B. Macešková; L. Smejkalová; P. Brauner; J. Frenzelová
Veterinary and Pharmaceutical University Brno
Čes. slov. Farm., 2010; 59, 256-262
The aim of this study was to evaluate the patterns in using authorized medicinal products for human use (HMPs) in treating animals. An analysis of the HMPs for oral administration prescribed both at the veterinary surgeries at the University of Veterinary and Pharmaceutical Sciences Brno (VFU) as well as outside the university (rural) was accomplished. Questionnaires (11 small animal practice surgeons) were processed and an analysis of the data on the human medicines dispensed at the pharmacy at VFU (2006–2007; veterinary prescriptions written in the university settings) was performed. The presence of dosage instructions in the Czech Pharmacopoeia, the pharmacotherapeutic group and the presence of equivalents among the VMPs (authorized veterinary medicinal product) were taken into consideration. The prescriptions at the surgeries at VFU comprised: 243 human HMPs (202 kinds) containing 168 different active substances involved in 47 pharmacotherapeutic groups. The recommended therapeutic dosage is stated in the Czech Pharmacopoeia for 127 substances. Thirty three of the HMP kinds (16%) could be replaced by the analogical VMPs. The small animal practice surgeons use only 152 HMPs, i.e. 112 kinds (55% of the HMP kinds used in VFU surgeries), which represents 106 active substances (63% of the scope prescribed in VFU surgeries) and 34 (72%) pharmacotherapeutic groups. For 56% of the 106 prescribed substances, no dosage is stated in the Czech Pharmacopoeia. Twenty four of the HMP kinds (21%) could be replaced by analogical VMPs. The prescription originated from order forms (VFU) shows the criteria of rational pharmacotherapy (mostly for one active substance – one HMP kind) and of the adherence to the law (“therapeutic cascades”). This study indicates that there exist different patterns in using HMP in veterinary practice among veterinary surgeons working at the University and in the small animal practice settings.
Key words: veterinary surgeon – pharmacist – medicinal product for human use – veterinary medicinal product – dosage
Using drugs in treating animals is an integral part of
veterinary medicine. The production of veterinary drugs is controlled worldwide
1). The main European directive is the Directive 2001/82 EC (as
amended by the Directive 2004/28 EC and in the wording of the latest
amendments) 2). It defines the requirements for correct veterinary
drugs production. The dispensation of the required drugs is performed by
veterinary surgeons in compliance with Act No 378/2007 Code of Law (CR) 3)
and Act No 166/1999 Code of Law (CR) 4), if they have the necessary
product. If not, they prescribe it and pharmacists dispense the medication
(Reg. No 54/2008 Code of Law 5)). The dispensation of less common
human and veterinary authorized medicinal products and all “magistral formula”
drugs lies within the pharmacists’ authority. Communication between veterinary
surgeons and pharmacists is very sporadic as can be seen in the Czech surveys,
as well as in those from abroad 6). The number of prescribed
veterinary “magistral formula” drugs is very small. The use of authorized
medicinal products for human use (HMPs) is subject to the law both abroad 7)
and in the Czech Republic, where there exists therapeutic “extra label” usage,
which means that the drug is administered with no reference to either the
authorized documentation or to the instructions established by the producer 8).
The veterinary surgeon is not prohibited from using a necessary medicinal
product, if the preconditions are accomplished (Reg. No 344/2008 Code of Law CR
9)). The correct dosage for a particular animal species appears,
then, to be the most important question. The information source has always been
and still is the formulary literature (the former editions of the Czech
Pharmacopoeia and the one valid in the time of this research, Pharmacopoea
Bohemica 2005 10), Ph.B. MMV including the Addenda11–13)),
where the recommended therapeutic dosages for particular animal species and
different ways of administration of common active substances are introduced.
The European Pharmacopoeia (Ph. Eur. 6.0) 14) does not state the
dosage for animals. The most comprehensive and detailed information can be
found in sources from abroad, such as US Pharmacopeia (2008) 15) and
its Veterinary Pharmaceutical Information Monographs, VetBase 4 (2007) 16)
and its instructions for 800 active substances applying to 130 animal
species, Sounders Handbook of Veterinary Drugs 17) or VPR V2.6 18)
where the dosage calculator and interaction descriptions are included. Some
information is also conveyed by magazines, e.g. in the USA 19). The
dosage of each authorized veterinary medicinal product is mentioned in detail
in the Summary Product Characteristics (SPC). Abroad, some obligatory rules for
the “magistral formulas” of veterinary drugs as well as the algorithms for the
“off label” use of human drugs in veterinary practice can be found at
Aims of the study
formulary literature analysis with regard to
the recommended dosages for animals,
survey of the range of authorized medicinal
products for human use (HMPs) prescribed by veterinary surgeons,
analysis of the active substances from the
aspect of the dosage,
evaluation of the found drugs collection
from the therapeutic cascade standpoint.
