The influence of hospitalisation on the initiation, continuation and discontinuation of benzodiazepines and Z-drugs - an observational study.

BACKGROUND AND OBJECTIVES: Hospitalisation influences drug therapy in ambulatory care and this influence is generally negatively perceived. The few studies that have explored changes in benzodiazepine or sleep medication use as a function of hospitalisation failed to precisely determine the hospital's role in initiating, continuing and discontinuing these drugs on a valid basis. The aim of the study was to ascertain the overall influence of hospitalisation on the prescription of benzodiazepines and Z-drugs in outpatient care with a special focus on the role of different hospital departments and drug classes. METHODS: In a secondary data analysis, we used prescription data for 181 037 patients who visited 127 hospitals and compared the numbers of patients with prescriptions of benzodiazepines and Z-drugs 50 days before and 50 or 100 days after hospitalisation. RESULTS: The proportion of patients who received benzodiazepines or Z-drugs increased from 3.1% before admission to 3.6% at 50 days after discharge and fell to the former level after an additional 50 days. A multivariable logistic regression showed that gender and department had an additional impact on these results. Of those patients without a prescription for a benzodiazepine or Z-drug before admission, 0.6% received a prescription in both time-windows after discharge. Of those patients who were prescribed a benzodiazepine, 38.0% received short-acting substances and 40.3% received long-acting substances before hospitalisation. After hospitalisation, these rates changed to favour short-acting substances (44.4% and 34.4%, respectively). CONCLUSIONS: The hospital effect on initiating and increasing hypnotic or sedative drug use seems to be only moderate and temporary. A change in favour of short-acting substances is even welcome. In less than 1% of patients, the hospital initiated the continuous use of benzodiazepines and Z-drugs, which may put pressure on primary care physicians. However, the widespread use of these drugs in hospitals does not seem to be continued on a large scale in primary care.

Dementia care management: going new ways in ambulant dementia care within a GP-based randomized controlled intervention trial.

BACKGROUND: Increasing prevalence of dementia is a major challenge for the German healthcare system. The study DelpHi-MV ("Dementia: life- and person-centered help in Mecklenburg-Western Pomerania") aims to implement and evaluate an innovative subsidiary support system for persons with dementia (PwDs) living at home and their caregivers. METHODS: DelpHi-MV is a GP-based cluster randomized controlled intervention trial. DelpHi-Intervention aims to provide "optimum care" by integrating multi-professional and multimodal strategies to individualize and optimize treatment of dementia within the framework of the established healthcare and social service system. The intervention is conducted by Dementia Care Managers (DCMs)--nurses with dementia-specific training--at the people's homes. Based on German guidelines for evidence-based diagnoses and treatment of dementia, a comprehensive set of 95 interventio--modules--the "DelpHi-Standard"--was defined. Each module consists of predefined trigger condition(s), a subsequent intervention task, as well as at least one criterion for its completion. The intervention begins with a comprehensive assessment of the care situation, needs, and resources. The DCM develops and implements an intervention plan tailored to the individual conditions in close cooperation with the GP. EXPECTED RESULTS AND CONCLUSIONS: We expect statistically significant differences between control and intervention group in primary outcomes (quality of life, behavioral and psychological symptoms of dementia, pharmacotherapy, caregiver burden). Results can provide evidence for the effectiveness and efficacy of dementia care management according to the "Delphi-Standard"--prerequisites for implementing this concept into routine healthcare.

Medication management for people with dementia in primary care: description of implementation in the DelpHi study.

BACKGROUND: As the population ages, the relative and absolute number of age-associated diseases such as dementia will increase. Evaluation of the suitability and intake of medication and pharmacological treatment is an important aspect of care for people with dementia, especially if they live at home. Regular medication reviews and systematic cooperation between physicians and pharmacists are not common in routine care. Medication management (MM), based on such a comprehensive home medication review could help to reduce drug-related problems and costs. The present article presents a medication management specifically for the application in the ambulatory setting and describes its implementation as part of a larger trial. METHODS/DESIGN: A home medication review (HMR) and MM is implemented as part of the DelpHi study, a population based prospective, cluster-randomized controlled intervention study to test the efficacy and efficiency of the implementation of a collaborative care model in primary care. PARTICIPANTS: people with dementia (PWD) and their caregivers are recruited by the patient's general practitioner. Inclusion criteria are a positive screening result for dementia, living at home and regular intake of drugs. PWD are asked to specify their regular pharmacy which is asked to participate in the study, too. INTERVENTION: a comprehensive HMR is conducted as computer-assisted personal interview by specifically qualified Dementia Care Manager (DCM) at the people's home. It includes detailed information about drugs taken, their storage, administration, adherence and adverse events. The MM is conducted in cooperation between DCM, pharmacist and general practitioner and consists of a pharmaceutical evaluation, pharmaceutical recommendations and their application. Pharmacists are trained and provided with regularly updated information. The MM is designed to give information and recommendations concerning antidementia drugs, occurrence of drug related problems, intake of anticholinergic drugs, potentially clinically relevant drug-drug-interactions, adverse drug events and medication adherence. DISCUSSION: The DelpHi-approach for medication management employs comprehensive instruments and procedures in the primary care setting under routine care conditions, and this approach should be useful in improving pharmacotherapy as part of the comprehensive treatment and care for people with dementia. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov, number NCT01401582.

