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  • Rantanen, Ilona (2023)
    Väestön ikääntyessä sairastavuus lisääntyy ja käytettyjen lääkkeiden määrä kasvaa altistaen lääkkeiden haitta- ja yhteisvaikutuksille. Iäkkäiden suuri sairastavuus, monilääkitys ja lääkkeiden aiheuttamat haitat voivat kasaantuessaan huonontaa elämänlaatua ja toimintakykyä. Lääkehoidon arviointien avulla voidaan tunnistaa ja ratkaista monilääkittyjen iäkkäiden lääkitysongelmia. Jos potilaan lääkehoidon kokonaisuutta ei arvioida säännöllisesti, lääkkeitä voidaan määrätä lisää perusteettomasti, mikä voi johtaa lääkkeiden kasautumiseen ja estettävissä olevien haittojen lisääntymiseen. Tämän tutkimuksen aineisto perustuu Lohjan kaupungin kotihoidossa vuosina 2015-2017 toteutettuun interventiotutkimukseen. Tämän tutkimuksen tavoitteena oli analysoida pseudonymisoiduissa lääkehoidon arviointiraporteissa (n=43) tunnistettuja lääkitysongelmia (drug-related problems, DRPs) 65 vuotta täyttäneillä PCNE-luokittelujärjestelmän avulla. Lisäksi tavoitteena oli tarkistaa erilaisten lääkehoidon tietokantojen ja työkalujen avulla olivatko farmasistien muutosehdotukset ja huomiot valideja ja hoitosuositusten mukaisia. Lisäksi tutkittiin, mihin ATC- pääryhmiin ja edelleen lääkeaineisiin muutosehdotukset kohdistuivat sekä miten ne toteutuivat. Muutosehdotuksille ja huomioille (n=167) yleisimmin koodattu PCNE-luokituksen mukainen ongelma (P) oli P2.1 “Lääkkeen haittatapahtuma (mahdollinen)” (65,3 % n=109). Yleisin koodattu syy (C) oli C1.1 “Epätarkoituksenmukainen lääke suhteessa suosituksiin” (34,1 %). Ehdotuksista toteutui seurannassa 37,7 % (n=63), joissa yleisimmät interventiot olivat I3.5 ”Lääkkeen lopetus tai tauotus” (n=27) ja I3.2 ”Annosmuutos” (n=23). Yleisimmin muutosehdotukset ja huomiot kohdistuivat hermostoon vaikuttaviin lääkkeisiin (43,7 %), ruuansulatuselinten sairauksien ja aineenvaihduntasairauksien lääkkeisiin (26,3 %) ja sydän- ja verisuonisairauksien lääkkeisiin (15,0 %). Muutosehdotuksista ja huomioista 37,1 % (n=62) liittyi Fimean Lääke 75+ -tietokannan mukaan iäkkäille varauksin soveltuviin (ns. C-luokka) ja 23,9 % (n=41) iäkkäillä vältettäviin lääkeaineisiin (ns. D-luokka). C-luokan lääkeaineisiin liittyneistä ehdotuksista toteutui 27,4 % ja D-luokan lääkeaineisiin liittyneistä ehdotuksista toteutui 37,5 %. Farmasistin muutosehdotuksista ja huomioista valideja oli 98,2 % (n=164/167). Farmasistien osaamista tulisikin hyödyntää enemmän lääkitysongelmien ratkomisessa, mikä tukisi lääkärien sekä muiden sosiaali- ja terveydenhuollon ammattilaisten työtä.
  • Sjöblom, Annika (2015)
    Background: Medication errors are the most important individual factor that jeopardizes patient safety in human care. The patient's medication process is a chain of successive operations which involves different health care providers and the medicine user. All the stages of the medication process are susceptible to the medication errors. Medication errors are approached from the system's point of view by James Reason`s (1990) theory of Human Error. Instead of blaming individuals the theory concentrates on developing operations models which enable identification of medication errors in the organizations. The development of medication safety culture in the human medication has led to systems which tolerate human mistakes and prevent errors. The increasing number of animals and pets and their changing status in the society have raised discussion about the medication safety in veterinary care. Little research has been conducted in this field. Objective: The objective of the study was to identify the most typical veterinary medication errors and their root causes. The medication management processes of veterinary care can be developed safer by becoming aware of the root causes of medication errors. Study design and data: All the cases investigated by the Assessment Board for Damages in Veterinary Practice in 2002-2013 considering medication errors (n=79) were analysed with the help of the structured data collection sheet by using descriptive statistics. The most typical cases were studied more in detail by using simplified Root Cause Analysis (RCA). Results: The medication errors found were related to the care of dogs (n=34), horses (n=26), bovines (n=10), cats (n=7) and pigs (n=2). The most general therapeutic groups that had caused medication errors were antibacterials for systemic use (17% of all the medicines related to the medication errors), NSAIDs and antirheumatic drugs (12%), neuroleptics and tranquillizers (12%), and analgesics (12%). Of the drugs, 39% were high alert medicines. Of the errors, 36% were related to the off label use (usage deviating from the summary of product characteristics, SPC). The error types which appeared most commonly in the cases were wrong route of administration (18% of all the medication errors), wrong dose (16%) and untreated diagnosed conditions left without the medicine by the veterinarian (15%). Because of the character of the data the majority of the medication errors occurred in the beginning of the medication process. It was estimated that 81% of the medication errors would have been preventable. Some of the root causes found were the lack of the commitment to the established care practice, environmental factors, communication problems, availability of tools, hurry and factors related to management, information and staff. Conclusion: The material of Assessment Board for Damages in Veterinary Practice gives valuable information about the veterinary medication errors. It is possible to influence the root causes of veterinary medication errors by paying attention to the management related factors and communication in veterinary care and improving access to therapeutic guidelines and electronic databases, and by expanding the electronic prescribing to veterinary care. The highest priority is to get Pharmaca Fennica Veterinaria to an electronic form.
