Roberto Frontini

EAHP survey 2010 on hospital pharmacy in Europe: parts 4 and 5. Clinical services and patient safety

Decentralised clinical services, with a pharmacist working in the ward at least 50% of the time or with pharmacists visiting the ward daily, are not very common in Europe. For-profit hospitals offer the service remarkably less than other hospitals, and 39.8% of hospital pharmacies offer clinical services occasionally. There is a variety of patient oriented clinical activities delivered by European hospital pharmacies, including the provision of drug information, pharmacokinetic consultations, therapeutic drug monitoring, management prevention of adverse drug reactions and medication errors. Hospital pharmacy involvement in managing the interface between primary and hospital care is less common. In general, clinical activities are not well documented. For inpatients, on average, only 14.7% and 21.9% of the hospital pharmacies that took part in the survey said they write down their interventions in the medical records and in pharmacy records, respectively. IT systems are broadly used in the provision of drug information but also in profiling patient medication and for dosage calculations. Patient safety is a major interest of hospital pharmacists and, on average, 55.0% of hospital pharmacies recorded that they have implemented a system to ensure patient safety.

Ambulatory Care of Children Treated with Anticonvulsants – Pitfalls after Discharge from Hospital

BACKGROUND Anticonvulsants require special consideration particularly at the interface from hospital to ambulatory care. PATIENTS AND METHOD Observational study for 6 months with prospectively enrolled consecutive patients in a neuropediatric ward of a university hospital (age 0-<18 years) with long-term therapy of at least one anticonvulsant. Assessment of outpatient prescriptions after discharge. Parent interviews for emergency treatment for acute seizures and safety precautions. RESULTS We identified changes of the brand in 19/82 (23%) patients caused by hospitals discharge letters (4/82; 5%) or in ambulatory care (15/82; 18%). In 37/76 (49%) of patients who were deemed to require rescue medication, no recommendation for such a medication was included in the discharge letters. 17/76 (22%) of the respective parents stated that they had no immediate access to rescue medication. Safety precautions were applicable in 44 epilepsy patients. We identified knowledge deficits in 27/44 (61%) of parents. CONCLUSION Switching of brands after discharge was frequent. In the discharge letters, rescue medications were insufficiently recommended. Additionally, parents frequently displayed knowledge deficits in risk management.

Purity determination of amphotericin B, colistin sulfate and tobramycin sulfate in a hydrophilic suspension by HPLC

A suspension comprising of the three antibiotic substances amphotericin B, colistin sulfate and tobramycin sulfate is often used in clinical practice for the selective decontamination of the digestive tract of patients in intensive care. Since no detailed procedures, specifications or stability data are available for manufacturing this suspension, there may be discrepancies regarding formulation and stability of suspensions prepared in different pharmacies. The aim of this work is to develop a standardized formulation and to determine its stability under defined storage conditions. This would help guarantee that all patients receive the same preparation, therefore ensuring similar efficacy and improved safety. The first step in this process is to develop the required analytical tools to measure the content and purity of the drug substances in this complex mixture. In this paper, the development and validation of these tools as well as the development of the drug suspension formulation is described. The formulation comprises of Ampho-Moronal(®)-Suspension (Dermapharm) and a buffered, preservated aqueous solution of colistin sulfate and tobramycin sulfate. Two simple, well established high-performance liquid chromatography (HPLC) methods in the European Pharmacopoeia (EP) for impurity profiling of the two active ingredients amphotericin B and colistin sulfate were combined with a newly developed sample extraction procedure for the suspension. Sufficient selectivity and stability-indicating power have been demonstrated. Additionally, a new robust routine method was developed to determine possible degradation products of tobramycin sulfate in the investigated suspension. The specificity, precision, accuracy and linearity of the analytical procedures were demonstrated. The recovery rate was in the range of 90-110%. The precision results for the calculated impurities showed variation coefficients of <10%. The calibration curves were found to be linear with correlation of greater than 0.9994 for all components. The results show the suitability of the methods for the quality control analysis of the suspension.

How to improve prescription of inhaled salbutamol by providing standardised feedback on administration: a controlled intervention pilot study with follow-up.