Effects of a three party healthcare network on the incidence levels of drug related problems.

BACKGROUND: Drug related problems (DRPs) are impairing patients' health and cause high costs. Neither delegation of home medication review nor regular pharmaceutical care are common in Germany. OBJECTIVE: We aimed to reduce several DRP by the implementation of a three party healthcare team [AGnES-practice assistant, pharmacist, general practitioner (GP)] and adherence supporting strategies (using a medication reminder chart, medication compliance aid). SETTING: The setting was ambulatory primary healthcare in German rural areas with a cohort of home-dwelling, elderly, mostly multimorbid patients with limited mobility (study period: 06/2006-12/2008). METHODS: We conducted a prospective non-randomized implementation cohort study with home medication review (home medication review module; mean participation time: 9 months). Data collection was delegated to additionally qualified AGnES-practice assistants (AGnES: GP-supporting, community-based, e-health-assisted systemic intervention). The intervention comprised pharmaceutical care by the local pharmacy in addition to medical interventions by the GP. 408 patients (mean age: women: 80.7 years; men: 75.3 years) received both pharmaceutical care and at least one follow-up visit. MAIN OUTCOME MEASUREMENT: Outcome measurements comprised self-reported DRPs, objectively evaluated DRP, and prevalence of adherence supporting strategies. RESULTS: The three party healthcare team approach reduced self-reported forgetfulness (7.7-3.2 %; p = 0.001), the proportion of patients with intermittent drug intake (5.3-1.3 %; p < 0.001), and the proportion of patients with potentially clinical relevant drug-drug interaction (61.6-51.2 %; p < 0.001). Self-reported adverse drug reactions decreased non-significantly (5.4-4.6 %; p = 0.564; all tests χ²-McNemar). The median number of active substances taken was reduced from 8 to 7 (p < 0.001; Wilcoxon signed rank test). The proportions of patients using medication charts and compliance aids increased significantly (75.2-90.3 %; p < 0.001) and (70.0-80.1 %; p > 0.001), respectively. CONCLUSION: This is the first study evaluating effects of a three party team on DRPs in a primary healthcare setting in Germany. This approach led to reduction in the occurrence of several DRPs and improved adherence supporting strategies. However, the study is a pre-post analysis, and had no control group.

Prevalence and determinants of controlled hypertension in a German population cohort.

BACKGROUND: Data of the German population-based cohort SHIP (Study of Health in Pomerania) were analysed to examine treatment rates, antihypertensive substances prescribed, and the proportion of hypertensive study participants reaching target values for blood pressure as well as determinants. METHODS: The study population was defined using baseline data of the cohort (collected between 1997 and 2001). Participants with blood pressure values ≥140/90 mmHg and/or antihypertensive medication with known hypertension and participants with risk-comorbidity (diabetes, stroke, angina pectoris, and/or myocardial infarction) and blood pressure values ≥130/80 mmHg were included. The analysis of treatment and target values was based on the 5-year follow-up of the cohort (collected between 2002 and 2006). Logistic regression was used to identify determinants for a normotensive blood pressure. RESULTS: 3278 SHIP-participants with hypertensive blood pressure values were included (mean age: 55.5 years; SD 13.6, range 21-80 years). The raw hypertension prevalence was 50.9% (N = 1761). 58.7% (N = 1074) of all hypertensive patients reported some form of antihypertensive treatment. Thereof 65.1% (N = 728) received combination therapy. Of the patients without risk-comorbidity, 42.1% (N = 489) reached their target blood pressure values at the time of the 5-year follow-up of the cohort. Of the patients with any risk-comorbidity this proportion was only 21.7% (N = 131). Significant determinants for reaching the target values were being female and having antihypertensive combination therapy. Increasing age, having risk-comorbidities, and obesity were negatively associated with reaching the target values. CONCLUSIONS: Both the proportion of participants receiving therapy and the number of participants reaching their target blood pressure values are very low. Combination therapy is associated with better blood pressure control as compared to mono therapy. However, even in the subgroup of hypertensive patients under combination therapy only 36% (both patients with and without comorbidity) reach target values.