  • Koskinen, Kati (2013)
    Ensuring patient and medication safety is a widely acknowledged challenge in health care. Key concepts in medication safety are: a patient safety incident, a safety barrier, and a medication error. A patient safety incident is an incident which has led or could have led to harm for the patient. A safety barrier is a structure built into the medication use process, and it is designed to improve medication safety. A medication error is a deviation from the medication process. The medication safety of cancer patients is especially important. Chemotherapeutic agents usually have a narrow therapeutic index and they have toxic side effects even in therapeutic doses. Accordingly, chemotherapeutic agents are classified as high alert medications. This means that they have an increased risk for patient harm if used improperly. Cancer patients are often elderly people and they have comorbid diseases. As a result, they are more susceptible to adverse drug effects. Moreover, the use of anticancer drugs varies between patients and the different indications of a drug, and supportive therapies are often needed. Thus, cancer pharmacotherapy is complicated. In this registry study, safety in the medication process of cancer treatment was studied using voluntary patient safety incident reports in one university hospital district in Finland. The aim of this study was to describe medication errors in cancer treatment, and safety barriers in the medication use process. The reported medication safety incidents were analysed by combining quantitative and qualitative methods. Altogether 176 incident reports were analysed relating to the use of anticancer drugs and supportive therapies. The most common medication errors were administration (27 %), prescribing (11 %), and ordering errors (10 %). These medication errors were typically omission errors. There were safety barriers in the medication process, such as double-checking of medicines, but they were not always fully effective. Some barriers were missing, for example, computer programs lacked important safety features. Safety barriers are needed, and should be further developed especially in the prescribing, ordering and administration phases of the process. More effective barriers would increase patient and medication safety in cancer treatment. The classification of medication errors in patient safety incidents was not always correct. Therefore, reporting and analysing of reports should be improved. The results of this study can be utilised for improving medication safety in all organisations giving cancer pharmacotherapy.
  • Englund, Nia (2023)
    Tausta: Lääkehoitoon liittyvät haittatapahtumat aiheuttavat merkittävää inhimillistä kärsimystä ja taloudellista taakkaa yhteiskunnalle. Lääkitykseen liittyviä haittatapahtumia voidaan ehkäistä tunnistamalla ja puuttumalla lääkitysriskejä aiheuttaviin tekijöihin. Tavoitteet: Tutkimuksen tavoitteena oli tutkia lääkitysriskien hallintakeinoja lääkkeen toimittamisen yhteydessä suomalaisissa avohuollon apteekeissa. Tavoitteena oli selvittää, miten apteekeissa tunnistetaan ja puututaan asiakkaan lääkehoitoon liittyviin ongelmiin ja millaista lääkitysriskien hallintaan liittyvää osaamista ja lisäkoulutustarvetta apteekeissa työskentelevillä farmaseuteilla ja proviisoreilla on. Aineisto ja menetelmät: Tutkimus oli valtakunnallinen poikkileikkaustutkimus, jonka aineisto kerättiin syksyllä 2022 sähköisellä kyselyllä. Alkuperäinen kyselylomake luotiin vuonna 2015 kirjallisuuden ja järjestelmälähtöisen riskien hallinnan teorian pohjalta ja päivitettiin tätä tutkimusta varten. Tulokset: Kyselyyn vastasi 192 apteekkia (n=610). Apteekeissa tunnistettiin ja puututtiin lääkehoito-ongelmiin, mutta toimintatavat olivat harvoin systemaattisia. Yleisin puuttumistapa oli keskustelu asiakkaan kanssa ja kehotus ottaa yhteyttä lääkäriin, näin toimi 78 % apteekeista tilanteessa, joissa asiakkaan lääkitys ei toiminut toivotulla tavalla. Suurimmalla osalla apteekeista ei ollut muun terveydenhuollon kanssa yhteisesti sovittuja toimintatapoja lääkehoito-ongelmien ratkaisemiseksi. Myös apteekin sisäiset toimintaohjeet olivat puutteellisia Johtopäätökset: Apteekkien ja muun terveydenhuollon välinen nopea viestintäkanava ja yhteisesti sovitut toimintatavat voisivat parantaa apteekkien mahdollisuuksia puuttua lääkehoito-ongelmiin. Apteekkien rooli lääkitysriskien hallinnassa tulee määritellä tarkemmin. Apteekkien ja muun terveydenhuollon välisessä yhteistyössä on paljon hyödyntämätöntä potentiaalia.
  • Toivonen, Salla (2023)
    The lack of up-to-date medication information in healthcare electronic information systems, the transfer of medication information with the patient, and the overall management of medication are key challenges in health care. The number of cancer patients in Finland will increase in the future due to the aging of the population, early detection of cancer, improvement in cancer prognosis and the development of cancer treatments. The development creates a need for operating models that improve medication safety. Medication safety of cancer patients can be improved with clinical pharmacy services, such as medication reconciliation and medication review. The aim of this study was to investigate the accuracy of the medication charts and identify the drug related problems and risks related to home medications among patients with newly diagnosed cancer in the Oncologic Outpatient Clinic of Turku University Central Hospital. This was a retrospective register-based study carried out as an operational development project to obtain information about the current operational model of pharmacist-led medication reconciliation and to further develop it. The theoretical starting point for the study was the theory of human error, according to which factors endangering patient safety can be prevented by using system-based safety defences. In the study, almost every (93 %, 69/74) patient's medication information differed from the hospital's information. A total of 392 discrepancies related to medication information and an average of 5,3 discrepancies per patient were observed in the data (range 0-15 discrepancies). High alert medications accounted for 14 % (n=53/392) of all discrepancies. It took an average of 19 minutes per patient to confirm a medication reconciliation (range 5-48 minutes). During medication reconciliation the pharmacist recorded observations for the doctor in 15 (20 %, n=15/74) patients. In the retrospectively performed medication review, a total of 183 possible drug related problems or risks related to patients’ home medications were observed in 31 (84 %, n=31/37) patients. Pharmacist-led medication reconciliation proved to be a fast and effective way to find out the patient's overall medication. In the future, the operating model should be developed to detect drug related problems, and risks related to patients’ home medications. In situations of limited resources, the clinical pharmacy services should be targeted to patients with the highest risk to drug related problems.
