Report by the Danish Medicines Agency’s working group on clinical pharmacy
The working group’s terms of reference
Summary of the report’s conclusions and recommendations
The medication process
The working group’s suggestions
The primary health care sector
The hospital sector
Cross-sectoral (from primary to hospital sector and vice versa)
The working group’s terms of reference
It depends on many factors whether a medicinal product is used properly. One of these factors is that doctors choose proper medicinal products and that patients use these products correctly. Over the last years, central authorities have launched a range of initiatives with a view to further rational pharmacotherapy. One of these initiatives is the establishment of the Institute for Rational Pharmacotherapy, which is especially directed at doctors’ prescription practice.
Several studies indicate that there is an increasing need to direct attention to the succeeding steps of medical treatment in order to optimise it. This would result in better treatment for patients and a more appropriate exploitation of financial resources. If medicinal products are used inappropriately, it could entail not only that the treatment does not work optimally but it could also directly cause harm.
On this background, in spring 2002 the Minister of the Interior and Health asked the Danish Medicines Agency to form a working group, which was given the task of identifying some focus areas in which health and economic benefits could be obtained through a more extensive use of clinical pharmacy.
Summary of the report’s conclusions and recommendations
The medication process
The working group has used the model of the medication process, which is outlined below and explained in chapter 2, to identify a number of problems that could negatively influence medical treatment and the economy to a greater or smaller extent.
|The medication process |
|Patient problem |
Is there an indication for treatment? (2.1.1)
Choice of treatment and the patient’s acceptance (2.1.2)
Prescription/drug chart etc. (2.1.3)
The medicinal product is dispensed/prepared for use (2.1.4)
Use of medicine/patient’s intake (2.1.5)
|Evaluation of effect |
Does the medicinal product have the expected effect? (2.1.6)
|Follow-up/reassessment of treatment |
Should it be continued or discontinued? (2.1.7)
Problems may arise at all stages of the medication process – from prescription to follow-up of treatment. Most problems are centred on administration, dispensing and the patient’s use of a medicinal product, but lack of follow-up and reassessment of medical treatment is also a major problem. Also problems regarding prescription could entail serious consequences. Special problems are related to transferring patients from the primary to the hospital sector, and in this phase it is often especially important to be able to get an overview of a patient’s medication.
The health and economic consequences of the medication problem may appear in many ways, for instance in the form of a large extent of drug related hospitalisations. This is also described in the report. Other consequences for patient and society are unnecessary drug expenses, uncomfortable symptoms, adverse drug reactions and a poorer state of health.
Many of these drug related problems could be prevented or reduced by various initiatives. Over the last years, a range of central and decentralised initiatives has been launched in
The medication process is often very complex and includes many actors – patient, relatives and a number of health care professionals. Regardless that the electronic medicine profile and other technical aids are clearly meeting a need, there is still cause for having a closer look at how medical treatment could be optimised. A more extensive use of clinical pharmacy is one of the possible target areas and the primary purpose of this report is to illuminate the health and economic effects of this.
Both Danish and international definitions of clinical pharmacy exist but common to them all is a focus on how to improve drug treatment by having a pharmacist working at patient level. This report deals with clinical pharmacy from the following point of departure:
Clinical pharmacy is a way of safeguarding an optimal and rational use of medicinal products for the benefit of patient and society by collaboration between pharmacists, other health care professionals and the patient.
Clinical pharmacy services and borderline disciplines may be visualised as shown in the following diagram:
| Clinical trials
Primary health care sector
- Pharmaceutical care/medication review process
- Pharmaceutical counselling for general practitioners
- Pharmaceutical counselling regarding patients at nursing homes/under home care
- Seamless care
- Discharge interviews
- Drug history at hospital admission
- Drug administration for discharged patients
|Clinical pharmacy service |
- Patient level
- Ward level
- Prescription interventions
- Advice on self-medication and self-care
- Dose dispensing
- Top up service
- Preparation service
Several studies have proven that a number of clinical pharmacy services could contribute to preventing or solving some of the drug related problems (cf. chapter 3). On this basis, the following activities and pilot projects are recommended – they are grouped according to affiliation to the primary health care sector (A-G), the hospital sector (H-L) and across the sectors (M-P).
The overall purpose of all suggestions in this report is to achieve a heightened quality of patient treatment, thereby increasing patient safety. The working group has decided to emphasise interdisciplinary aspects on the ground that patients are often in contact with many health care professional groups, underlining the need for co-operation and co-ordination. At the same time it is emphasised that as far as possible the problems should be solved where they arise or – if possible – be prevented from arising.
