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PAGB Endorses New Labelling for Medicines
Containing Codeine and Dihydrocodeine
The Proprietary Association of Great Britain (PAGB), the trade
association representing manufacturers of over-the-counter medicines and
food supplements, welcomes the decision to introduce new labelling for
painkillers containing codeine and dihydrocodeine.
In a joint decision between the Medicines and Healthcare
products Regulatory Agency (MHRA) and the over-the-counter medicines
industry it has been agreed to put strengthened warnings, about the
possible risk of addiction or medication overuse headache due to
inappropriate use, on packs of painkillers which contain codeine and
dihydrocodeine.
The vast majority of people use these over-the-counter medicines safely
and correctly, but to help the small minority which might be at possible
risk of addiction as a result of incorrect use, the industry has
voluntarily agreed to add the following warnings onto the packs of
painkillers which contain codeine and dihydrocodeine:
* If you need to
use this medicine for more than three days at a time, see your doctor,
pharmacist or health care professional.
* Taking codeine
regularly for a long time can lead to addiction, which might cause you
to feel restless and irritable when you stop the tablets.
* Taking
a painkiller for headaches too often or for too long can make them
worse.
The industry has also voluntarily agreed to a maximum pack size of 32
tablets for all over-the-counter medicines containing codeine or
dihydrocodeine.
PAGB contributed to a review presented to the Sub Committee on
Pharmacovigilance (SCOP) and the Committee on Safety of Medicines (CSM),
which assessed the number of reports of abuse of OTC codeine and
dihydrocodeine containing medicines. The MHRA reviewed this
report and concluded that the number of reports of abuse of OTC codeine
and dihydrocodeine medicines is exceedingly small, compared to volume of
sales. From the report the MHRA also concluded that the
benefits of the availability of OTC medicines which contain codeine and
dihydrocodeine outweigh any potential risks.
Helen Darracott, PAGB Director of Legal and Regulatory Affairs said:
"OTC medicines which contain codeine or dihydrocodeine do not lead
to addiction if used according to the instruction on the pack. They
should be taken only to relieve symptoms of pain and only for short
periods unless a doctor has advised otherwise. Combining
codeine with paracetamol or ibuprofen produces pain relief products
which have been shown to be more effective than simple analgesics. They
therefore play a useful role as over-the-counter medicines. As
with all medicines, people should consult their pharmacist or doctor if
their symptoms persist or get worse.
These medicines are already strictly regulated - they are only available
from pharmacists and have clear instructions on how to use the medicine
and when not to use the medicine. We hope by adding these
extra warnings it will help the minority of people who might be at risk
of addiction to use these medicines appropriately."
Notes
* PAGB is committed to helping
empower people to take an active role in managing their own health. It
is therefore supportive of this and any other initiatives that are
created to improve safe use of OTC medicines
* PAGB funds the Over-the-Counter
Medicines Advice Line which has been set up to help people who have
questions or concerns about using over-the-counter medicines. The
advice line is open from
10am - 3pm
, Mondays to Fridays and is manned by nurses. The number is
020 8742 7042.
No central funding for
courses
No central funding is available for pharmacists in
Wales
to undertake supplementary prescribing training, the All Wales Medicines
Strategy Group has said.
Welsh Assembly spokeswoman Ann Jones confirmed there was currently no
central money available for pharmacist or nurse supplementary
prescribing courses and said she had no details on any future funding.
Phoenix
puts in offer for Numark
Details of the offer being put forward by the wholesaler
Phoenix
to buy Numark have been announced. A statement says that
Phoenix
is offering 410 pence in cash per Numark Share. This will value the
entire existing issued share capital of Numark at approximately £30.3
million, representing a premium of approximately 82.2 per cent over the
Numark Share price of 225 pence used in the last share dealing facility
as at
July 1, 2004
. The offer price also represents a premium of approximately 310 per
cent over the Numark Share price of 100 pence per Numark Share in August
2002, when Numark converted from an industrial and provident society to
an unlisted public limited company.
Phoenix
, part of the pan-European Phoenix Pharmahandle Group, based in
Mannheim
,
Germany
, already has a 14.7 share holding in Numark. In the
UK
,
Phoenix
operates under a wholesale group (Phoenix Healthcare Distribution
Limited) which distributes pharmaceutical products and equipment and a
retail group (L Rowland & Company (Retail) Limited) which operates
384 retail pharmacies.
