Evaluation of Medicines Use Review in Slovenia

Adherence, Medication Clinical Trial

— SLOPUZ  

Official title:

Benefits of Medicines Use Review Service in Slovenia: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04417400
• Other study ID #: MZ 0120-321/2016-2
• Secondary ID: P1-0189
• Status: Completed
• Phase: N/A
• Start date: May 9, 2017
• Est. completion date: September 16, 2017

Study information

• Verified date: June 2020
• Source: University of Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Medicines Use Review service (PUZ) has been officially introduced in Slovenian pharmacy practice in 2015 and has been offered to pharmacy customers by pharmacist, certified to provide the service. Patients can to talk to a pharmacist and discuss their medicines, how they use it and any issues or question they might have. We designed a study to evaluate how Medicines Use Review (PUZ) work and how it is reaching the set objectives. The objectives of the PUZ service are to address actual patient medicines use and consequently improve medication adherence, identify and solve drug related problems and enhance medication knowledge. Pharmacists, who are certified to provide the service, recognized the patients, who might need the service and invited them to participate in the study. The study consisted of two visits in 12 weeks' time period. Patients, who decided to participate, were randomly allocated in two groups - intervention and control. Both groups were interviewed and fulfilled questionnaires at visit 1 (V1). Afterwards the test group patients received PUZ. After 12 weeks both groups attended the visit 2 (V2), where they were re-interviewed and fulfilled questionnaires again. After the study completion also the patients from control group received PUZ due to ethical reasons.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: September 16, 2017
• Est. primary completion date: September 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• at least one prescription medicine for a chronic condition for at least six months

• deemed to be suitable for MUR by a pharmacist, certified to provide the MUR service;

• ability to communicate in Slovenian; The inclusion of patients was performed in accordance with the SOP MUR, to reflect how patients are generally offered MUR service in Slovenia.

Exclusion Criteria:

• urgent need of MUR (the service delay due to randomization would risk their health);

• referred for MUR by a healthcare professional (general practitioner, nurse, etc.);

• the patient's carer, rather than the patient themselves, was able to attend the interviews and receive MUR;

• previously received MUR or an advanced medication review;

• difficulties understanding, communicating or other issues (vision, hearing) that might affect study outcomes.

Related Conditions & MeSH terms

• Adherence, Medication
• Medicines Use Review Service
• Multiple Medication

Intervention

Behavioral:
• medicines use review
The provision of MUR service as defined in the SOP MUR (Slovene Chamber of Pharmacies). It is classified as a type 2a review (PCNE typology) and it is intended for the patients to support them in regular and proper medicines use. MUR is performed based on medication history and information provided by the patient in a purposely scheduled conversation with the pharmacist. Pharmacists must be certified to provide MUR. MUR goal is to identify DRPs and recommend interventions to resolve them. During the MUR interview, the pharmacist completes a working sheet that records information regarding medicines, identified DRPs and recommended interventions. After the MUR interview, patients are provided with a personal medicines card that contains all the information that is needed to support effective and safe medicines use (dosing regimen, taking with/without food, special warnings, recommendations, etc.).

Locations

Country	Name	City	State
Slovenia	Community pharmacy "Žalske lekarne Žalec"	Žalec
Slovenia	Community pharmacy "Lekarna Brežice"	Brežice
Slovenia	Community pharmacy "Celjske lekarne javni zavod"	Celje
Slovenia	Community pharmacy "Kraške lekarne Ilirska Bistrica"	Ilirska Bistrica
Slovenia	Community pharmacy "Lekarna Kocevje"	Kocevje
Slovenia	Community pharmacy "Obalne lekarne Koper"	Koper
Slovenia	Community pharmacy " Gorenjske lekarne"	Kranj
Slovenia	Community pharmacy "Lekarna Ljubljana"	Ljubljana
Slovenia	Community pharmacy "Javni zdravstveni zavod Mariborske lekarne Maribor"	Maribor
Slovenia	Community pharmacy "Pomurske lekarne Murska Sobota"	Murska Sobota
Slovenia	Community pharmacy "Goriška lekarna Nova Gorica"	Nova Gorica
Slovenia	Community pharmacy "Lekarna Ormož"	Ormož
Slovenia	Community pharmacy "Lekarne Ptuj"	Ptuj
Slovenia	Community pharmacy "Lekarna Sevnica"	Sevnica