Within the framework of the working group it has not been possible to make new investigations or health economic analyses, which is why the exact financial circumstances are not explained for all suggestions. The available health economic analyses have been evaluated and form the basis of this report’s recommendations. The working group has decided not to take a stand on who should finance the suggestions as this should be a matter for decisionmakers on the basis of the recommendations.
Chapter 4 offers a more thorough explanation of the report’s suggestions and chapter 3 describes the underlying studies, hereunder possible financial aspects. Finally, the working group recommends that attention should also be directed towards the ongoing projects described in chapter 4.
The working group’s suggestions
The primary health care sectorA: Pharmaceutical care. Pharmacist medication review consultations
A structured course of patient-pharmacist consultations on usage of medicinal products (pharmaceutical care) has proved to prevent hospitalisations and/or other kinds of contact with health care services and has proved that patients’ health and quality of life can also be improved. In Danish studies positive results have been found for patients with asthma and elderly people who use at least 5 prescription-only medicinal products.The working group recommends:
- that pharmaceutical care as a course of pharmacist consultations is extended to become an offer for asthma patients as well as patients in regular treatment with approximately 5 or more prescription-only medicinal products daily.
Pilot projects in which the following is tested:
B: Pharmaceutical counselling for general practitioners
- pharmaceutical care/course of pharmacist consultations for other selected groups of chronically ill people with a large consumption of drugs (e.g. patients with diabetes, heart problems and arthritis)
- different rules of payment and referrals
- the value of the fact that doctors and pharmacies (with patients’ acceptance) enter information into the patient’s electronic medicine profile when the patient’s medication is revised. This information can be a valuable aid to other health care professionals, who can thus avoid much unnecessary work
- the health and economic effect of other staff groups conducting drug consultations in controlled studies. Here, pharmacist consultations might be included as a positive control.
In other European countries it has been proven that it saves money and leads to more appropriate prescribing of medicinal products if pharmacists advice general practitioners. A Danish pilot study, in which a pharmacist worked in a medical practice, has shown that it is potentially possible to achieve something similar in Denmark. Initiatives have already been taken for new projects (cf. chapter 4). The working group recommends:
C: Review of medicine profiles of patients at nursing homes/under home care
- that more pilot projects are launched in several counties based on the project from Frederiksborg County and results from other countries. The pilot projects should include controlled effect studies that illuminate both quality effects and financial effects of clinical pharmacy in medical practices as well as the pharmacist’s affiliation to both medical practice and pharmacy.
Danish and foreign studies have shown that review of medication at nursing homes can reduce drug expenses and that the consumption of psychoactive drugs decreases. A British study has shown the potentially positive effect on the health of nursing home residents in the form of fewer deaths. The working group recommends:
D: Quality assurance of drug handling routines at nursing homes/in home care
- that review of nursing home residents’ medicine is established as an offer by means of co-operation between pharmacists, nurses and doctors
- launching a pilot project enabling visiting nurses to identify risk patients, the scope of which is to offer medicine reviews by doctor or pharmacist according to fixed criteria.
Several Danish dispensing chemists teach nursing staff about quality assurance of drug handling. At a nursing home, a team consisting of a pharmacist and a pharmaconomist (a chemist’s assistant) have assisted in quality assurance of the nursing home’s routines regarding drug handling, hereunder teaching, drafting of instructions, registration and follow-up on deviations. The staff finds that the safety has improved and that they have been given recognition for the new quality system in connection with the inspection by the medical officer of health.The working group recommends:
- structured teaching of health care personnel in the primary health care sector about general quality assurance aspects and patient safety with a focus on medication problems
- that pharmaceutical teaching and consulting services for quality assurance of drug handling is extended as an offer for those nursing homes and home care nurses who are interested and have a need for it.
E: Prescription interventions
Today, pharmacies detect errors and problems in connection with prescription dispensing and patient contact at the counter, which leads to some kind of action that is honoured through a general distribution profit margin. Experience from other countries suggests that rearranging part of the profit margin for specific drug related activities might increase the incentive for intervening and enhance dialogue between doctor and patient. References in the electronic medicine profile will frequently be relevant in connection with unravelling of such problems. The working group recommends:
F: Counselling on self-medication and self-care
- launching a pilot project to uncover the extent and significance of formal interventions and the honouring of this, for instance a pilot project focusing on problems related to drug duplication.
Self-medication with non-prescription medicine is frequent in Denmark, but knowledge is limited about the extent to which this self-medication is inappropriate and whether it leads to actual health problems. It is proved that Danish pharmacy customers with dyspepsia achieve improved health when they are given targeted counselling on self-medication and self-care.The working group recommends:
G: Tools for better compliance
- launching pilot projects to shed light on the use of resources and the effect of counselling by pharmacists and other professional groups with regard to self-medication with a number of frequently used non-prescription medicinal products.
