Martin Schulz, PhD is an Adjunct Professor at Johann Wolfgang Goethe University, Department of Pharmacology, Frankfurt at Main, Germany. In his main job, he is Head of the Centre for Drug Information and Pharmacy Practice (ZAPP) of the ABDA - Federal Union of German Associations of Pharmacists, Berlin. In addition, Dr. Schulz is Director Pharmacy of the German Institute for Drug Use Evaluation (DAPI). He graduated as a pharmacist from the University of Hamburg, Germany, in 1983. From 1983-1984, he was a hospital pharmacist, and studied Medicine at the University of Hamburg from 1984-1986. In 1988, he obtained his Ph.D. in Pharmacology from the University of Hamburg. In 1989, he was named "Expert in Pharmacology DGPT" by the German Society for Experimental and Clinical Pharmacology and Toxicology (DGPT). He specialized as a Drug Information Pharmacist in 1993. Evaluation and implementation of the pharmaceutical support (pharmacy practice, pharmaceutical care); Promotion of an effective and safe self-medication; Pharmacoepidemiology and -economics; Drug information and drug supply and -usage etc. are some of the areas where Prof. Schulz has expertise. Main interests: Outcomes research; Quality and effectiveness of interventions (in particular medicines); Drug information and regulation; Health-/pharmacoeconomics. He has more than 370 publications to his name and has also delivered 230 lectures, seminars and has written some books as well. Prof. Schulz is a member in various committees and commissions like BfArM, Bonn; BMG, Berlin; FIP, The Hague, and serves on various advisory/expert committees.
Abstract: Nahrungsergänzungsmittel sind heute aus der Apotheke nicht mehr wegzudenken. Trotzdem ist nicht jede Supplementierung ein Fall für die Selbstmedikation. Bei der Abgabe von Calcium-, Magnesium- oder Eisen-Präparaten sollte der Apotheker den Patienten auf Besonderheiten der Einnahme, Nebenwirkungen, Wechselwirkungen und Limitationen der Selbstmedikation hinweisen. Konkrete, individualisierte Empfehlungen sind von grösserem Nutzen als der allgemeine Hinweis auf eine "ausgewogene und gesunde Ernährung". Hinweise zur Erstattungsfähigkeit von Calcium-, Magnesium- oder Eisen-Präparaten sind in Tabelle 4 gegeben.
Abstract: In this paper the data on the duplicate use of ACE inhibitors among a community-dwelling elderly population are presented. Using a questionnaire, 1000 subjects were interviewed concerning the use of drugs, 654 females, mean+/-SD age: 72.6+/-6.5 years. They were divided into two groups: Group A (5%) taking at least two ACE inhibitors (n=50) and Group B: those who used either a single ACE inhibitor or no ACE inhibitor (n=950). In Group A, 49 individuals were taking two different ACE inhibitors concomitantly and one was using three. The most commonly used ACE inhibitor was enalapril (29 of 50 subjects). Subjects in Group A consumed significantly more drugs, both of prescription (Rx) and nonprescription (OTC), compared to those in Group B (total means: 8.4+/-2.8 vs. 6.7+/-3.2; p<0.01, Rx means: 6.3+/-2.5 vs. 5.2+/-2.8, p<0.05, OTC means: 2.0+/-1.6 vs. 1.6+/-1.5, p<0.05). Also, they were more likely to have consulted a cardiologist (17/50 vs. 201/950, p<0.05). The duplicate use of ACE inhibitors in 5% of a population of community-dwelling elderly patients seems to be caused by both poor doctor-doctor communication and polypharmacy. This phenomenon could possibly be dangerous especially when potential additive adverse effects are taken into account.
