Gunda Gittler MagPharm
Pharmacy, Brothers of Charity Hospital,
The implementation of a patient-focused medication management system with the installation of a unit/multi-dose dispensing robot in an Austrian hospital pharmacy is discussed
The main task of the medication management system today is to combine the highest quality and safety of care for the patient with maximum economy. The provision of the right medicine at the right time in the right place calls for a multi-step operation in which workers with differing education and qualifications are responsible for individual steps in the process.
According to an investigation by Imelda Colman from the Ochsner Clinic in New Orleans, the Harvard Medical Practice Study, which involved 30,000 patients in a number of New York hospitals, quoted an error rate of 3.7%(1) Medication errors between diagnosis of the patients and the administration of medication in a hospital occurred at three main stages:
- Handwritten documentation
- Administration of the medicines
- Documentation of administration.
Therapy changes and the introduction of new medicines had a particular negative influence on these point-of-entry errors. The introduction of a computer system resulted in a halving of errors relevant to patients.
A further study from Mehrtens and Carstens in Hannover reported a similar result.(2) An error rate of 5.1% was established, using a standardised method of investigation that excluded, as far as possible, chance results in 308 patients who received a total of 2335 medicines. These were divided into six possible error categories:
- Documentation error 67%
- Dose error 19%
- Errors of omission 9%
- Drug error 3%
- Administration at wrong time 2%
Although ‘documentation error’ is not a category on the American Society of Health-System Pharmacists error list, when the errors were analysed and separated into 16 categories this was by far the largest group. They resulted from the plethora of interruptions, telephone calls and questions from nurses and other ward staff directed at those writing the prescriptions.
The identification of errors at the time of administration and the associated avoidance strategies involves hospital pharmacists today more than ever and they represent significant contributions to the elevation of the profile of patient safety in hospital and in other care settings. Eight years ago a major problem arose in the Johannes von Gott Care Centre in Kainbach with the costing of medicines for the individual wards. Problems resulted, in particular, with determining the stock levels and reordering of medicines and the checking of the part-used packs. In each of the 25 wards, care staff were involved in the dispensing of medicines and with fetching them from the medicines store (because there was no pharmacy on site).
These weaknesses must not only be recognised but also be remedied. For these reasons it seemed to us eight years ago the introduction of a computerised system of medication management was the best solution for the 600 neurological patients of the Johannes von Gott Care Centre in Kainbach.
The implementation of a patient-focused medication management system with the installation of a unit/multi-dose dispensing robot in the Barmherzigen Brüder (Brothers of Charity) hospital pharmacy in Linz was the result. As more than 90% of prescribed medicines were tablets, dragees or capsules, this solution was particularly suitable.
Baxter Automat FDS 330
The first Baxter Automat FDS 330 dispensing system was installed in Linz in September 2004, and all oral dosage forms (tablets, dragees, capsules) can be packed in patient-specific fashion by this robot. In 2009, a second identical robot was purchased. The machines run off two independent servers. In the event of a power failure, the robots can be operated from the emergency electricity supply for the hospital and the servers can be operated from the emergency electricity supply for the hospital computer department. Thus, the hospital pharmacy can guarantee a high-capacity, 100% accident-free service.
Selection of medicines
The selection of medicines for use in the robot is made by the pharmacist and is based on expiry dates. In addition, the galenical presentation is determined and documented by the pharmacist. Each medicine that is packed in the robot is defined for ingredients, excipients, light-sensitivity, moisture-sensitivity and pharmaceutical form and shelf-life of between one and three months.
The stability data, together with photographs of the pack, the tablets and the wording on the pack are retrievable for each medicine in the patient information.
Since 2004 we have regularly requested stability data for the deblistered medicines from the manufacturers, but sadly with little success. At the time of approval by the authorities, the pharmaceutical firms must present a number of stability test data (for example, stress tests). For reasons of liability these data are provided to the pharmacist either unwillingly or not all. The authorities may not release the data because they belong to the pharmaceutical firms.
