Beate Hennie Garcia

Co-prescription of cytochromeP450 2D6/3A4 inhibitor-substrate pairs in clinical practice. A retrospective analysis of data from Norwegian primary pharmacies

Objective Inhibition of cytochrome PP450 (CYP) enzymes, in particular CYP3A4 and CYP2D6, is an important drug-interacting mechanism. The objective of our study was to assess how frequently CYP3A4 and CYP2D6 inhibitors are co-prescribed with substrates of the respective enzymes.Methods Included inhibitors were clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole and nefazodone (CYP3A4 inhibitors) and bupropion, fluoxetine, paroxetine and terbinafine (CYP2D6 inhibitors). The inhibitors were combined with substrates shown to be pharmacokinetically sensitive towards inhibition (190 drug pairs in total). Lists of patients receiving inhibitors and substrates were drawn from prescription databases (~43,500 patients) of three Norwegian primary pharmacies during a 6-month period (July 2002 to January 2003). The lists were matched on name and date of birth to identify patients using drug pairs. Concurrent use was made probable from dates of purchase and drug profiles.Results Inhibitors were prescribed to 2,062 patients. Altogether, 369 events of substrate co-prescription were registered. The highest frequencies of co-prescribed substrates were found for paroxetine (101 events per 267 patients, 38%), fluoxetine (36 events per 110 patients, 33%) and clarithromycin (59 events per 242 patients, 24%). The drugs most often detected in combination with inhibitors were codeine (116 events) and metoprolol (38 events) for CYP2D6 and zopiclone (45 events) and simvastatin (26 events) for CYP3A4.Conclusion Several commonly used CYP2D6 and CYP3A4 inhibitors are frequently co-prescribed with substrates in Norwegian clinical practice. Alertness when inhibitors are prescribed would aid physicians and pharmacists to detect many drug combinations with potential interaction risk.

MAT-CHDSP, a novel medication assessment tool for evaluation of secondary prevention of coronary heart disease.

Quality of health performance is of increasing international importance. The potential value of the implementation of a guideline‐based medication assessment tool (MAT) has been evaluated in order to measure and improve adherence to guideline recommendations in secondary prevention of coronary heart disease (CHD).

A pharmacist-led follow-up program for patients with coronary heart disease in North Norway–a qualitative study exploring patient experiences

BackgroundCoronary heart disease (CHD) is one of the leading causes of death worldwide. Scientific literature shows that prevention of CHD is inadequate. The clinical pharmacist’s role in patient-centred care has been shown favourable in a large amount of studies, also in relation to reduction of risk factors related to CHD. We developed and piloted a pharmacist-led follow-up program for patients with established CHD after hospital discharge from a hospital in North Norway. The aim of the present study was to explore how participants in the follow-up program experienced the program with regard to four main topics; medication knowledge, feeling of safety and comfort with medications, the functionality of the program and the clinical pharmacist’s role in the interdisciplinary team.MethodsWe performed semi-structured thematic interviews with four patients included in the program. After verbatim transcribing, we analysed the interviews using “qualitative content analyses” by Graneheim and Lundman. Trial registration http://www.clinicaltrials.gov: NCT01131715.ResultsAll participants appreciated the follow-up program because their medication knowledge had increased, participation had made them feel safe, they were reassured about the appropriateness of their medications, and they had become more involved in their own medication. The participants reported that the program was well structured and the clinical pharmacist was said to be an important caretaker in the health-care system. The importance of collaboration between pharmacists and physicians, both in hospital and primary care, was emphasized.ConclusionOur results indicate that the follow-up program was highly appreciated among the four participants included in this study. The results must be interpreted in the context of the health care system in Norway today. Here, few pharmacists are working in hospitals or in close relation to the general practitioners. In addition, physicians are short of time in order to supply appropriate medication information, both in hospital and primary care. Involving pharmacists in follow-up of patients with CHD seems to be highly appreciated among patients and may be a step towards improving patient care. The study is limited by the low number of participants.

MAT‐CAP: a novel medication assessment tool to explore adherence to clinical practice guidelines in community‐acquired pneumonia

Community‐acquired pneumonia (CAP) is a disease with high morbidity and mortality. Adherence to clinical practice guidelines (CPGs) in treatment of CAP is associated with favourable outcome. We aimed to develop and validate a medication assessment tool (MAT) to explore adherence to CPG recommendations in patients with CAP admitted to a Norwegian hospital. The tool is named MAT‐CAP.

Safety and efficiency of a new generic package labelling: a before and after study in a simulated setting

Background Medication errors are frequent and may cause harm to patients and increase healthcare expenses. Aim To explore whether a new labelling influences time and errors when preparing medications in accordance with medication charts in an experimental setting. Method We carried out an uncontrolled before and after study with 3 months inbetween experiments. Phase I used original labelling and phase II used new generic labelling. We set up an experimental medicine room, simulating a real-life setting. Twenty-five nurses and ten pharmacy technicians participated in the study. We asked them to prepare medications in accordance with medication charts, place packages on a desk and document the package prepared. We timed the operation. Participants were asked to prepare medications in accordance with as many charts as possible within 30 min. Results Nurses prepared significantly more medication charts with the generic labelling compared with the original 3.3 versus 2.6 (p=0.009). Mean time per medication chart was significantly lower with the generic labelling 6.9 min/chart versus 8.5 min/chart (p<0.001). Pharmacy technicians were significantly faster than the nurses in both phase I (6.8 min/chart vs 9.5 min/chart; p<0.001) and phase II (6.1 min/chart vs 7.2 min/chart; p=0.013). The number of errors was low and not significantly different between the two labellings, with errors affecting 9.1% of charts in phase I versus 6.5% in phase II (p=0.5). Conclusions A new labelling of medication packages with prominent placement of the active substance(s) and strength(s) in the front of the medication package may reduce time for nurses when preparing medications, without increasing medication errors.