BackgroundThe effectiveness of inhaled salbutamol in routine care depends particularly on prescribed dosage and applied inhalation technique. To achieve maximum effectiveness and to prevent drug-related problems, prescription and administration need to work in concert.MethodsWe performed a controlled intervention pilot study with 4 consecutive groups in a general paediatric unit and assessed problems in salbutamol prescribing and administration. Control group [i]: Routine care without additional support. First intervention group [ii]: We carried out a teaching session for nurses aimed at preventing problems in inhalation technique. Independently from this, a pharmacist counselled physicians on problems in salbutamol prescribing. Second intervention group [iii]: Additionally to the first intervention, physicians received standardised feedback on the inhalation technique. Follow-up group [iv]: Subsequently, without any delay after the second intervention group had been completed, sustainability of the measures was assessed. We performed the chi-square test to calculate the level of significance with p ≤ 0.05 to indicate a statistically significant difference for the primary outcome. As we performed multiple testing, an adjusted p ≤ 0.01 according to Bonferroni correction was considered as significant.ResultsWe included a total of 225 patients. By counselling the physicians, we reduced the number of patients with problems from 55% to 43% (control [i] vs. first intervention [ii], n.s.). With additional feedback to physicians, this number was further reduced to 25% ([i] vs. [iii], p < 0.001). In the follow-up [iv], the number rose again to 48% (p < 0.01 compared to feedback group).ConclusionsTeaching nurses, counselling physicians, and providing feedback on the quality of inhalation technique effectively reduced problems in salbutamol treatment. However, for success to be sustained, continuous support needs to be provided.Trial registrationGerman Clinical Trials register: DRKS00006792.

Use of Levetiracetam in Neonates in Clinical Practice: A Retrospective Study at a German University Hospital.

OBJECTIVE We performed a retrospective chart analysis in neonates routinely treated with levetiracetam (LEV) in a university setting. Patients and Methods We assessed clinical characteristics of the included neonates. Documented LEV doses and the duration of treatment were evaluated. To assess LEV effectiveness, we compared the need of any additional anticonvulsant as co- and rescue therapies before and following the initiation of LEV treatment. To assess LEV tolerance, we sought to identify documented adverse drug reactions resulting in a termination of LEV treatment. RESULTS We analyzed a total of 72 neonates receiving LEV with a median gestational age at initiation of LEV treatment of 30 (4/7) gestational weeks (min., 24(5/7)/max., 43(0/7) weeks). LEV was applied in target doses of 41.7 mg/kg/d (min., 14.4/max., 106.2 mg/kg/d). Patients received LEV treatment at hospital for a median of 28 days (min., 1/max., 195 days). Additional anticonvulsant therapy decreased a week after LEV treatment was initiated (p = 0.008). We did not find any cases of terminated LEV treatment resulting from adverse drug reactions. CONCLUSION Long term use of high LEV doses is rather frequent in immature neonates. Our data indicate good effectiveness and a low risk of adverse drug reactions.

EAHP Survey 2010 on hospital pharmacy in Europe: Part 3. Production and quality assurance

The number of hospital pharmacies in Europe producing sterile as well as non-sterile medicines has decreased significantly since 2000. In addition, the number of pharmacies preparing total parenteral nutrition, cytotoxics and intravenous admixtures (24.6%, 43.8% and 8.0% of pharmacies, respectively) is quite low and depends to a large extent on the size of the pharmacies, with larger units generally demonstrating significantly higher production activity. There are some differences between eastern and western Europe. Quality control and good manufacturing practice (GMP) seem to be well implemented (61.3% of pharmacies have adopted GMP) and many pharmacies have external certification.