the publications of the Pharmacopoeia (Formulary) valid in the Czech
(Czechoslovak) Republic since 1947 (including the Addenda) 20–33)
were included in the analysis. The results are summarized in Tables.
authorized medicinal products for human use (HMPs) range used in veterinary
medicine was investigated in detail:
a questionnaire survey of 11 veterinary
surgeons working at rural veterinary care centers (small animal practice) in
North Moravia, 2002;
analysis of the electronic records of the
dispensation of the authorized medicinal products for human use (HMPs)
prescribed on veterinary prescriptions at the pharmacy on the premises of VFU,
information on the dosage of the active substances included in particular
authorized medicinal products for human use (HMPs) and on their possible
analogs in the range of the authorized veterinary medicinal products (VMPs)
distributed in the Czech Republic was found with the help of the following
Automated System of Medicinal Products
(ASMP), publication 2008.4 34),
Czech Pharmacopoeia 2005 10) and
its Addenda 2006, 2007 11, 12),
The analysis of editions of the Czech (Czechoslovak)
analysis of eight Czech (Czechoslovak) Pharmacopoeia publications and their
Addenda revealed that all the editions except Czechoslovak Pharmacopoeia 1st
ed. (PhBs I) and Czechoslovak Pharmacopoeia 4th ed. (PhBs IV) introduced
instructions for veterinary medicinal products dosages (Table 1). PhBs
I states that there are 151 active substances that cannot be dispensed
without a medical (veterinary) prescription. The Czechoslovak Pharmacopoeias
use the term “the highest dosages”. This dosage cannot be exceeded by the
pharmacist unless a veterinary surgeon asks for it on the prescription.
The Pharmacopoeias based on particular editions of the European Pharmacopoeia
(Ph. B. MCMXCVII 28), Ph. B. MMII 30), Ph. B. MMV 10),
Ph. B. MMIX 33)) supplemented with “national specificities” use the
term “recommended therapeutic dosage used in animals” defined as “the average
dosage”, with the postscript that “the veterinary surgeon often prescribes
different dosages depending on the circumstances”.
Prescribers’ behaviour evaluation
the purpose of this study, the number of prescribed HMPs was transformed to the
number of HMP kinds, which means that the different packages sizes and
strengths of the same HMP were considered to be one HMP kind.
The questionnaire survey (outside VFU premises
152 different HMPs (i.e. 112 kinds) representing 106
different active substances out of 34 pharmacotherapeutic groups were
identified, assuming that HMPs with different concentrations and sets are
considered as one medicinal products kind. The recommended therapeutic dosage
in animals is included in the Pharmacopoeia valid at that time for 47 of the
aforementioned substances. Twenty four of the HMP kinds identified have analogs
in the range of the authorized veterinary medicinal products (VMPs) in the same
or a similar form (e.g. pills = pellets, capsules).
Analysis of archival data (ambulatory centres and clinics
analysis is focused on the electronic records from February 2006 to April 2007
collected in the pharmacy located in the campus (VFU).
File “VFU – Order Forms”
file contains 114 different HMPs (i. e. 107 kinds) with 100 different active
substances out of 42 pharmacotherapeutic groups. The recommended therapeutic
dosages for 65 of the used active substances are introduced in the
Pharmacopoeia valid at that time. There are analogs of the same or
a similar form of medicine for 14 of the HMP kinds found in the range of
the authorized veterinary medicinal products (VMPs).
“magistral formula” drugs for oral application were assessed as well. Seven
different “magistral formula” drugs with five different active substances were
found. The recommended therapeutic dosage involved in Ph. B. MMV 10)
(including the Addenda 11–13)) was found for two active substances.
File “VFU – Prescriptions”
HMPs (202 kinds) out of 47 pharmacotherapeutic groups (with 168 different
active substances) were found in this file. The recommended therapeutic dosage
for 127 of the used active substances is stated in the Pharmacopoeia valid at
that time (Ph. B. MMV 10), including the Addenda 11–13)).
There are analogs of the same or a similar drug form for 33 of the found
HMP kinds in the range of the authorized veterinary medicinal products (VMPs).
comparison of the found results is shown in Figures 1 and 2.
summary of the data from the veterinary prescriptions brought the following
facts to light:
1. Prescribed authorized medicinal products for human use (oral administration)
that do have analogs in the range of authorized veterinary medicinal products
are listed in Table 2.
2. Active substances often prescribed in the
form of authorized medicinal products for human use (HMPs) on the grounds that
there are no authorized veterinary medicinal products (VMPs) available (oral
administration): acetylcysteinum, aciclovirum, allopurinolum, ambroxololum,
cetirizinum, ciprofloxacinum, diazepamum, diltiazemum, famotidinum,
furosemidum, ibuprofenum, metoprololum, pancreatinum, phenobarbitalum,
B. MMV 10) (including Addenda11–13)) states the dosages
for animals for 11 of the above listed substances.