Abstract: The most efficient way to manage diabetes and its complications is to prevent diabetes. Recent studies have convincingly demonstrated that prevention of diabetes and its complications are possible and cost effective. Life-style interventions and also early pharmacological preventive strategies have yielded a 25-75% diabetes risk reduction and an even more promising reduction in cardiovascular risks. These findings offer the evidence-base for diabetes prevention, but essential is the delivery of intervention into our societies. The challenge, therefore, is the management of prevention and intervention programs considering scientific aspects and practical requirements during implementation. This can only be addressed in a coordinated interdisciplinary setting and across sectors which requires the development of a comprehensive, integrated prevention management program also on an European level. Pharmacies have to play an important role in this concept because of their widespread distribution and the frequency of pharmacy visits of the general population. They should be established as places where patients can continuously offer risk assessment including recommendations on how to prevent the disease. Developing the role of the prevention manager and continuous evaluation and quality control are key factors in performing high quality intervention and care. Community pharmacies could take an active part in this prevention program, its evaluation, and quality assurance. Implementing structured prevention programs will enable nationwide prevention of diabetes mellitus without consuming large resources from health care insurances. This process will be challenging and time consuming, requiring many partners but resulting in a profitable "health" investment.
Abstract: BACKGROUND: A drug-related problem (DRP) is defined as an event or circumstance that actually or potentially interferes with desired health outcomes. DRPs can lead to ineffective pharmacotherapy and may cause drug-related morbidity and mortality. Most DRPs are avoidable and community pharmacies are assuming an active role in preventing and solving DRPs. OBJECTIVE: To identify the spectrum of DRPs encountered in community pharmacies. METHODS: In 2005, a nationwide survey in Germany was conducted in community pharmacies to record all identified DRPs. Participating community pharmacies were free to select one week within the designated study period (February-May) and were instructed to record basic statistics (eg, number of patient interactions, number of prescriptions filled/nonprescription [over-the-counter; OTC] drugs dispensed per week), as well as patient-, problem-, and intervention-related data (eg, patient age and sex, whether a prescription-only or OTC drug was involved in the DRP, the time needed for problem resolution). DRPs were categorized using a modified version of the PI-Doc (problem-intervention-documentation) classification system. RESULTS: Community pharmacies that participated in the study (N = 1146) documented 10,427 DRPs (9.1 DRP per pharmacy per week). A broad spectrum of DRPs was identified, with 9 of 10 cases involving prescribed medicines. DRPs arose on 3 primary levels: the prescription-, the patient-, and the delivery level. Overall, drug-drug interactions were the most frequently reported DRP (8.6%) and, according to community pharmacies, more than 80% of identified DRPs could be resolved completely. The prescribing physician was contacted in 60.5% of all such cases. Median time needed for solving a DRP was 5 minutes. CONCLUSIONS: Pharmacists in the community pharmacy setting are well suited to identify and resolve DRPs. Ensuring the proper use of both prescription and OTC drugs is one of the basic responsibilities of pharmacists. This specific role of pharmacists within the healthcare system needs to be more fully recognized.
Abstract: OBJECTIVE: To assess the feasibility and impact of the activities of pharmacy interns on German hospital wards as well as the acceptance of their activities by medical and pharmaceutical staff. METHOD: The project was carried out for 36 months in six hospitals on different wards. Seventeen interns spent three months first in the pharmacy followed by another three months in the wards. Information about their tasks on different wards was obtained through reporting by interns on a standardized data collection form. Questionnaires regarding acceptance and impact of pharmacy interns were answered by medical and pharmaceutical staff. RESULTS: After having adjusted to their tasks, the interns investigated and developed solutions for structural and process-related slacks in the handling of medicines in the wards. They focused on drug information, on the detection and prevention of medication and documentation errors and storage of medicines in the wards. One hundred and forty six questionnaires regarding acceptance, impact and possible tasks of the interns were answered. Ninety percent of the surveyed medical staff considered the work of the interns as useful and 89% were in favour of permanent interns in the wards. The acceptance by pharmaceutical staff was slightly lower. CONCLUSION: This pilot study represents a landmark for the implementation of clinical pharmacy in daily practice especially on medical wards in Germany. Working in wards offers interns a possibility to extend their knowledge and skills. The project demonstrates that pharmacy interns can play an important role in drug safety in hospital wards. The acceptance by physicians and nurses is high. The majority of them requested the continuation of the project.
