The Royal Pharmaceutical Society’s Veterinary Pharmacists Group met
for its annual conference in Edinburgh on October 14 and 15. One day of the
conference was devoted to the Government-ordered independent review of
the dispensing of prescription-only veterinary medicines. Steven Kayne reports
The first speaker of the day, Mr CHRIS BEAN (head of European and information
policy, Veterinary Medicines Directorate, and secretary of the review group)
spoke on two separate issues: the background leading to the establishment of
the independent review of veterinary dispensing, and current European issues
on the licensing of veterinary medicines.
Mr Bean explained that the review had resulted from comments made at agricultural
events to Agriculture Ministers, primarily by farmers but also by pet owners.
At the same time, frequent references were being made in the public domain to
the fact that veterinary surgeons made much of their income from selling medicines.
Such a system, it was suggested, must inevitably lead to a conflict of interests,
particularly overprescribing. This was one of the major concerns raised in relation
to the sales of antibiotics for farm animals and increased antibiotic resistance.
Mr Bean said that at least three factors could affect the cost of veterinary
medicines: first was the prices manufacturers charged to veterinary surgeons,
second was the charges that veterinary surgeons made to animal owners when dispensing
medicines, and third was currency fluctuations which affected prices in different
countries.
The concern about the high cost of veterinary medicines had been brought to
the attention of the Office of Fair Trading which, independently, had decided
to investigate whether there was any evidence of uncompetitive practices among
manufacturers. The OFT’s investigation was continuing and it was currently
gathering information from manufacturers, veterinarians and others. Mr Bean
emphasised that the OFT
investigation was separate from and independent of the review of dispensing.
The OFT was focusing on manufacturers’ and veterinary surgeons’ sales.
During the past winter, as the crisis in the farming industry had deepened,
the Government had announced a financial aid package for British farming. This
package included a wide range of measures, among which was an independent review
of the dispensing of prescription-only veterinary medicines by veterinary surgeons.
Although the review was announced as part of a strategy for agriculture, it
covered both companion animals and farm animals.
The review group was a small one. Its chairman was Professor Sir John Marsh,
an agricultural economist, and there were three members: Dr Jeremy Lucke (a
past president of the Royal College of Veterinary Surgeons), Mr John Moffitt
(a dairy farmer from Northumberland) and Lady Patsy Yardley (a regional adviser
to the Burmese Cat Club).
A review was also being undertaken by consultants engaged by the European Commission
into the European procedures for the authorisation of both human and veterinary
medicines. It was just over five years since the European Medicines Evaluation
Agency had been set up at Canary Wharf, London, and new European procedures
for centralised and decentralised authorisation of medicines (both human and
veterinary) had been introduced. The Community Regulation 2309/93, which set
up the EMEA and the new authorisation procedures, required this review to be
carried out.
Mr Bean then referred to the commission’s proposal to consolidate the various
existing directives governing the manufacture, sale and supply of veterinary
medicines into a single text. This would happen in two stages. First, a consolidation
of the texts would be achieved, then areas where substantive changes were required
would be addressed.
A first draft had been published in November, 1999. Progress had been slow and
it was unlikely that the whole exercise would be completed by the end of this
year as originally planned, Mr Bean said.
Mr ROGER COOK (director, National Office Animal Health) observed that the activities
within the commission seemed to be divorced from what was happening in Europe
regarding the supply of veterinary medicines across national borders. Consumers
were not willing to wait for the painfully slow review process to resolve itself.
The veterinary perspective
Mr EIfion Evans (immediate past president of the British Veterinary Association
and retired principal in a large mixed practice in North Wales) gave his profession’s
view of the prescribing review.
Mr Evans said that the OFT was also conducting an investigation, looking back
along the veterinary medicine distribution chain from the consumer to the manufacturer
and it was likely that the two reviews would have a bearing on each other.
At the recent BVA congress in Chester, a full day had been given over to discussing
the implications of the review with presentations from interested parties, including
the Royal Pharmaceutical Society’s Veterinary Pharmacists Group (see p700).
Mr Evans said that, despite reassurances to the contrary, many of his colleagues
believed that the Government might have already decided that veterinary surgeons
had a monopoly. It was important that their case was stated in a positive and
non-protective matter, for monopolies were unacceptable in the current competitive
climate.
Mr Evans said that there were suggestions that veterinary surgeons dispensed
too many antibiotics, overcharged for veterinary medicines, had too much control
over the distribution of veterinary medicines, did not respond to competition,
and promoted illegal imports through some or all the above.