Managing of oral medicines in paediatric oncology: can a handbook and a pharmaceutical counselling intervention for patients and their parents prevent knowledge deficits? A pilot study

Objectives To assess knowledge deficits of patients/parents and prevention strategies. Methods After receiving ethics approval, we performed a controlled, quasi-randomised, prospective intervention study. We enrolled patients/parents involved in managing oral medicines in three groups: control (routine care only), handbook intervention and pharmaceutical counselling intervention group. At baseline and after the interventions, we assessed patients’/parents’ knowledge deficits (incorrect or missing answers) by questionnaire. Results We enrolled 64 patients/parents. At baseline, knowledge deficits among the groups were similar: 17% in controls, 22% in the handbook group and 24% in the pharmaceutical counselling group. After the intervention, knowledge deficits decreased to 13% in the handbook group and to 8% in the pharmaceutical counselling group (NS; p=0.003 compared with controls, respectively). For controls, knowledge deficits remained almost unchanged (19%). Results for the pharmaceutical counselling group showed a strong correlation between baseline knowledge deficits and the extent of the deficit decrease after the intervention (τ=−0.74; p<0.001), whereas no significant correlation was found in the control or handbook group. Conclusions In paediatric oncology, patients’/parents’ knowledge of managing oral medicines was improved. Pharmaceutical counselling substantially reduced high knowledge deficits but no significant improvement was seen with the handbook approach. Pharmaceutical counselling should be offered to patients/parents with high knowledge deficits to reduce errors in managing medicines and increase safety.

EAHP Survey 2010 on hospital pharmacy in Europe: Part 6. Education and research

Hospital pharmacies in Europe are very involved in the education of pharmacy and medical students as well as in the training of technicians and nurses. The picture is similar regarding internal continuing education (which includes education on patient safety), but full or partial reimbursement of expenses is rare. Hospital pharmacists in Europe are involved in clinical research (mostly for clinical trials), drug evaluation and epidemiology studies. Oncology and general teaching hospitals are the most active in this field with general non-teaching hospitals carrying out less research.

Hospital and Community Pharmacists’ Perceptions of Which Competences Are Important for Their Practice

The objective of the PHAR-QA (Quality assurance in European pharmacy education and training) project was to investigate how competence-based learning could be applied to a healthcare, sectoral profession such as pharmacy. This is the first study on evaluation of competences from the pharmacists’ perspective using an improved Delphi method with a large number of respondents from all over Europe. This paper looks at the way in which hospital pharmacists rank the fundamental competences for pharmacy practice. European hospital pharmacists (n = 152) ranked 68 competences for pharmacy practice of two types (personal and patient care), arranged into 13 clusters. Results were compared to those obtained from community pharmacists (n = 258). Generally, hospital and community pharmacists rank competences in a similar way. Nevertheless, differences can be detected. The higher focus of hospital pharmacists on knowledge of the different areas of science as well as on laboratory tests reflects the idea of a hospital pharmacy specialisation. The difference is also visible in the field of drug production. This is a necessary competence in hospitals with requests for drugs for rare diseases, as well as paediatric and oncologic drugs. Hospital pharmacists give entrepreneurship a lower score, but cost-effectiveness a higher one than community pharmacists. This reflects the reality of pharmacy practice where community pharmacists have to act as entrepreneurs, and hospital pharmacists are managers staying within drug budgets. The results are discussed in the light of a “hospital pharmacy” specialisation.

A cohort study investigating medication management by pharmacists to prevent drug-related problems in pain therapy

Objectives We aimed at identifying drug-related problems in pain therapy and assessed the effect of medication management by pharmacists in routine care. Methods We performed a cohort study consisting of a control (no pharmaceutical service) and a medication management group receiving pharmaceutical services including recommendations to physicians. We defined pharmacotherapeutic and administrative drug-related problems in pain therapy and analysed patient charts to assess the outcomes. Active participants in the study were not involved in study assessment. Outcomes were the number of patients and the number of analgesic prescriptions with drug-related problems. Results We analysed 414 medication records (controls: 208, medication management: 206). Our intervention had no influence on the number of patients with drug-related problems following analgesic prescriptions (control: 166/208, 80% vs medication management: 155/206, 75%, p=0.266). In 98 control group patients (47%), we found at least four drug-related problems. This fraction was smaller in the medication management group, with 66 patients (32%; p=0.002). The number of analgesic prescriptions leading to drug-related problems decreased from controls with 381/627 (61%) to 308/654 (47%) in the medication management group (p<0.001). Conclusions Current pain therapy standards were not strictly adhered to in routine analgesic prescriptions for orthopaedic patients. The inclusion of pharmacists into the team successfully decreased drug-related problems. However, further interventions are required to achieve optimal effects.