Cold comfort for blocked noses

Many cold and flu remedies sold in New Zealand have been reformulated to remove pseudoephedrine to frustrate local 'P' makers. Photo / Supplied

Pseudoephedrine is an ingredient of pure methamphetamine. It is also one of the most effective medicines for Nasal congestion. Prime Minister John Key has effectively decided to remove it from public use. Chris Barton reports on the reasoning behind the decision and its ramifications

Prime Minister John Key is convinced all Kiwis stand to gain from his decision to designate pseudoephedrine a Class B2 drug.

He wants hundreds of thousands of law abiding citizens to do the decent thing - forgo using their perfectly legal and effective cold medication and snuffle in silence in the fight against "P" ("pure" methamphetamine).

"I think New Zealanders are fair-minded enough to see that," Key said in an opinion piece in the Herald outlining his "war on P" initiatives.

Some New Zealanders don't see it that way at all - seeing instead a failure of logic, draconian legislation and a restriction of individual freedoms.

"We acknowledge there is currently a major social problem with methamphetamine misuse, but respectfully point out that it is methamphetamine that is the problem, not pseudoephedrine," chief pharmacist adviser of the Pharmaceutical Society Euan Galloway told Prime Minister's Science Advisory Committee in July.

"Goodbye Aunty Helen, hello Uncle John," wrote Professor John Shaw, head of the School of Pharmacy at Auckland University in a letter to the editor.

"Some will no doubt applaud the Government's efforts to be doing something to combat P addiction, but ordinary citizens have been deprived of an effective non-prescription medicine for no particular gain."

Contrary to Key's assertions, the pharmacists and others point out alternatives to pseudoephedrine-based medications don't work nearly as well; that "domestically diverted pseudoephedrine" used to make P accounts for just 10 per cent of the total P market here; that clandestine P labs and P use are in decline; and that pharmacies were poised to introduce a sales intelligence system to thwart opportunistic pill shoppers without unduly inconveniencing genuine consumers.

"Pharmacists feel a bit slapped in the face over this," says Shaw. "They have worked pretty hard to try to contain the problem."

Key admits the B2 classification will inconvenience some consumers. "As Prime Minister, my job is to weigh that cost up against the wider public interest," he says, pointing out we all pay a price for the scourge of P.

Examples: "Having our house burgled by a P-addict, watching a loved one being sucked in by addiction, or fearing another murderous P-induced rampage."

Key rightly points out the difference between these things and the effects of the common cold are worlds apart.

But his proposed legislation brings these very separate realms into collision - law abiding citizens suffering from a common cold will be denied access to medication because of P addicts and criminals.

In reaching his decision, the Prime Minister was given extensive advice - from his chief science adviser Professor Sir Peter Gluckman, to a bevy of officials on the Expert Advisory Committee on Drugs.

Here we attempt to unravel how and why they decided to classify the cold remedy ingredient pseudoephedrine as a dangerous B2 controlled drug.

P in decline

Research on the P problem in New Zealand indicates the market peaked in 2001 when around 5 per cent of the population in the 15-45 age group had used the drug in the past 12 months.

By 2006 that had fallen to 3.4 per cent.

The drop coincides with falls in other statistics - fewer calls about methamphetamine to the Drug and Alcohol helpline, fewer positive amphetamine screens among new entrants to drug treatment services and fewer labs detected.

Researchers say the trend indicates the P market has an entered a mature phase with fewer but entrenched, frequent users of the drug.

Declining or not, the methamphetamine market in New Zealand is still huge - estimated by the National Drug Intelligence Bureau in 2007 to be about $1 billion (about 1000kg of drug) per annum.

The drop in the number of clan labs detected - down from around 250 to 170 a year according to Environmental Science and Research (ESR) - has led to a number of theories.

"One is that it is genuine - that there has been a peak followed by a falling off in the total number of clan labs," says ESR Forensic general manager Keith Bedford.

