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Medication safety

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This issue of HPE marks the launch of a new section, called Benchmark. In an initiative spearheaded by Paul LeBrun, the international Editorial Advisory Board has identified topics that are of key concern to hospital pharmacists. In each issue of HPE, they will give their perspectives on one of the topics, in a bid to encourage new ideas and new initiatives across Europe. It will not surprise anyone that medication safety is the first item to be discussed – after all, it is in the genes of every hospital pharmacist.

Spain: María José Tamés PhD
Hospital Pharmacy Specialist, Assistant Manager Pharmacy Department, Onkologikoa Foundation,
San Sebastian, Spain
When it comes to medication safety, few groups of drug pose as big a challenge as do antineoplastic drugs. Medication errors in chemotherapy are very important, not only because of their serious consequences but also because of their high incidence. Some of the variables that contribute to this include: individual dosage for patients, high variability of dosages for each cytostatic in different protocols, protocol complexity and proliferation of new cytostatics. Finally, medication errors in chemotherapy are linked to the complexity of the chemotherapy process.
In July 2012, the Spanish Society of Hospital Pharmacists (SSHP) started a project whose main objective was defining a standardised process to reduce errors in the chemotherapy process, with special focus on the dispensing and preparation stages. SEFH developed this project with the support of two other organisations: Celgene provided financial support and oversight, and Lodestone, as the consultancy company, provided methodology and expertise and brought external challenge.
Seven Spanish hospitals were engaged in the project, including small and big hospitals as well as hospitals with technology-supported processes and hospitals using manual procedures.
Based on a Lean process improvement approach, the project started with understanding the current state of the process in four of the seven hospitals, through site visits of Lodestone staff to map the process and gather data. Having understood the existing process, issues and risks were identified and then prioritised. Having identified and prioritised the risks in the processes, the hospital pharmacists worked in teams to identify the control options for the risks. The project is now is in its last phase, where the final output is to establish good practice recommendations for both manual and technology-supported processes.
UK: Michael Scott BSc PhD FPSNI
Head of Pharmacy and Medicines Management,
Northern Health and Social Care Trust,
Antrim, UK
Pharmacy is the healthcare profession that has the responsibility for ensuring the safe, effective and rational use of medicines. The current healthcare system faces great challenges due to increasing numbers of adverse events and medication incidents as well as poor adherence.
To address these issues effectively it is vital to re-engineer the medicines management system. In Northern Ireland, this work started in the secondary care sector with the integrated medicines management programme. This entailed much greater involvement of the pharmacy team at all stages of the patient journey, resulting in reduced errors, improved medicines appropriateness and reduced length of stay. In addition, the introduction of lockers and one-stop dispensing resulted in faster and safer medicines administration rounds, as evidenced by a significantly improved medicines administration error rate.
Current initiatives to build on this include the introduction of prescribing pharmacists in both primary and secondary care, in addition to pilots with consultant care of the elderly pharmacists in both nursing homes and intermediate care settings, with preliminary results being very positive. In relation to improving patient adherence, pilot work is also ongoing, as this is a major issue in achieving effective medicines use and is a key EU objective.
Enabling technology, such as pharmacist intervention recording and medicines reconciliation software, has been and continues to be developed and introduced to further improve safety. The introduction of the electronic care record, allowing healthcare professionals to readily access patient data, is a major advance  and will help achieve much greater integration between primary and secondary care. Further work is well underway to bring in electronic prescribing in secondary care, which will enhance the medicines management system with clinical rules also being looked at as a further aid.
The Netherlands: Paul PH LeBrun PharmD PhD
Hospital Pharmacist and Clinical Pharmacologist,
Central Hospital Pharmacy,
The Hague,
The Netherlands
Medication safety is of paramount importance to every (hospital) pharmacist in Europe and it is part of our daily work. The mission of the Dutch Society of Hospital Pharmacists (NVZA) for the coming years includes further contribution to safer care.
In The Netherlands, an important means for the day-to-day improvement  is a national reporting system for care-related incidents (CMR). Incidents occurring from prescribing to administration can be reported to the CMR anonymously.
Reported incidents are classified by independent specialists. Thus insight is obtained as to why incidents occur and how they can lead to harm. This gives the opportunity to identify risks in the medication process, to define necessary improvement and to support a national medication safety policy.
The CMR was developed by the Dutch Society of Hospital Pharmacists in 2006 and has developed as an independent institution of patient and medication safety. To date, most general and academic hospitals, community pharmacies and psychiatric hospitals participate. In 2012 a total of 13,390 incidents were reported and evaluated. In 5% of cases, serious harm was reported. Most incidents are reported in the phase of administration and followed by the phase of prescription. The main cause of incident was related to individual behaviour during the transfer phases of the process.