Abstract: OBJECTIVE: The pharmacist-run national German drug information service (DIS) has operated since 1988. Answering a steadily increasing demand over the past decade, our centre has, in total, provided information in more than 14,000 cases, mainly for community pharmacists. Information on user's satisfaction and on possible direct or indirect benefits for patients is as yet scarce. Our objectives were to assess user's satisfaction with the DIS and to identify any patient-related benefits based on the user's judgment. SETTING: Independent national drug information centre at ABDA headquarters. METHOD: A questionnaire was developed, pre-tested, optimized, and used in daily practice over a period of one year (09/2003-08/2004). The questionnaire comprised seven items, aimed only at inquiries which pertained to a patient-related issue. RESULTS: During the study period, a total of 1,639 inquiries were answered. Of these, 1,017 (62%) were eligible. The response rate was 45% (455/1,017). Ratings (1 = poor to 5 = very good, mean +/- SD) showed positive evaluations for professional quality of advice (4.7 +/- 0.5), clarity/understandability of advice (4.7 +/- 0.5), timeliness of response (4.6 +/- 0.7), and helpfulness regarding counselling patients and/or physicians (4.6 +/- 0.6). Potential patient benefits could be identified in 42% of the cases that were available to follow-up (190/455). CONCLUSION: This evaluation showed high satisfaction among users of a nationwide DIS, based on quality, understandability, timeliness, and helpfulness regarding counselling. According to its users, DIS was also able to provide positive patient outcomes.
Abstract: INTRODUCTION: Intoxications with carbachol, a muscarinic cholinergic receptor agonist are rare. We report an interesting case investigating a (near) fatal poisoning. METHODS : The son of an 84-year-old male discovered a newspaper report stating clinical success with plant extracts in Alzheimer's disease. The mode of action was said to be comparable to that of the synthetic compound 'carbamylcholin'; that is, carbachol. He bought 25 g of carbachol as pure substance in a pharmacy, and the father was administered 400 to 500 mg. Carbachol concentrations in serum and urine on day 1 and 2 of hospital admission were analysed by HPLC-mass spectrometry. RESULTS: Minutes after oral administration, the patient developed nausea, sweating and hypotension, and finally collapsed. Bradycardia, cholinergic symptoms and asystole occurred. Initial cardiopulmonary resuscitation and immediate treatment with adrenaline (epinephrine), atropine and furosemide was successful. On hospital admission, blood pressure of the intubated, bradyarrhythmic patient was 100/65 mmHg. Further signs were hyperhidrosis, hypersalivation, bronchorrhoea, and severe miosis; the electrocardiographic finding was atrio-ventricular dissociation. High doses of atropine (up to 50 mg per 24 hours), adrenaline and dopamine were necessary. The patient was extubated 1 week later. However, increased dyspnoea and bronchospasm necessitated reintubation. Respiratory insufficiency was further worsened by Proteus mirabilis infection and severe bronchoconstriction. One week later, the patient was again extubated and 3 days later was transferred to a peripheral ward. On the next day he died, probably as a result of heart failure. Serum samples from the first and second days contained 3.6 and 1.9 mg/l carbachol, respectively. The corresponding urine concentrations amounted to 374 and 554 mg/l. CONCLUSION: This case started with a media report in a popular newspaper, initiated by published, peer-reviewed research on herbals, and involved human failure in a case history, medical examination and clinical treatment. For the first time, an analytical method for the determination of carbachol in plasma and urine has been developed. The analysed carbachol concentration exceeded the supposed serum level resulting from a therapeutic dose by a factor of 130 to 260. Especially in old patients, intensivists should consider intoxications (with cholinergics) as a cause of acute cardiovascular failure.
Abstract: OBJECTIVE: To discuss the provision of pharmaceutical care in community pharmacies in Germany including community pharmacy, organization and delivery of health services, pharmacy education, community pharmacy services, research in community pharmacy, and future plans for community pharmacy services. FINDINGS: In Germany, cognitive pharmaceutical services have been developed for more than 12 years. Several studies and programs have shown that pharmaceutical care and other pharmaceutical services are feasible in community pharmacy practice and that patients benefit from these services. In 2003, a nationwide contract was established between representatives of the community pharmacy owners and the largest German health insurance fund. In this so-called family pharmacy contract, remuneration of pharmacists for provision of pharmaceutical care services was successfully negotiated for the first time. In 2004, a trilateral integrated care contract was signed that additionally included general practitioners, combining the family pharmacy with the family physician. Within a few months, the vast majority (>17 000) of community pharmacies have registered to participate in this program. CONCLUSIONS: German community pharmacies are moving from the image of mainly supplying drugs toward the provision of cognitive pharmaceutical services.
