkeava viitehintaryhmä, joka koski epilepsialääkkeistä pregabaliinia neuropaattisen kivun käyttöaiheessa. Tutkimuksen tavoitteena oli tarkastella epilepsialääkkeiden (pregabaliinin, gabapentiinin, topiramaatin, lamotrigiinin ja valproiinihapon) vaihtamista sekä hintojen kehitystä lääkevaihtoon ja viitehintajärjestelmään sisällyttämisen jälkeen vuoden 2017 alusta vuoden 2019 puoliväliin. Lisäksi tarkasteltiin näiden lääkeaineiden kustannusten, korvausmenojen sekä käyttäjä- ja reseptimäärien kehitystä. Aineistona käytettiin Kansaneläkelaitoksen reseptirekisteriin pohjautuvia tilastoja epilepsialääkkeiden lääkeostoista sekä lääkkeiden hintalautakunnan päätöksiä epilepsialääkkeiden viitehintaryhmistä ja viitehinnoista. Epilepsialääkkeiden vaihtaminen yleistyi tarkastelujakson aikana kaikilla lääkevaihdon piirissä olleilla viidellä lääkeaineella, ja vaihtokieltojen osuus resepteistä laski useimmilla lääkeaineista. Viitehinnat laskivat useimmissa tarkastelluista viitehintaryhmistä, mutta lähes yhtä usein viitehinta ei muuttunut. Viitehinnat laskivat enemmän viitehintaryhmissä, joissa oli useampia vaihtokelpoisia valmisteita. Lääkevaihdon ensimmäisenä vuonna 2017 lääkevaihtoon kuuluvien epilepsialääkkeiden kustannukset ja korvausmenot pääosin laskivat, vaikka lääkkeiden käyttö ei vähentynyt. Lääkevaihdon toisena vuonna kustannukset eivät juuri laskeneet. Pregabaliinin poikkeavan viitehintaryhmän vuoksi vaihtamatta jääneet reseptit aiheuttivat merkittävän osan lääkevaihtoon kuuluvien epilepsialääkkeiden kustannuksista. Pregabaliinille jäi siten todennäköisesti yhä säästöpotentiaalia poikkeavan viitehintaryhmän voimassaolon päätyttyä vuoden 2019 heinäkuussa, mitä on syytä tarkastella jatkotutkimuksissa.
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