Changes in blood pressure in patients with hypertension in the context of delegated GP-home visits: a prospective implementation study.

BACKGROUND: The AGnES-concept (GP-supporting, community-based, e-health-assisted, systemic intervention) includes the delegation of general practitioner (GP)-home visits to qualified practice assistants, especially in underserved areas. Most visited patients were elderly, multimorbid patients with limited mobility. We analyzed a subgroup of hypertension patients to assess the proportion of patients with controlled hypertension, the number of patients that changed between different categories of blood pressure during the project, and to identify possible determinants for these changes. MATERIALS AND METHODS: Eligible patients were selected by the participating GPs. Hypertensive patients with at least two blood pressure measurements were included. Two-level mixed-effects multiple binary logistic regression analyses were conducted to evaluate possible determinants for the found effects. RESULTS: Overall, 776 patients (mean age 79.2 years; SD 8.1 years; range 38-98 years) were included in the analysis. During the project, the mean values for systolic (from 136.1 to 131.0 mmHg, P<0.0001) and diastolic (from 77.0 to 75.7 mmHg, P=0.0026) blood pressure decreased. In 26.0% of the patients there was a change from hypertensive blood pressure values to normotensive values and vice versa in 14.3% (P<0.0001). Multilevel regression models did not show single elements of the complex intervention as determinants for changing to normotensive blood pressure values. CONCLUSION: Although the study was conducted under real life conditions and therefore had some methodological limitations, the delegation of home visits to qualified practice assistants may have had a positive influence on changes of blood pressure with elderly hypertension patients. The study population represents a relevant population for medical care, which might benefit from the implementation of the AGnES-concept.

Cognitive impairment in primary ambulatory health care: pharmacotherapy and the use of potentially inappropriate medicine.

OBJECTIVE: Drug intake is associated with a risk of drug-related problems, for example, the intake of potentially inappropriate medication (PIM), especially for cognitively impaired individuals. The proportion of PIM taken by immobile individuals, especially patients with suspicion of dementia in the AGnES studies (German: Arzt-entlastende Gemeinde-nahe E-Health-gestützte Systemische Intervention), and possible determinants were analyzed. METHODS: In a community-based, prospective cohort study in the ambulatory healthcare sector, a sample of 342 patients aged ≥65 years were screened for dementia and received a home medication review. The screening for dementia was positive in 111 cases (32.5%). Data assessment included sociodemographic variables and medical diagnoses. The German PRISCUS list was used to detect PIM and drug-condition interactions. RESULTS: Potentially inappropriate medication in dementia was identified in 22 (19.8%) patients with suspicion of dementia. A multivariate binary logistic regression revealed that the number of drugs taken (one to four drugs: OR = 0.059; 95% CI 0.006-0.55, p = 0.0133; Ref.: >9 drugs) and female gender (OR = 10.362; 95% CI: 1.28-83.87) were risk factors for PIM intake in patient with suspicion of dementia. CONCLUSIONS: Inappropriate medication use in a community-based sample positively screened for dementia appears to be determined by sex and the number of drugs taken. The intake of fewer than five drugs and receiving support with regard to drug intake protects from the intake of PIM. Patients could benefit from medication management in a collaborative network of healthcare professionals. The implementation of systematic medication review and drug documentation should be extended and standardized in both research studies and routine primary health care.

Life- and person-centred help in Mecklenburg-Western Pomerania, Germany (DelpHi): study protocol for a randomised controlled trial.

