Sleep medicines are often prescribed for older adults (≥75 years) without appropriate dosing instructions: A nationwide retrospective register study in Finland.

BACKGROUND: Sleep medicines should be prescribed cautiously, accompanied by instructions that ensure appropriate use and reduce risks. This is especially important for older adults, for whom many of these medicines are classified as potentially inappropriate medicines. METHODS: We investigated the use and appropriateness of dosing instructions for sleep medicines (described in the Finnish National Current Care Guideline for Insomnia) prescribed for older adults (≥75 years) and dispensed with instruction label in pharmacies. The retrospective reimbursement register data for year 2020 by the Social Insurance Institution of Finland was used as the data source (1,080,843 purchases by 143,886 individuals of which 565,228 purchases were pharmacy dispenses). The appropriateness of the pharmacy dosing instructions containing keyword(s) referring to insomnia treatment was examined according to the prescribed dose, time of intake, frequency of use, and warnings/remarks. A random sample of 1000 instructions was used to manually analyze the phrasing and appropriateness. OUTCOMES: We focused our analysis on 58.1% (328,285 purchases by 87,396 individuals) of the pharmacy dispenses, which contained dosing instructions referring insomnia treatment. Of these, zopiclone and mirtazapine were the most prescribed drugs (134,631 and 112,463 purchases, respectively). Dose and time of intake were specified in most of the instructions (98.4% and 83.4%, respectively), whereas frequency of use was specified in 57.3%. A small percentage of the instructions included warnings/remarks (2.8%). Overall, only 2.1% of the instructions contained information about a single dose, time of intake, temporary use, and warnings/remarks and were thus defined as sufficient. Notably, 47.7% (n = 515,615) of all the purchases in our dataset were dispensed via automated multi-dose dispensing systems, which is aimed for long-term treatment. INTERPRETATION: It is common to prescribe sleep medicines for older adults without appropriate dosing instructions, particularly excluding warnings against long-term, regular use. Actions to change the current prescribing practices are warranted.

Drawing up the public national Rational Pharmacotherapy Action Plan as part of social and health services reform in Finland: a bottom-up approach involving stakeholders.

BACKGROUND: Ensuring equal access to medicines and their appropriate and safe use at reasonable costs are core functions of health systems. Despite that, few descriptions of national medicines policies' development processes and implementation strategies have been published. This study aimed to describe the government program-based development of the Rational Pharmacotherapy Action Plan in Finland as a part of the undergoing major health and social service system reform, also covering the implementation of rational pharmacotherapy in the reformed system and processes. METHODS: The data of this qualitative study consisted of public reports and Steering Group meeting memos related to the development of the national Rational Pharmacotherapy Action Plan that the Ministry of Social Affairs and Health coordinated. Qualitative content analysis applying systems theory and the conceptual framework of integrated services as theoretical frameworks was used as an analysis method. RESULTS: The national Rational Pharmacotherapy Action Plan covering 2018-2022 was created in a bottom-up development process involving a wide range of stakeholders. Rational pharmacotherapy was redefined by adding equality as the fifth pillar to complement the previously defined pillars of being effective, safe, high-quality, and cost-effective. The Action Plan formed a normative framework for long-term development, with a vision and principles focusing on people-centeredness, better coordination and management of the medication use processes, the continuity of treatment paths and the flow of patient and medicines information through partnerships, and evidence-informed policies and practices. CONCLUSION: Through intensive stakeholder participation, the bottom-up approach created a national vision and principles of rational pharmacotherapy along with strong commitment to implementing the goals and measures. The concern lies in ensuring the continuity of the Action Plan implementation and achieving a balanced long-term development aligned with the integrated and reformed national social and health services system. The development of the pharmaceutical system has several national and EU-level dependencies requiring political long-term commitment. While the Action Plan differs from the national medicines policy, it forms a good basis for long-term development covering important parts of medicine policy at the micro, meso, and macro levels of the service system.

Applicability of drug-related problem (DRP) classification system for classifying severe medication errors.

