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Vol 278 No 7436 p102
27 January 2007

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News feature

How reclassifying a CD could affect supplies of cold remedies that work

Last week, methylamphetamine became a Class A Controlled Drug in an attempt to stop it becoming a major drug of abuse in the UK. The reclassification has cast a shadow over the continued availability of pseudoephedrine as a pharmacy medicine. Mike Thompson (on the staff of The Journal) investigates




Methylamphetamine — street names include crystal meth, tweak and ice — is now a Class A Controlled Drug, which means that it is considered to be one of the most harmful drugs of abuse. At the beginning of last week it was a Class B CD.

Reclassification was recommended by the Advisory Council on the Misuse of Drugs because of fears that an epidemic of abuse in the Far East, the US and parts of Europe could spread to the UK.

The recommendation reversed the ACMD’s 2005 advice to leave methylamphetamine in Class B because there was, at that time, little evidence of significant misuse in the UK and fears that reclassification could draw attention to the drug. But, in mid-2006 the ACMD decided that the abuse of methylamphetamine was becoming more widespread in the UK — although it remains rare — and the police had discovered a number of illicit laboratories synthesising it. This, coupled with increased media attention to the drug, made the advisory council reconsider.

Simple synthesis

The ACMD has also now pointed out that methylamphetamine is simple to synthesise in domestic kitchens from pseudoephedrine and ephedrine. It recommended that steps be taken to limit their availability.

Such steps have already been taken in countries where methylamphetamine abuse is an established problem, including the US, Australia and New Zealand.

In the US last year, federal legislation moved ephedrine and pseudoephedrine from the over-the-counter category to a new behind-the-counter category, meaning that products cannot be available by self-selection, that purchasers have to prove their identity and that records of sales have to be kept for at least two years. Some individual states introduced legislation that made them available only on prescription.

Down under

In Australia, pseudoephedrine-containing products were made subject to tighter controls last year as well. Some products became prescription-only; others had to be sold personally by pharmacists. Things went further in New Zealand, where ephedrine and pseudoephedrine became Controlled Drugs, but with exemptions to allow sales to continue under certain circumstances and under pharmaceutical supervision.

In both Australia and New Zealand much of the supply of illicit methylamphetamine was being synthesised using pseudoephedrine and ephedrine extracted from stolen or illicitly imported medicines.

These facts raise the question of whether medicines that contain pseudoephedrine or ephedrine should be more tightly controlled in the UK. Currently, both ingredients are classified as prescription-only medicines, but with exemptions that allow products containing limited doses to be available as P medicines.

Sheila Kelly, executive director of the Proprietary Association of Great Britain, is clear that there is no justification for changing this. “There is not that much of a problem with crystal meth in the UK at the moment,” she said. “And pseudoephedrine is one of the most important P ingredients.”

In the US, only 10 per cent of illicit methylamphetamine is produced from OTC medicines. And most of this involves medicines stolen from factories or from pharmacies by ram-raiders, Mrs Kelly says. Although she accepts that some is obtained from pharmacies by people going from shop to shop buying medicines. The rest is manufactured on an industrial scale — mainly in Mexico.

But Mrs Kelly is adamant that there is no evidence that OTC medicines are being used to make methylamphetamine in Europe.

“The police have never found OTC products in places where they have found crystal meth,” she said. “People who are making it are getting the raw material. We’re a long way from people going from shop to shop.”

So what would happen if pseudoephedrine, in particular, was no longer available as an active ingredient for OTC use?

The immediate impact would be that the public would no longer have easy access to remedies to relieve the symptoms of the common cold.

“Only 3 per cent of people go to the doctor for a cold because effective products are available,” Mrs Kelly said.

Disruption of cold treatments

Reformulation would also mean lengthy delays to the introduction of replacement products — it could take as long as two years for them to be fully tested, validated and authorised by the Medicines and Healthcare products Regulatory Agency, according to Mrs Kelly.

Ron Eccles, of Cardiff University’s Common Cold Centre, said: “Pseudo-ephedrine has been shown to be effective in clinical trials. One can argue about the level of decongestion achieved with an oral product and whether it is clinically effective, but there are objective changes in congestion and people do feel better.”

Conversely, Professor Eccles says that no clinical trials in the public domain support the efficacy of phenylephrine, which is the main alternative ingredient. “Phenylephrine is a poor substitute for pseudoephedrine as an orally administered decongestant as it is extensively metabolised in the gut and its efficacy as a decongestant is unproven.”

Nevertheless, reformulation is seen as the way forward by the advisory council. ACMD member Kay Roberts said: “In the UK, I’m not sure we would miss pseudoephedrine, although phenylephrine is probably not as effective.”

She explained that the ACMD’s recommendation that the availability of pseudoephedrine be restricted was based on evidence of the environmental damage illicit conversion can do (see Panel below).

“My inclination is to err on the side of caution,” she said. “We did look at it very carefully and this is not a knee-jerk reaction.”


The Society p114

Why the worry about methylamphetamine?

Methylamphetamine is chemically closely related to amphetamine, but has more intense central pharmacological effects than amphetamine and less pronounced peripheral effects. It can be taken by smoking — unlike amphetamine, which breaks down before it vaporises — and produces much more long-lasting effects than amphetamine (it has a longer half-life) or inhaled “crack cocaine”.

Methylamphetamine readily crosses the blood-brain barrier leading to euphoria and excitement through the release of noradrenaline (norepinephrine) and dopamine. Users who smoke it risk developing “meth mouth” characterised by broken, discoloured and rotting teeth as a result of suppressed salivary secretion.

It is readily synthesised from pseudoephedrine and ephedrine by reduction with red phosphorus and iodine, although people who do this illicitly put themselves and property at considerable risk because it involves the use of volatile solvents and the production of toxic waste.

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