Outsourcing of manufacturing and analysis, and access to information about medicines were the topics presented at Conference sessions held in conjunction with the Royal Pharmaceutical Society’s Industrial Pharmacists Group on September 11. The chair was shared between Mr Steve Wicks (director of pharmaceutical sciences, Pfizer Ltd) and Mr Mel Smith (chairman of the IPG)
Mr RICHARD EGGLESTON (research and development director, Galpharm International)
presented a paper from Patricia Liston, the company’s head of quality and
compliance, which addressed the issues and practicalities in forming outsourcing
partnerships.
Contract manufacturing had been given a boost by mergers and commercial relationships
involving the larger pharmaceutical companies and by virtual companies, he said.
Activities conducted under contract might extend through any or all of product
development, routine manufacturing and packaging, method development, testing
for stability, release by Qualified Persons, distribution and regulatory control.
Clients who worked successfully with contractors managed to strike a balance
between handing overall responsibility and getting too involved. Hence the importance
of establishing a client/contractor charter — “knowing me, knowing
you” — which defined expectations and needed to precede the technical
agreement.
Requirements being specified both for product development and manufacturing
should cover quality standards (definition, in-process checks, complete inspection);
validation (of product, process, equipment, etc); agreed protocols; regulatory
licensing (manufacturer’s and wholesale dealer’s licence provisions,
plus access to approval documents for the specified dosage form); formulation
and packaging; and distribution (including policy on handling returns).
It was all too easy for plans to overlook or forget things, such as approval
of instructions, specifications and methods; analytical results, including the
format of certificates of analysis; or batch test records, Mr Eggleston said.
Change control procedures needed to be documented, likewise audits and the customer
complaints system. Measurement of product quality might need to take account
of factors not covered by the specification but which were essential for marketing.
A product information pack could serve a very useful purpose for briefing members
of staff. It was important to encourage teamwork, a consistent operating format
and a willingness to share ideas.
Success depended on having a good service: meeting regulatory and launch timetables;
getting stock into the warehouse; and reporting test results on time. Annual
product reviews were essential, and should refer to any batch variations, analytical
trends and customer complaints. Mutual recognition agreements ought to reduce
the complexity of the business, benefit portfolio management and help to further
the concept of the “one-market pack”. Their effect, however, including
impact on costs, had yet to be seen, Mr Eggleston concluded.
The contractor’s view
Ms SUE RICHARDSON (managing director, PCI Analytical Services) highlighted some
of the “whys” and “hows” of contracting out product analyses
from the contractor’s viewpoint.
Client companies variously saw benefits in being able to concentrate on their
core competencies, using their inhouse resources more effectively, taking advantage
of external expertise, apparatus and instruments and being able to have their
own results verified through contracting. Customers were influenced by a range
of factors such as location, accreditation, general resources and training,
facilities for storage of samples, the sample submission process, documentation
(standard operating procedures, methods, archives, etc), audits, contracts and
agreements when selecting a suitable contractor.
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Ms Richardson summarised the respective responsibilities of the contract giver
and contract acceptor (See Figure 1).
Problems could be pre-empted if, for example, sample submission was in a format
that was quick and easy for the customer and compliant for the contractor; if
hazard data accompanied the samples; if the named
responsible person was in a position to respond rapidly to out-of-specification
results; and if the customer made the agreed payment terms known to the accounts
department.
Access to information on medicines
The Association of the British Pharmaceutical Industry’s “Informed
patient” initiative was presented by Mr MARTIN ANDERSON, (commercial affairs
manager, ABPI). Its aim, he said, was to increase the ability of the industry
to communicate information more directly to patients about the development and
usage of prescription medicines.
Health Minister Gisela Stuart had pointed to the need to build concordance between
patients and health care professionals in the choice of treatment and care,
Mr Anderson said. Account needed to be taken of legislation on freedom of information
and human rights. Patient support groups were increasingly vocal and better
informed.
The internet had become one of the key drivers. The ABPI intended to issue advice
on the internet, following guidelines set by the World Health Organisation.
In the United States, 20 years’ discussion had preceded the introduction
of direct-to-consumer (DTC) advertising and subsequent Food and Drug Administration
guidance. The aim of DTC advertising was to improve health gain. A national
survey of US consumer reaction had shown that good risk and benefit information
in advertisements encouraged patient dialogue with the doctor. However, there
was no real sign that the United Kingom contemplated US-style consumer advertisements,
he said. The informed patient concept was much wider.
A review of the European legal framework for prescription only medicines was
pending and lobbying was under way. At the same time a cultural shift was starting
to occur within society from “health need” to “health want”,
where consumers would be seeking more customised, preventative health care.
The resulting change in the role of medicines would have major implications
for both pharmaceutical research and development and information services.
Electronic Medicines Compendium
Mr STEVE MOTT (general manager, Datapharm Communications) talked about
the Electronic Medicines Compendium (EMC). It represented a major investment
by the pharmaceutical industry. The EMC was a definitive publication with every
entry stemming from two components of a product’s marketing authorisation:
the summary of product characteristics (SPC) and the patient information leaflet
(PIL). An agreement with the Medicines Control Agency would ensure that these
entries were kept up to date (something which was impossible with the book version);
and drug information scientists were helping with quality assurance.