As a result of the success in Kainbach, and the associated economic and qualitative improvements, the scheme was progressively rolled out to other hospitals and clinics. This is summarised in Box 1.
It is important that items are blister-packed in response to medication ordering and delivery is completely automated and requires no manual steps. For this reason the pharmacy of the Brothers of Charity makes available, free of charge to all customers, the MedCaSol® programme (developed by Care Solutions, a daughter company of the Brothers of Charity, Austria) so that there is a validated interface with the robot. All prescriptions for medicines for patient care that are dispensed using doses packed in sachets must be supported by the databank and electronically quality-assured. The pharmacists have had a considerable influence on the establishment and ongoing operation of the MedCaSol® system.
The MedCaSol® programme – which was for the most part developed in close cooperation with the pharmacy – and accurate filling of the FDS machine ensures that each individual medicine is checked with the prescription and each individual sachet is traceable, even after several months.
The medicines file (SIS data and product directory) is based on the database of the pharmacy publishers, which has been imported.
Medicines that are put into the robot (having determined in advance stability and suitability for packing in sachets) are marked with a question mark (?). A red question mark is for medicines that that need a box. Those labelled with a blue question mark need to be packed using the loading tray. The prescriptions can be printed directly from the MedCaSol system.
The following information is shown on the list of options:
- Box code/label: G = green box, Y = yellow box, R = red box, N = no box
- The medicines are shown in the colour of the cassette
- Additional item code/label: ‘2’ if two packs can be ordered on the prescription
- Approval status code/label: information about the approval status
- Cash price of the package: the calculated unit price of the tablet
- Description of the medicine (according to the product directory).
The prescriptions are evaluated by clinical pharmacists taking into account administration time, indication, possible interactions, and dosing and, if necessary, making direct contact with the prescribing doctor in order to optimise the therapy.
The pharmacy of the Brothers of Charity hospital is the first and only pharmacy in Austria that holds a manufacturing license under the new-blister-packing regulations from the authority (the Austrian Agency for Health and Food Safety).
The establishment of a quality management system ensures that consistent quality of the manufacturing process is guaranteed and that there is continual process improvement.
Key elements of the system include:
- Written operating procedures and worksheets
- Education and training
- Robots capable of packing single or multiple solid oral doses into individual sachets
- Suitable medication software
- Structured computer solutions
- Risk management system
- Class D clean room
- Hygiene and cleansing plans.
Particular attention is paid to compliance with all the regulatory requirements for the whole of the manufacturing process.
The pharmacy of the Brothers of Charity hospital uses a risk management system that focuses on the risks of the manufacturing process. Processes that can significantly influence the quality of the end product count as high risk. Next comes the identification of risks (precise definition of risks, description of the negative consequences and possible causes of the error source) and analysing their implications. On the basis of this assessment corresponding measures (for example, ongoing checks in the process) can be taken to manage and minimise the risks. The purpose of risk management is to make the risks of a production process controllable or manageable.
The most commonly-used tablets are put into the robot in cassettes. The Baxter calibration centre in The Netherlands calibrates the cassettes for the relevant products.
With the FDS robot, all tablets, capsules and dragees and also dispersible-tablets (which must remain in original blisters) can be packed. Less commonly-used medicines that do not have a fixed position in the machine or that are divided tablets are packed by means of the loading drawer, known as the tray. The filling of the tray is undertaken with the support of software from Baxter, which also deals with the documentation of the packed tablets. Each sachet is scanned and a picture of the tray with the positions in which the preparation was placed marked with a background colour appears on the screen.
One pharmacist and one technician work together on this, following the ‘four eyes principle’. Addictive medicines (narcotics) are only processed in this way in the robotic packing process.