BACKGROUND: Several classification systems for medication errors (MEs) have been established over time, but none of them apply optimally for classifying severe MEs. In severe MEs, recognizing the causes of the error is essential for error prevention and risk management. Therefore, this study focuses on exploring the applicability of a cause-based DRP classification system for classifying severe MEs and their causes. METHODS: This was a retrospective document analysis study on medication-related complaints and authoritative statements investigated by the Finnish National Supervisory Authority for Welfare and Health (Valvira) in 2013-2017. The data was classified by applying a previously developed aggregated DRP classification system by Basger et al. Error setting and harm to the patient were identified using qualitative content analysis to describe the characteristics of the MEs in the data. The systems approach to human error, error prevention, and risk management was used as a theoretical framework. RESULTS: Fifty-eight of the complaints and authoritative statements concerned MEs, which had occurred in a wide range of social and healthcare settings. More than half of the ME cases (52%, n = 30) had caused the patient's death or severe harm. In total, 100 MEs were identified from the ME case reports. In 53% (n = 31) of the cases, more than one ME was identified, and the mean number of MEs identified was 1.7 per case. It was possible to classify all MEs according to aggregated DRP system, and only a small proportion (8%, n = 8) were classified in the category "Other," indicating that the cause of the ME could not be classified to specific cause-based category. MEs in the "Other" category included dispensing errors, documenting errors, prescribing error, and a near miss. CONCLUSIONS: Our study provides promising preliminary results for using DRP classification system for classifying and analyzing especially severe MEs. With Basger et al.'s aggregated DRP classification system, we were able to categorize both the ME and its cause. More research is encouraged with other ME incident data from different reporting systems to confirm our results.

Risk assessment tools for QT prolonging pharmacotherapy in older adults: a systematic review.

PURPOSE: Many drugs are associated with the risk of QT prolongation and torsades de pointes (TdP), and different risk assessment tools (RATs) are developed to help clinicians to manage related risk. The aim of this systematic review was to summarize the evidence of different RATs for QT prolonging pharmacotherapy. METHODS: A systematic review was conducted using PubMed and Scopus databases. Studies concerning risk assessment tools for QT prolonging pharmacotherapy, including older adults, were included. Screening and selection of the studies, data extraction, and risk of bias assessment were undertaken. RESULTS: A total of 21 studies were included, involving different risk assessment tools. Most commonly used tools were risk scores (n = 9), computerized physician order entry systems (n = 3), and clinical decision support systems (n = 6). The tools were developed mainly for physicians and pharmacists. Risk scores included a high number of risk factors, both pharmacological and non-pharmacological, for QT prolongation and TdP. The inclusion of patients' risk factors in computerized physician order entry and clinical decision support systems varied. CONCLUSION: Most of the risk assessment tools for QT prolonging pharmacotherapy give a comprehensive overview of patient-specific risks of QT prolongation and TdP and reduce modifiable risk factors and actual events. The risk assessment tools could be better adapted to different health information systems to help in clinical decision-making. Further studies on clinical validation of risk assessment tools with randomized controlled trials are needed.

National and transnational drug shortages: a quantitative descriptive study of public registers in Europe and the USA.

BACKGROUND: Drug shortages are a growing global problem, posing clinical and economic challenges. To understand them better, we conducted an inventory of national public drug shortage registers and their comparability in Europe and the USA. METHODS: The study was based on openly accessible drug shortage notifications published by national drug authorities. These data were obtained from all national data sources mentioned on the European Medicines Agency's (EMA's) web page and FDA in the USA. After selection of the countries with comparable data, descriptive statistics were used to present characteristics of the shortages both across countries and within countries for 9 months (January-September) in 2020. We studied whether the shortages that occurred in these countries were the same, and how shortages were distributed by therapeutic uses and formulations. We also investigated price variation between the United States and Finland among drugs in shortage in one formulation category (creams and gels). RESULTS: Finland, Sweden, Norway, Spain, and the United States had suitable registers and were included. Altogether 5132 shortage reports from Finland (n = 1522), Sweden (n = 890), Norway (n = 800), Spain (n = 814), and the United States (n = 1106) were published during the study period. Of active ingredient level shortages 54% occurred in only one country, and 1% occurred in all five. However, at the country level, where there was one or more shortage notifications in an ATC active ingredient category, 19-41% were in a single country. The distributions by ATC therapeutic class and drug formulation differed substantially between countries, particularly between the USA and European countries. Injectables had a high shortage risk in the USA (57% of all shortages versus 17-31% of all shortages in the European countries). By contrast, shortages in gels and creams occurred only in European data (4-6% of all shortages). In the price comparison, creams and gels in shortage in Finland were 160% more expensive in the USA where these shortages were not detected. CONCLUSIONS: Public drug shortage registers are vital data sources for proactively maintaining and managing a reliable drug supply. However, our study demonstrates that much work remains to standardize the contents and quality of public register data. Shortages may not be solely a consequence of manufacturing disruptions but may reflect other contributing factors in the international drug distribution and supply mechanisms, including price differences and profit margins between national pharmaceutical markets. Data to perform practical and useful international comparisons to understand these shortages are required.