Abstract: The emergence of safety concerns associated with the use of selective cyclooxygenase-2 (COX-2) inhibitors (coxibs) led to market withdrawals of rofecoxib in September 2004 and valdecoxib in April 2005. These events were accompanied by safety alerts from drug authorities and recommendations from professional medical associations. This study analysed the temporal influence of these measures on drug use in Germany, with the objective to assess overall appropriateness of prescribing and to evaluate the potential for pharmaceutical interventions. Drug prescriptions for patients within the statutory health insurance system (GKV) were analysed based on the total amount of DDDs of single drug substances dispensed every month in German pharmacies. The market withdrawal of rofecoxib in September 2004 resulted initially in increased prescribing of other coxibs. New safety warnings on coxibs later in 2004 and the withdrawal of valdecoxib in April 2005 led to pronounced reductions in coxib prescribing. Comparing the third quarter of 2005 with 2004, coxib prescriptions dropped from 47.5 to 10.4 million DDDs. Conversely, in the same time frame, NSAID prescriptions increased by 19.0 million DDDs. This is mostly due to increased prescribing of ibuprofen, diclofenac and, to a lesser degree, meloxicam, acemetacin, piroxicam, and naproxen. However, total prescribing of inhibitors of cyclooxygenases decreased by about 8.4%, indicating a relative reluctance to prescribe these drugs after cardiovascular safety warnings have been issued by drug authorities. Unexpectedly, also prescribing of metamizol (dipyrone) increased by 2.8 million DDDs (20%), despite recommendations to limit its use by medical associations. Furthermore, increased prescribing of proton pump inhibitors of 12.6 million DDDs could be observed. NSAIDs and coxibs are to a larger extent prescribed by a broad range of medical specialist groups including orthopaedists and surgeons, whereas drugs used in gastrointestinal or cardiovascular disorders are mainly prescribed by general practitioners and internal specialists, respectively. Therefore, the individual physician may not always be aware of the risk profiles of their patients. Pharmacists can close this gap by providing comprehensive medication records and information on self medication used by the patient to prescribing practitioners, thereby contributing to improved patient safety.
Abstract: INTRODUCTION: Mucoactive substances such as ambroxol, available in several countries as over-the-counter (OTC) medicines, are used for the treatment of acute and chronic bronchitis. OBJECTIVE: This study was designed to evaluate the "real life" behavior of consumers with non-prescription access to an ambroxol cough syrup with special focus on tolerability and the pattern of product usage. METHODS: Customers who bought the ambroxol syrup were recruited in 300 community pharmacies in Germany. Baseline data were collected from the participants in the pharmacy. Completing a self-administered questionnaire, participants provided information on tolerability, self-perceived effectiveness and usage pattern. RESULTS: 2,707 participants were recruited in 266 pharmacies. 2,664 questionnaires were evaluable. At baseline, the respondents reported a complex pattern of symptoms. Productive cough, congested airways, dry cough, cough irritation in the throat and soreness in the throat were the most common ones. 67 patients (2.5%) reported a total of 81 adverse events (AE) which were usually mild in nature and mostly affecting the gastrointestinal tract (n = 53) followed by skin and subcutaneous tissue disorders (n = 9). No serious or unknown AE were reported. In general, 97% of the participants assessed the safety as "very good" (51%) or "good" (46%). Overall, the respondents complied with the indications for use and the recommended dosages, with only 0.7% of the participants using the maximum daily dose. 92% of the patients assessed the self-perceived effectiveness as "very good" (29%) or "good" (63%) and 89% were willing to purchase this ambroxol cough syrup again. CONCLUSIONS: This study confirms that ambroxol is used according to the advice given in the patients' leaflet and supports the already established safety and efficacy of this product in acute bronchitis. It also demonstrates that the use of an OTC cough medication can be successfully monitored in a pharmacy-based cohort study.