  • Kähkönen, Asta (2017)
    According to international studies, medication records are often incomplete in hospitals' patient information system. Medication reconciliation is an effective method to prevent medication errors and improve medication safety. A medication review is a useful tool in the assessment of drug-related problems (DRPs). DRPs can cause severe patient harm and even cause death. Approximately one third of Finnish people are diagnosed with cancer during their lifetime. About 16 000 patients receive cancer treatments in the Helsinki University Central Hospital Cancer Centre (HUCHCC). There are no clinical pharmacy services in the division of the solid tumors of HUCHCC. Internationally clinical pharmacy services in oncology are patient oriented and often include medication reconciliations and reviews. The clinical pharmacy services have increased patient safety also in the oncological specialty. The aim of this study was to find out the accuracy of the medication charts and identify the DRPs among 70-80-year-old patients with 6 or more medicines in uro-oncological outpatient clinic of HUCHCC. Accuracy of the medication charts was assessed by pharmacist-led medication reconciliation with patient interview. Information concerning patient's medication was also searched from the national electronical prescription centre and from the records of previous hospital visits. DRPs, such as drug-drug interactions, adverse drug reactions and overlapping medications, were identified with the pharmacist-led medication review. Special attention was paid to renal insuffiency, high-alert medications and potentially inappropriate medication for patients over 75 years old. Pharmacist discussed the DRPs with the oncology specialist. The theoretical framework of this study was the theory of human error, where patient safety hazards can be prevented by using safety defences such as medication reconciliation and medication review. Altogether 30 patients with urological cancer were included in this study. On average, they were 74.3 years old and used 12.4 medications. On average, there were 6.8 discrepancies per patient in the hospital medication chart. Only one patient had the accurate medication chart. The discrepancies were most commonly related to paracetamol (n = 10), vitamin-D (n = 9) and the combination of calcium and vitamin-D (n = 8). The most common discrepancies of high-alert medications were related to enoxaparin (n=6) and oxycodone (n=6). Of the potentially inappropriate medications for over 75 years old, the most common discrepancies were related magnesium (n=8) and metoclopramide (n=5). In the medication review process, 4 acute and 44 non-acute DRPs were identified with 22 patients (2,2 per patient). 60 % of these were regarded clinically relevant and lead to actions by the oncology specialist. Reconsidering the need or efficacy of the medication was recommended 19 times and inappropriate dose or medication with renal insufficiency were identified six times in medication reviews. DRPs were usually related to non-oncological medications such as pantoprazol (n=8), the combination of calcium and vitamin-D (n=4) ja bisoprolol (n=3). The medication reconciliation process should be developed in the urology-oncology outpatient clinic. Multiprofessional medication review can be used to detect and resolve DRPs of patients with urological cancer. The results of this study can be exploited when clinical pharmacy services will be created and developed in HUCHCC.
  • Sulkava, Siiri-Sofia (2024)
    Maailman terveysjärjestö on linjannut yhdeksi lääkitysturvallisuutta vaarantavaksi tekijäksi lääkitystiedon ajantasaisuuden puutteen. Myös Suomessa on havaittu puutteita lääkitystiedon ajantasaistamiskäytännöissä. Vuonna 2023 hyvinvointialueiden muodostumisen myötä syntyi Satakunnan hyvinvointialueella tarve yhtenäistää lääkitystiedon ajantasaistamisen, lääkityksen tarkistuksen ja lääkehoidon arvioinnin käytäntöjä. Tutkimuksen tavoitteena oli kartoittaa, mitä Satakunnan hyvinvointialueen asiantuntijoiden mielestä tulisi sisältyä lääkitystiedon ajantasaistamiseen, lääkityksen tarkistukseen ja lääkehoidon arviointiin. Tutkimuksen tavoitteena oli parantaa lääkitysturvallisuutta yhtenäisen toimintamallin muodostamisella Satakunnan hyvinvointialueella lääkitystiedon ajantasaistamiseen, lääkityksen tarkistamiseen ja lääkehoidon arviointiin. Tutkimuksen tavoitteena oli myös muodostaa yhtenäinen toimintamalli lääkitystiedon ajantasaistamisen, lääkityksen tarkistuksen ja lääkehoidon arvioinnin kirjaamisesta potilastietojärjestelmään. Tutkimus suoritettiin kaksikierroksisella Delfoi-menetelmällä. Delfoi-menetelmä on laadullinen tutkimusmenetelmä, jossa tavoitteena on löytää konsensus tutkittavasta aiheesta. Asiantuntijapanelistit (n=20) rekrytoitiin Satakunnan hyvinvointialueelta ja lopulliseen paneeliin sisältyi 5 lääkäriä, 5 sairaanhoitajaa sekä 10 farmaseuttia. Delfoi-kierrokset suoritettiin maalis-huhtikuussa 2024. Tutkimuksen asiantuntijapaneelilla oli vahva konsensus siitä, miten lääkitystiedon ajantasaistaminen, lääkityksen tarkistus sekä lääkehoidon arviointi tulisi toteuttaa. Tutkimuksessa saadut tulokset olivat samankaltaisia kuin aiemmat kansainväliset tutkimukset liittyen lääkitystiedon ajantasaistamiseen, lääkityksen tarkistukseen ja lääkehoidon arviointiin. Jatkotutkimusta tarvitaan selvittämään sitä, miten lääkitystiedon ajantasaistaminen, lääkityksen tarkistus ja lääkehoidon arviointi toteutuu tutkimuksen pohjalta koostetun yhteisen toimintamallin mukaisesti. Lisäksi tutkimusta tarvitaan siitä, parantavatko tutkimuksen perusteella muodostetut yhteiset toimintamallit lääkitysturvallisuutta Satakunnan hyvinvointialueella.