Before outlining the BVA’s response to these concerns, Mr Evans stressed
that any changes in United Kingdom legislation should be carried out within
the framework of the European Union. It was more than 25 years since Europe-wide
legislation had been mooted. Since then directives had been incorporated into
national legislation in a fragmented way. Unharmonised arrangements were distorting
competition because of differing channels of distribution and pricing structures.
The trend in Europe appeared to be towards prescription-only medicines rather
than away from it, and Mr Evans queried the wisdom of adopting the opposite
approach in the UK.
In 1998, the BVA had set up a medicines select committee comprising a mix of
professions (but no pharmacists) to look at aspects of medicine supply. The
report had been published earlier this year and among its many recommendations
was a call for harmonisation across Europe.
Dealing with overprescribing, Mr Evans told the audience that the BVA published
a code of practice for the sale and supply of veterinary medicines. There were
guidelines for the prudent supply and usage of antibiotics. In any case the
major concern was overuse of oxytetracycline, most of which was not directly
prescribed by veterinary surgeons.
Moving on to the issue of overcharging, Mr Evans said that there had been a
number of BVA surveys looking at practice costs but so far none had specifically
addressed the issue of pharmacy costs. The association had recently commissioned
an independent survey of 14 widely used drugs in 750 British veterinary practices.
Forty per cent of those surveyed had responded and preliminary results had shown
that the median profit margin was around 33 per cent. Drug sales accounted for
approximately 42 per cent of practice income. The survey showed that the cost
of providing a 24-hour pharmacy service was actually much higher than had been
thought. Mr Evans contended that these margins were modest under the circumstances
and that veterinary surgeons did not overcharge. The proportion of the total
annual farming bill taken by drug costs was small — in the order of 2 to
3 per cent — so any financial advantage would, in any case, be small. In
addition, he said that veterinary surgeons’ consultation fees were being
subsidised by drug sales and that if income from this was curtailed then prices
for veterinary treatment would inevitably rise. Mr Evans claimed there was little
evidence from clients for change to take place.
As for distribution, it was doubtful whether many pharmacies would want to become
involved in servicing the contracting farming industry. Then there was the problem
of low numbers of pharmacies in rural areas and the wide range of relatively
slow moving stock that would need to be carried.
There was definitely competition in the veterinary profession. Some veterinary
surgeons were opting out of large animal practices or combining into multi-partner
practices. There was concern about drug residues and traceability of medicines
if veterinary surgeons’ involvement in the supply chain was reduced significantly.
In conclusion, Mr Evans said that he doubted whether significant changes in
current arrangements would be beneficial. However, he acknowledged the value
of the suggestion expressed in a letter written to the Veterinary Record by
VPG members Andrew Cairns and Steven Kayne that the British Veterinary Association
and the Royal Pharmaceutical Society should meet urgently in order to identify
areas of interprofessional co-operation.
After Mr Evans’s talk, Mr Alan Nathan (a member of the Royal Pharmaceutical
Society’s Council) wondered if Mr Evans was attempting to defend the indefensible.
It was unrealistic to hold on to a monopoly. Consumers should be given the choice
of where to obtain veterinary medicines, with veterinary surgeons offering the
option of issuing a prescription rather than the normal practice of dispensing
it themselves.
Mr EVANS replied that he had seen the current scheme work effectively over the
past 35 years. The professions had to accept the remit of the review body which
would make its decision based on facts derived from independent bodies.
The industry’s perspective
Mr Roger Cook (director, National Office of Animal Health Ltd) introduced the
industry’s perspective. He explained that the corporate members of his
organisation accounted for 95 per cent of all veterinary medicines supplied
in the UK. The industry was diverse, ranging from two companies with an annual
turnover in excess of £50m to 11 companies with a turnover under £2.5m.
Mr Cook said that the proportion of POMs used in the treatment of large animals
was 46 per cent in a 1999 survey and 51 per cent in 2000. The figures for companion
animals were 83 per cent and 81 per cent, respectively.
He said that he was broadly in favour of maintaining the status quo, believing
that the current system needed “evolution not revolution”.
Mr Cook referred to the difficulties being experienced by manufacturers in providing
resources to develop new products. Approximately 40 per cent of research budgets
in the UK was swallowed up by product defence compared with only 17 per cent
in the United States. He maintained that this was the result of over-regulation.
Many companies were switching their activities to companion animals and dropping
medicines for the treatment of minor species. The resulting increased use of
the cascade and off-label indications effectively converted more and more products
to POM.
The on-farm medicine prices presently comprised manufacturing costs, research
and development costs, regulatory costs, distribution costs and veterinary fees.