Abstract: OBJECTIVES: To investigate a new method for evaluating counselling performance of staff in community pharmacies and to assess the quality of patient counselling. METHOD: Trained pseudo customers, instructed to play their role according to two different self-medication scenarios, visited voluntarily participating community pharmacies in Berlin. After documenting the counselling process, immediately after each visit, outside the pharmacy on an assessment form, the pseudo customer re-entered the pharmacy and gave detailed performance feedback to the counsellor and the pharmacist in charge in order to provide support for improving counselling skills and practice behaviour, when appropriate. This was followed with a written summary of the general performance of all participating pharmacies and additional individual feedback and suggestions for improvement. Educational needs were identified for subsequent performance-based educational strategies such as group-workshops, team-training and on-site team-coaching. RESULTS: Forty-nine community pharmacies in Berlin volunteered to participate in this pilot study. Ninety-eight per cent of the participating pharmacies offered advice. However, in 36% of the cases, advice was only given on request. The different types of scenarios--presentation of a symptom or request for a specific product--made a great difference to the spontaneity of questions and advice. At least one question to check on accuracy of self-diagnosis was asked in 95% of the cases of symptom presentation but in only 47% of the cases of specific product request. Information on appropriate self-medication was provided on at least one item in 74% of pseudo customer visits, but most of the time the information was not sufficient. Communication skills (nonverbal elements, comprehensibility etc.) were very good or good in 54% of the visits. Potential for improvement was mainly in relation to the use of open-ended questions to gain more information and on counselling about appropriate self-medication. Direct feedback was given in 96% of the pharmacies (one person refused to accept feedback and one feedback had to be postponed because of time shortage). All of the participants regarded counselling as an important subject in pharmacy practice. CONCLUSION: The pseudo customer method was successfully used in this study of German community pharmacies. It was shown that pseudo customer visits and performance feedback following the counselling process, were feasible in daily practice and well accepted by the participants. A training program, focussing on areas in most need of improvement, has been developed. The promising results have led to the Federal Chamber of Pharmacists in Germany adopting this method as part of a continuous quality improvement program in community pharmacies.
Abstract: BACKGROUND: Despite significant progress in asthma drug therapy in recent years, there has been no major change in asthma morbidity and mortality. It is still important to determine whether pharmaceutical care (PC) influences health outcomes. OBJECTIVE: To evaluate the effectiveness of PC with regard to clinical, humanistic, and economic outcomes in adults with asthma. METHODS: An intervention study was conducted over 12 months. At baseline, 39 community/retail pharmacies, 84 primary care physicians (general practitioners, internal specialists, chest physicians), and 183 patients (aged 18-65 y) diagnosed with asthma were included. To evaluate economic outcomes, 2 German statutory health insurance funds provided 2 years of claims data for their insured patients (n = 55). A 1:10 matching was carried out to compare the data of this intervention subgroup with those of a control group (n = 550). RESULTS: Significant improvements were found for all humanistic outcomes (eg, asthma-specific quality of life, self-efficacy, knowledge, medication adherence). In addition, asthma severity, self-reported symptoms, peak expiratory flow, and patients' inhalation technique improved. Increases in forced expiratory volume in 1 second and vital capacity were not significant over time. Evaluation of the insurance claims data revealed a shift toward better adherence to evidence-based therapy. CONCLUSIONS: The study shows that PC for people with asthma has a positive impact on humanistic and, to some extent, on clinical outcomes. To determine potential economic benefits, future research should focus on patients with more severe asthma.
Abstract: This article discusses the concept of pharmaceutical care especially from the European perspective. It tries to clarify the current status of pharmaceutical care research and implementation, and if and how it can be part of the practice of pharmacy. Pharmaceutical care basically means improving the medication use process in order to improve outcomes, including the patients' quality of life, and that involves a focus change for pharmacy from product to patient. This change in focus also implies that the pharmacy curriculum should be adapted, in order for the pharmacist to be able to acquire new knowledge and skills. In most countries this change currently is taking place but not in very deliberate or structured manner. Some basic decisions have to be made, in order to guarantee that every patient receives pharmaceutical care when needed.