Every three months, an overview is put together. Besides structural reports, alerts are send out in case of major incidents when the probability of  harm is high, or when the incident could easily occur elsewhere or when there is an immediate educational value resulting from the incident.  An example is the interchange of a normal amphotericin B dosage form with a liposomal form. The normal amphotericin was prepared based on the prescribed liposomal dose and thus the patient was overdosed. This incident was an alert because of a high probability of recurrence. Several prevention measures, such as separated logistics, education to nurses and special warning texts, were sent out.
More information can be found on the website www.medicatieveiligheid.info – unfortunately only in Dutch, but the system might be an encouragement for a European initiative.
Germany: Martin J Hug PhD
Pharmacy, University Medical Centre,
Freiburg, Germany
It has often been said that Germany, despite having an advanced healthcare sector, is lagging behind in terms of medication safety. While it is true that only few German hospitals have implemented computer physician order entry (CPOE) systems, it still needs to be proven whether CPOE will improve medication safety significantly. Germany is, in fact, not a novice to the subject of medication safety. As a collaborator in the Global initiative Action on Patient Safety – High 5s (see page 23), Germany will help to implement and evaluate standardised patient safety solutions. Long before the High 5s project was launched in 2006, national bodies such as the drug commissions of the German medical association and German pharmacists had already recognised the importance of medication safety by reporting drug-related problems to the public.
In addition, the German Federal Ministry of Health has issued the ‘Action Plan for Medication Safety’, which states a number of subjects relevant to the safety of patients. The German Coalition for Patient Safety, a non-profit organisation open to both healthcare professionals and patients, develops strategies to prevent errors.
Medication safety is also the focus of the German Society of Hospital Pharmacists (ADKA). To improve patient safety in hospitals, the Society has developed an error reporting system under the name DokuPIK, which is freely available to all members. In addition to the mere collection of errors, DokuPIK also offers the possibility to enter the respective pharmaceutical interventions. This feature is aimed to develop specific strategies to avoid medication errors while keeping human and financial resources at an optimum. Tools such as DokuPiK are a means to assess the state of medication safety among the Member States of the EU.
Czech Republic: Irena Netikova PhD PharmDr
Hospital Clinical Pharmacist,
Teaching Hospital Na Bulovce, 
Prague, Czech Republic
Medication safety is a very important issue for pharmacists, especially in hospitals. In our country, PC programmes for drug storage and dispensation, often connected to the drug interaction software, are used.
New quality in medication safety is the concern of clinical pharmacy. Rapid development of clinical pharmacy practice during a few past years has represented the most important change for hospital medication safety in the Czech Republic.
From this year, every hospital is obliged to have clinical pharmacy services. Clinical pharmacy has been, in our country, a postgraduate specialisation for more than twenty years.
But in the healthcare practice, it was very little integrated. Today, clinical pharmacists work in independent hospital departments or in hospital pharmacies. Their daily work is medication checking and optimisation for newly admitted patients or complicated cases on the wards. They are involved in solving the problem of pharmacovigilance and drug side effects. They have finally begun to be a part of the multiprofessional team in many hospital departments.
Italy: Anna Carollo PharmD PhD MS
Hospital Clinical Pharmacist,
ISMETT Hospital,
Palermo, Italy
Medication safety is a critical component of safe patient care. Despite significant national attention, medical errors continue to pervade the European healthcare system. Medication-related errors consistently rank at the top of all medical errors. The Italian Medicines Agency (AIFA) is the national authority responsible for drug regulation.
It is a public body operating autonomously, transparently and according to cost-effectiveness criteria, under the direction of the Ministry of Health and under the vigilance of the Ministry of Health and the Ministry of Economy. It cooperates with the Regional Authorities, the National Institute of Health, Research Institutes, Patients’ Associations, Health Professionals, Scientific Associations, the Pharmaceutical Industry and the Distributors. The Agency controls and analyses drug utilisation at national, regional and local levels, it monitors clinical trials approved by Local Ethics Committees and integrates the information obtained from the national pharmacovigilance network.
The definition of standards of health system is established at the regional level in accordance with the regional authorities. In Sicily, all health systems prepare and implement their annual safety plans for clinical risk management and define their safety goal for the year.
Thanks to an agreement between Sicily and the Joint Commission International (JCI), the selection of the standards has been taken from JCI’s manual for international accreditation of hospitals for the areas at major risk of errors. There is a wide range of concerns in relation to medication safety and there exists a number of practical solutions, according with JCI, that can realistically be implemented in the hospital setting to prevent errors:
  • Better communication
  • Keeping records
  • Involving the pharmacist
  • Double-checking
The take-away message for all health leaders is this: enhanced communication between providers, patients and pharmacists is critical to reducing the likelihood of medication errors. Communication among those healthcare professionals responsible for prescribing, administering, preparing and dispensing, or monitoring medication is critical to optimising treatment. Leaders must inspire teamwork and open communication. Understanding the value of communication pertaining to the use of medications and fostering an environment that supports excellent communication can decrease the incidence of medication errors and resulting harm to the patient.






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