Against that is police and customs data which doesn't show any significant drop in seizures at the border, or any fall in the street price which might indicate a reduction in demand.

It's possible too that the labs have moved to other areas where they're yet to be detected.

Then there's the issue that the labs found to date are invariably small, improvised "Ma and Pa" type operations and likely to be mainly P junkies cooking for themselves.

Bedford says some are clearly low-level commercial operations producing quantities in the order of tens or hundreds of grams.

That's a far cry from the sophisticated large volume facilities, found overseas but yet to be found here, that produce in the order of tens and hundreds of kilograms of P.

Many paths to P

The most surprising figure in Gluckman's report is that just 10 per cent of P in New Zealand comes from domestically diverted pseudoephedrine.

The remainder comes from illegal imports of pseudoephedrine, mainly as ContacNT granules - a brand of cold and flu capsule manufactured in China - and from imports of methamphetamine.

It's also possible to make P from precursor chemicals other than pseudoephedrine - such as phenyl-2-propanone or benzylchloride.

While there are claims savvy local P-cooks have already moved on to phenyl-based precursors, Bedford says ESR is yet to see evidence of that change.

At the moment, the way P is cooked in New Zealand is always variations of the hydriodic acid/red phosphorus method known as "HI/Red P".

Based on the information gathered by ESR when it's called in to investigate and dismantle the P labs, Bedford says it's not always clear just where the pseudoephedrine comes from.

The lack of hard data about how much pseudoephedrine has been diverted from domestic pharmaceutical products to make P has led to a wild variance in statistics.

In his opinion piece, Key preferred to use police estimates - that up to a third of the P labs busted in New Zealand are using domestically bought pseudoephedrine as their base ingredient - rather than Gluckman's 10 per cent.

But if such a small proportion of P production is down to locally sourced pseudoephedrine, why are we taking such extreme measures to stamp it out?

"While not in itself reducing the volume of methamphetamine abuse, such a measure has the potential to significantly reduce the number of illicit production laboratories and that in itself has a social benefit," says Gluckman's report.

"More speculatively, it may also allow the police and other authorities to better focus their attention on border controls."

Dr Janet Ransley, senior lecturer at Queensland's Griffith University School of Criminology and Criminal Justice, agrees that shutting down clan labs, which have dangerous environmental and health effects, is a good thing.

But, as seen in the United States and elsewhere, she notes methamphetamine markets are very flexible. When one avenue closes down, supplies are simply sourced elsewhere.

The B2 chill

When Government makes pseudoephedrine a Class B2 controlled drug, you may still be able to get the re-classified cold medications, but the punitive process will have a chilling effect on the already chilled.

Law abiding citizens will first have to go to an approved prescriber - most likely their GP.

In order to prescribe a Class B2 medicine, a medical practitioner must write the prescription on a controlled drug prescribing pad, and the amount of medicine that can be prescribed is limited to 30 days supply.

Controlled prescriber pads are in triplicate form with one copy going to the Ministry of Health.

The Ministry of Health says reclassification of pseudoephedrine to Class B2 under the Misuse of Drugs Act does not automatically restrict access to the product to hospital pharmacies - as asserted by Gluckman in his report.

Class B2 medicines can be dispensed from a community pharmacy, but pharmacies that do decide to stock the medicines will be required to store them in a locked safe and must record in their controlled drugs register each time they dispense a medicine.

Pharmacists point out that such draconian restrictions will have the effect of taking pseudoephedrine-based medications off the market.

The Government argues that most people suffering winter colds and flu either use no medication to manage the symptoms, or already use medication that contains no pseudoephedrine.

It points out that up to 80 per cent of over-the-counter cold and flu tablets already contain no pseudoephedrine and are effective for most patients.

Gluckman's report notes most manufacturers of tablets containing pseudoephedrine introduced a parallel range of phenylephrine-containing products in the early 2000s which have 60 to 70 per cent of the market share.