Mr Cook suggested that the intervention of an extra tier of supply, namely pharmacists,
could only add to cost and not reduce it. He said that farm medicines represented
only 2 to 3 per cent of the farm gate output of £8.25bn annually and doubted
that costs could be reduced substantially. Even if medicines costs were reduced
by 50 per cent the savings to farmers would be very modest.
The current distribution system was designed to serve 2,500 veterinary practices.
If 12,000 pharmacy premises were added to the supply chain there would be a
massive problem for manufacturers and wholesalers to service the increased number
of outlets. Another problem was that veterinary surgeons frequently used multidose
packs with clients being given (and charged for) a single dose from the container.
If a prescription had to be issued for a single dose container prices would
be pushed up.
Mr Cook then expressed a number of other concerns he had about changing the
current system of supplying veterinary medicines. He acknowledged that most
were “not insurmountable”. They included a necessity for guaranteed
24-hour supply of a wide range of medicines all over Britain, proper storage
conditions for vaccines, and post-marketing surveillance. Mr Cook was also worried
about the potential time lag between diagnosis and treatment and whether the
inconvenience of having to take a prescription to the pharmacy and return to
the veterinary surgeon for administration would deter owners from seeking routine
vaccination.
He did, however, suggest that changes in the classification of veterinary medicines
might be appropriate with a shift towards product-based licensing rather that
therapeutic group licensing as at present.
He summarised what he believed to be the salient points thus:
Finally, Mr Cook advised pharmacists that if they wished to become more deeply
involved in the distribution of veterinary medicines there were a number of
actions that could be taken:
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| The flea treatment Frontline is available from pharmacies in France, but is a prescription-only veterinary medicine in the UK |
After Mr Cook’s presentation, Mr Douglas Davidson (Blairgowrie) pointed
out that most veterinary medicine products were subject to specific licensing.
In the human field, the Government had driven prescribers toward generics because
of price. Was there any possibility of similar savings being effected in veterinary
practice by a switch towards generics, he asked.
Mr Cook replied that there were few generics in veterinary medicine at present.
One example was ivermectin. However, veterinary generic prescribing on a large
scale would undermine the amount of resources available for research and development.
He reminded his audience that there was a lot more to a product than just the
active ingredient. Few patented products were currently out of their 10-year
protection period, but the generics market might grow in future.
The POM(E) category in the Republic of Ireland
Mr Giles Barrett (a pharmacist from the republic of Ireland) reviewed the development
of veterinary medicines legislation in Ireland since 1985. He explained that
there were currently four professional categories and two non-professional categories
under which medicines could be classified:
Veterinary surgeon only (VSO) This category includes medicines that might only be used by veterinary surgeon and included such drugs as barbiturates for euthanasia.
Prescription only (POM) This category included medicines subject to prescription only constraints.
Prescription only (exempt) (POM[E]) Medicines in this category were subject to all POM requirements except that the animal did not need to be seen by a veterinary surgeon before they could be supplied.
Pharmacy only (PS) Medicines in this category might be supplied
only in a registered pharmacy under the supervision of a pharmacist.
One of these — POM(E) — might provide a useful addition to the UK
system of distributing veterinary medicines.
The non-professional categories were medicines that could be supplied by a licensed
merchant and companion animal medicines.
It was mandatory in Ireland to split a veterinarian’s professional and
retail sales activities and records had to be kept of purchases and sales.
Mr Barrett explained that medicines normally considered to be POM but whose
prescription did not require clinical examination of the animal might be designated
POM(E). The Irish Medicines Board was responsible for taking this decision.
POM(E) supplies could be made personally by a pharmacist from a pharmacy or
by a veterinary surgeon in the course of treating animals in his or her care.
The category contained 21 products for such conditions as redwater, ringworm
and pasteurella, and a number of vaccines. Intramammaries were also available
in Ireland through pharmacies; in most of Europe they were POM. Mr Barrett said
that it was impossible for veterinary surgeons to see every single mastitis
case prior to prescribing, so the POM(E) category was ideal. The farmer was
obliged to keep records for the veterinary surgeon to inspect on a future visit.
Other products, eg, antibiotics for prophylactic use in lambing, could be transferred
to the POM(E) category. But a prescription might be imperative to reduce overuse
and incremental amounts could be supplied by a pharmacy, as necessary.
Discussions were taking place in Ireland as to whether the POM(E) category should
be renamed Pharmacist Vet Supply (PVS).
Raising the standard
The final speaker, Mr David Evans (director of Vet-Medic and Brian G. Spencer
Ltd) presented his vision of how pharmacy practice in the small companion animal
market might develop over the next few years, and how that vision could raise
the standards of access and practice.
