| Product life cycle management generally brings little or no
added value to the majority of patients, according to Linda Dodds, specialist
pharmaceutical adviser at Ashford Primary Care Trust (PCT) and teacher-practitioner
at the Medway University School of Pharmacy. Mrs Dodds focused her criticisms
of the practice on instances where minor changes to products (such as
using a different isomer or mixture of isomers or changing from capsules
to tablets) had been made by pharmaceutical companies and the “original” product
withdrawn.
New presentations or the different dosage instructions that accompany new
formulations can confuse patients, she explained. This means that health
professionals working in primary care need to devote time to counselling
patients about the changes. Other associated increases in workload include
amending computer systems and contacting suppliers to sort out stock shortages. “The
risk of prescribing and dispensing errors is also increased,” she
added. Administration errors, particularly when formulations are changed
such that they can no longer be used in feeding tubes, are also an issue.
Moreover, Mrs Dodds found it hard to understand “what is in it for
the pharmaceutical industry”. Although she assumed that introducing
such products produces short-term financial gains, she could not see any
long-term monetary advantages. From a UK perspective, there is a finite
pot of money within PCT budgets, she explained, and once it is spent buying
these types of products it is not available for the purchase of the real
novel drugs. Also, patients were often switched back to the original presentation
or formulation once generics became available anyway, she said.
Introducing products that have been “life cycle-managed” can
also result in a loss of credibility for the companies concerned, Mrs Dodds
continued. In particular, it can put a strain on what can be good relationships
between PCT staff and pharmaceutical industry representatives that have
built up over time. She presumed that this could be particularly problematic
for pharmaceutical companies now that individual PCT staff often have a
lot of responsibility for formulary and budget issues within their geographical
area.
Real advantages mean positive attitudes
Mrs Dodds went on to explain that the attitudes of PCT staff to new
formulations are much more positive where they are associated with real
advantages
for patients (such as, for example, longer acting preparations of insulin
and goserelin). However, she stressed that the perceptions of industry
staff as to what are real advantages are not always shared by those
working for PCTs. For example, bringing out “once a day” oral
preparations instead of “three a day” oral preparations
does not generally improve compliance in patients who are not taking
any (or many) other medicines. Moreover, single dose preparations can
sometimes decrease therapeutic outcome in such patients, she continued,
because missing one dose becomes more of an issue.
According to Mrs Dodds, “the way forward is for companies to develop
and promote drugs that we [ie, PCTs] really want to use”. It might
also be a good idea for PCTs to become involved in endorsing company
promotions, she added. In addition, there are untapped areas where product
life cycle management could really benefit patients, such as bringing
out eye drops in devices that people with disabilities can use and working
on creating innovative packaging from a patient safety perspective.
Mrs Dodds pointed out that she had approached colleagues working for
Ashford and other PCTs when putting together her presentation and the
views she expressed were representative of those with whom she had spoken.
Product life cycle management is an issue pertinent to many staff working
for pharmaceutical companies, and not just those involved in regulatory
issues, according to Paul Gellert, principal scientist at AstraZeneca.
Dr Gellert urged companies to educate their scientists that “patents
are not just something someone else does”. For example, research
staff, particularly those involved in formulation, need to be aware that: “a
[scientific] problem solved is a potential patent opportunity”.
He pointed out that a recent survey by the patent and trade mark attorneys,
Marks and Clerk, concluded that companies were still not necessarily
maximising their patent strategies.
Dr Gellert pointed out that pharmaceutical companies operate in an increasingly
competitive environment. Research and development costs are increasing
but lower prices are being paid for medicines. Market exclusivity is
also being eroded — once a new drug is put on the market the average
time to a similar product being launched is now two years, as compared
with the 10 years it used to be, he added. Other ways to maximise revenue
include reducing the attrition rates during the drug discovery and development
phases, he pointed out. High throughput screening might help here, he
added. Looking at clinical trial design is also relevant, because clinical
trials can account for half the costs of developing a new medicine.
Thus product life cycle management is just one of the routes that companies
can use to maximise their revenue in order to continue to fund the discovery,
development and commercialisation of innovative new medicines that benefit
patients. |
The
Pharmaceutical Journal