Effectiveness of inhalation technique assessment service for patients with Respimat® inhaler.

OBJECTIVES: The objective of this study was to examine how Inhalation Technique Assessment Service (ITAS) by community pharmacies affect patients' inhalation techniques when using the Respimat® soft mist inhaler. The inhaler was simultaneously updated into a reusable inhaler. The study focused on the Respimat® inhaler because its use is known to be challenging for patients. METHODS: The study was performed as a pre-post design in 33 community pharmacies (CPs) in Finland. Patients' inhalation technique was assessed before ITAS (baseline) and immediately after ITAS (follow-up 1). Follow-up 2 was performed when the patient came to the pharmacy for a refill (1-3 months after the baseline and the follow-up 1). A Respimat specific twenty item checklist was used to assess inhalation technique. The checklist included 1) preparation steps before the first use of the Respimat® inhaler (8 items) and 2) daily use steps of the Respimat® inhaler (12 items). After ITAS, the patients received a brief questionnaire to assess their asthma/COPD history. RESULTS: A total of 228 patients were enrolled at the first visit (mean age 67.8 years, 61.0% female, 85.5% had previous Respimat® use experience) and 42 of them attended the follow-up 2, 1-3 months later (mean age 70.1 years, 69.0% female, 92.9% had previous Respimat® use experience. The median number of the steps performed correctly increased from 17/20 at the baseline to all the 20 steps at the follow-up 1 (p < 0.001). At the baseline, 27.6% of the patients (n = 228) performed all preparation steps correctly, while 87.3% at the follow-up 1 and 71.4% at the follow-up 2. The percentage of the patients with acceptable inhalation technique (all critical daily use steps correct) increased from 69.7% at the baseline to 93.0% at the follow-up 1 (p < 0.001). The corresponding figure at the follow-up 2 was 69.0%. At the baseline, 30.3% of patients had optimal inhalation technique (all daily use steps correct). At the follow-up 1 corresponding figure was 85.1%, and 54.8% at the follow-up 2. CONCLUSIONS: A pharmacist-led intervention significantly improved asthma and COPD patients' inhalation technique with the Respimat® inhaler. Significant improvements were found in the daily use steps and the preparation steps before the first use.

Integrating medication risk management interventions into regular automated dose dispensing service of older home care clients - a systems approach.

BACKGROUND: Automated dose dispensing (ADD) services have been implemented in many health care systems internationally. However, the ADD service itself is a logistic process that requires integration with medication risk management interventions to ensure safe and appropriate medication use. National policies and regulations guiding ADD in Finland have recommended medication reconciliation, review, and follow-up for suitable risk management interventions. This implementation study aimed to develop a medication management process integrating these recommended risk management interventions into a regular ADD service for older home care clients. METHODS: This study applied an action research method and was carried out in a home care setting, part of primary care in the City of Lahti, Finland. The systems-approach to risk management was applied as a theoretical framework. RESULTS: The outcome of the systems-based development process was a comprehensive medication management procedure. The medication risk management interventions of medication reconciliation, review and follow-up were integrated into the medication management process while implementing the ADD service. The tasks and responsibilities of each health care professional involved in the care team became more explicitly defined, and available resources were utilized more effectively. In particular, the hospital pharmacists became members of the care team where collaboration between physicians, pharmacists, and nurses shifted from parallel working towards close collaboration. More efforts are needed to integrate community pharmacists into the care team. CONCLUSION: The transition to the ADD service allows implementation of the effective medication risk management interventions within regular home care practice. These systemic defenses should be considered when national ADD guidelines are implemented locally. The same applies to situations in which public home care organizations responsible for services e.g., municipalities, purchase ADD services from private service providers.

Developing and piloting a self-assessment tool for medication review competence of practicing pharmacists based on nationally set competence criteria.