  • Kuitunen, Sini (2014)
    The role of community pharmacy is to ensure and promote medication safety in treatment of outpatients. In Finland a national four-year medication safety program Apila was launched in 2012. The Apila program aims to improve medication safety with pharmaceutical counselling and followup, support development and implementation of new tools and practices promoting medication safety, increase awareness of medication safety as part of patient safety and increase co-operation between community pharmacies and other social- and healthcare services. The objective of this study was to investigate medication safety situation of Finnish pharmacies in the beginning of Apila program. Research data was collected electronically at the end of 2012 by using a two structured survey instruments. Target of the study was the whole pharmaceutical staff of Finnish community pharmacies. There were two separated study samples. Survey instruments were alike for both samples with the exception of one section. One survey was sent to all independent pharmacy owners (n=593) and managers of university pharmacies (n=18). The other survey was sent to one member of pharmaceutical staff in every community pharmacy (n=618) and university pharmacies (n=17). The response-rate of pharmacy owners (O) was 39 % (n=241) and response-rate of pharmaceutical staff (S) was 29 % (n=182). Representativeness of data was good compared to standard population. According to study the barriers built into the dispensing process worked well. Verifying dose (O: 100 %, S: 98 %), interactions (O: 97 %, S: 94 %) and duplicated medications (O: 79 %, S: 70 %) was a common part of dispensing process. Over half of pharmacies had a written standard operating procedure to medication counselling given when dispensing prescribed (O: 74 %, S: 60 %) and over the counter medicines (O: 60 %, S: 60 %). About 90 % of the pharmacies had a standard operating procedure to reporting and managing dispensing errors (O: 92 %, S: 84 %). According to almost all respondents (O: 96 %, S: 91 %) medication errors were reported in their workplace. Though discussing dispensing errors with whole staff (O: 73 %, S: 53 %) and changing course of action after managing dispensing errors (O: 85 %, S: 63 %) was not as common. The respondents were of the opinion that pharmacy had closer co-operation with home care and social services than with health care services. Some pharmacies had agreed with local healthcare how to manage interactions (O: 39 %, S: 23 %), contraindications (O: 36 %, S: 19 %) and prescribing errors (O: 28 %, S: 15 %) discovered in pharmacy. The study indicates that Finnish community pharmacies have good abilities to identify medication related problems. Co-operation between community pharmacies and other social- and health care services should be promoted, because it seems to be superficial. The biggest challenges in risk management are complete invocation of data collected through error reporting and including medication safety audits into quality management. Pharmacy owners' answers to the questionnaire were more positive than staff members', which indicates that actions to promote medication safety should be made more visible. Coordination of medication safety should be emphasized both national and individual pharmacy level. Low response-rates weaken the reliability of the study, but the results are suggestive.
  • Harju, Helena (2010)
    Immunoglobulin G is very unstable and that is why it is very challenging to formulate and process it. Because of the unstability, IgG is vulnerable to changes in pH, heat and mechanical stress. Exposure to these stresses makes IgG aggregate more easily and lose its biological activity. To restore stability, IgG is formulated to a solid product from which it can be regenerated. With TFF (Tangential Flow Filtration) IgG can be purified from other components. The filtration is based on a half-permeable membrane which permeates the other components except for the IgG. The filtration pressure is the force which keeps the liquid flowing. It is important to control this pressure, too high or too low pressure will damage the IgG. IgG can also be protected with polysorbate which is a surfactant going to the protein/liquid interface and therefore stabilizing IgG. IgG does not stay stable in liquid very long so it has to be lyophilized to improve its process- and storage stability. Lyophilization is a long and energy consuming process. Optimisation of the process is therefore essential to save time and resources. First IgG is freezed to produce ice. Primary drying is the second step, sublimation will change ice to water vapor. Secondary drying is based on water desorption, that way residual water is removed from the lyophilizate. The drying process is carried out altering shelf temperature on which the samples are placed. Chamber pressure is also an important factor in IgG stabilisation. These factors have their impact on IgG stability. Also adding disaccharide, trehalose, in the formulation increases the stability of IgG. The purpose of this work was to optimise both the filtration and lyophilisation process so that IgG would remain as stable as possible. During preliminary testing the results showed that magnetic stirring prior to filtration will damage the IgG, showing aggregation and less biological activity. Aggregation was measured with DLS and biological activity with ELISA. Changes in the secondary structure after lyophilisation were measured with CD. The actual filtration tests were carried out using three different filtration pressures and two different polysorbate 20 concentrations, and water. The results showed that IgG is most stable in 1,25 bar filtration pressure and 0,01 % polysorbate concentration. There was less aggregation and more biological activity. The filtration tests proved to be challenging because there were several parameters that were difficult to control. The same challenge was faced when analysing the results. Lyophilisation tests were carried out using three different pressures during primary drying and three different heating rates during secondary drying. The analysis methods were the same as during filtration tests. In addition, the IgG secondary structure changes were under investigation. The lyophilisation tests showed that trehalose clearly protects the IgG. Visually lyophilised samples which contained trehalose were mechanically more stable than those which did not contain trehalose. The analysis showed that the pressure of 60 mTorr and low heating rate (5 °C/h) resulted in better stability of IgG, aggregation was lower and biological activity higher. During lyophilisation no changes in the secondary structure was seen in CD. This was possibly due to lack of sensitivity of the analysis method.
  • Kraft, Hanna (2018)
    Liposomes are nanosized drug delivery vesicles composed of phospholipid membranes. They present an attractive drug delivery system due to their bioavailability and flexibility. Liposomes can be prepared by different techniques. They can carry both hydrophobic and hydrophilic molecules and their surface can be modified with targeting molecules. Coating the liposome surface with the PEG derivative makes their pharmacokinetics easier to predict. There are several liposome-based medicinal products already on the market. Triggering of drug delivery systems by different external or internal stimuli allows precise control of drug release. Light-triggered drug release is an attractive alternative due to the easy control and regulation of the stimulus. The problem with light-triggered therapy has previously been the need to use high-energy ultraviolet light that penetrates badly to the tissues and is not safe. In TTA-UC process the low-energy red or green light is converted to high-energy blue light. In this process photosensitive molecules are excited by visible light and after that the energy is transferred from sensitizer to annihilator molecules. Collision of two annihilators leads to the excitation of the other molecule while the other returns back to its general energy state. The excitation breaks up with fluorescence. In this process the highly permeable and safe red light is converted to blue light which has enough energy to induce drug release. The aim of this work was to optimize liposomal preparation method and prepare a pegylated and stabile liposome formulation for TTA-UC process. Hydrophobic light sensitive molecules were loaded into the phospholipid membrane as much as possible. One of the problems in this work was to find proper methods to measure the concentrations of these molecules. The lipid composition for formulation was chosen after thermostability studies. As a quality control, the size, capability to load calcein and phase transition temperature of liposomes were measured. The quality control of light sensitive molecules was operated too. In this work, the formulation for TTA-UC was prepared. In further studies TTA-UC process happened with sufficient efficacy. The formulation was pegylated and stable in physiological conditions and the concentrations of the molecules were high enough. This was the very first time to get TTA-UC to happen in this kind of liposome formulation that may be useful as a drug carrier. Long-term stability studies and further optimization of TTA-UC method are needed in the future. Some drug release studies are important to arrange in the future, too.
