Association of the European Self-Medication Industry
Australia a laboratory for OTC switches
Juliet Seifert: Xenical became an OTC medicine after only four years |
Australia is an interesting laboratory for exploring the potential
of medicines in over-the-counter environments, according to Juliet Seifert,
executive director of the Australian Self-Medication Industry.
Speaking at the combined annual meeting of the Association of the European
Self-Medication Industry and general assembly of the World Self-Medication
Industry in Geneva last week, Ms Seifert said that Xenical (orlistat)
had been launched as an OTC medicine in Australia only four years after
its launch as a prescription medicine.
Ms Seifert said that people taking Xenical — which became available
from pharmacies in May 2004 — were able to lose almost twice as
much weight during weight loss programmes as those taking placebo.
Xenical had been placed in Australia’s “pharmacist only” category
for medicines which could only be sold with appropriate advice and counselling
and for which specific approval would be required for any planned advertising.
Roche had applied for the reclassification three times before being successful.
The first application, in June 2002, failed because of concerns over
the weight of responsibility to be placed on pharmacists for counselling
and worries about promotional weight loss claims that might be made.
A second application, in February 2003, also failed. The, third, successful
application was made in October 2003, but no brand advertising was approved — only
generic weight loss advertisements were allowed, which directed people
to pharmacies for advice.
Xenical was suitable for OTC switching, Ms Seifert said, because pharmacists
could easily diagnose obesity, orlistat had a high safety and tolerability
profile, interactions were minimal, close monitoring of patients was
not required and its adverse effects
militated against abuse. Also, the incidence of serious side effects
was the same as for placebo.
The OTC availability of Xenical led to a near doubling of the number
of people who sought weight loss advice from pharmacies from 29 per cent
to 54 per cent. Since, May 2004, 200,000 packs of OTC Xenical had been
sold and an estimated 210,000kg of excess weigh lost.
Pace of UK switching is accelerating
The accelerating pace of over-the-counter switching in the UK was outlined
by June Raine, director of the Medicines and Healthcare products Regulatory
Agency’s post-licensing division.
The key to moving products from prescription control to OTC availability
lay in laws that facilitated the change coupled with high level support
for switching, Dr Raine explained.
This was proved by the fact that only six ingredients had been switched
across the EU from 2000–2004. But in the UK 30 switches had taken
place in the past three years, compared with 15 in the preceding 10.
Dr Raine told the meeting that consultations on plans to make products
to treat migraine and cystitis available over-the-counter would be launched
in the UK in the next few months. Potential future switches included
products for urinary incontinence and appetite suppressants.
Health professionals are not enough
Health professionals cannot meet the world’s demand for care for
chronic diseases, the meeting heard.
JoAnne Epping Jordan, World Health Organization co-ordinator of health
care for chronic conditions, said that health professionals needed to
be able to equip the real providers of primary care — patients
themselves — to manage their own conditions. Patients needed to
be able to recognise changes in their own diseases and adjust their care
accordingly. They had to be trained to find and use available health
care resources, interact effectively with health care providers and to
manage their conditions on a day-to-day basis.
To this end, evolution in the basic training of all health professions
was needed. Five new core competencies — patient-centred care,
partnering, quality improvement, information and communication technology,
and public health — were essential.
A new EU approach towards self-medication
The EU approach to self-medication was evolving from a mechanistic
approach of setting criteria that products must meet in order to be freely
available
to one of official recognition that self-medication has a role to
play in promoting public health.
Key factors contributing to this change included recognition that
self-medication could reduce the burden placed on public health systems
in terms of cost
and pressure on health professionals, coupled with demands from patients
for a greater say in their own treatment, said Georgette Lalis, director
of consumer affairs in the European Commission directorate general
of enterprise and industry.
Mrs Lalis took the opportunity presented by the meeting to announce
a new EU strategy for the pharmaceutical sector intended to restore
Europe’s
place as the world’s pharmacy. Part of this strategy was aimed
at increasing competitiveness on pricing.
“We see no health or public benefit reason for price controls,” Mrs
Lalis said. “Most states don’t have them.”
Other elements of the strategy sought to promote innovation, particularly
by helping smaller companies develop biotechnology, and to improve
patient information through a public-private partnership.
Mrs Lalis expected substantial progress to be made within two to three
years. She hoped that the timescale would be shorter where information
for patients was concerned, but feared that progress on pricing would
take longer.
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The
Pharmaceutical Journal