PHARMACHEM NEWS BULLETIN
NOVEMBER 1998
EDITORS COMMENT
POM(E) Prescription
Only Medicine (Exempt) nothing too difficult there on the face of it.
Shouldn't be too difficult to get ones head around it. And yet..............
Still no product has found its way into this much heralded category.
I swear, every time I see the letters POM(E)
in writing I feel as if I'm reading about the Good Friday Agreement or
the South African Truth Commission. The framework is in place, the
legalities are in place, the good-will seems to be in place, a new EC paper
mountain has been created and shredded every month for the past yonks.
Fine tuning, arguing and debating every detail until all was no more.
And as for all the hot gas that has been blown off on the subject,
well Richard Branson would be round the world
twice in his little balloon and still have enough over for a "brute of
a fry-up".
No, I think enough has been said, enough written
and more than enough steps taken back from the brink. It is time
for us all to get up off our collective derrieres, get down for one last
scrum and with an almighty heave, finally push the opposition (whoever
they are)
off the ball and ruck this thing forward to wherever
it leads us. If that be down a blind alley well so be it. I'm fed
up waiting to turn the corner just to find out. So is just about
everyone else so what are we waiting for ? Christmas ??
Ooops !!!!
Ian McGirr,MPSI,
Carnew.
*********
CONGRATULATIONS
The Pharmachem committee expressed their congratulations
to Gerry Headon, at the recent committee meeting, on the management buy
out of Boileau & Boyd, Whelehans and Perrans. The committee look
forward to the continued growth of the business and the excellent relations
between the committee and Boileau & Boyd.
****
Article published in Irish Farmers
Journal November 7, 1998
POM, Prescription Only Medicine,
is affecting every livestock farmer in the land. It is a key part
of the 1996 Animal Medicines Regulations. It was introduced in an effort
to put order and control on antibiotics. But along with the controls has
come anomalies, inefficiencies and major animal welfare problems.
However, a solution may be at hand in the form of POM(E)
POM(E)
A Solution to animal health
and welfare crisis ?
POM(E) is a separate category in the Animal Medicines
Regulations. Animal health products listed in the POM category, including
all antibiotics, can only be administered by a vet to an animal that he/she
has seen. In this respect, Ireland has the strictest definition of
Prescription Only Medicines in the EU. Products listed in the Irish
POM(E) category can be sold by a vet
or a pharmacist without him/her having to visit
the animal to make a diagnosis. Indeed, many of the conditions such
as sheep sponging, do not need a diagnosis. In all cases of POM(E)
sales, the farmer would be known to the vet/pharmacist. Advice could
be given on the use of the drug, withdrawal period etc.
An industry-wide effort is underway to persuade
the Irish Medicines Board to re-classify certain products form POM to POM(E)
These products include:
-
Sheep sponges and PMSG
-
Topical antibiotics and foot sprays for sheep
-
Calf scour products, such as Hyspan, which is based
on Neomycin, an antibiotic not used in human medicine.
-
Treatment for Pink Eye.
-
The local anaesthetic Lignocaine, which can be used
for dehorning calves. It is now compulsory to use a local anaesthetic
if dehorning a calf of over two weeks. Coils, CIDRs and other products
used in reproduction in cattle.
-
Imizol - the vaccine/drug of choice for use against
Red water in cattle.
-
Intra uterine products, such as Metrijet.
Under existing law, a herd owner or farmer can only
use these productsunder direct veterinary supervision. The vet must
see the animaland in the case of Lignocaine, it must be administered by
the vet. The manufacturers of these products have applied to have them
re-classified
as POM(E) This move is backed by the Animal and
Plant Health Association (APHA) - who have put together a position paper
on the issue - the IFA, ICOS, the ICMSA, the ICSA and Pharmachem.
These organisations have held meetings on the
issue. As of yet the country's veterinary organisations are still
considering their stance. The veterinary supply companies, the farm organisations
and the pharmacists believe that the Department of Agriculture is in favour
of any sensible moves which will reduce the level of pain and suffering
in farm animals
without any risk to human health.
Since the heat synchronising products, such
as Prid/CIDR etc. were made POM, their use has collapsed in AI stations.
Vets also are handling less of them now than before the POM ruling.
A useful cattle breeding tool has effectively been made unavailable to
farmers.
SHEEP
Speaking at the recent Irish Grassland Association
meeting in Wicklow, UCD veterinary lecturer Dr. Michael Doherty said that
there is a need for an arrangement whereby a flock-owner has access to
a limited range of antibiotics to treat sheep, without having to call out
the vet each time.
The collapse in the value of sheep has raised
a major animal welfare issue. In the early days after the Animal
Medicines Regulations became law, some vets showed flexibility in selling
antibiotics. More recently, the Department of Agriculture has clamped
down on this activity, and insists that the full letter of the law be observed.
Indeed, some vets are re-considering the value of having shops which retail
antibiotics.
Nobody questions the desirability of prudent and
responsible antibiotic use on farms to minimise the threat of resistance
to antibiotics in humans At the recent EU "microbial threat" conference,
enormous blame was being put on farmers for abuse of antibiotics.