  • Nuolimo, Sirpa (2016)
    Tavoitteet. Työn tavoitteena oli pyrkiä selvittämään, kuinka lääkevalmisteiden ja CE-merkittyjen terveydenhuollon laitteiden ja tarvikkeiden välinen rekisteröintiprosessi ja rekisteröinnin käytännön työ eroavat toisistaan. Hakemusprosessien ja dokumentaation erojen tutkiminen viranomaisvaatimusten ja työn käytännön suorittamisen näkökulmista katsottiin tärkeäksi, jotta on mahdollista vertailla lääkevalmisteiden ja laitteiden välisiä rekisteröintiprosesseja kokonaisuutena sekä tarkastella valmisteen rekisteröintistatuksen vaikutusta rekisteröinnistä vastaavien henkilöiden työmäärään, ajankäyttöön ja työtehtävien sisältöön. Menetelmät. Tutkimus suoritettiin sähköisen kyselytutkimuksen avulla, joka lähetettiin Suomessa toimiville lääkkeiden myyntiluvan haltijoille ja CE-merkittyjen terveydenhuollon laitteiden ja tarvikkeiden rekisteröinnistä vastaaville valmistajille. Kyselytutkimus toteutettiin Helsingin yliopiston verkkolomaketyökalulla, jota hyväksikäyttäen rakennettiin kyselytutkimuksen runko, kerättiin vastausaineisto sekä käsiteltiin tutkimusaineistoa raportointivalmiiksi. Kysymysten sisältö määriteltiin rekisteröinnin jäsenjärjestön julkaisemiin urakuvauksiin sekä yritysten työpaikkailmoitusten työnkuvauksiin perustuen. Kyselytutkimuksen tekninen ja sisällöllinen toimivuus testattiin pilotoinnin avulla. Vastausaineiston sisältöanalyysi suoritettiin kvantitatiivisten tutkimusmenetelmien keinoin. Tulokset ja johtopäätökset. Lääkevalmisteiden ja CE-merkittyjen terveydenhuollon laitteiden ja tarvikkeiden rekisteröintiprosessit eroavat toisistaan merkittävimmin hakemusprosessien rakenteen ja viranomaistoiminaan osalta, vaikkakin molemmilla sektoreilla perimmäinen tavoite on sama; osoittaa valmisteen teho ja turvallisuus sille aiotussa käyttötarkoituksessa. Hakemusrakenteiden ja viranomaistoiminnan erojen voidaan nähdä olevan perustekijät, joista johtuvat muut rekisteröintityötä ja dokumentaatiovaatimuksia erottavat tekijät, myös käytännön tasolla. Kyselytutkimuksen vastausaineiston perusteella merkittävimmin käytännön työssä vaikuttavat erot liittyivät rekisteröintityön osuuteen kokonaistyöajasta, hallinnollisten tehtävien osuuteen sekä työn sisällön aiheuttamiin vaatimuksiin. Lääkerekisteröintityötä tekevien rekisteröintityön osuus kokonaistyöajasta ja hallinnollisen työn osuus rekisteröintityöstä oli laiterekisteröintityötä tekeviä merkittävästi suurempi. Työn sisällön asettamat vaatimuserot näkyivät muun muassa lääkerekisteröintityössä vastaajien enemmistön farmaseuttisena koulutustaustana ja laiterekisteröintityössä teknisenä koulutustaustana. Kaiken kaikkiaan työssä havaitut erot vaikuttaisivat rekisteröintistrategisesti suosivan valintaa CE-merkityksi lääkinnälliseksi laitteeksi sellaisissa rajatapaustilanteissa, joissa valmiste on mahdollista rekisteröidä joko lääkkeeksi tai lääkinnälliseksi laitteeksi.
  • Raekivi, Pauliina (2021)
    The Finnish medicine reimbursement system is complex and several different conditions required by the Health Insurance Act (1224/2004) and the Social Insurance Institution of Finland (Kela) must be met in order to receive medicine reimbursement. The understanding of medicine reimbursement criteria from the perspective of medicine users has not been studied in Finland before, and little research has been done on the subject internationally. Medicine user-oriented research on the medicine reimbursement system, both in Finland and internationally, has largely focused on the financial opportunities of medicine users to purchase medicines and their opinions on the fairness of medicine reimbursements. The aim of this study was to obtain information on the understanding of medicine reimbursement criteria and the background factors affecting it, the implementation of price, generic substitution and medicine reimbursement counselling in pharmacies, seeking advice on medicine reimbursement, and the financial difficulties of buying prescription medicines. The material used in this study was from the population survey (n=1650), which examined the activation of price competition for pharmaceutical products and customers' expectations of pharmacy operations. The understanding of medicine reimbursement criteria, the price counselling provided in a pharmacy, the effect of financial challenges on the non-buying of medicines and the use of sources of advice related to the medicine reimbursement were described as frequency distributions. The effect of background factors on the understanding of medicine reimbursement criteria was compared using the chi-square test and logistic regression analysis. About a third (31%) of respondents told that they do not understand the basis on which medicine reimbursement is usually received for prescription medicines, and 13% had unclear why they had not been reimbursed for their prescription medicine in the past year. Especially younger age, low income, low medication use, depression and other mental health problems, lack of long-term illness, and insufficient medicine reimbursement counselling in a pharmacy were found to be associated with poorer understanding of medicine reimbursement. 72% of the participants in the study felt that they usually receive sufficient information about the prices of medicines and 61% about the reimbursement of medicines when buying prescription medicines from a pharmacy. Less than half (47%) of respondents felt that they have usually received sufficient information about how the amount of reimbursement for medicines is determined. Slightly over 70% of respondents said that they are usually told about the cheapest medicine available when buying a prescription medicine and/or are suggested to switch to a cheaper one. About 60% were usually told about the difference between the two interchangeable medicines. 88% of respondents would seek information about medicine reimbursement primarily from a pharmacy or pharmacy´s online services. About 3% of all respondents in the study had not bought a medicine prescribed by a doctor for financial reasons in the last six months. Based on the study, about a third of medicine users have remained unclear regarding medicine reimbursements, and not everyone feels that they have received sufficient counselling and information about medicine prices and medicine reimbursements when buying prescription medicines from a pharmacy. Counselling from a pharmacy was found to be related to understanding of medicine reimbursement criteria. Advise on the pricing, medicine reimbursement and generic substitution should continue to be actively provided to medicine users, so that the counselling meets the requirements of the law and the knowledge of the reimbursement system of medicine users can be improved. Based on the results of this study, counselling should be targeted in particular at younger, low-income and from mental health problems suffering medicine users, as well as those who are less familiar with reimbursement issues, for example due to low morbidity or medicine use.