3. Assessment of pharmacotherapeutic groups (defined in Automated System of
Medicinal Products 34) prescribed by veterinary surgeons, see Table
majority of the Pharmacopoeias issued in the Czech (Czechoslovak) Republic
contains information on the drug dosage for animals. The spectrum of animal
species has not changed for more than 60 years, but the range of the drugs used
is continually increasing (by 64% in the last 20 years). Compared both with the
European Pharmacopoeia valid nowadays and with its previous
editions, there is no similar detailed information. Nevertheless, veterinary
surgeons can use other sources which provide instructions on the dosage for
a large number of drugs in a wider range of animal species than those
covered by the valid Pharmacopoeia edition. The Formulary Board – Department of
Veterinary Medicinal Products – has repeatedly dealt with the problem of the
further need in the medicinal table VI. Recommended therapeutic dosages in
animals. The newest edition of the Czech Pharmacopoeia (Ph. B. MMIX33))
continues to keep it. From the practical viewpoint, the more important fact is
that the dosage of each authorized veterinary medicinal product is mentioned in
detail in Summary Product Characteristics (SPC).
The number of the active substances found in the
research shows that there is and has been a lack of the authorized
veterinary medicinal products (VMPs) needed for therapeutic practice both in
the past and nowadays. The small animal practice surgeons used authorized
medicinal products for human use (HMP kinds) in 21% of the cases when analogous
authorized veterinary medicinal products were available, the veterinary
surgeons at VFU in 16% for prescriptions and in 13% for order forms. The total
number of authorized veterinary medicinal products (VMPs) that are available
did not change significantly during the research: 2002 – 1307 VMPs, 2006 – 1279
VMPs (Authorized Veterinary Medicinal Products 2007)35). The small
animal practice surgeons more often prescribed drugs containing active
substances which have no recommended dosages in the valid Pharmacopoeia – 56%
of all prescribed authorized medicinal products for human use (HMP kinds). The
same cases appeared at VFU in 24% (prescriptions), or 35% (order forms). The
small animal practice surgeons use, for their prescriptions, 55% of the range
of the authorized medicinal products for human use (HMP kinds) prescribed by
the veterinary surgeons at VFU (which represents 63% of the active substances
and 72% of the pharmacotherapeutic groups found in veterinary prescription at
VFU). The veterinary practice outside VFU is probably based on a smaller
range of drugs according to the previous experience of the veterinary surgeon,
and apparently it was not influenced by the marketing efforts of the
pharmaceutical companies producing generic medicinal products in the period of
the study. The prescription originated from the order forms (VFU) reveals the
criteria of the rational pharmacotherapy (mostly for one active substance – one
HMP kind) and of the adherence to the law (“therapeutic cascades”). The most
frequent pharmacotherapeutic groups from the whole range of prescribed human
medicinal products are: antibiotics, hormones, vitamins, antacids including
antiulcer drugs, antiphlogistics, and hypotensive drugs. Four out of six of the
most frequent pharmacotherapeutic groups of authorized medicinal products for
human use (HMPs) are common for both groups of veterinary surgeons. Some
pharmacotherapeutic groups are not available in the range of the authorized
veterinary medicinal products (VMPs) at all. If they do appear there, there are
no medicinal products with the indicated substances involved in these groups.
The reason for the use of the authorized medicinal products for human use
(HMPs) in the other cases, which means when there is an analogous VMP (the most
frequent groups are antibiotics, hypotensive drugs, antiphlogistics), can be
both a professional decision and also a decision guided by the different
price of the same product in human and veterinary forms.
In conclusion, the range of authorized medicinal
products for human use (HMPs) used in veterinary medicine is rather extensive.
There may be various reasons for this, such as that it would be uneconomical to
produce an analogous VMP, or that there is at that moment a shortage of
the required VMP. Authorized medicinal products for human use (HMPs) when used
for animals always follow the “off label” use rules. Although such
prescriptions are always issued in accordance with the contract between the
veterinary surgeon and the animal owner, the pharmacist should be able to give
some professional advice as well as some necessary information when the HMP is
actually dispensed. A large number of drugs are commonly used, yet still
the pharmacist does not have enough reliable sources of information and has to
look up the appropriate references abroad. The use of authorized medicinal
products for human use (HMPs) in veterinary practice, especially in small
animal practice, often becomes the only reasonable therapeutic solution.
Veterinary surgeons at VFU prescribe a wide range of authorized medicinal
products for human use (HMPs). The dosage of the contained substances is most
often included in commonly available literary sources, and they use less often
those authorized medicinal products for human use (HMPs) whose analogs can be
found in the range of the authorized veterinary medicinal products (VMPs), as
compared with the small animal practice surgeons. This study indicates that
there exist different patterns in using authorized medicinal products for human
use (HMPs) in veterinary practice among veterinary surgeons working at the
University and in the small animal practice.
18. November 2010 / Accepted 15. October 2010
Address for correspondence: PharmDr. Lenka
Smejkalová, Ph.D. Department of Applied
Pharmacy Faculty of Pharmacy VFU
Brno Palackého 1–3,
612 42 Brno e-mail:
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