Phoenix
also operates a joint venture, NTL, with the Numark Group for the supply
of medicinal and non-medicinal over the counter products to Members in
the
United Kingdom
.
Phoenix
has not prepared consolidated financial statements.
The Numark Group provides buying and marketing support services to its
members under the Numark brand. Since becoming a retailer-owned
industrial and provident society in 1994, it has grown from 820
membership pharmacies to 1,735 membership pharmacies as at the date of
this announcement. In 2002, Numark converted from an industrial and
provident society into a public limited company and its shareholder
base, excluding
Phoenix
’s shareholding, is predominantly comprised of independent pharmacies.
Consultation
on OTC availability of tryptans starts
The medicines regulator, the MHRA, is consulting on proposals to allow
sumatriptan and zolmitriptan to be sold over the counter for the acute
relief of migraine attacks.
"As triptans should be taken as early as possible in a migraine
attack, the pharmacy availability of these important medicines would be
beneficial to patients who suffer from migraines, especially those who
have infrequent attacks and may not always have prescription medicines
to hand," says the MHRA. "The ability to buy these medicines
in a pharmacy would enable patients to get treatment straight away
without having to spend time visiting their doctor, and would reduce the
burden of migraine."
Details of the proposal are given in the MHRA's consultation document,
ARM 32, which is available on the MHRA website (www.mhra.gov.uk).
Comments should be with the MHRA by October 6.
(This begs the question as to whether a pharmacist is competent to
diagnose migraine)
RPSGB
seeks clarification over OTC trimethoprim
The Royal Pharmaceutical Society is questioning some of the restrictions
being proposed to allow over the counter availability of the antibiotic
trimethoprim 200mg for cystitis.
While welcoming the overall proposal to switch trimethoprim from
Prescription Only to Pharmacy medicine status, the Society is seeking
clarification on why there is a need for “previous diagnosis of the
same condition confirmed by a doctor”.
(The arrogance of the
pharmacist knows no bounds)
Hospital
debts hit wholesalers
Pharmaceutical wholesalers could be left £200 million out of pocket by
financially mismanaged NHS hospitals, according to industry experts.
Poor budgeting by NHS trusts has left many wholesalers acting as “de
facto overdraft facilities” for struggling hospitals, said Steve Dunn,
group managing director of AAH pharmaceuticals.
Mr Dunn blasted the NHS for a system that allowed 80 per cent of
hospitals to build significant commercial debts with wholesalers in the
past two years.
He said: “Nobody can run a business without payment from customers.
Wholesalers aren’t charities. We’re in a cleft stick situation as
refusing to supply drugs until hospitals pay up means patients would
suffer.”
AAH predicted a long battle for wholesalers to recover the projected £200m
debt.
Pack spells out fee rise for technicians
Three documents in the Royal Pharmaceutical Society’s pharmacy
technician registration pack have been revised following an overall 3
per cent increase in fees for 2006.
The increases are in line with those agreed for pharmacists at the last
Council meeting (C&D, August 13, p4). The retention fee will be £88
for practising technicians and £67 for non-practising.
Other fees vary according to which quarter the application is submitted
and whether or not it is subject to screening.
(Another benefit from falling into the hands of the chemists?)
Merck Vioxx defeat
triggers boom in lawsuits
Drugs manufacturer Merck faces a barrage of legal action from Britons
after a
US
court ruled that its blockbuster drug Vioxx caused the death of a
59-year-old man.
Legal firms across the
UK
reported a surge in the number of people seeking claims against Merck
after a
Texas
jury found the firm liable for the death of Robert Ernst and ordered the
payment of $250 million in punitive damages to his widow, Carol.
Lipitor
recall
The Medicines and Healthcare products Regulatory Agency has issued a
Class 3 recall for Lipitor 10mg tablets (atorvastatin calcium).
Bearing the batch number 0533094G and expiry date 08/2007, blister
strips of the affected stock have been incorrectly over-labelled as
Lipitor 20mg tablets. Pharmacists are asked to quarantine any remaining
stock and return it to their supplier for credit.
For more information, contact Lexon (UK) returns department on 0800 138
2293.
(1/9/05) |
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