Mr Evans stated that pharmacists were currently involved in less than 15 per
cent of the £200m market. He said that there were many products currently
marketed as prescription only in the UK that met the VMD’s own criteria
for a lesser classification, but none had actually been deregulated. One example
was the flea treatment Program, a medicine widely available from pharmacies
in every other EU country, yet was still POM in the UK, some 12 years after
its global launch and after 11 years on the UK market. Another example was Frontline,
another flea treatment, which available through pharmacies in France. There
were many more products that continental pharmacists were able to supply to
which UK pharmacists and consumers were denied ready access.
At the recent British Pharmaceutical Conference, Lord Hunt (Parliamentary Under-
Secretary of State for Health) had made many observations and promises regarding
the future of the profession and the distribution of human medicines. Lord Hunt
had highlighted several areas in which pharmacy made, or could make, a positive
contribution. Mr Evans felt that much of Lord Hunt’s speech could be applied
to the practice of veterinary pharmacy. He said that the public not only wanted
fast and efficient product delivery at a time and location convenient to them,
but they were also increasingly demanding quality add-on services. Advice and
monitoring were becoming more important. “So can we deliver pharmaceutical
care for companion animals?” he asked.
Mr Evans presented some specific areas in which pharmacists could become involved:
Untreated indications Pharmacy could provide an access point whereby companion animal owners, who might only visit the veterinary surgery for annual vaccinations or when the animal was unwell, were able to obtain routine treatments for a variety of minor, non life-threatening conditions without delay and without appointment.
Improper drug selection By making more efficacious drugs available through the pharmacy supply route and under the supervision of the pharmacist at the point of sale, pet owners would be able to access the correct treatments without delay and be able to seek professional advice rather than self select incorrect or inappropriate products from supermarket shelves.
Subtherapeutic doses Professional advice would mean more efficient treatment as dosages and regimens could be reinforced at the point of supply.
Failure to receive drugs Many companion animal owners did not
seek the advice
of veterinary surgeons as often as they should. This could be due to economic
reasons or, equally likely, just plain forgetfulness. People specifically sought
advice regularly in community pharmacies — some 200,000 per day according
to the National Pharmaceutical Association. There was a golden opportunity to
highlight the need and availability of preventative treatments for their pets.
“In order to deliver my vision, more products should be declassified.”
said Mr Evans. “Why should the public be denied ready access to these preparations,
if they are considered safe enough to be non-
prescription in both of our nearest European partners, France and Ireland?”
he asked.
Mr Evans suggested that with increased access and availability of medicines,
pharmacists would have the opportunity to treat more of the UK pet population,
and therefore increase the health and well-being of companion animals nationally.
The public would benefit too, as there would be less potential for transmission
of common zoonotic diseases. Another advantage would be that, as the public
became more familiar with the concept of seeking professional pharmaceutical
advice for pets, there would be more likelihood for referral of serious untreated
indications to veterinary surgeons, rather than these conditions being inappropriately
“self-treated” by owners or not treated at all.
Concluding, Mr Evans said that there were three main requirements for raising
the standard of veterinary pharmacy — deregulation, improved support from
manufacturers, and better supplies to pharmacies.
Review will keep “an open mind”, says chairman
During a period set aside for questions, Sir JOHN MARSH (chairman, independent
veterinary review group) assured conference participants that the whole question
of veterinary prescribing and dispensing would be viewed with a completely open
mind. He confirmed that there was no hidden agenda and no preconceived ideas.
At present, he and his colleagues were gathering information from the many stakeholders
involved. The group’s remit was clear and it would carry out its duties
as it saw fit. The outcome might not be liked by certain interested parties.
High-quality, testable evidence was required and this should be backed up by
accurate data, he said.
Sir John said that the report would be submitted to Ministers in March next
year, but interested parties could keep up to date with the latest developments
by accessing the review group’s website (www.vmd.gov.uk/ird/irdhome.htm).
The report would make a number of recommendations and it would be up to Ministers
to determine exactly what should be done.
Professor JOY WINGFIELD (Nottingham) raised the question of the rapid increase
in sources of knowledge and how this might affect issues of safety. If medicines
were deregulated, was it a case of letting people buy whatever they felt was
appropriate and letting them get on with it? She suggested that competition
was incompatible with legislation. The panel of speakers agreed that there was
some difficulty in striking an appropriate balance.
Margins?
Other speakers wanted to know how it was that pharmacists managed to survive
on dispensing margins of between 7 and 9 per cent while veterinarians obtained
margins of 33 per cent.
Mr EIFION EVANS (immediate past president, British Veterinary Association) said
that he could not divulge his defence as he was saving the facts for the BVA’s
submission to the review group.