COOPERATION AND SYNERGY IN QUALITY STANDARDS
BEYOND THE EUROPEAN PHARMACOPOEIA
More than 100 representatives from all parties concerned from 18 countries met on an initiative of the EDQM
to discuss quality standards for unlicensed medicines. A better knowledge of the different national situations
will evoke new prospects for European harmonisation as we work together.
his symposium was the rather than to expect hard-working medicines prepared for the specific
first held under the aus- extremely busy healthcare workers, who needs of individual patients when there
pices of the European have no real experience in handling phar- were no marketed equivalent products. It
Pharmacopoeia (EP) to maceuticals, to make rapid calculations is this environment that the pharmacist
discuss unlicensed medi- and aseptic manipulations to a powder, must know and understand in order to
cines. It was held by the European or concentrate, available on the market. operate safely both for themselves and
Directorate for the Quality of Medicines for the patients they serve.
& Healthcare (EDQM) 15-17 June in Unfortunately so few patients need these
Strasbourg, France, as part of “New products that there is no commercial Between Member States the process
frontiers in the quality of medicines”. basis for their manufacture and therefore varied. In the German model the State
those patients most in need will never be draws up the product specification file,
The European Pharmacopoeia has tradi- satisfied by a fully licensed product. for a list of traditional products, so that
tionally focused on the pharmaceutical anyone can follow them through. The
industry which supplies licensed prod- Currently, there is a great variety of Italian model allows most preparation to
ucts which are assured to be safe by the approaches in the various Member be contracted out to industry. The UK
competent authorities of member states, States regarding the control of the prepa- model works on the basis of ‘Specials’
even though the historical basis for phar- ration of these drugs, which are not cov- manufacturing licence which can be
macopoeias was to ensure patient safety ered by European directives. From obtained by anyone who has the facili-
from potions and nostrums made by the research in the UK it is obvious that ties and expertise.
pharmacist. Among other things, the there is a large number of products
meeting examined the interest and rele- that are unlicensed and used in patients. It was agreed that the patient's needs
vance of the general chapters of the EP There is also no uniformity in demand were the prime concern of all involved
and the general methods of analysis in the and the top 10 varies from year to year. in the process, and they are the prime
case of pharmaceutical products delivered objective (patient's needs) of all health-
without a marketing authorisation. The legal status under which a pharma- care professionals.
cist would carry out this function and the
The symposium was addressed by a legal status of the products were dis- The patient expects to receive a medi-
number of individuals with hospital cussed. The role of a pharmacist was cine that is:
experience and all indicated the wide- originally enshrined in the EC directive • of a guaranteed quality
spread need for and use of unlicensed of 65/65 which has been updated by • therapeutically effective
medicines across Europe. The reasons 2001/83 and the pharmacist's function • the same no matter where it is dis-
for this demand were: defined in Article 5 and further amended pensed.
• Not all patients equate to the average in 2003.
person . There is now a need to consider the
• Some cannot swallow due to inborn diffi- Each Member State has enshrined those standards that should apply to these
culties or difficulties following surgery. rights in their own laws but they have medicines and these standards must be
• Some patients are allergic to ingredi- given it their own interpretation and relevant to the needs of the product and
ents widely used such as lactose, each operates in slightly different legal the patient. The problem of quality con-
colour etc. environments. The symposium was pre- trol concerns thousands of patients
• Safety: on some occasions it may be sented with an overview of the manner across Europe who must have the same
safer to prepare a product so that it is by which a number of Member States guarantees of quality control from one
ready to be administered to a patient allowed for the preparation of special country to another.
84 • Volume 13 • 2007/5 www.ejhp.eu
Before drawing up these standards the • to supply uniform, quality assured year discussion on what quality the
following points are discussed: product material should be.
• single preparations for an individual • to supply a product which has no batch
patient to batch variations The finished extemporaneous products
• large batches made in anticipation of • of significance for a mobile popula- will remain specific to Member States
the needs of many patients that are tion, a product which will have the for many years. In the UK there are pat-
expected in clinics or outpatient same characteristics no matter where it terns and different usage from hospital
departments is dispensed. to hospital. This will also be found
across Member State boundaries. Intra-
There are many local standards available Patients living in one town may wish to state cooperation is needed so that each
which have been independently drawn go on holiday and have their medicines hospital or dispensary within a Member
up in different Member States. Currently dispensed wherever they are; patients State can work from the same quality level.
under discussion is the draft from the may move town; children may be moved
Pharmaceutical Inspectors Convention by their parents from one town to anoth- Interstate cooperation is needed so we
which is being designed in order to try er due to job changes. One would expect can come together and help each other in
and define the universal standard that the medicine made in the next village to the formulation of former variants and to
hospital pharmacists may work to supply be of the same therapeutic and quality share the difficulties undoubtedly faced
extemporaneous and bulk prepared standard as that dispensed in the previ- by most formulation pharmacists. There
products for their patients. ous village. is a need for support and encouragement
from the European Pharmacopoeia com-
The risk/benefit ratio must be considered It should be noted that the GMP concept mission with the development of local
before making these products. If an item is of a validated system does not sit well level of uniform standards. There were
dispensed for an individual patient, by the with these special products. Only when suggestions that the European Pharma-
very nature of things, little or no quality they become large batches, and regular- copoeia could start to draw up har-
control is applied to a single dispensed ly made, could anyone afford the invest- monised monographs.
product. However the effect of having ment that is required to validate the sys-
something go wrong, while significant to tems and products. In summary
the patient who receives it, is very small in It was agreed that patient’s health
global population terms. The Conference discussed ways to assist depends on the extemporaneously pre-
in producing acceptable standards for pared and manufactured products.
The extent of preparation/manufacture the whole of Europe to guarantee the
ranges from that of single items to batch- protection of the patient; to guarantee The practice will continue to be needed.
es of 200-2000 items. If that is taken the protection of the professionals making There is a duty to draw up and agree on
through its logical conclusion and there the products and to ensure the continu- relevant standards.
is a hospital that produces a large batch ance of a needed service.
of a particular product, it can afford to There is a duty to ensure that all medi-
implement a much greater degree of Decisions must be taken at a cines dispensed are effective, reproducible
quality control and assurance into that European level and of the right quality.
product. However the greater the batch Standards are needed for the raw materi-
size, the greater the significance to a als. The European pharmacopoeia satis- Author
population of an error. The risk assess- fies many of the needs but not all of V’Iain Fenton-May BPharm, FRPharmS
ment can be further refined by consider- them. There is a need for a European Honorary Science Adviser, EJHP
ing the technical risk (which will include Forum to allow for a faster processing of email@example.com
the manipulative difficulties, the chemi- special needs. These products of which
cal and physical stability of the entity) we are speaking are often needed imme- For more information visit: www.edqm.eu/
and the clinical risk (which will include diately and there is no time for a two- site/page_628.php (accessed 20 July 2007)
the therapeutic safety profile). These
together can be used to target the
resources of local interest groups.
Now consider the needs of the
The outcome of any quality system must
• Volume 13 • 2007/5 EJHP is the Official Journal of the European Association of Hospital Pharmacists (EAHP) www.ejhp.eu 85