| • |
| COUNCIL OF EUROPE COMMITTEE OF MINISTERS
Resolution ResAP(2001)2 (Adopted
by the Committee of Ministers The
Committee of Ministers, in its composition restricted to the
Representatives of Austria, Belgium, Cyprus, Denmark, Finland, France,
Germany, Ireland, Italy, Luxembourg, The Netherlands, Norway, Portugal,
Slovenia, Spain, Sweden, Switzerland and the United Kingdom, Member
States of the Partial Agreement in the Social and Public Health Field, Recalling
Resolution (59) 23 of 16 November 1959, concerning the extension of the
activities of the Council of Europe in the social and cultural fields; Having
regard to Resolution (96) 35 of 2 October 1996, whereby it revised
the structures of the Partial Agreement and resolved to continue, on the
basis of revised rules replacing those set out in Resolution (59) 23,
the activities previously carried out and developed by virtue of that
resolution, these being aimed in particular at: a.
raising the level of public health protection in its widest
sense, including a constant contribution – in the field of products
having a direct or indirect impact on the human food chain as well as in
the field of pesticides, pharmaceuticals and cosmetics - to harmonising
legislation, regulations and practices governing, on the one hand,
quality, efficiency and safety controls for products and, on the other
hand, the safe use of toxic or noxious products; b. integrating people with disabilities into the community: by defining, and contributing to the Europe-wide implementation of, a model of coherent policy for people with disabilities, taking simultaneous account of the principles of full citizenship and independent living; and by contributing to the elimination of all types of barrier to integration, whether psychological, educational, family-related, cultural, social, professional, financial or architectural; Having
regard to the action carried out for several years for the purpose of
harmonising legislation in the public health field and, in particular,
in the pharmacy sector; Bearing
in mind the measures proposed in Resolutions AP (93) 1 on the
role and training of community pharmacists, AP (94) 1 on the rational
use of medicines and AP (97) 2 on the development of the
function of pharmacists and the adaptation of their initial training,
and the need to implement them; Bearing
in mind the proceedings of the Seminar on “The pharmacist at the
crossroads of new health risks: an indispensable partner for their
management!”, held at the Council of Europe in Strasbourg from 20 to
22 October 1999; Considering
the emergence of new therapies with their associated risks; Considering
that iatrogenic effects, including medication errors, are not only a
public health problem but also lead to increased health expenditure; Considering
the growing trend towards self-medication; Considering
the dangers inherent in counterfeit products; Considering
the problems posed by distance sales of medicinal products and the
development of this practice through the Internet; Considering
the challenges of new information technologies; Considering
the need to ensure that the application of technological progress
benefits the patient; Considering
that pharmacists provide added value both through their scientific and
pharmaceutical expertise and in terms of ethics; Considering
the need to promote the pharmacist's role in the management of new
health risks; Considering
that community pharmacists are the health professionals most readily
accessible to patients and that they help to personalise the delivery of
patient care; Considering
that pharmaceutical care helps to reduce iatrogenic risks, including
medication errors; Considering
the need to take professional services into account in the remuneration
of pharmacists; Considering
that health expenditure must not be curbed at the expense of quality of
care; Considering
that regulations need to be adapted to address the emergence of new
health risks and the development of the pharmacist's role in their
management, Recommends
that the governments of the member states of the Partial Agreement in
the Social and Public Health Field take the following principles into
consideration for the purpose of adapting their regulations to reflect
the pharmacist's developing role in relation to health security, and
that they encourage pharmacists, professional bodies, academic
institutions, health insurance funds and patients' and consumers'
associations to take them into account: 1.
With the developments in communication systems and
scientific progress, there is a risk of less personal contact. Patients,
as of right, should be able to have direct contact with a pharmacist. It
is also essential to establish co-operation through networks linking
pharmacists, health authorities and other health professionals.
Pharmacists must be able to function freely and dispassionately within
these networks. The system under which they are remunerated must be
reviewed to reflect the professional service they provide rather than
the profit margin or volume of their sales, in accordance with
Resolution AP (93) 1 on the role and
training of community pharmacists. Pharmacists' basic and
further training should include behavioural sciences and communications
skills. 2.
Health spending cannot be curbed at the expense of quality of
care. In order to reconcile quality with the need to keep costs down,
the contribution of the pharmacist to quality improvement and cost
control should be recognised and the regulatory framework should ensure
a role for pharmacists at every stage of the medication chain. 3.
One of the pharmacist's basic functions, as an expert in
medicinal products, is to help prevent avoidable iatrogenic risks. There
are various means of reinforcing the pharmacist's role in this
respect. An epidemiological network on medication errors, involving
pharmacists and other health professionals, must be set up, with
systematic notification. Pharmaceutical care and clinical pharmacy (in
hospitals and community pharmacies and in primary healthcare) should
also be developed. The pharmacist's role as a supplier of information
to prescribing doctors, patients and other health-care providers must be
strengthened. In particular, pharmacists must give patients not only
oral but also written advice on the proper use of medicinal products. 4.
