Recommendations for wider adoption of clinical pharmacy in Central and Eastern Europe in order to optimise pharmacotherapy and improve patient outcomes.

Clinical pharmacy as an area of practice, education and research started developing around the 1960s when pharmacists across the globe gradually identified the need to focus more on ensuring the appropriate use of medicines to improve patient outcomes rather than being engaged in manufacturing and supply. Since that time numerous studies have shown the positive impact of clinical pharmacy services (CPS). The need for wider adoption of CPS worldwide becomes urgent, as the global population ages, and the prevalence of polypharmacy as well as shortage of healthcare professionals is rising. At the same time, there is great pressure to provide both high-quality and cost-effective health services. All these challenges urgently require the adoption of a new paradigm of healthcare system architecture. One of the most appropriate answers to these challenges is to increase the utilization of the potential of highly educated and skilled professionals widely available in these countries, i.e., pharmacists, who are well positioned to prevent and manage drug-related problems together with ensuring safe and effective use of medications with further care relating to medication adherence. Unfortunately, CPS are still underdeveloped and underutilized in some parts of Europe, namely, in most of the Central and Eastern European (CEE) countries. This paper reviews current situation of CPS development in CEE countries and the prospects for the future of CPS in that region.

Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications.

INTRODUCTION: While medicine shortages are complex, their mitigation is more of a challenge. Prospective risk assessment as a means to mitigate possible shortages, has yet to be applied equally across healthcare settings. The aims of this study have been to: 1) gain insight into risk-prevention against possible medicine shortages among healthcare experts; 2) review existing strategies for minimizing patient-health risks through applied risk assessment; and 3) learn from experiences related to application in practice. METHODOLOGY: A semi-structured questionnaire focusing on medicine shortages was distributed electronically to members of the European Cooperation in Science and Technology (COST) Action 15105 (28 member countries) and to hospital pharmacists of the European Association of Hospital Pharmacists (EAHP) (including associated healthcare professionals). Their answers were subjected to both qualitative and quantitative analysis (Microsoft Office Excel 2010 and IBM SPSS Statistics®) with descriptive statistics based on the distribution of responses. Their proportional difference was tested by the chi-square test and Fisher's exact test for independence. Differences in the observed ordinal variables were tested by the Mann-Whitney or Kruskal-Wallis test. The qualitative data were tabulated and recombined with the quantitative data to observe, uncover and interpret meanings and patterns. RESULTS: The participants (61.7%) are aware of the use of risk assessment procedures as a coping strategy for medicine shortages, and named the particular risk assessment procedure they are familiar with failure mode and effect analysis (FMEA) (26.4%), root cause analysis (RCA) (23.5%), the healthcare FMEA (HFMEA) (14.7%), and the hazard analysis and critical control point (HACCP) (14.7%). Only 29.4% report risk assessment as integrated into mitigation strategy protocols. Risk assessment is typically conducted within multidisciplinary teams (35.3%). Whereas 14.7% participants were aware of legislation stipulating risk assessment implementation in shortages, 88.2% claimed not to have reported their findings to their respective official institutions. 85.3% consider risk assessment a useful mitigation strategy. CONCLUSION: The study indicates a lack of systematically organized tools used to prospectively analyze clinical as well as operationalized risk stemming from medicine shortages in healthcare. There is also a lack of legal instruments and sufficient data confirming the necessity and usefulness of risk assessment in mitigating medicine shortages in Europe.

Observational Study of Antibiotic Usage at the Children's Clinical University Hospital in Riga, Latvia.