Abstract: In order to assess the significance of drug levels measured in clinical and forensic toxicology as well as for Therapeutic Drug Monitoring (TDM) it is essential that good collections of data are readily available. For more than 800 substances, therapeutic ('normal') and, if data was available, toxic, and fatal plasma concentrations as well as elimination half-lives were compiled in a table. The compilation includes data for hypnotics, benzodiazepines, neuroleptics, antidepressants, sedatives, analgesics, anti-inflammatory agents (e.g., NSAIDs), antihistamines, antiepileptics, betaadrenergic antagonists, antibiotics (penicillins, cephalosporins, aminoglycosides, gyrase inhibitors), diuretics, calcium-channel blockers, cardiac glycosides, antiarrhythmics, antiasthmatics, ACE-inhibitors, opiate agonists, and local anesthetics, among others. In addition, toxicologically relevant xenobiotics were listed. Data have been abstracted from published information, both compilations and primary sources and have been completed with data collected in our own forensic and clinical toxicology laboratories. Wherever possible, ranges for therapeutic plasma concentrations are expressed as trough concentration at steady state. The half-life values given for each drug are chosen to represent the terminal log-linear phase at most. It is the purpose to rapidly assess the significance of drug levels for the therapeutic monitoring of patients, and to facilitate the diagnostic and clinical assessment in case of intoxications.
Abstract: BACKGROUND AND OBJECTIVE: In conjunction with the introduction of disease management programmes in Germany there is an ongoing scientific debate on the desirable goals for HbA1c in the management of patients with type 2 diabetes mellitus. PATIENTS AND METHODS: In this study, a novel computer-based simulation model (diabetes mellitus model = DMM) was used to estimate the consequences of different levels of metabolic control as assessed by HbA1c for the development of short- and long-term complications of this disease. RESULTS: At a mean difference of 1 % the rate of severe hypoglycaemic events over 10 years was by 32-84 % higher in those with a lower HbA1c. In contrast, the incidence of microvascular complications (proliferative retinopathy, end-stage kidney disease, clinical neuropathy) was by 20-33 % lower in the group with the lower as compared to the higher HbA1c level according to the scenario applied. The rates of myocardial infarction and stroke were reduced by 15-20 % under these conditions. CONCLUSIONS: This model calculation suggests that a more strict metabolic control in patients with type 2 diabetes mellitus results in a greater reduction of microvascular complications than of macrovascular complications, but is associated with a higher rate of hypoglycaemic episodes. The diabetes mellitus model is a non-expensive alternative to simulate clinically relevant questions on the management of type 2 diabetes and to provide rapid and realistic answers.
Abstract: OBJECTIVE: To determine whether the nonsteroidal antiandrogenic drug flutamide is a clinically relevant inducer of methemoglobinemia in patients with prostatic cancer. METHODS: Fifty consecutive outpatients with prostatic cancer stage D2 entered the study (age 71.1 +/- 7.3 y). Five patients were lost to follow-up; the remaining 45 patients received the recommended oral dose of flutamide 250 mg three times daily. Total hemoglobin (Hb) and methemoglobin (Met-Hb) concentrations were measured on varying days using an ultraviolet/visible-spectrophotometric method with an intra- and interday variability < 8%. In 12 patients, Met-Hb was analyzed before initiating flutamide therapy and after therapy was begun. RESULTS: On average, 2.6 venous blood samples per patient were analyzed with a mean Met-Hb concentration of 1.9% of total Hb. Mean concentrations of > or = 3% were detected in only six patients (13%). The data from 12 patients evaluated before and after initiating flutamide therapy were without significantly different changes. During the study period, no clinical signs of methemoglobinemia were reported or observed. CONCLUSIONS: This study found no clinically relevant increase of Met-Hb concentrations in elderly patients with prostatic cancer during chronic treatment with flutamide. However, clinicians should be aware of the very rare possibility of flutamide-induced methemoglobinemia.
Abstract: As asthma is associated with an enormous social, psychological, and economic burden, various patient education programs have been developed to improve outcomes, including quality of life. The authors evaluated the effectiveness of community pharmacy-based interventions on lung function, health-related quality of life, and self-management in asthma patients in a 12-month controlled intervention study in 26 intervention and 22 control pharmacies. Pharmacies opted whether to take part as intervention or control pharmacies. According to this, patients (ages 18-65) with mild to severe asthma attending the pharmacies were allocated to the intervention (n = 161) or control group (n = 81), respectively. Intervention patients were educated on their disease, pharmacotherapy, and self-management; inhalation technique was assessed and, if necessary, corrected. Pharmaceutical care led to significantly improved inhalation technique. Asthma-specific quality of life and the mental health summary score of the SF-36 improved significantly in the intervention group. At 12 months, the intervention group showed significant improvements with regard to evening peak flow, self-efficacy, and knowledge.