Understanding Pain and Pain Management in Elderly Nursing Home Patients Applying an Interprofessional Learning Activity in Health Care Students: A Norwegian Pilot Study

Abstract Background: Pain is common among elderly patients in nursing homes. However, pain assessment and treatment are inadequate. Interprofessional treatment is recommended, and consequently interprofessional education in pain management is necessary. Aims: This pilot project aimed to describe how two interprofessional groups of students approached pain management in two nursing home patients. Design: We formed two teams comprising one student from the nursing, physical therapy, pharmacy, and medical educations. Each team spent one day examining a patient with chronic pain at a nursing home and they developed pain management plans. Methods: We collected data through video recordings during teamwork before and after examining the patients and field notes during the patient examination. We analysed the video‐recordings applying the seven‐step model including 1) viewing the video data, 2) describing the video data, 3) identifying critical events, 4) transcribing, 5) coding, 6) constructing storyline and 7) composing a narrative. Field notes supplied the transcripts. Results: Both teams succeeded in making a pain management plan for their patient. The common examination of the patient was crucial for the students’ approaches to pain management and changed their pre‐assumptions about the patients’ pain. By sharing knowledge and reflecting together, the students reached a common consensus on suggestions for management of the patients’ problems. Interprofessional collaboration fostered enthusiasm and a more holistic pain management approach. However, students’ lack of knowledge limited their understanding of pain. Conclusion: Knowledge of pain management in nursing home patients and the practice of interprofessional cooperation should be included in pain curricula for health care professionals.

Adverse drug reaction reporting: how can drug consumption information add to analyses using spontaneous reports?

PurposeSpontaneous reporting of adverse drug reactions (ADRs) is a cornerstone in pharmacovigilance. However, information about the underlying consumption of drugs is rarely used when analysing spontaneous reports. The purpose of this study was to combine ADR reports with drug consumption data to demonstrate the additional information this gives in various scenarios, comparing different drugs, gender-stratified sub-populations and changes in reporting over time.MethodsWe combined all Norwegian ADR reports in 2004–2013 from the EudraVigilance database (n = 14.028) with dispensing data from the Norwegian Prescription Database (more than 800 million dispensed prescriptions during 2004–2013). This was done in order to calculate drug-specific consumption-adjusted adverse drug reaction reporting rates (CADRRs) by dividing the number of reports for each drug with the number of users of the drug during the same time period.ResultsAmong the ten drugs with the highest number of ADR reports and the ten drugs with the highest CADRR, only four drugs were in both categories. This indicates that drugs with a high number of reports often also have a high number of users and that CADRR captures drugs with potentially relevant safety issues but a smaller number of users. Comparing reported ADRs in females and males using methylphenidate, we found that the two groups report different ADRs. Finally, we showed that changes in ADR reporting for simvastatin and atorvastatin during 2004–2013 were due to changes in consumption and that atorvastatin had a higher CADRR but fewer reports than simvastatin.ConclusionsCADRR provides additional information compared with number of reports alone in studies using spontaneous reports. It is important for researchers to adjust for consumption whenever possible in pharmacovigilance studies.

Interdisciplinary collaboration across secondary and primary care to improve medication safety in the elderly (IMMENSE study): study protocol for a randomised controlled trial

Introduction Drug-related problems (DRPs) are common in the elderly, leading to suboptimal therapy, hospitalisations and increased mortality. The integrated medicines management (IMM) model is a multifactorial interdisciplinary methodology aiming to optimise individual medication therapy throughout the hospital stay. IMM has been shown to reduce readmissions and drug-related hospital readmissions. Using the IMM model as a template, we have designed an intervention aiming both to improve medication safety in hospitals, and communication across the secondary and primary care interface. This paper presents the study protocol to explore the effects of the intervention with regard to healthcare use, health-related quality of life (HRQoL) and medication appropriateness in elderly patients. Methods and analysis A total of 500 patients aged ≥70 years will be included and randomised to control (standard care) or intervention group (1:1). The intervention comprises five steps mainly performed by pharmacists: (1) medication reconciliation at admission, (2) medication review during hospital stay, (3) patient counselling about the use of medicines, (4) a comprehensible and patient-friendly medication list with explanations in discharge summary and (5) postdischarge phone calls to the primary care level. The primary outcome is the difference between intervention and control patients in the rate of emergency medical visits (acute readmissions and visits to emergency department) 12 months after discharge. Secondary outcomes include length of index hospital stay, time to first readmission, mortality, hip fractures, strokes, medication changes, HRQoL and medication appropriateness. Patient inclusion started in September 2016. Ethics and dissemination The trial was approved by the Norwegian Centre for Research Data and the Norwegian Data Protection Authority. We aim to publish the results in international peer-reviewed open access journals, at national and international conferences, and as part of two PhD theses. Trial registration number NCT02816086.