Background and objectives: Many pediatric patients have been treated with antibiotics during their hospitalization. There is a need to improve antibiotic prescribing for pediatric patients because many of these prescriptions are inappropriate. Antibiotic consumption analysis was conducted at the Children's Clinical University Hospital to identify targets for quality improvement. Materials and Methods: A one day cross-sectional point prevalence survey (PPS) was conducted in May and November 2011⁻2013 using a previously validated and standardized method. The survey included all inpatient pediatric and neonatal beds and identified all children receiving an antibiotic treatment on the day of survey. Total consumption of systemic antibiotics belonging to the ATC J01 class (except amphenicols (J01B) and a combination of antibacterials (J01R)) was also analyzed by using a defined daily dose (DDD) approach and antibiotic drug utilization (90%DU) for the period 2006⁻2015. Results were compared with results in 2017 using the DDD and 90%DU methodology. Results: The most commonly used antibiotic group in all PPS, except in May and November 2011, was other ß-lactam antibiotics (J01D): 42 (40%) prescriptions in May 2013 and 66 (42%) and November 2011. In 2006⁻2015 and also in 2017, the most commonly used antibiotic groups were penicillins (J01C) and other ß-lactam antibiotics (J01D)-76% (90%DU) of the total antibiotic consumption registered in 2006, 73% in 2015 and 70% in 2017. Starting in 2008, amoxicillin was the most commonly used antibiotic at the hospital. The usage of ceftriaxone increased from 3% in 2006 to 13% in 2015, but decreased in 2017 (7%). Conclusions: Study results from 2006⁻2015 showed that there was a need to establish a stronger antibiotic prescribing policy in the hospital reducing the use of broad-spectrum antibiotics (especially 3rd generation cephalosporins) and increasing the use of narrower spectrum antibiotics. It was partly achieved in 2017 with some reduction in ceftriaxone use.

A retrospective and observational analysis of harmful excipients in medicines for hospitalised neonates in Latvia.

BACKGROUND: Medicines used in neonates contain different excipients, which may not be safe in this age group. OBJECTIVE: To analyse the frequency at which hospitalised neonates are exposed to harmful excipients (HEs) and to identify substitution possibilities for medicines containing HEs. MATERIALS AND METHODS: Retrospective, observational study at a university paediatric hospital from 1 September 2015 till 29 February 2016. All hospitalised neonates who received a prescription for medicines containing an HE were included. Neonates were divided into four groups according to gestational age (<28 weeks; 28 to <32 weeks; 32 to <37 weeks and ≥37 weeks). The following excipients were analysed: parabens, polysorbate 80, propylene glycol, benzoates, saccharin sodium, sorbitol, ethanol and benzalkonium chloride. Excipients were identified from the Summaries of Product Characteristics. RESULTS: 296 (102(34.5%) preterm) neonates included in the study received 1472 prescriptions for 106 medicines. The most often used formulations were intravenous (48/106; 45.3%) and oral solid formulations (20; 18.9%). The total number of different excipients was 169. In total, 29/106 (27.4%) medicines contained at least one HE. In total 82/102 (80.4%) preterm and 118/194 (60.8%) term neonates received medications with at least one HE. Substitution was possible for 9/29 (31.0%) HE-containing medicines. CONCLUSIONS: Use of HEs can be reduced by using HE-free products available on the European market. However, medicine substitution was possible in only a small number of cases. Therefore the main focus should be on information and education of the hospital specialists about HEs used in medicines and their adverse reactions.

Prescription of antibiotics in Riga and Vilnius tertiary children's hospitals.

OBJECTIVES: The aim of this study was to compare the use of antibiotics among hospitalised children in Riga (Latvia) and in Vilnius (Lithuania) at two tertiary paediatric centres. METHODS: A point prevalence survey (PPS) was conducted using validated and standardised Antibiotic Resistance and Prescribing in European Children (ARPEC) project methodology during November 2012. All inpatients less than 18 years old were included in the study. All data were recorded for patients with active antimicrobial prescriptions at 8 am on the day of the survey. Data were entered into the ARPEC-webPPS programme and were validated online for accuracy. RESULTS: The proportion of patients receiving antimicrobial therapy was statistically different: 128 (37.0%) patients in Riga and 83 (26.3%) in Vilnius. The most common age group in Riga and Vilnius was 1-5 years. The most commonly used antibiotic classes for the treatment and prophylaxis of infection were third-generation cephalosporins (38; 25.5% prescriptions) in Riga and second-generation cephalosporins (16; 19.8%) in Vilnius. Parenteral use of antimicrobials was higher in Riga than in Vilnius: 111 (74.5%) prescriptions to paediatric patients in Riga and 45 (55.6%) prescriptions in Vilnius. CONCLUSIONS: The PPS identified differences in antibiotic use in both hospitals and problem areas for improvement: high use of third-generation cephalosporins for paediatric patients (in Riga) and predominant use of parenteral antibiotics. Further collaboration between both centres is needed because sharing audit data and antimicrobial stewardship initiatives may encourage further changes in practice at both institutions.