BACKGROUND: The provision of appropriate medical and nursing care for people with dementia is a major challenge for the healthcare system in Germany. New models of healthcare provision need to be developed, tested and implemented on the population level. Trials in which collaborative care for dementia in the primary care setting were studied have demonstrated its effectiveness. These studies have been conducted in different healthcare systems, however, so it is unclear whether these results extend to the specific context of the German healthcare system.The objective of this population-based intervention trial in the primary care setting is to test the efficacy and efficiency of implementing a subsidiary support system on a population level for persons with dementia who live at home. METHODS AND STUDY DESIGN: The study was designed to assemble a general physician-based epidemiological cohort of people above the age of 70 who live at home (DelpHi cohort). These people are screened for eligibility to participate in a trial of dementia care management (DelpHi trial). The trial is a cluster-randomised, controlled intervention trial with two arms (intervention and control) designed to test the efficacy and efficiency of implementing a subsidiary support system for persons with dementia who live at home. This subsidiary support system is initiated and coordinated by a dementia care manager: a nurse with dementia-specific qualifications who delivers the intervention according to a systematic, detailed protocol. The primary outcome is quality of life and healthcare for patients with dementia and their caregivers. This is a multidimensional outcome with a focus on four dimensions: (1) quality of life, (2) caregiver burden, (3) behavioural and psychological symptoms of dementia and (4) pharmacotherapy with an antidementia drug and prevention or suspension of potentially inappropriate medication. Secondary outcomes include the assessment of dementia syndromes, activities of daily living, social support health status, utilisation of health care resources and medication. DISCUSSION: The results will provide evidence for specific needs in ambulatory care for persons with dementia and will show effective ways to meet those needs. Qualification requirements will be evaluated, and the results will help to modify existing guidelines and treatment paths. TRIAL REGISTRATION: NCT01401582.

[Medication review for dementia patients]. / Medikationsreview in der psychiatrischen Institutsambulanz.

Due to demographic changes we are faced with several challenges as an increasing prevalence of dementia patients. We report on a medication review of a patient with Alzheimer's disease as well as Lewy body dementia. The intake of risperidone was interrupted instead of a dose reduction which was recommended by the psychiatrist to improve mobility. As an adverse event the patient developed serious psychiatric symptoms which were treated in an acute care facility. We discussed several alternative treatment options (pipamperon, melperon, haloperidol, risperidone, clozapine, olanzapine, aripiprazol, and quetiapin) in a case conference. Due to a short half life period and insignificant anticholinergic effects we decided to choose quetiapin. Despite a small number of taken drugs we identified several potential drug related problems which were solved in a multipartite health care professional team.

Frequency and determinants of potential drug-drug interactions in an elderly population receiving regular home visits by GPs--results of the home medication review in the AGnES-studies.

PURPOSE: There is limited knowledge about prevalence and determinants of potential drug-drug-interactions (pDDI) in the ambulatory health care setting. In this manuscript we analysed the prevalence and determinants of pDDI in the AGnES home visit population (GP-supporting, community-based, e-health-assisted, systemic intervention). METHODS: 779 Home-dwelling patients received an IT-supported home medication review (HMR). The interaction monographs of the ABDA-database were used to identify pDDI. A binary multivariate logistic regression model was used to analyse determinants for occurrence of moderate and serious pDDI, respectively. RESULTS: Patients (mean age f: 79.8 yrs; m: 76.2 yrs) took a mean number of 6.8 active substances (SD = 3.3) regularly. 626 patients (80.4%) with an HMR had at least one pDDI (mean = 4.8; SD = 4.4). In 454 patients (58.3%) we found at least one pDDI with moderate or serious relevance (mean = 2.9; SD = 2.8). The most frequent moderate pDDI was the combination of potassium excretion diuretics (e.g. hydrochlorothiazide) with anti-inflammatory drugs (e.g. ibuprofen; n = 258 patients). Adjusted for age and gender, multiple binary logistic regression showed significant results for the number of taken active substances (continuous variable; OR = 1.48; 95%-CI 1.382-1.585), metabolic diseases (OR = 1.52; 95%-CI 1.039-2.223), a diagnose of a muscular-skeletal disease (OR = 1.741; 95%-CI 1.204-2.517), infectious disease (OR = 0.127; 95%-CI 0.021-0.783), and gastro-intestinal disease (OR = 0.538; 95%-CI 0.322-0.899). CONCLUSION: Using a comprehensive, computer-assisted HMR in an ambulatory care setting we have identified a high proportion of pDDI of moderate or serious clinical relevance. These pDDI require an intervention from intensified monitoring to a change in medication. Further investigations should focus on clinical outcome of pDDI.

Frequency of inappropriate drugs in primary care: analysis of a sample of immobile patients who received periodic home visits.