But this was
mainly in pig and poultry units. Last week
the Irish Green Party also launched a broadside against antibiotic use
on farms. But APHA director Declan O'Brien, speaking at last weeks;
veterinary congress, defended the farm situation and accused the Green
Party of scare mongering.
Also at the conference Mr. O'Brien welcomed the
Irish Medicines Board decision to allow injectable calcium and magnesium
products to remain on sale through licensed merchants. The most recent
survey of Irish meat products showed a nil level of antibiotic residue
in beef or
lamb, and one per cent in pork; this is one per
cent more than it should be, Pat McCarthy, Managing Director of Co-op Animal
Health, told a recent AHD* veterinary meeting in Tullow, Co. Carlow.
*AHD - Animal Health Distributions
- is a new company, established in 1998 by United Drug PLC and Co-op Animal
Health. It is involved in distributing animal health products from
the manufacturer to the
wholesaler.
*********
Cat ID's in UK
The Cats Protection League has expressed concern
that the passportsfor pets scheme (to include all dogs and cats) will increase
the numbersof abandoned pets. Pet owners will be reluctant to pay
to have theirpets microchipped, and for this reason a voluntary system
would be more successful .
******
Article published in Farming Independent
NORBROOK WINS US APPROVAL FOR ANIMAL DRUGS
Norbrook Laboratories, the Newry, Co. Down veterinary
pharmaceuticalscompany, has won approval from the US regulatory authority,
the Foodand Drug Administration (FDA) for its penicillin G procaine injectablesuspension
USP product. Up to now Norbrook had to buy the raw material from
a licensed producer,but now it has approval to produce the raw material
itself.
The company has orders for more than $15 million
(£10 million) with target sales of $35 million to $40 million. A
spokesman noted that £6.5 million had been spent on research and
development over the past three years.
The product, Norbrook said, put it in a "unique position in the world"
as it is now a primary producer of penicillin G procaine as well as
being a manufacturer of the finished product.
Norbrook has also obtained clinical approval from the FDA for its formulation
of the long acting oxytetracycline injection. This product
has been registered in Europe and is said to
have achieved "considerable market success".
Following the two approvals, Norbrook said it
now had access to a "multi-million dollar segment of the market" where
it expected to be "highly competitive". This should result in the
company growing to become one of the 10 top veterinary pharmaceutical companies
in
world, according to the group.
Norbrook employs 660 people. Formed 30
years ago, it is one of the largest producers in the world of sterile antibiotic
injections for animals. It has just completed a £38million
investment programme which has taken three years to complete.
Norbrook's main manufacturing site is in Newry
but is also has manufacturing facilities in Co.Monaghan and in Nairobi,
Kenya. It generates around £40 million in annual sales.
This is projected to grow substantially.
The company has no immediate plans to go public
but its founder and chairman, Dr. Edward Haughey, has said "We haven't
ruled out going public after the millennium".
The Company intends to expand its product line
next year to include products for humans.
*********
UK RESIDUE LEVELS
Over 99% feed samples were within the maximum
pesticide residue limits (MRL's). Of the samples tested 70% had no
residues; 29% had residues below the legal MRL; and less than 1% had residues
above the MRL, though none high enough to cause concern for consumer safety
*********
Irish Residue Levels
Cattle
Pigs Sheep
Vension
No. % No
% No %
No %
CattleGrowth Promoters
26 .12%
Banned Hormones
26 3.9%
Antibiotics
45 2.8% 227 1%
4 0.8% 20 35%
******
IVOMEC LADY
Article from Irish Times, 27th Nov
1998
Shoplifters are
'Cancer on Society'
Shoplifters who travelled around the
state were a cancer on society like "locusts descending on small towns",
said Judge Frank O'Donnell when he imposed a three-year suspended sentence
on Mary Smith (51), of Casino Park, Marino, Dublin.
Smith told gardai she was being
paid £80 to keep stolen property overnight for someone she was afraid
to name. Mr. Ross Maguire, defending, said his client's patio had
been smashed since her arrest on this matter last year. She was really
terrified of naming the person who
pressured he into this crime.
Sgt. Fergus Dwyer told Judge O'Donnell
Smith had some of the goods wrapped up as Christmas presents when he house
was searched. The items found had a total value of almost £1,200
and had been stolen from shops in Kilkenny, Castlebar andCarrickmacross.
Smith pleaded guilty at Dublin
Circuit Criminal Cournt to handling stolen designer clothes, cosmetics,
electrical and communication equipment, and Waterford crystal on December
20th 1996. She had no previous convictions.
Judge O'Donnell said he knew she
was not the real culprit but was concerned that threats of the kind refered
to by Sgt. Dwyer might make her do it again. He didn't accept her
claim of just keeping the stolen property overnight and normally anyone
who handled stolen property has to go to jail.
Editors Note
Should anyone meet Mary Smith please advise her
that Ivomec does not cure cancer
****
ANTIBIOTICS FOR
HUMAN USE ONLY
The topic of saving certain antibiotics for human
use only was debated at a symposium of the German Animal health academy.
To permit only second choice antibiotics for livestock use was deemed "utopian".
Professor Hoffman stressed that all actions prompted by resistance
should have a basis in science. Piece meal
and over hasty moves to ban products were inappropriate, given both the
complex nature of resistance and therapeutic needs.
******
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