Lack of medicine compliance is a frequent problem – especially in long-term treatment. Important causes for lack of medicine compliance include complicated dosage regimes for many medicinal products that must be used several times a day, poor communication between patient and doctor as well as patients’ motivation and understanding of drugs and illness. All large bibliographies from the recent years show that effective interventions are complex and multidimensional. Depending on the character of the problem means regarding technique, behaviour, expertise and motivation/emotions are used in combination. A project on medicine compliance of blood pressure patients is already running (cf. chapter 4).The working group recommends:
- launching several development projects and pilot projects on alarm technologies coupled with doctors’ record keeping, prescription dispensing at pharmacies and/or the electronic medicine profile
- launching of pilot projects for testing intervention technologies, hereunder motivational talks with a basis in health pedagogical methods.
The hospital sectorH: Clinical pharmacy service at patient level
Foreign studies have proven financial benefits as a result of a clinical pharmaceutical service in which a pharmacist reviews patient records. A Danish study found savings on drug expenses . Some foreign studies and a single Danish study have found positive clinical benefits and savings on hospitalisation days due to pharmacokinetic services (calculation of dose and adjustment based on plasma concentration measurings).The working group recommends:
- that clinical pharmacists are involved in the preparation and implementation of procedures for the prevention, uncovering and reporting of adverse reactions arising from medicinal products
- that clinical pharmacists perform a pharmacokinetic service, suggest dosage (e.g. anticoagulation treatment) and participate in monitoring patients in close co-operation with doctors.
I: Clinical pharmacy service at ward level
- clinical pharmacists participate in ward rounds and contribute to preventing inappropriate prescriptions by suggesting intervention in patients’ medication
- including of clinical pharmacists in the prescription phase in order for them to give advice on the choice of pharmaceutical form etc. as regards optimal compliance for self-administering patients
- drafting of quality control procedures for calculating doses for specific patient groups, small children for instance
- shedding light on the effect of systematic interventions performed by clinical pharmacists in connection with review of records
- exposing patient groups who have a special need to be informed about and taught how to handle and administer medicines
- on hospitalisation and discharge interviews (cf. suggestion M).
Problems with correct drug handling and medication errors are well-documented in both the primary and the hospital sector. It is reasonable to expect that pharmacists and pharmaconomists can contribute, to a greater extent than what is currently the case, with their knowledge and experience and thereby optimise the handling of medicine. Clinical pharmacists may be involved in other areas, namely in the preparation and implementation of instructions for preparing drugs as well as in the preparation of protocols for clinical trials.The working group recommends:
That clinical pharmacists are involved in:
- preparation of a drug section in protocols for clinical trials so that these comply with the GCP guidelines
- teams performing root cause analyses within the medicine area
- audits on medical records and medications
- follow-up on consumption patterns and treatment regimes
- adverse reaction reports and procedures for reporting preventable adverse drug events related to medicinal products
- that clinical pharmacists are at the disposal of doctors and nurses as regards training in and information about medicinal products in daily clinic
J: Clinical pharmacy service at management level
- in which clinical pharmacists become co-responsible for pursuing goals and standards within the medicines area. Elements of this are preparation of standard regimes for the handling and storage of high-risk preparations as well as maintenance of protocols and treatment instructions, in which drugs are included.
The hospital service focuses on patient safety, quality development and quality control. The Copenhagen Hospital Corporation (Hovedstadens Sygehusfællesskab) has good experience with using pharmacists for quality control processes on drug handling. In their work at different hospital wards, clinical pharmacists observe medication errors and inappropriate procedures that may increase the risk of preventable adverse drug events.
In the USA, the introduction of the electronic drug record and dose dispensing have proven to reduce the number of medication errors and other preventable adverse drug events. The success of these systems depends on, among other things, validation and continuous updates of support decisions in the electronic drug records. There are several ongoing projects about introducing the electronic drug records as well as dose dispensing at Danish hospitals.The working group recommends:
That clinical pharmacists:
- are involved in hospitals’ organisation of the accreditation process within the pharmaceutical area
- participate in preparation and implementation of procedures for reporting and assessing preventable adverse drug events
- participate in drug committees, hygiene committees and commission work on optimising or performing quality controls of the usage or handling of drugs.
Pilot projects in which clinical pharmacists are included:
K: Top up service
- a co-ordinating function as regards selection of medicinal products within the hospital sector with a view to subsequent use in the primary health care sector
- implementation of drug recommendations at ward level.