It was now coming to be seen that once a medicine had been prescribed, patients
needed an opportunity for access to accurate information about it throughout
their course of treatment. The aim of the EMC was to make information services
available, accessible and focused. The EMC website (www.emc.vhn.net) could be
accessed by the public as well as by health care professionals and the industry.
By July this year, usage had reached 2.5m hits per month.
The target was for the EMC to become self-financing. Its development had cost
£2.5m and maintenance would cost £1m per year, less income from
licensing. By comparison, continuing with the book version would cost £1.5m
per year and a lot of trees.
Patient packs: “an initiative that was botched”
The long-running, and often controversial, topic of patient packs was discussed in the final session of the day. Speakers representing patients, the pharmaceutical industry and community pharmacy put forward their points of view.
The patient’s view Mr David Dickinson (editor, Connect) described the
patient pack project as an initiative that had been botched, with some commentators
putting the blame on the failure of pharmacy negotiators to agree the proper
terms of service.
There was consequently still a big disparity between the quality of dispensed
and non-prescription medicine presentations in many cases. Information was an
ingredient, he emphasised, and needed to be there. There was a prospect that
regulatory restrictions on the presentation of patient information leaflets
would be overhauled, which would present further opportunity to improve communication.
Pharmacy needed to take its opportunities as a communicating profession. Information
on its own was not enough. It had to be internalised and acted upon in order
for it to become knowledge. The pharmacist’s professional role should be
about communicating knowledge about medicines or “piloting the ship safely
ashore”.
This role included helping people realise what they did not have to worry about.
The public was data rich and knowledge poor. People developed their own misconceptions
if they were not properly informed. There were disparities between what health
care professionals and the public rated as most important. In a survey carried
out by Reading university, general medical practitioners put side effects 10th
on a list of information they wanted to see, whereas patients put them top.
Modern software should enable information services to become more personalised.
The industry’s view The background to the current situation
with patient packs was summarised from the industry’s perspective by Mr
MARTIN ANDERSON (commercial affairs manager, Association of the British Pharmaceutical
Industry). Packs now carried the full information required by European Directive
92/27/EC, with labelling customised by the pharmacist, to encourage compliance.
They also offered pack integrity. They presented an opportunity to rationalise
treatment courses for most patients. The aim had been to encourage matching
of complete packs with prescriptions for these courses.
A joint working group had proposed a phased introduction alongside a temporary
legislative provision to enable prescribed quantities to be rounded at the point
of
dispensing, if necessary. It had discussed appropriate pack sizes in therapeutic
categories where there was the greatest potential for mismatch. Computer software
suppliers had resolved to review their prescribing modules, starting with the
top 100 prescribed medicines.
A phasing programme had got under way, with the full co-operation of the Medicines
Control Agency. Medical education and public awareness campaigns, commissioned
by the joint working group and funded by the industry, had reached an advanced
stage of planning and consultation.
However, all these activities were dealt a severe blow when, following the change
in Government, officials failed to convince Mr Alan Milburn, then the new Minister
of State for Health, of the benefits of patient pack prescribing and reimbursement
to the NHS. As a consequence, in an effort to meet the requirements of the Directive,
the MCA had issued a consultation document (MLX 247) which proposed, among other
things, that spare pack labels and leaflets should become available in the supply
chain.
However, unleashing a snowstorm of loose components into every dispensary was
inconsistent with good manufacturing practice and patient safety, Mr Anderson
said. The whole matter was unresolved, although most new medicine were now marketed
in patient pack format despite these failures.
The community pharmacist’s view The final speaker, Mr ROB DARRACOTT (professional
services director, Moss Pharmacy), said that patient packs had lots of good
points but, as introduced, had often added a new challenge to the dispensing
process. The increase in cost of a tablet or capsule seemed a small price to
pay for the benefits accruing to patients, who now received their medicines
in professional presentations more often than before. The dispensing time per
prescription had been reduced, though, as a side effect, patients seemed to
expect an instant service — the “it is only tablets” syndrome.
Although the patient pack initiative had stalled, there had been an explosion
in the introduction of these packs in place of bulk containers. Finding space
to accommodate them had become a real challenge, Mr Darracott said. Refitted
dispensaries were getting bigger and others were creaking at the seams.
An associated problem had now emerged. It was difficult to recognise, on dispensary
shelves, packs of different strengths or even different ingredients from the
same manufacturer. For the busy pharmacist, the product should be presented
in a way that established the identity of the contents immediately and without
ambiguity.
Mr Darracott continued: “In the rest of life, if you choose the wrong shade
of paint or the wrong food tin in the supermarket, it can easily be put right.
Medicines, however, are different; and a minor cognitive malfunction —
however momentary — could be a matter of life or death.”
He commended manufacturers to a website [www.patientpacks.com] which proposed
an information plate (on the lines of a car number plate) detailing prominently
the brand and generic name, formulation, strength and quantity.
He acknowledged, however, than none of this diminished the pharmacist’s
responsibility for paying meticulous attention both to product location on the
shelf and to dispensing process management.