Sponsors (15)

Lead Sponsor

Collaborator

Mitja Kos

Comunity pharmacy Žalske lekarne Žalec, Comunity pharmacy Celjske lekarne, Comunity pharmacy Gorenjske lekarne, Comunity pharmacy Goriška lekarna Nova Gorica, Comunity pharmacy Javni zdravstveni zavod Mariborske lekarne Maribor, Comunity pharmacy Kraške lekarne Ilirska Bistrica, Comunity pharmacy Lekarna Brežice, Comunity pharmacy Lekarna Kocevje, Comunity pharmacy Lekarna Ljubljana, Comunity pharmacy Lekarna Ormož, Comunity pharmacy Lekarna Sevnica, Comunity pharmacy Lekarne Ptuj, Comunity pharmacy Obalne lekarne Koper, Comunity pharmacy Pomurske lekarne Murska Sobota

Country where clinical trial is conducted

Slovenia, 

References & Publications (2)

Griese-Mammen N, Hersberger KE, Messerli M, Leikola S, Horvat N, van Mil JWF, Kos M. PCNE definition of medication review: reaching agreement. Int J Clin Pharm. 2018 Oct;40(5):1199-1208. doi: 10.1007/s11096-018-0696-7. Epub 2018 Aug 2. — View Citation

Nabergoj Makovec U, Kos M, Pisk N. Community pharmacists' perspectives on implementation of Medicines Use Review in Slovenia. Int J Clin Pharm. 2018 Oct;40(5):1180-1188. doi: 10.1007/s11096-018-0644-6. Epub 2018 Jun 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	medication adherence	Self-reported medication adherence to multiple medications, evaluated by an 8-item Morisky Medication Adherence Scale (©MMAS-8) and scored with ©Morisky Widget MMAS-8 Software. MUR impact was defined as the relative difference in in MMAS-8 score after 12 weeks (V2-V1) between test and control group.	12 weeks (V2-V1)
Secondary	drug-related problems	The changes in the proportion of manifested DRPs, the proportion of patients with at least one mDRPs, and the risk of the mDRPs between visits. This outcome only considered for the intervention group (test group), therefore the before-after analysis was applied.	12 weeks (V2-V1)
Secondary	Medicine-associated burden	MUR impact on medicine-associated burden was defined as the mean relative difference in the score of Living with Medicines Questionnaire (©LMQ), visual analog scale (VAS) and each domain score between test and control group after 12 weeks (V1-V2).	12 weeks (V1-V2)
Secondary	Patient information ('knowledge') regarding medicines	Interview with the patients. Patients answered three questions regarding each of their regularly used prescription medicines: (i) "What are you taking the medicine for?", to state the purpose of medicine use; (ii) "How are you supposed to take the medicine?", to state the daily dose; and (iii) "Do you know of any special warnings regarding the medicine? If yes, which ones?". Accuracy of answers regarding the purpose of medicine and its daily dose were checked by comparing them with either physician instructions or, when physician instructions were unavailable, Summary of Product Characteristics (SmPC). Answers were deemed to be 'correct' if they matched the information in these sources, 'incorrect' if they did not match or 'not known' if patients responded with "I don't know" or 'no'. Proportions of correct and incorrect answers per patient-medicine, and proportions of improvement or deterioration in given information between visits for the test and control group, were assessed.	12 weeks

External Links

•   Standard operating procedure for Medicines Use Review service in Slovenia was published in 2016. It is in Slovenian.