BACKGROUND: New competence requirements have emerged for pharmacists as a result of changing societal needs towards more patient-centred practices. Today, medication review competence can be considered as basic pharmaceutical competence. Medication review specific competence criteria and tools for self-assessing the competence are essential in building competences and a shared understanding of medication reviews as a collaborative practice. The aim of this study was to develop and pilot a self-assessment tool for medication review competence among practicing pharmacists in Finland. METHODS: The development of the self-assessment tool was based on the national medication review competence criteria for pharmacists established in Finland in 2017 and piloting the tool among practicing pharmacists in a national online survey in October 2018. The pharmacists self-assessed their medication review competence with a five-point Likert scale ranging from 1 for "very poor/not at all" to 5 for "very good". RESULTS: The internal consistency of the self-assessment tool was high as the range of the competence areas' Cronbach's alpha was 0.953-0.973. The competence areas consisted of prescription review competence (20 items, Cronbach's alpha 0.953), additional statements for medication review competence (11 additional items, Cronbach's alpha 0.963) and medication review as a whole, including both the statements of prescription review and medication review competence (31 items, Cronbach's alpha 0.973). Competence items closely related to routine dispensing were most commonly self-estimated to be mastered by the practicing pharmacists who responded (n = 344), while the more clinical and patient-centred competence items had the lowest self-estimates. This indicates that the self-assessment tool works logically and differentiates pharmacists according to competence. The self-assessed medication review competence was at a very good or good level among more than half (55%) of the respondents (n = 344). CONCLUSION: A self-assessment tool for medication review competence was developed and validated. The piloted self-assessment tool can be used for regular evaluation of practicing pharmacists' medication review competence which is becoming an increasingly important basis for their contribution to patient care and society.

Comparison of drug-related problem risk assessment tools for older adults: a systematic review.

PURPOSE: This study aims to systematically review studies describing screening tools that assess the risk for drug-related problems (DRPs) in older adults (≥ 60 years). The focus of the review is to compare DRP risks listed in different tools and describe their development methods and validation. METHODS: The systematic search was conducted using evidence-based medicine, Medline Ovid, Scopus, and Web of Science databases from January 1, 1985, to April 7, 2016. Publications describing general DRP risk assessment tools for older adults written in English were included. Disease, therapy, and drug-specific tools were excluded. Outcome measures included an assessment tool's content, development methods, and validation assessment. RESULTS: The search produced 15 publications describing 11 DRP risk assessment tools. Three major categories of risks for DRPs included (1) patient or caregiver related risks; (2) pharmacotherapy-related risks; and (3) medication use process-related risks. Of all the risks included in the tools only 8 criteria appeared in at least 4 of the tools, problems remembering to take the medication being the most common (n=7). Validation assessments varied and content validation was the most commonly conducted (n = 9). Reliability assessment was conducted for 6 tools, most commonly by calculating internal consistency (n = 3) and inter-rater reliability (n = 2). CONCLUSIONS: The considerable variety between the contents of the tools indicates that there is no consensus on the risk factors for DRPs that should be screened in older adults taking multiple medicines. Further research is needed to improve the accuracy and timeliness of the DRP risk assessment tools.

Inclusion of medication-related fall risk in fall risk assessment tool in geriatric care units.

BACKGROUND: Falls are common undesirable events for older adults in institutions. Even though the patient's fall risk may be scored on admission, the medication-induced fall risk may be ignored. This study developed a preliminary categorization of fall-risk-increasing drugs (FRIDs) to be added as a risk factor to the existing fall risk assessment tool routinely used in geriatric care units. METHODS: Medication use data of older adults who had experienced at least one fall during a hospital ward or a nursing home stay within a 2-year study period were retrospectively collected from patient records. Medicines used were classified into three risk categories (high, moderate and none) according to the fall risk information in statutory summaries of product characteristics (SmPCs). The fall risk categorization incorporated the relative frequency of such adverse drug effects (ADEs) in SmPCs that were known to be connected to fall risk (sedation, orthostatic hypotension, syncope, dizziness, drowsiness, changes in blood pressure or impaired balance). Also, distribution of fall risk scores assessed on admission without considering medications was counted. RESULTS: The fall-experienced patients (n = 188, 128 from the hospital and 60 from nursing home records) used altogether 1748 medicaments, including 216 different active substances. Of the active substances, 102 (47%) were categorized as high risk (category A) for increasing fall risk. Fall-experienced patients (n = 188) received a mean of 3.8 category A medicines (n = 710), 53% (n = 375) of which affected the nervous and 40% (n = 281) the cardiovascular system. Without considering medication-related fall risk, 53% (n = 100) of the patients were scored having a high fall risk (3 or 4 risk scores). CONCLUSION: It was possible to develop a preliminary categorization of FRIDs basing on their adverse drug effect profile in SmPCs and frequency of use in older patients who had experienced at least one documented fall in a geriatric care unit. Even though more than half of the fall-experienced study participants had high fall risk scores on admission, their fall risk might have been underestimated as use of high fall risk medicines was common, even concomitant use. Further studies are needed to develop the FRID categorization and assess its impact on fall risk.