BACKGROUND: drug intake is associated with the risk of drug-related problems (DRPs), e.g. the intake of PIM. OBJECTIVE: the proportion of potentially inappropriate medication (PIM) taken by elderly people was analysed. DESIGN: community-based, prospective cohort study. SETTING: ambulatory health-care sector in a German rural area. SUBJECTS: seven hundred and forty-four patients with age >65 years and regular intake of drugs. METHODS: comprehensive home medication review (HMR) provided by specially qualified assistants of GP practices using electronic case reporting forms (eCRFs), and GP's diagnoses were extracted from patients' health records. Updated Beers' list of Fick et al. was used to detect PIM for patients >65 years and drug-condition interaction. RESULTS: a total of 18% (n= 134) of the patients received 163 inappropriate drugs. Out of these drugs, most prevalent PIM were benzodiazepine derivates (n= 45). Out of all drugs, 25 drug-condition interactions were identified. The intake of PIM was slightly associated with self-reported falls (: 0.1074; P= 0.0244). Multivariate logistic regression showed significant results for the number of taken substances (OR = 1.176; 95% CI 1.121-1.234, P< 0.001). CONCLUSIONS: a high proportion of patients taking PIM in a community-based setting were investigated. Statistical associations with self-reported falls were found. Confounding may influence data. Further research to investigate findings is needed.

Detection of drug related problems in an interdisciplinary health care model for rural areas in Germany.

OBJECTIVE: The disparity between an increasing complexity of patients' treatment and the declining number of general practitioners (GP) require action. The AGnES-concept (general practitioner-relieving, community-based, e-health assisted, systemic intervention) is based on the delegation of original physician-activities to qualified AGnES-practice assistants. Purposes of AGnES part 1 were to determine the feasibility of community-based home medication reviews (HMR) and the establishment of a health professional network to identify drug related problems (DRP) in the domicile of elderly patients. Two consecutive studies (AGNES 2 + 3) were conducted to implement HMR. SETTING: General practices on the isle of Rugia in Mecklenburg-Western Pomerania, a German rural area. Patients who receive regular home visits by their GP were addressed. METHOD: Study-instruments for the feasibility study (AGnES 1) were designed by an expert panel and modified for the implementation (AGnES 2 + 3) studies. HMR were conducted by additionally qualified AGnES-practice assistants regarding DRP like drug-drug interaction (DDI), adverse drug reactions (ADR), and compliance. DRP-selection was inspired by the coding system Pi-Doc. Pharmacists checked DRP and intervened, if necessary. 18 (AGnES 1) and 60 (AGnES 2 + 3) geriatric patients received a minimum of two home visits by an AGnES-practice assistant. MAIN OUTCOME MEASURE: Feasibility was assessed by patients' satisfaction with care provided by the AGnES-practice assistant. For implementation reported DRP and the conducted interventions were evaluated. RESULTS: During AGnES 1 a documentation sheet was developed and tested. 56 potential DDI were identified. 37 of 112 drugs which caused potential interactions were attributed to OTC medication and food components. 84% of respondents judged the systematic evaluation of their pharmacotherapy as helpful. During AGnES 2 + 3 local pharmacists identified DDIs in 45% of patients. Seven patients (11.6%) reported at least one ADR attributable to their current medication. Those patients who received a second HMR (n = 29) during AGnES 2 + 3 rated the HMR as reasonable 65.5% (n = 19), and partly reasonable 24.1% (n = 7). CONCLUSIONS: By comprehensive HMR conducted by AGnES-practice assistants in delegation of the patients' GPs in cooperation with local pharmacists we could identify a considerable prevalence of DRP under real-life conditions. Further studies should recruit more participants including a control group with usual care.

AGnES: supporting general practitioners with qualified medical practice personnel: model project evaluation regarding quality and acceptance.

BACKGROUND: The German AGnES (community-based, e-health-assisted systemic support for primary care) project allows general practitioners (GPs) to delegate certain elements of medical care, including house calls, to qualified AGnES employees and thereby provide primary care to a larger number of patients. AGnES projects of various types have been carried out in a number of German federal states from 2005 onward. In this article, an evaluation of the AGnES projects to date is presented. METHODS: Patient data (age, sex, diagnoses, level of care, mobility, etc.) and each of the specific activities carried out in the AGnES framework were documented with standardized computer-based instruments. The GPs, AGnES employees, and patients also underwent standardized interviews. The acceptance of the AGnES project, competence of the AGnES employees, and quality of medical care within the projects were evaluated. The participating GPs themselves assessed the quality of medical care. RESULTS: By July 8, 2008, 8386 house calls on a total of 1486 patients had been made within the framework of the AGnES projects. The evaluation revealed a high degree of acceptance of the project among the participating GPs, AGnES employees, and patients. The GPs considered the quality of medical care within the AGnES project to be good for the vast majority of patients. CONCLUSION: Structural redundancy is avoided by directly placing the AGnES employees in the general practitioners' practices. Based on the results of the AGnES projects, the law in Germany has now been amended to enable implementation of the AGnES project in the regular health care system from January 2009 onward. The next steps to be taken are the establishment of adequate reimbursement within the catalog of the statutory health insurance scheme and a detailed definition of the required qualifications.