New pharmacy facilities
As part of the rebuilding of the hospital, completely new pharmacy facilities were built in the summer of 2009, including new rooms for the two FDS robots. The design and fitting of the rooms was similar to those used for initial/original blister-packing in the industry. In one room, which can only be entered through an air-lock, tablets are deblistered and in the next room they are packed using the FDS robot. These rooms are built to class D. Entry for people is through an air-lock and goods are brought in via a separate goods air-lock. The rooms regularly undergo hygiene monitoring and only appropriately-trained personnel are allowed to work there. All work steps are laid down in standard operating procedures in order to guarantee consistent quality. The health of the workers is regularly checked and those working in the clean room must wear gloves, hoods and gowns and when deblistering they must also wear a mask.
The machines are serviced at regular intervals by Baxter, worn parts are replaced and, when necessary, a company technician is available for emergencies (as specified in the service contract).
The purchase of a photo-detector module for the final check, which Baxter co-developed, was also considered. However, the check performed by this gadget is based only on the colour and shape of the tablet. The photographs are stored in the system. So far, the checking system cannot handle halved tablets and these have to be processed by hand afterwards. Thus, this checking system offers no advantage, in the sense of making the work lighter, because divided tablets are packed for almost all customers.
In 2012, we plan to provide the first ward in our hospital with medicines packed in individual sachets. We have chosen the neurology ward for this project. The pharmacy has for some time had a clinical pharmacist visiting the ward once a week.
First, however, the medications tool of the MedCaSol® programme must be well-established on the ward as electronic prescribing constitutes an essential requirement for the linkage/connection.
Raising the safety profile
In order to raise the profile of medication safety, various processes have been put in motion by the authorities. So, for example, in Germany in November 2007, the ministry of health published the ‘Action plan 2008/2009 for improvement of medication safety (AMTS) in Germany’, which called for systematic analyses and improvements of adverse events in pharmacotherapy.
This was followed by a second initiative (‘Action plan 2010/2012 for improvement of medication safety (AMTS) in Germany’, which assumed the successful implementation of the measures in the first action plan. Among other measures, this included the use of computerised decision-support and prescribing systems together with a scientific evaluation of risk-minimisation measures. We presume that the patient-focused medication logistics in future will also lead to the improvement of medication safety in hospitals.
For the patient
- As a consequence of the multi-dose packaging the patient receives exact information about the type and dosing of his treatment – there is transparency of drug treatment
- Hygienically packed medicines
- The consumption of medicines can be checked easily – improved compliance
- Checking of medication by clinical pharmacists (time of administration, interactions).
For quality and safety
- Complete computerised documentation of medication
- Reduction in medication errors
- Optimisation of workflow on the ward with fewer staff: sorting and putting away of medicines on the ward is no longer required, more time for patients
- Increased transparency and standardisation of medication prescribing
- Transparent substitution and exchange of medicines on the basis of Drug and Therapeutic Committee decisions
- Medication profiles accessible (in the pharmacy) through the online network
- For emergency and first doses rapid electronic retrieval of medication history/previous medication.
- Reduction in quantities of medicines needed
- Reduction in the ward stocks of medicines, smaller medicines’ cupboards in the new plans
- Exact consumption control at the cost-centre level
- Less wastage
- Value of ward inventory decreases
- Calculation of case costs and reimbursement and the patient/diagnosis-related costs in the drug/medicines sector.
- The main task of the medication management system today is to combine the highest quality and safety of care for the patient with maximum economy.
- The provision of the right medicine at the right time in the right place calls for a multi-step operation in which workers with differing education and qualifications are responsible for individual steps in the process.
- The pharmacy of the Brothers of Charity hospital is the first and only pharmacy in Austria that holds a manufacturing license under the new-blister-packing regulations from the Austrian Agency for Health and Food Safety.
- The first Baxter Automat FDS 330 dispensing was installed in our facility in September 2004, and all oral dosage forms (tablets, dragees, capsules) can be packed in patient-specific fashion by this robot. In 2009, a second identical robot was purchased.
- Wyeth-Ayerst Laboratories. Trends in pharmacy and pharmaceutical care. Medical errors: Picking up the pieces. An ongoing programme of the University of Mississippi School of Pharmacy;1999.
- Mehrtens T, Carstens G. Medikationsfehler auf einer Station. Krankenhaus Pharmazie 1997;18:168–70.