Factors associated with health service orientation and active product marketing orientation in Finnish community pharmacies: a nationwide study among private pharmacy owners.

BACKGROUND: Little is known about pharmacy owners' commitment to public health and health policy goals in the strategic planning of their business. The aim of this study was to explore factors associated with health service orientation and active product marketing orientation of Finnish community pharmacy owners. METHODS: A national cross-sectional e-mail survey was sent to private community pharmacy owners in Finland (n = 581) in 2013. Based on the structured, Likert-type survey instrument, two sum scales measuring strategic orientation towards health service provision (13 items, score range 0-26) and active product marketing (8 items, score range 0-16) were developed (Cronbach's Alpha 0.836 and 0.699, respectively). Characteristics of the pharmacy owners and their pharmacy business as well as actual service provision were used as background variables. RESULTS: Concerning health service orientation, 50% of the respondents received at least 20 points out of the maximum 26 points (score range: 0-26). For active product marketing orientation, 75% of the pharmacy owners had at least 14 points and 44% received full 16 points (score range: 0-16). The score distribution was skewed towards strong health service orientation, but the actual service score was heavily skewed towards few services or no services. Two-thirds of the pharmacy owners reported having available 2 or less services. The health service orientation was not influenced by any of the background variables used, but three of them influenced active product marketing orientation, namely business location, annual prescription volume and belonging to a marketing chain of individual community pharmacies. CONCLUSION: Large pharmacies located close to rivals and belonging to marketing chains of individual community pharmacies differentiated as those having a high product marketing orientation. The health service orientation was not influenced by any of the explanatory variables used in this study. The discrepancy between high health service orientation scores and low actual service provision scores needs further investigation. The contradiction that exists between pharmaceutical policy goals and the generation of income of pharmacies should also be examined as a contributing factor in this respect.

Enhanced coordination of care to reduce medication risks in older home care clients in primary care: a randomized controlled trial.

BACKGROUND: As populations are aging, a growing number of home care clients are frail and use multiple, complex medications. Combined with the lack of coordination of care this may pose uncontrolled polypharmacy and potential patient safety risks. The aim of this study was to assess the impact of a care coordination intervention on medication risks identified in drug regimens of older home care clients over a one-year period. METHODS: Two-arm, parallel, cluster randomized controlled trial with baseline and follow-up assessment at 12 months. The study was conducted in Primary Care in Lohja, Finland: all 5 home care units, the public healthcare center, and a private community pharmacy. PARTICIPANTS: All consented home care clients aged > 65 years, using at least one prescription medicine who were assessed at baseline and at 12 months. INTERVENTION: Practical nurses were trained to make the preliminary medication risk assessment during home visits and report findings to the coordinating pharmacist. The coordinating pharmacist prepared the cases for the triage meeting with the physician and home care nurse to decide on further actions. Each patient's physician made the final decisions on medication changes needed. Outcomes were measured as changes in medication risks: use of potentially inappropriate medications and psychotropics; anticholinergic and serotonergic load; drug-drug interactions. RESULTS: Participants (n = 129) characteristics: mean age 82.8 years, female 69.8%, mean number of prescription medicines in use 13.1. The intervention did not show an impact on the medication risks between the original intervention group and the control group in the intention to treat analysis, but the per protocol analysis indicated tendency for effectiveness, particularly in optimizing central nervous system medication use. Half (50.0%) of the participants with a potential need for medication changes, agreed on in the triage meeting, had none of the medication changes actually implemented. CONCLUSION: The care coordination intervention used in this study indicated tendency for effectiveness when implemented as planned. Even though the outcome of the intervention was not optimal, the value of this paper is in discussing the real world experiences and challenges of implementing new practices in home care. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02545257). Registered September 9 2015.

Patient involvement is essential in identifying drug-related problems.

