The KNMP Medication Safety Programme
Frans J. van de Vaart, Pharm.D., Royal Dutch Association for the Advancement of Pharmacy
The Hague, The Netherlands
Since the To Err Is Human1 report of the late nineties, patient safety is high on the health policy
agenda all over the world. However, some basic principles of safety management in health care, e.g.
primum non nocere (first do no harm) and in dubio abstine (in case of doubt, do not intervene), go
back to ancient history. In modern health care, this rather conservative approach is still valid and an
even bigger challenge than ever. Health science and technology have developed strongly, and
resulted in powerful therapeutic instruments. To find the delicate balance between their benefits
and risks for patients is not an easy task.
Pharmacists have been aware of safety issues already for centuries. They recognised the importance
of quality assurance in the preparation of medicines and put effort in standardisation of raw
materials and production methods in pharmacopoeias. In the sixties, the thalidomide tragedy was
the start of extensive legislation and regulation. Product registration and marketing authorization
were introduced to ensure quality of design, followed by GMP and manufacturer licensing to
guarantee quality of production. With these systems in place, pharmacists – although still
responsible for the quality of the medicines they dispense – can focus on the safe use of medicines
rather than on product quality.
The Royal Dutch Association for the Advancement of Pharmacy (KNMP) is currently running a
Medication Safety Program. The agenda for this program is set mainly by two scientific reports that
were issued during the last five years. In 2006, the HARM (Hospital Admissions Related to Medicines)
study2 showed that in the Netherlands each year almost 40.000 patients are admitted to hospitals
due to problems with their medicines use. Almost 50% of these problems are classified as
“potentially avoidable”; approximately 1.200 patients die each year. All cases were analysed
extensively. The conclusions are given in a second report, under the title HARM-wrestling3 (2011).
About 40 recommendations are given to reduce the number of HARMs.
The KNMP Medication Safety Program gives high priority to those issues that are expected to result
in the highest reduction of HARMs. Some of these are medication related, some are patient related
and some are related to risky situations or processes during the treatment of patients.
By far the highest number of HARMs are observed with patients using medicines that interfere with
blood coagulation: vitamin K inhibitors, platelet aggregation inhibitors and NSAIDs. Other
medications that often cause HARMs are diuretics, corticosteroids and blood glucose lowering
agents. Patient related risk factors are e.g. high age, cognitive problems and renal impairment. The
lack of exchange of patient data between health care providers is another important factor, which
means that e.g. admittance to and release from the hospital are high risk processes.
When combining these different perspectives, it is obvious that attention from health care
professionals is urgently needed when e.g. an elderly patient, using multiple medications is released
from the hospital to his or her own home (Figure 1).
1
Linda T. Rohn, Molla S. Donaldson, Janet M. Corrigan. To err is human – Building a safer health system.
National Academy Press [2000]
2
Patricia M.L.A. Van den Bemt, Antoine C.G. Egberts, Anne Leendertse. Hospital Admissions Related to
Medication (HARM).Utrecht Institute for Pharmaceutical Sciences; 2006.
3
Margaretha F. Warlé-Van Herwaarden, Cees Kramers, Miriam C. Sturkenboom, Patricia M.L.A. Van den Bemt,
Peter. A.G.M. De Smet. HARM Wrestling. KNMP [2011]
Medication surveillance
In the Netherlands pharmacists have formal tasks in checking physicians’ prescriptions and helping
the patient with the safe use of medicines. All pharmacists use computerized information systems to
check for appropriate dosing, the occurrence of drug-drug interactions, the unintended use of similar
medicines, the existence of contraindications, etc. Individual patient records are kept for at least 10
years, and include not only the medicines dispensed but more often also other data relevant for the
safe and effective use of medicines, such as diagnosis and certain clinical parameters. Each
prescription is double checked through the pharmacy information system as well as manually by the
pharmacist. Through this workflow, 1-2 clinically relevant adverse drug events are prevented each
day in each pharmacy, as well as many more minor problems.
An increasing number of pharmacists are expanding their role in medication surveillance by taking
into account clinical values for renal clearance, checking the prescribed dose in case of renal
impairment and proposing dose adjustments to the prescriber when appropriate.
The first thing to organize is pharmacists’ access to the relevant patient data. One possibility is to
agree with the physicians that medication records will be accessible to the pharmacist as well.
Especially in hospital settings and in primary care centres, where general practitioners and
pharmacists already work closely together and make use of the same computer system, this can be
arranged easily. Another possibility is to obtain values for renal clearance directly from the clinical
lab. In all cases, good collaboration between all health professionals involved and explicit consent of
the patient is necessary.
As part of the Medication Safety Programme, KNMP promotes and facilitates the implementation of
this new feature in medication surveillance by developing toolkits, sharing best practices and making
available education for pharmacists and technicians about how to interpret clinical values and how to
calculate safe dose regimens. Although practical experience is still limited, most pharmacists starting
with this service identify considerable numbers of potentially suboptimal prescriptions, and are
generally successful in optimizing the dose to safe levels considering the current renal function of the
patient in good collaboration with physicians.
In the near future, more clinical values might be taken into account in a similar way, e.g. Na+ and K+
levels, INR, or pharmacogenetic characteristics. The algorithms to be used, however, can become
quite complex when more patient parameters are taken into consideration. KNMP currently
develops these algorithms together with experts in this area, and after proper validation it is
intended to include these “clinical rules” into the computer systems that are currently used in the
pharmacy. This will then lead to more individualized medication surveillance, tailored to the patient’s
condition and needs.