  • Aalto, Aura (2019)
    Medicinal products, medical devices and combination products, that include both the medicinal product and medical device part, need to fulfill the regulatory requirements for their efficacy, safety and quality before they can be placed on the market. Documentation requirements, application processes and authoritative processing differ between medicinal product and medical device registration. In European Union, combination products are registered either as medicinal products or medical devices according to their principal mode of action. Registration requirements for medical devices are currently changing since the new medical device regulation 2017/745 (MDR) in the EU came into force in May 2017. Transition period in MDR implementation will last until May 2020. This study is continuation to an earlier study (Nuolimo 2016) where registration process differences between medicinal products and medical devices were investigated. In the earlier study it was concluded that registration process differences seem to favour the registration of the product as CE marked medical device in borderline cases where the product can be registered both as medicinal product and medical device. The aim of this theme interview study was to further clarify registration process differences and particularly underlying factors affecting the selection of the registration status. Furthermore, the study aimed to clarify how the registration process for combination products differs from other registration processes and how the new European medical device regulation 2017/745 influences registration work in practice. In the theme interview study, regulatory affairs professionals with experience from the different product groups were interviewed. In total, eight interviewees participated in the study. Regulatory professionals’ job descriptions varied so much that it was difficult to compare registration processes. Registration process for medical devices was discovered to be lighter than the equivalent for medicinal products. Registration status is chosen product-specifically. Load in registration process for combination products depends on whether the product is registered as a medicinal product or as a medical device. Regarding combination products, borderline cases where it needs to be determined whether the product is registered as a medicinal product or a medical device, can be challenging. Implementation of the new medical device regulation (MDR) was still incomplete when the study was conducted. However, the regulation had already increased workload in medical device and combination product registration and created new business opportunities for contract research organisations.
  • Westerholm, Aleksi (2021)
    Poor adherence to and non-compliant use of medications are common in long-term patients, and it is estimated that only half of medication use worldwide is appropriate. Poor adherence to medication undermines public health, reduces the cost-benefit of resources invested in medication care, and burdens health care. Various interventions have sought to improve adherence to drug treatment, but they have not brought about the desired change in medication adherence. The aim of this master's thesis was to develop a method and pilot it to investigate the reasons for the non-compliant use of medications in the context of the medication reconciliation process. The aim of this new method was to find out the reason for non-compliant use of a medicine in a patient-centered way, and the possibility for the pharmacist to motivate the patient to use the medicine according to the instructions. In addition, it was examined whether the method can measure prevalence of non-compliant use of medicines differs according to the ATC classification of medicines and whether the total number of medicines contributes to the non-compliant use of medicines. The pilot study was carried out as part of a standard pharmacist's medication reconciliation process at Vantaa primary health care. The data required for the study were collected on the electronic HUSeCRF platform. Patients were collected to the extent that we were able to verify the functionality of the method and to plan the reporting of the results of the actual study with larger research data. The data were collected during the year of 2021. The theoretical framework of the study was the Medication-Related Burden model and the iceberg model of non-compliant use of medicines. The research material was analyzed using descriptive statistical analysis in IBM SPSS 27. The analysis of the data was done in terms of the functionality and development of the new method. A total of 8 patients participated in the pilot study (women 63% n = 5). Patients had an average of 16 medications per patient (range 8-22), and the last time their medications were reconciliated was on average 1 year ago. Non-compliant use of medicines was observed in 88% of patients (n = 7). In total, there were non-compliant use of medicines in the data for 21 drugs. The most common medicines which were used non-compliant were for the treatment of cardiovascular diseases. The total number of medicines and the number of non-compliant use correlated with each other (Pearson correlation coefficient 0.472), but the result was not statistically significant (p = 0.238). The most common reason for non-compliant use was a drug-induced side effect. After a motivational discussion which was involved in the medication reconciliation process with pharmacists, in 14 % of non-compliantly used medicines, patients decided to start taking the medication as directed. The pharmacist was able to motivate the patient to use the medicine as directed when the reason for non-compliant use of medicine was unclear instructions. In this study, a method was developed and validated to determine the reasons for non-compliant use of medicines. During medication reconciliation process, the pharmacist was able to find out the reasons for non-compliant use of medicines. Pharmacists may motivate the patient to use the drug as directed, however, most patients did not want to change the use of the medicine as directed. As the total number of medications increase, the probability of non-compliant use of medicines may increase.
  • Helle, Emilia (2021)
    Background. Parallel importing of pharmaceuticals has potential to generate significant savings but results of previous theoretical and empirical studies on the consequences of parallel importing and its ability to generate competition have been contradictory. Little research on the effects of parallel importing has been conducted in Finland. In April 2017, the reference price system in Finland was extended to also cover substitution groups determined on the basis of parallel imports. The aim of the reform was to increase competition between direct and parallel imports and thus to generate savings in reimbursement costs. However, the impact of the reform has not yet been significantly studied. Aim. The aim of this study was to examine the effects of parallel importing and the expansion of the reference price system on the price development of direct and parallel imported medicines and reference prices. The purpose was to investigate in general the price development of products and reference prices in the period following the expansion of reference price system, to examine the importance of how long a reference group was involved in the system on price development, to examine the impact of the extension of the reference price system and the market entry of a competing parallel import in particular on prices of direct imported products and to examine the importance of the number of parallel imports competing with the direct imported product on price development. Methods. Reference price decisions and lists of prices of reimbursable medicinal products were used as research material. The data was found on the website of the Pharmaceuticals Pricing Board. Quarterly price data on the prices of products belonging to the reference price groups determined on the basis of parallel imports was extracted from the data. Price data was examined from January 2016 to October 2019. Price development was monitored as percentage changes on a quarterly and annual basis. The effect of extension of the reference price system and the entry of a competing parallel import was examined using a sort of before-after set-up by comparing the price development of products before the change to the price development of products after the change. Regression analysis was used to assess the statistical significance of the variables explaining price development of products. Results and conclusions. During the period, the prices of direct and parallel imports and the reference prices decreased in most of the reference price groups. Price increases amongst the groups were very rare. Based on price development and regression analyzes, both the expansion of the reference price system and the market entry of a competing parallel import significantly reduced the prices of direct imports. However, the time that the reference group was involved in the reference price system or the number of parallel imports competing with the direct import did not have a significant impact on the price development of direct and parallel imports. It can be stated that parallel imports are likely to generate significant savings in Finland and the expansion of the reference price system has contributed to the ability of parallel imports to generate savings. However, further research on the real savings generated by parallel imports is still needed.