AIMS: The aim of this study is to evaluate how critical patient involvement is in pharmacist-led clinical medication reviews and in identifying the most significant clinical drug-related problems (DRPs). METHODS: Pharmacist-led clinical medication reviews were conducted with 161 consenting patients aged ≥75 years with at least seven prescribed medicines, living independently at home in Finland. A pharmacist, a nurse and a physician evaluated the clinical significance of the DRPs identified during the patient interview at an interprofessional case conference. It was evaluated whether the most significant clinical DRPs could also have been identified through reviewing the medication list only or the medication list and certain patient details. RESULTS: Altogether, the 111 most significant clinical DRPs were evaluated. Only 6% could have been identified through reviewing the medication list only, and 16% through reviewing the medication list and certain patient details. Hence, 84% of the most significant clinical DRPs could only have been identified with patient involvement. The most common DRPs were: poor therapy control (25%); nonoptimal drug (22%); intentional nonadherence (12%); and additional drug needed (11%). patient involvement was critical when identifying DRPs related to additional drug needed, unintentional nonadherence, use of over-the-counter medicines or dietary supplements, or contradictions in counselling. CONCLUSION: Patient involvement is essential when identifying clinical DRPs. Indeed, poor therapy control, nonoptimal drug use, intentional or unintentional nonadherence might otherwise be missed.

Trends in the long-term use of benzodiazepine anxiolytics and hypnotics: A national register study for 2006 to 2014.

PURPOSE: Long-term benzodiazepine (BZD) treatment continues to be a debated topic. Because individual BZDs have different clinical profiles, we assessed the nationwide trends of long-term BZD use at active substance level during years 2006 to 2014. METHODS: This study covered all reimbursed BZD purchases (n = 408 572-521 823 annually) for adults recorded in the Finnish Prescription Register. We assessed long-term use (annual cumulative purchase of ≥180 defined daily doses) in general, and at active substance level with the most commonly used BZD anxiolytics (oxazepam, diazepam, alprazolam, and clonazepam for nonepilepsy indications) and hypnotics (zopiclone, zolpidem, and temazepam) included. The persistence rates for each substance were assessed separately. RESULTS: The prevalence of long-term BZD use among Finnish adults declined significantly from 5.3% to 3.6%, during years 2006 to 2014. Despite this decline, there was a significant increase in the long-term use of clonazepam for nonepilepsy indications and zolpidem (28.0% and 17.5%, respectively). Long-term use was common in the aged population, as well as among the users of hypnotics or clonazepam. Persistent use of 9 consecutive calendar years varied between 7.5% for incident alprazolam users and 21.0% for incident clonazepam users. CONCLUSIONS: We found a declining trend in long-term BZD use, but the decline was not uniform between the substances-the long-term use of clonazepam and zolpidem even increased. Follow-up research is needed to assess whether the decline in BZD use is accompanied by an increased use of other types of anxiolytic or hypnotic drugs or other forms of treatment.

Coordinating resources for prospective medication risk management of older home care clients in primary care: procedure development and RCT study design for demonstrating its effectiveness.

BACKGROUND: The magnitude of safety risks related to medications of the older adults has been evidenced by numerous studies, but less is known of how to manage and prevent these risks in different health care settings. The aim of this study was to coordinate resources for prospective medication risk management of home care clients ≥ 65 years in primary care and to develop a study design for demonstrating effectiveness of the procedure. METHODS: Health care units involved in the study are from primary care in Lohja, Southern Finland: home care (191 consented clients), the public healthcare center, and a private community pharmacy. System based risk management theory and action research method was applied to construct the collaborative procedure utilizing each profession's existing resources in medication risk management of older home care clients. An inventory of clinical measures in usual clinical practice and systematic review of rigorous study designs was utilized in effectiveness study design. DISCUSSION: The new coordinated medication management model (CoMM) has the following 5 stages: 1) practical nurses are trained to identify clinically significant drug-related problems (DRPs) during home visits and report those to the clinical pharmacist. Clinical pharmacist prepares the cases for 2) an interprofessional triage meeting (50-70 cases/meeting of 2 h) where decisions are made on further action, e.g., more detailed medication reviews, 3) community pharmacists conduct necessary medication reviews and each patients' physician makes final decisions on medication changes needed. The final stages concern 4) implementation and 5) follow-up of medication changes. Randomized controlled trial (RCT) was developed to demonstrate the effectiveness of the procedure. The developed procedure is feasible for screening and reviewing medications of a high number of older home care clients to identify clients with severe DRPs and provide interventions to solve them utilizing existing primary care resources. TRIAL REGISTRATION: The study is registered in the Clinical Trials.gov ( NCT02545257 ). Registration date September 9 2015.