In May the Pharmacy Guild reported pseudoephedrine-based sales had dropped 20 per cent year on year - "matched by a 41 per cent increase in sales of the less effective alternative phenylephrine".

It should be noted, however, that while phenylephrine-based medications can be sold from supermarkets, pseudoephedrine products, currently Class C drugs, can only be sold from pharmacies.

A B2 classification also means harsher penalties for importing the drug into the country, but it could also cause problems for tourists arriving with pseudoephedrine-based cold and flu medications.

The Prime Minister's Office said the problem could be dealt with by regulations defining what would constitute "presumption for supply".

Do the alternatives work?

As an oral decongestant, pseudoephedrine provides effective relief from the symptoms of colds, flu and allergies.

"It is second to none for the treatment of Nasal, sinus and eustachian tube congestion," says Galloway. "Without it [patients] would have to spend the day in bed."

Shaw agrees: "As a registered pharmacist for more than 30 years and an occasional cold sufferer, I can state categorically that there is simply no better Nasal decongestant than pseudoephedrine, no matter what the expert reports may say."

Gluckman's report has a similar finding: "The evidence supporting orally administered phenylephrine as a Nasal decongestant at the doses available in New Zealand is less good than that for pseudoephedrine."

That's largely because in oral form phenylephrine is metabolised by the body before it acts on the congested area.

"I have received reports of patients wanting their money back under the Consumer Guarantees Act because the phenylephrine product recommended to them by the pharmacist as an alternative to pseudoephedrine was ineffective," says Galloway.

In a briefing by the Science Media Centre, Dr Peter Black, professor of Clinical Pharmacology at the University of Auckland noted: "In randomised controlled trials phenylephrine is not much more effective than placebo."

Despite what the experts say, Key maintains medical evidence backs his view "that in almost all cases patients will receive similar relief from cold and flu symptoms using a non-pseudoephedrine alternative".

The only alternative likely to give cold and flu suffers congestion relief is topical Nasal sprays.

The downside of sprays is something particularly nasty called "rebound congestion" that often occurs if they're overused or used for more than three days.

"It is difficult convincing patients that if they aren't getting relief, then using more isn't going to help," says Galloway.

Project Stop

Many pharmacists are particularly annoyed by the Government's heavy handed response because it ignores the responsible attitude taken by them in trying to restrict the "pill-shopping" problem.

"Most pharmacists have worked extremely conscientiously to make sure this product doesn't get into the wrong hands," says Shaw. That includes photo ID checks on every purchaser and recording the information which can be accessed by the police on request - something that puts quite an imposition between the pharmacists and their patients.

But what gets the pharmacists even more annoyed is that they were ready to implement Project Stop - a computer-based system that would have provided real time intelligence on sales.

The system immediately lets pharmacists know how often and where an ID has been used for purchases and can automatically send details of overuse to the police.

Key argues the system can be defeated by gangs and drug cooks using organised "pill-shopping" syndicates - a practice known as "smurfing".

He says the Government was reluctant to adopt such a monitoring system "at great cost to the taxpayer, with a huge administrative burden for police and pharmacists, when it was so open to smurfing-type abuse." Gluckman notes that use of the system in Queensland has reportedly resulted in a 39 per cent decrease in the number of clan labs.

Galloway advised Key in August that New Zealand pharmacies had been offered the system free of charge for one year by the Pharmacy Guild of Australia; that the Ministry of Health intended to have 95 per cent of pharmacies connected to secure broadband (for online payment for dispensing) by July 2010; and that the Pharmacy Council could use its powers to ensure all pharmacies used the system.

"We are confident that this is the best way in which to balance the imperative of eliminating illicit methamphetamine production from pharmacy-supplied products with the public's requirements for efficient and inexpensive access to useful and safe medicines."

Disclosure: Chris Barton uses the pseudoephedrine-based Day Night Codral to get him through days when he has a severe head cold and a deadline. He's tried alternative medications. They don't work.