GP-support by means of AGnES-practice assistants and the use of telecare devices in a sparsely populated region in Northern Germany--proof of concept.

BACKGROUND: In many rural regions in Germany, the proportion of the elderly population increases rapidly. Simultaneously, about one-third of the presently active GPs will retire until 2010. Often it is difficult to find successors for vacant GP-practices. These regions require innovative concepts to avoid the imminent shortage in primary health care.The AGnES-concept comprises the delegation of GP-home visits to qualified AGnES-practice assistants (AGnES: GP-supporting, community-based, e-health-assisted, systemic intervention). Main objectives were the assessment of the acceptance of the AGnES-concept by the participating GPs, patients, and AGnES-practice assistants, the kind of delegated tasks, and the feasibility of home telecare in a GP-practice. METHODS: In this paper, we report first results of the implementation of this concept in regular GP-practices, conducted November 2005--March 2007 on the Island of Rügen, Mecklenburg-Western Pomerania, Germany. This study was meant as a proof of concept.The GP delegated routine home-visits to qualified practice employees (here: registered nurses). Eligible patients were provided with telecare-devices to monitor disease-related physiological values.All delegated tasks, modules conducted and questionnaire responses were documented. The participating patients were asked for their acceptance based on standardized questionnaires. The GPs and AGnES-practice assistants were asked for their judgement about different project components, the quality of health care provision and the competences of the AGnES-practice assistants. RESULTS: 550 home visits were conducted. 105 patients, two GPs and three AGnES-practice assistants (all registered nurses) participated in the project. 48 patients used telecare-devices to monitor health parameters. 87.4% of the patients accepted AGnES-care as comparable to common GP-care. In the course of the project, the GPs delegated an increasing number of both monitoring and interventional tasks to the AGnES-practice assistants. The GPs agreed that delegating tasks to a qualified practice assistant relieves them in their daily work. CONCLUSION: A part of the GPs home visits can be delegated to AGnES-practice assistants to support GPs in regions with an imminent or already existing undersupply in primary care. The project triggered discussions among the institutions involved in the German healthcare system and supported a reconciliation of the respective competences of physicians and other medical professions.

Pharmaceutical care for migraine and headache patients: a community-based, randomized intervention.

BACKGROUND: Despite the high prevalence of headache and migraine in the general population, many people do not receive adequate medical attention and treatment. OBJECTIVE: To evaluate the effects of pharmaceutical care (defined as intensified structured counseling between patient and pharmacist, including the use of drug databases), for patients with headache or migraine, on both clinical and psychological endpoints. METHODS: A prospective, randomized, controlled intervention study was conducted using pharmacies in Northern Germany. A total of 112 pharmacies (26% of all pharmacies in the study region) recruited 410 patients with headaches. Pharmacies were randomly assigned to an intervention or control group. Patients were interviewed by telephone prior to the intervention and again after 4 months. Primary endpoints were number of days with headache, number and severity of headaches, self-efficacy, and the patients' perceptions of their health-related quality of life. RESULTS: Each pharmacy treated an average of 4.6 patients (total time effort 9 h). The intervention group consisted of 201 patients who received pharmaceutical care, whereas the control group comprised 209 patients who received standard counseling. In both groups, the number of headache attacks and intensity of pain in treated headache attacks did not change significantly between the first and second interviews. However, a statistically significant improvement in mental health and self-efficacy was shown in the intervention group. Intensity of pain in untreated headache attacks and the number of days with headache decreased in both groups. Most participants described this intervention as helpful and effective and 90% reported that they would recommend pharmaceutical care to other patients with headache. CONCLUSIONS: A short-term pharmaceutical care intervention improved patients' mental health and self-efficacy, although it did not significantly change the number and severity of headaches. The increase in self-efficacy and mental health associated with pharmaceutical care may be instrumental in improving long-term pharmacotherapy of patients with migraine and headache. To fully assess the effects of pharmaceutical care, a longer study may be required.