Analysis of antibiotic surgical prophylaxis in hospitalized children suffering upper and lower extremity injuries.

BACKGROUND: Surgical prophylaxis may account for one-third of all antibiotic use in paediatric hospitals. OBJECTIVE: To evaluate the appropriateness of surgical prophylaxis and to analyse adherence of surgeons to surgical prophylaxis guidelines. METHOD: Retrospective study at a university paediatric hospital. Patients younger than 18 years with injuries of lower and upper extremities were included. The study period was from January 1st 2011-December 31st 2013 and January 1st 2001-December 31st 2003. The appropriateness of the antibiotic use was analysed in accordance with international and local guidelines. RESULTS: Antibiotic prophylaxis was needed by 1125 (55.0 %) patients in 2011-2013 and by 816 (44.4 %) patients in 2001-2003. However, it was administered to only 66.0 % of those in need of prophylaxis in 2011-2013 and to 70.8 % of those in 2001-2003. A single antibiotic dose was administered to 73.8 % of those who received antibiotics in 2011-2013 and to 34.1 % of those in 2001-2003. The timing of the first dose was correct in 370 (52.9 %) prescriptions in 2011-2013 and in 10 (20.4 %) prescriptions in 2001-2003. The most often used antibiotics for prophylaxis were cefazolin in 2011-2013 and cefuroxime in 2001-2003. CONCLUSION: Overall adherence rate to the international and hospital guidelines was low, indicating that in order to improve this situation, there is a need for multiple interventions.

Antimicrobial usage among hospitalized children in Latvia: a neonatal and pediatric antimicrobial point prevalence survey.

BACKGROUND AND OBJECTIVE: The point prevalence survey was conducted as part of the Antibiotic Resistance and Prescribing in European Children (ARPEC) Project. The study aimed at analyzing pediatric and neonatal antimicrobial prescribing patterns in Latvian hospitals, to identify targets for quality improvement. MATERIALS AND METHODS: A one day cross-sectional point prevalence survey on antibiotic use in hospitalized children was conducted in November 2012 in 10 Latvian hospitals, using a previously validated and standardized method. The survey included all inpatient pediatric and neonatal beds and identified all children receiving an antimicrobial treatment on the day of survey. RESULTS: Overall 549 patients were included in the study; 167 (39%) patients admitted to pediatric wards and 25 (21%) patients admitted to neonatal wards received at least one antimicrobial. Pediatric top three antibiotic groups were third-generation cephalosporins (55 prescriptions, 28%), extended spectrum penicillins (n=32, 16%) and first-generation cephalosporins (n=26, 13%). Eleven pediatric patients (85%) received surgical prophylaxis more than 1 day; 143 pediatric patients (86%) received antibiotics intravenously. Lower respiratory tract infections were the most common indications for antibiotic use both in pediatric (n=60, 35.9%) and neonatal patients (n=9, 36%). The most used antibiotics for neonatal patients were benzylpenicillin (n=12, 32%), and gentamicin (n=9, 24%). CONCLUSIONS: We identified a few problematic areas, which need improvement: the high use of third-generation cephalosporins for pediatric patients, prolonged surgical prophylaxis, predominant use of parenteral antibiotics and an urgent need for local antibiotic guidelines.