Can Practical Nurses Identify Older Home Care Clients at Risk of Drug-Related Problems-Geriatricians' Appraisal of Their Risk Screenings: A Pilot Study.

Background: Home care (HC) clients are increasingly older, have many chronic diseases, and use multiple medicines and thus are at high risk for drug-related problems (DRPs). Objective: Establish the sensitivity of practical nurse (PN) administered DRP risk assessment tool (DRP-RAT) compared with geriatrician's assessment of the medical record. Identify the clinically most significant DRPs needing action. Methods: Twenty-six PNs working in HC of Härkätie Health Center in Lieto, Finland, 46 HC clients (≥65 years), and a geriatrician participated in this pilot study. The geriatrician reviewed HC clients' medications using 3 different methods. The reviews were based on the following: (1) the PN's risk screening (ie, PN-completed DRP-RAT) and medication list, (2) health center's medical records, and (3) methods 1 and 2 together. The main outcome was the number of "at-risk patients" (ie, the patient is at risk of clinically significant DRPs) by using each review method. Secondary outcomes were clinically most significant DRP-risk predicting factors identified by the geriatrician. Results: The geriatrician reviewed 45 clients' medications using all 3 methods. Based on PN-completed DRP-RAT and medication list, 93% (42/45) of the clients were classified as "at-risk patients." Two other review methods resulted in 45/45 (100%) "at-risk patients." Symptoms suggestive of adverse drug reactions were the most significant risk predicting factors. Small sample size limits the generalizability of the results. Conclusions: The PN-completed DRP-RAT was able to provide clinically important timely patient information for clinical decision making. DRP-RAT could make it possible to more effectively involve PNs in medication risk management among older HC clients.

The value of patient reporting to the pharmacovigilance system: a systematic review.

AIMS: Current trends in pharmacovigilance systems are veering towards patient involvement in spontaneous reporting of adverse drug reactions (ADRs). The aim of the current systematic review was to identify what is known and what remains unknown with respect to patient reporting to pharmacovigilance systems. METHODS: A systematic literature search was conducted in PubMed, CINAHL, Journals@Ovid and the Cochrane Library. Studies were included if they contained: (i) reviews about patient reporting; (ii) evaluation of patient reports to national or supranational pharmacovigilance authorities; (iii) a comparison between patient and healthcare professional (HCP) reports submitted to pharmacovigilance authorities; and (iv) surveys of patient experiences, opinions and awareness about reporting ADRs. The methodological quality of the studies was assessed according to principles of Grading of Recommendations, Assessment, Development and Evaluations (GRADE). RESULTS: A total of thirty four studies were included. Five of the studies were reviews (two of which systematic reviews), fourteen retrospective observational studies, nine surveys and six applied mixed research methods. Patient reporting has the advantages of bringing novel information about ADRs. It provides a more detailed description of ADRs, and reports about different drugs and system organ classes when compared with HCP reporting. In addition, patients describe the severity and impact of ADRs on daily life, complementing information derived from HCPs. Patient reporting is relatively rare in most countries. CONCLUSIONS: Patient reporting adds new information, and perspective about ADRs in a way otherwise unavailable. This can contribute to better decision-making processes in regulatory activities. The present review identified gaps in knowledge that should be addressed to improve our understanding of the full potential and drawbacks of patient reporting.

Off-label use of antimicrobials in neonates in a tertiary children's hospital.