  • Tapanila, Tiina (2022)
    Lääkkeiden saatavuushäiriöt ovat yleistyneet Suomessa ja muualla maailmassa aiheuttaen lisätyötä ja -kustannuksia lääkealan toimijoille. Saatavuushäiriöt voivat aiheuttaa katkoksia lääkehoitoon tai saatetaan joutua turvautumaan muihin hoitovaihtoehtoihin, mikä voi johtaa potilasturvallisuuden vaarantumiseen. Tämän tutkimuksen tavoitteena oli antaa yleiskuva saatavuushäiriöistä ja saatavuushäiriövalmisteiden ominaispiirteistä Suomessa keväällä 2020. Tutkittaviin ominaispiirteisiin kuuluivat mm. lääkkeen terapiaryhmä, myyntiluvan haltija, häiriön kesto, valmisteen hintaluokka, kuuluminen velvoitevarastoitavien valmisteiden tai Maailman terveysjärjestö WHO:n välttämättömien lääkkeiden luetteloon ja myyntiluvan myöntövuoteen perustuva lääkkeen elinkaarivaihe. Saatavuushäiriövalmisteiden (n=879) tiedot kerättiin myyntiluvan haltijoiden Lääkealan turvallisuus- ja kehittämiskeskus Fimealle kahden kuukauden aikana (14.2.–15.4.2020) toimittamista tai voimassa olevista saatavuushäiriöilmoituksista. Aineistoa täydennettiin hinta- ja korvattavuustiedoilla Kansaneläkelaitoksen lääketietokannasta sekä tiedoilla muista markkinoilla olevista pakkauskoista, vahvuuksista ja vaihtokelpoisista lääkevalmisteista. Aineistosta tehtiin kuvaileva tilastollinen analyysi käyttäen perustunnuslukuja ja -jakaumia. Analyysissä keskityttiin pääasiassa avohoidossa käytettäviin reseptivalmisteisiin (n=654). Ihmislääkkeiden saatavuushäiriöt (n=829) koskivat etenkin sairausvakuutuksesta korvattavia reseptivalmisteita (65 % kaikista saatavuushäiriöistä), ja ne keskittyivät suurten potilasryhmien käyttämiin lääkkeisiin, kuten sydän- ja verisuonisairauksien lääkkeisiin (31 %) ja hermostoon vaikuttaviin lääkeaineisiin (28 %). Avohoidon reseptivalmisteiden häiriöistä yli puolet (53 %) kohdistui rinnakkaisvalmisteisiin. Häiriövalmisteet kuuluivat elinkaarivaiheeltaan vanhempiin ja hintaluokaltaan edullisempiin valmisteisiin. Viidennes valmisteista (19 %) kuului velvoitevarastoitavien tai WHO:n välttämättömien lääkkeiden luetteloon. Rinnakkaisvalmiste löytyi 73 prosentille häiriövalmisteista. Vain kolme prosenttia myyntiluvan haltijoista oli tehnyt ilmoituksen saatavuushäiriöstä Fimealle vaadittua kahta kuukautta ennen myynnin keskeytymistä saatavuushäiriön vuoksi. Tulosten perusteella saatavuushäiriöt Suomessa koskevat samankaltaisia lääkevalmisteita kuin muuallakin maailmassa. Tämän osoitti myös tutkielman kirjallisuusosassa toteutettu kansainvälistä empiiristä saatavuushäiriötutkimusta koskenut systemaattinen kirjallisuushaku. Valtaosaan saatavuushäiriöistä on mahdollista reagoida apteekissa toimittamalla rinnakkaisvalmiste, kun taas osa vaatii yhteydenottoa lääkkeen määränneeseen lääkäriin. Saatavuushäiriötiedon linkittämistä sähköiseen reseptijärjestelmään ja lääkevaihdon laajentamista farmasian ammattilaisille voisi harkita toiminnan kehittämiseksi saatavuushäiriötilanteissa. Covid-19-pandemia on lisännyt kansainvälisiä toimia häiriötilanteiden hoitamiseksi. Tätä varten kehitetään yhteisiä toimintatapoja muun muassa Euroopan unionissa, jossa tavoitteena on luoda kaikki jäsenmaat kattava saatavuushäiriöportaali.
  • Korhonen, Mira (2021)
    Good availability of medicines means that authorised medicines are placed on the market and not in a short supply. Drug shortages have increasingly become a common problem that has compromised the continuous availability of medicines. Drug shortages are caused by many complex factors, such as capacity constraints, manufacturing difficulties, business decisions, availability of raw materials, and sudden increase in demand. Drug shortages can cause adverse effects, medication errors, allergies, and delays in necessary treatments. There have been studies that have explained the reasons behind medicines shortages. However, more information is needed especially from the perspective of markets in Finland. The aim of this study was to reinforce and deepen the knowledge concerning the availability of medicines in Finland. The aim was to identify the group of medicines that are more exposed in short supply than others and define the root causes of medicine shortages. In addition, the aim was to form an overview of the availability of medicines in Finland. The study was based on a Finnish medicine agency's registry. Data were collected retrospectively from materials that contained shortage notifications from marketing authorisation holders and mandatory reserve supplies permissions for exemption to maintain lower stock levels. The study was dated between the years 2017 and 2020. More detailed data from the medicine shortage was only available from the year 2020 because of changes in procedures. The study also contained data from the register for all marketed and non-marketed medicinal products with marketing authorisation. The data classified with ATC-codes, because it is used internationally and thus makes the study to comparative to other studies. Data were analysed with cross-tabulation and frequency distributions. The study addressed that drug shortages were reported of medicines that are commonly used in Finland, such as nervous and cardiovascular system drugs. These medicines covered almost half of the annual shortage notifications. The number of drug shortage notifications has increased annually by approximately 40 percent. Correspondingly mandatory reserve supplies permission for an exemption to maintain lower stock levels were reported most on nervous system drugs and anti-infectives for systemic use. The number of annual permissions remained quite constant. The amount of the permissions increased 14 percent between the years 2017 and 2018 and a further 6 percent to the year 2019. However, the amount of permissions increased 26 percent in the year 2020. There is clearly recognized the effect of the COVID-19 pandemic when considered the rate of shortage notifications and mandatory reserve supplies permissions. The main reasons for the shortages were capacity constraints (32%) and increased demand (21%). Most of the drugs in short supply were drugs with national (33%) or decentralised (30%) marketing authorisation procedures. Broadly were able to state that the availability of medicines was at an acceptable level. 62 percent of all medicinal products with marketing authorisation were placed on the market. In addition, only 29 percent of older drugs with marketing authorisation accept during the years 1996 to 2003 were withdrawn from the market. In future, more large-scale studies are needed based on this study to improve the system that maintains the continuous and high-quality medicine distribution. Most important is to create a better tracking system and co-operation between national and international officials.