Exchange of medication related patient data
It is important that whenever a physician wants to change the medicines use of a patient, he has
access to a complete patient record including all medicines currently used. This seems obvious but is
not an easy task when the patient is treated by several doctors; general practitioners as well as
medical specialists at the same time. In the Netherlands, the vast majority of all patients always go to
the same pharmacy. This means that the pharmacist is in an excellent position to manage the
medication records of their patients, and make these available to physicians when they want to alter
the current pharmacotherapy.
In 2008, Dutch health care inspectors took the initiative to establish a guideline on this. After quite
some debate, all associations of health care providers agreed to this guideline, and took effort in
implementing it in daily practice. The general expectation at that time was that a national system for
the electronic exchange of patient data would be in place soon. However, after working on that for
many years, the Dutch parliament in 2011 did not agree with the proposed system because of
privacy reasons. Although new efforts have been made since then to organise the exchange of
patient data, currently no nationwide system is in place.
Still, many improvements can be made without such a system. As part of the KNMP Medication
Safety Programme, tools have been developed and best practices collected for processes and
situations where extra attention and effort is necessary to assure correct information about
medication(s) in the patients’ records. This includes procedures for the intake of new patients in a
pharmacy, and for the exchange of data when a patient is admitted in or released from the hospital.
A uniform format for a medication overview has been developed, including all relevant data on
current medication(s), reason for prescription(s), clinical laboratory data, contraindications, etc.
The patient himself plays an important role; to be sincere and transparent about the actual use of
the medicines from day-to-day, and to provide information about additional medicines taken from
other sources, including over-the-counter (OTC) medications and herbal supplements. Patients are
encouraged to ask for a medication overview whenever they feel this necessary (Figure 2). In case of
planned hospital admission, the medication(s) must be verified by the hospital staff; after release
from hospital a standardised medication overview should be transferred to the community pharmacy
in order to adjust the patient records to the current pharmacotherapy.
Medication safety in institutions for resident care
In 2010 Dutch health inspectors reported many medication related problems occurring in nursing
homes, rest homes, homes for handicapped people and with domiciliary care. Problems included:
medication reviews and administration protocols were often altered through hand written changes
on printed documents, some alteration of pharmacotherapy were not recorded at all, medicines
were not stored properly, for people suffering from swallowing problems the medicines were
crushed and mixed with food or beverage without checking if this would affect the pharmacological
effects of the medicines, etc.
KNMP then installed a task force: The Taskforce for Medication Safety in the Care Sector. Community
and hospital pharmacists worked together with doctors, nurses and patient representatives to
establish safe principles for medication use in institutions for resident care. Furthermore, a
standardised protocol format for the administration of medicines was developed. This approach has
already lead to considerable improvements as found by the inspectors when some of the institutions
were revisited this year.
Reporting and evaluation of medication errors
The safe reporting of errors was one of the major recommendations from To Err is Human. In 2006,
hospital pharmacists in the Netherlands took the initiative to collect medication related error reports
in a national database, to investigate these reports in order to find the causes of the errors and to
publish relevant case reports in order to stimulate other hospital pharmacists to check their
operating systems and prevent such errors from occurring again.
In 2009 a project granted by the Minister of Health was started to expand this approach to
community pharmacy. Just before the summer of 2011, this project was successfully finished. More
than 60% of all community pharmacists had subscribed to the Central Medication Incidents
Reporting organisation (CMR) that has been established. Reporting forms and supporting ICT had
been adjusted for community pharmacy, and an organisation had been staffed to evaluate all reports
with potentially high impact within one week. The system is suitable for the registration in the
pharmacy of all incidents and errors and also for complaints by patients. Pharmacists can upload all
reports into a central database, indicating whether in their opinion the incident had or could have
had high impact on the patients’ health, has a high probability to occur in other pharmacies and has a
high educational value. If this is all the case, a CMR Alert is published in the Pharmaceutisch
Weekblad, the Dutch pharmaceutical journal, giving an extensive analysis of the incident and
recommendations to prevent such incidents in the future.
The CMR database contains now about 3.500 reports from community pharmacists and over 26.000
reports from hospital pharmacists. The lessons learned are shared not only by all pharmacists that
joined CMR, but are also communicated to the licensing authorities in case product characteristics
played a role in the incident, e.g. name similarity, inadequate product information, similar
appearance for different strengths, etc. In several cases, corrective actions have been taken by the
authorities. Error reports can also lead to adjustment of practice guidelines, or to improvements in
pharmacy ICT.
Currently, efforts are made to expand the system further to other health care providers in primary
and secondary care, in order to have a standardised way of reporting and to build a comprehensive
database with maximum learning capacity.
Medication safety is and will remain a primary task for pharmacists. The KNMP Medication Safety
Programme recognises this and will continue to explore new strategies to prevent adverse drug
events, reduce risks and improve safety. To be successful, close collaboration between pharmacy
practitioners, other health care providers and most of all, patients, is absolutely crucial and therefore
an obligation for all.
For information about the KNMP Medication Safety Programme, please contact
Brigit van Soest – programme coördinator (b.van.soest@knmp.nl)
Figure 1. Risk model of KNMP Medication Safety Programme