PURPOSE: Off-label (OL) use of drugs for hospitalized children is very common. OL use occurs especially in the youngest patients, neonates. This study focused on the OL use of antimicrobials in neonates. To our knowledge, only few studies have focused on the prevalence of OL use of antimicrobials in neonates. METHODS: We investigated the OL use of antimicrobials in neonates in a tertiary children's hospital. First, we investigated what were the most consumed OL antimicrobials in defined daily doses according to hospital's registry data from neonatal intensive care unit (NICU) during 2009-2014. Second, we conducted a targeted retrospective study of premature neonates (400-2000 g) with blood culture-positive infections and receiving antimicrobial therapy between 2005 and 2014 (N = 282). The data were obtained from the electronic patient records and from the hospital's electronic infection registry. Statistical analysis was conducted by using a univariate logistic regression model fitted for OL usage. RESULTS: In NICU, 35% (7/20) of antimicrobials used were OL. Eighteen percent (51/282) of premature neonates with blood culture-positive infections received at least one antimicrobial OL. The most commonly used OL antimicrobials in neonates were meropenem 88% (45/51), rifampicin 18% (9/51), and ciprofloxacin 8% (4/51). The odds for OL use were significantly higher the smaller the neonate birth weight was. An increase in birth weight was found to statistically significantly decrease the probability of OL usage (odds ratio = 0.85 for 100 g increase in birth weight, p value <0.001). CONCLUSION: More studies in neonates on especially dosing and pharmacokinetics of antimicrobials are urgently needed.

Impact of the automated dose dispensing with medication review on geriatric primary care patients drug use in Finland: a nationwide cohort study with matched controls.

OBJECTIVE: In an automated dose dispensing (ADD) service, medicines are dispensed in unit-dose bags according to administration times. When the service is initiated, the patient's medication list is reconciled and a prescription review is conducted. The service is expected to reduce drug use. The aim of this national controlled study was to investigate whether the ADD service with medication review reduces drug use among geriatric primary care patients. DESIGN, SETTING AND PATIENTS: This is a nationwide cohort study with matched controls. The study group consisted of all primary care patients ≥65 years enrolled in the ADD service in Finland during 2007 (n = 2073). Control patients (n = 2073) were matched by gender, age, area of patient's residence and number of the prescription drugs reimbursed. The data on all prescription drugs reimbursed during the 1 year periods before and after the ADD service enrollment were extracted from the Finnish National Prescription Register. Drug use was calculated as defined daily doses (DDD) per day. RESULTS: The studied 20 most used drugs covered 86% of all reimbursed drug use (in DDD) of the study group. The use of 11 out of these 20 active substances studied was reduced significantly (p < .001-.041) when the drug use was adjusted by the number of chronic diseases. Two of these drugs were hypnotics and six were cardiovascular system drugs. CONCLUSIONS: Drug use was decreased after initiation of the ADD service in primary care patients ≥65 years compared to matched controls in this 1 year cohort study. Further studies should be conducted in order to explore the causality, assess the ADD service's impact on drug use quality and costs, as well as impact of accompanied prescription review on positive outcomes.

Towards interprofessional networking in medication management of the aged: current challenges and potential solutions in Finland.

OBJECTIVE: The Finnish Medicines Agency (Fimea) initiated a programme in 2012 for enhancing interprofessional networking in the medication management of the aged. The goal is to develop national guidelines for interprofessional collaboration with respect to medication management. This study aims to explore the challenges and potential solutions experienced by existing health care teams in managing medication of the aged: (1) at the individual and team level (micro level), (2) organisational level (meso level) and (3) structural level (macro level). DESIGN: Group discussions (n = 10), pair (n = 3) and individual interviews (n = 2). Abductive content analysis combining data and theory was applied. Networking was used as a theoretical framework. SETTING: Meetings (n = 15) organised by Fimea in the formation phase of the interprofessional network in 2012. SUBJECTS: Health care professionals (n = 55). MAIN OUTCOME MEASURES: Challenges and solutions in the medication management of the aged at the micro, meso and macro levels. RESULTS: Challenges in interprofessional collaboration, problems with patient record systems, and the organisation of work and lack of resources were present at all the levels contributing to patients' medication problems. Participants suggested multiple potential solutions to improve interprofessional collaboration, sharing of tasks and responsibilities, better exploitation of pharmaceutical knowledge and developing tools as being the most commonly mentioned. CONCLUSIONS: Optimising medication use of the aged requires new systemic solutions within and between different system levels. The main challenges can be solved by clarifying responsibilities, enhancing communication and applying operational models that involve pharmacists and the use of information technology in medication management. KEY POINTS An interprofessional team approach has been suggested as a solution to promote rational medicine use among the aged. Fragmented health care system and lack of coordinated patient care are reasons for medication related problems of the aged. Challenges in the implementation of interprofessional collaboration in medication management appear in legislation, information systems, operational models and individuals' attitudes. Optimising medications requires better interprofessional networking and new systemic solutions within and between macro, meso and micro levels.