In Denmark, there is good experience with stock control of hospital wards’ medicine stocks, and this service is now offered at most Danish hospital pharmacies. Clinical pharmaceutical staff – pharmacists and pharmaconomists – has a pharmacoeconomic approach to the clinical use of medicinal products . Several projects indicate that significant savings may be made on drug expenses and liberation of nursing time, although documentation in the form of controlled studies is not very solid. At most hospitals, a certain share of quality control aspects is included in the service.The working group recommends:
L. Preparation service
- that the medicine service should also be used in the future and be extended to all hospital wards with a large consumption of drugs.
Preparation service (making liquid preparations ready to use at hospital pharmacies) entails a higher level of patient safety as the medicinal products are prepared under quality controlled conditions and the manufacturing process is documented. When it comes to working environment, hygiene and patient safety, it may be problematic that medicine is mixed locally at the ward. Conversely, it could become a problem for the patient safety if it is required that nurses should be capable of completing preparations in the right dose only when they are on duty, on weekends and on public holidays. The working group recommends:
As the final target:
- that liquid medicinal products delivered to wards are ready-mixed i.e. ready for use for each individual patient, and that this service is available 24 hours a day.
In the interim :
- that IT systems are implemented which support the prescribing procedure for patient-specific mixtures of medicinal products
- that clinical pharmacists implement documentation procedures for the staff’s completing of preparations at patient level, provided that these preparations cannot be delivered from a hospital pharmacy
- that clinical pharmacists are involved in dose calculation of patient-specific medicinal products for special risk groups, children for instance
- that the clinical staff mixing medicinal products are trained in GMP by clinical pharmacists.
Cross-sectoral (from primary to hospital sector and vice versa)M: Drug history at hospital admission and discharge interviews with pharmacist
Studies from abroad show that discharge interviews with pharmacists lead to fewer re-hospitalisations. Follow-up, for instance in the form of a home visit by a pharmacist and a nurse, results in improved health. The working group recommends:
Pilot projects in which:
N: Nursing teams with pharmaceutical advisory service
- clinical pharmacists record drug history at patients’ admission to hospital and/or discharge interviews of e.g. older patients, polypharmacy patients, children or others who may be particularly exposed to inconsistencies (cf. suggestion H)
- dispensing chemists offer intensified counselling which includes a medicine review for relevant patients who are recently discharged from hospital (cf. suggestion A).
A few Danish municipalities have positive experiences with acute nursing teams attending patients who would otherwise be hospitalised. Other countries have positive experience with using pharmacists as co-ordinators for a service in the patient’s own home with regard to conditions that would otherwise require hospitalisation. Therefore, there might be potential in a project in which a pharmacist as sparring partner on drug issues is attached to an acute nursing team ad hoc as basis for further projects within that area.The working group recommends:
O: Cross-sectoral collaboration on the electronic drug module of the electronic patient record and the electronic medicine profile
- that the project idea about an acute nursing team with support from a pharmacist is presented to other municipalities.
The introduction of documentation in the form of the electronic patient record in clinical practice is expected to increase patient safety and quality of treatment. However, there is both a wish and a need for an enlargement of the decision support systems. Clinical pharmacy can contribute to developing and exploiting the decision support systems, thereby liberating resources for evaluating and advising health care personnel about those problems which the decision support does not take into account. Another challenge is to make the electronic drug modules work optimally in interaction with the electronic medicine profile as regards technique, organisation and clinical relevance. The working group recommends:
P: Mechanical dose dispensing
- launching a pilot project in which pharmacists from the primary and the hospital sector collaborate on developing an advisory function which ensures, with aid from the drug modules, that patients experience continuity in their medical treatment when passing between the sectors.
There is a major problem with errors and lack of procedures for identification and documentation in manual medicine dose dispensing. Mechanical dose dispensing is expected to result in greater safety, less waste of drugs and fewer drug expenses, which is mainly documented for the hospital sector. In the primary health care sector, it is also expected to have an effect on compliance. Dose dispensing in the hospital sector depends on whether the electronic prescription system in the electronic drug record functions properly.
In Denmark, one pilot project is completed within the hospital sector and at the moment three new projects on dose dispensing are pending in the primary health care sector. The working group recommends:
- at first that attention should be directed at the results from the 4 projects and that concrete initiatives are launched in accordance with the conclusions of the 4 projects
- launching a pilot project to find solution models for the problems involved in resuming dose dispensing in the primary health care sector on discharge from hospital.
Read the entire report in Danish.
For further information, please contact Dorte Glintborg, phone: +45 4488 9126.
The Danish Medicines Agency, 30 June 2005