Reformulations of pseudoephedrine- and ephedrine-containing drugs in the UK look unlikely following the announcement of less extreme restrictions on the sale of the pharmaceuticals.
The Medicines and Healthcare products Regulatory Agency (MHRA) announced last week tighter controls would be placed on cold and flu remedies containing the pharmaceutical active ingredients pseudoephedrine and ephedrine, but the drugs would retain their over-the-counter (OTC) status.
Following an MHRA proposal in March this year, there was the fear the drugs would be reclassified as prescription-only in a bid by health authorities to tackle the rare but concerning problem of OTC ephedrine- and pseudoephedrine-based drugs being used illicitly in the production of the Class A controlled drug methylamphetamine (crystal meth).
A decision to reclassify to prescription-only was described by pharmaceutical industry professionals at the time as a "disproportionate response to the problem" and could have a variety of impacts, including a drive by manufacturers to reformulate products to stay in the OTC game, which could be an expensive and risky process.
But, the tighter controls, following public consultation between March and June, would now see the drugs retaining their OTC status, but pack size would be restricted to 720mg (equivalent to 12 tablets or capsules of 60mg or 24 tablets or capsules of 30mg), there would be a limit of one pack per customer and the recommendation that the sale should be carried out by a pharmacist.
The MHRA also announced the legal status of the products would be reclassified to prescription-only in July 2009 if the current measures to be implemented did not control the risk that the drugs could be misused.
But the Proprietary Association of Great Britain (PAGB) was "confident" there would be no need to reclassify the drugs.
"We are confident the new restrictions will work as a precautionary measure," PAGB executive director Sheila Kelly told in-PharmaTechnologist.com.
Because the drugs were still OTC there was no real need to reformulate them, though it would be up to individual manufacturers whether they wanted to go down that path, Kelly said.
"We support the measures being introduced to restrict the supply of medicines containing pseudoephedrine. Whilst acknowledging the serious harm methylamphetamine can inflict, this is a sensible and proportionate approach to a problem that is still almost nonexistent in this country, but one we all want to avoid," she said.
Kelly believed there would be little impact on manufacturers to reduce the pack size, when only seven products on the market were above the MHRA recommended size. As a result there would be a minimal cost to manufacturers, she said.
The UK is not considered to have a major methylamphetamine problem, though there are concerns regarding immigrants arriving from countries where the black market is well established such as the Czech Republic.
The move to introduce restrictions is in line with other countries such as the US, Canada and Australia
The US introduced restrictions last year where drugs are only available from locked cabinets or behind the counter and the pharmacist is required to keep a record of the sale with the purchaser required to show photo ID.
The state of Oregon and Mexico have gone one step further making pseudoephedrine a prescription only medicine.
Meanwhile, the Netherlands withdrew pseudoephedrine from the market in 1989 because of concerns regarding cardiac safety.
A Commission on Human Medicines expert working group will be set up next month to develop further plans for pharmacy controls in the UK including sales tracking and monitoring, recording of sales, and a proposal to the Home Office to make pseudoephedrine and ephedrine a controlled drug under the Misuse of Drugs Regulations.
MHRA director of vigilance and risk management of medicines Dr June Raine said in a statement: "The MHRA is introducing these measures to protect the public health following concern that was highlighted during the consultation process. All stakeholders will be working together to ensure the controls are effective. The expert group will be carrying out a continuous programme to monitor the situation."
Pseudoephedrine is a decongestant, used in cough and decongestant remedies to treat nasal and sinus congestion caused by the common cold, sinusitis, hay fever and other respiratory allergies. It has been available over the counter for more than 50 years, either in single-ingredient preparations, or more commonly in combination with antihistamines, paracetamol and or ibuprofen.
There are 97 authorised products containing pseudoephedrine and 17 containing ephedrine.
In 2006, just over 10 million packs of medicines containing pseudoephedrine were sold, at a retail value of £40m (€59.2m). Pseudoephedrine products account for 40 to 50 per cent of the oral decongestant market.
Methylamphetamine was reschedules to a Class A drug on January 18 this year to reflect the true harms of the drug when it is misused.
The new controls will be phased in over the next few months.