Pharmaceutical care is an essential element in the prevention and
reduction of iatrogenic risks and should be implemented systematically.
It includes: -
the keeping of pharmaceutical records that contain details of the
patient's case-history, medicines supplied, clinical information,
available therapeutic and biological results, and recommendations made
to the patient; - the monitoring of prescriptions, particularly in the light of the patient's pharmaceutical record in order to check for consistency and for possible interactions with other medicines; -
the evaluation of patients' overall medication; -
the rationalisation of the advice given to patients: procedures
must be developed whereby, in particular, patients will in certain
circumstances receive information in writing; -
the systematic exchange of information with other health
professionals (via networks). In order to achieve
these tasks, full use should be made of the various information
technologies and relevant databases, and it should be possible to access
patient profiles and incorporate them in pharmaceutical records. 5.
The risks associated with self-medication can be reduced if
patients are well informed and pharmacists have an important role in the
process. The pharmacist must inform the patient about significant
interactions. Moreover the patient must be informed about the risks
associated with “borderline” products and medicines available
outside pharmaceutical control, both by health professionals and through
information campaigns. Pharmacists must evaluate all patient requests.
They must be able to rely on guidelines including criteria for
evaluating the patient's condition and offering advice. Pharmacists
must, if necessary, put their opinions in writing and, with the
patient's agreement, address them to his or her doctor. Where a patient record is kept, it should also
include information about self-medication. 6.
Given the high risks inherent in new therapies, such as gene and
cell therapies, it is essential to: -
draw up a set of good practices in co-operation with all the
professionals concerned, and monitor their implementation; -
ensure, at every level, that therapeutic protocols are documented
in detail and verified; -
set up multi-disciplinary teams that will make the best possible
use of their members' different skills; -
establish criteria for deciding when treatment is appropriate,
given the dangers and the high cost of such therapies; -
ensure that there is an exchange of information between the
relevant health professionals inside and outside hospitals; -
make mandatory the recording of all steps in the research,
production and use of pharmaceutical products resulting from genetic
engineering. The pharmacist, as one of the experts in the
management of healthcare risks, must be integrated at every stage and
play an active role in decision making. 7.
As therapies are increasingly used to enable people to exceed
their natural capacities, rather than to treat their illnesses,
pharmacists must be given a greater role in discouraging such practices.
They must make patients aware of the inherent risks, and evaluate their
requests in the light of their patient record. Health authorities must
organise campaigns to inform people about the dangers of using medicines
in this way. 8.
Counterfeit pharmaceuticals pose real threats. In order to combat
these dangers, the authorities, manufacturers, wholesalers, pharmacists
and intergovernmental and non-governmental organisations must
co-operate. The authorities must: -
set up systems of surveillance involving pharmacists at every
stage of the medication chain; -
require that a person (as a rule a pharmacist) be made
responsible for quality at each stage of the distribution process; -
reinforce the system of inspection of manufacturers' and
wholesalers' premises; -
act against uncontrolled importation, distribution and marketing; -
take a cautious approach to the opening of markets and to
price-reduction policies. Manufacturers must: -
develop packaging that makes falsification difficult; -
recognise the need to lodge complaints about counterfeiting as a
matter of course; -
when they are victims of counterfeiting, notify the health
authorities and those responsible at every stage in the distribution
chain. Pharmacists must take due care in choosing their
suppliers. Patients must be made aware of the inherent dangers
of counterfeit medicines. 9. Public health authorities should guarantee the quality, safety and efficacy of medicines on the market. But such guarantees are jeopardised by certain practices related to the Internet, as well as by illicit importation and illegal distance sales. A specific set of pharmaceutical good practices for
the Internet (GIP) must be drawn up.
These should, in particular, be implemented by those governments
contemplating the sale of medicines by Internet. If necessary, they
should guarantee real (as opposed to virtual) contact between the
patient and a health professional. International legislation should be drawn up, or in
its absence the legislation of the country of final sale should prevail
over that of the country of origin. With regard to information and advertising, it is
necessary to introduce an accreditation system and a quality mark. Consumers must be made aware of the issues, both
individually and through mass information campaigns. Public health authorities should use the Internet
to direct the public to reliable information. 10.
In order to optimise patient care, networks should be set up
including hospital and community pharmacists and those working in
primary healthcare teams, doctors
and, where appropriate, health authorities, health insurance funds and
universities. They must also facilitate co-operation between
professionals inside and outside hospitals. The primary aim of such networks must be to serve
the patient's interests. It should be ensured that: -
patient retains freedom of choice; -
patient data is confidential and only selected parties have
access to it; -
network quality and security criteria are established, and
networks are validated and compatible; -
levels of responsibility are determined. The use of new technology will also make it easier
to keep patient records and monitor prescriptions. 11.
In order to achieve these aims, the basic and further training of
the various practitioners involved must be adapted on an ongoing basis.
Glossary
|