  • Granfors, Eija (2015)
    In hospital care many medicines should be usually prepared before they are administered to patients. In Finland Finnish Medicines Agency (Fimea) gives regulatory requirements and instructions for preparation of medicines in hospital pharmacies and action in hospital pharmacies is strictly controlled regularly by Fimea. According to Fimea's instructions hospital pharmacies should also ensure that medicines are prepared properly before they are administered to the patients in hospital wards. Preparing of medicines in hospital wards should be done in accordance with instructions given from the hospital pharmacy. Medicines should be prepared by using aseptic technique in order to protect patient safety. Aim of this study was to develop an assessment tool which can be used to assess the quality of ward- prepared medicines. The assessment tool should be suitable for self-assessment and external audit. Aim of the assessment tool is to ensure the safety of preparation of medicines in the wards and at the end improve patient safety. For the assessment tool ISMP Guidelines for safe preparation of sterile compounds were translated to Finnish. The assessment tool was then developed from the translated ISMP-guideline and other literature. The assessment tool was validated by using two-rounded Delphi-method. Delphi-method is a consensus method in which selected experts evaluate the data. At the first Delphi-round suitability and feasibility of the tool were evaluated and new items were created based on the consensus of experts. At the second round the feasibility of the tool items, which were developed by the first round, were evaluated once again. A total of 19 experts were participated to the Delphi-rounds. After the Delphi-rounds the developed assessment tool contained 64 items for safe preparing of medicines in hospital wards. The developed assessment tool reviews the entire process of preparing medicines and it can be used to identify which items are not followed in preparing of medicines before administering to patients in hospital wards. The developed assessment tool for safe preparation of medicines in hospital wards can be used widely in Finnish hospitals in order to ensure the quality of preparing medicines and detect the deficiencies and errors in preparation processes. By detecting deficiencies and errors in preparing medicines, they can be corrected and processes can be modified appropriate. In this way patient safety can be improved.
  • Saarinen, Jukka (2014)
    The aim of this thesis was to investigate the potential of label-free CARS microscopy as a new method for chemically-specific imaging of live cells and particle-cell interactions in a drug delivery context. Cells used to mimic the intestinal epithelium, Caco-2 cells and HT-29 cells and nano-/ microcrystal particle interactions with macrophages were studied. More information about drug absorption from intestinal and particle cell interactions are needed, since many novel drugs lack properties needed for good bioavailability. It would be beneficial if these events could be visualized without labels. CARS microscopy was found to be well suited to imaging live Caco-2 and HT-29 cells that were grown on PTFE Transwell inserts. CARS microscopy revealed lipid droplets inside these cells. The size of lipid droplets increased in Caco-2 cells a lot during a three week period so that at the end a large part of the inner part of the cell was filled with lipid droplets. It was also observed that Caco-2 cells and HT-29 cells can grow on top of each other on Transwell inserts and not just as a monolayer. These two facts could cause variations in drug absorption studies based on Caco-2 cell monolayers. CARS microscopy was able to detect nanocrystals as small as about 500 nm with label-free, molecular-specific CARS microscope inside RAW 264.7 macrophages after incubation of 120 min. This observation was important, since nanocrystal drug formulations are gaining interest in the field of pharmacy. Nanocrystals can be used in parenteral drug formulations as well as in oral dosage forms. In suspensions, nanocrystals can be used to cause long lasting drug release. Nanocrystals can be also used to enhance poor bioavailability of drugs. Whether these nanocrystals are used in parenteral formulations or in oral drug formulations it is evident that imaging techniques are needed to image interactions between these nanocrystals and cells. CARS microscopy could be one of those techniques, since it is suitable for live cell imaging and it can be used to image nanocrystals that are not labeled. The results in this thesis suggest that CARS microscopy could be used as fast imaging technique for nanocrystal particle cell interactions. Overall, CARS microscopy is a relatively new imaging method that shows much promise as a label-free chemically specific imaging technique for imaging cells and cell-particle interactions in a drug delivery context. As the technique becomes more widely available and undergoes some technical developments, it will become much more widespread imaging method in the future.
  • Pakarainen, Leena (2016)
    Healthcare professionals in patient care, including practical nurses, need medicines in-formation in their work. One strategic goal in national Medicines Information Strategy in Finland is to make sure, that healthcare professionals use reliable information sources and services. One part of the national medicines information network in Finland is work-ing group on medicines information for healthcare professionals. It's central aim is to advance availability of reliable medicines information in different environments in social- and healthcare. Objective of this study was to explore medicines information sources and needs among practical nurses. This study concentrated on practical nurses who work in atypical areas of medical care (for example at school and day care), homecare and social care and were members of The Finnish Union of Practical Nurses. Survey was made in co-operation by working group on medicines information for healthcare professionals and The Finnish Union of Practical Nurses. The survey was carried out in December 2013 - January 2014 by e-mail. The random sample consisted of 1 000 practical nurses. The material was analyzed using direct distributions, cross tabulation, Kruskal-Wallis -test and Mann-Whitney U-test. Open ended questions were analyzed by qualitative methods. The response rate was 67 (n = 666). The most commonly utilized medicines information among practical nurses were package leaflets (PL) and medical database Terveysportti. Those sources were also the most preferred ones. Practical nurses reported they would like to have additional medicines information about drug-drug interactions (86 %) and adverse effects (63 %). Information was also needed about generic drugs. The majority of practical nurses in this study were satisfied with current medicines information sources. Additional information about pharmacological treatment was needed by respondents, 14 % daily and 31 % weekly. 82 % of respondents would benefit from pharmacy's services in their work. 64 % of practical nurses had always or usually and 28 % had never mobile device for information seeking. 73 % of practical nurses took part in education concerning pharmacological care less than once in one to two years. Package leaflets and Terveysportti were the most commonly utilized and preferred medicines information sources. There is still need for detailed information about practical nurses' medicines information sources in various working environments.