Proposed restrictions to accessing cold tablet ingredient

Following the announcement last week of the Prime Minister’s action plan on methamphetamine, some confusion has arisen over how tightly pseudoephedrine (a key precursor) will be controlled if it becomes a Class B2 drug.

meth-ephedrineMany media reports stated that under the new rules, pseudoephedrine will become “prescription-only”, without reference to any possible further restrictions on who can prescribe it and how. Others reported that the drug could be restricted to hospital pharmacies, and speculated that prescribing guidelines might limit it to sufferers of non-cold related conditions, like priapism.

The SMC approached an expert on drug classification and the Prime Minister’s Office for clarification.

Dr Keith Bedford, General Manager Forensic at ESR and current member of the Expert Advisory Committee on Drugs, which advises the Ministry of Health on classification of controlled drugs, comments:

“Drugs or substances listed as Class B2 under the Misuse of Drugs Act, may include both “banned” substances and drugs available on prescription.

“In general, conditions or restrictions around the availability of a drug are determined by medicines legislation and regulations, including Medsafe approval for use as a medicine, as well as any scheduling under the Misuse of Drugs Act.

“Another, well-known medicine that is listed as Class B2 under the Misuse of Drugs Act is methylphenidate (“Ritalin”).

“Substances that are listed as Class B2 under the Misuse of Drugs Act and are “banned” include N-ethyl MDA (also known as MDEA, one of the “ecstasy” class of drugs) and methaqualone.

“Scheduling of pseudoephedrine and ephedrine as Class B2 has implications for:

* Secure storage and handling requirements

* Prescription procedures in circumstances where either drug continues to be approved for use as a medicine. (Note that the Government has indicated that Medsafe will be asked to consider the pros and cons of a total ban on pseudoephedrine.)

* The powers and penalties available for law enforcement. For example, the penalty for importing or supplying a Class B2 drug is up to 14 years imprisonment, significantly higher than the penalties applicable for pseudoephedrine and ephedrine under their current scheduling.”

The Office of the Prime Minister issued this statement:

“Ministers have decided in principle to make Pseudoephedrine a Class B2 drug. Class B2 drugs require special prescribing procedures, including sign off from the Minister of Health. In practice, this is usually delegated to the manager of Medsafe but the Minister can delegate this approval to a class of medical practitioner, such as GPs or medical specialists. There is no intention to restrict PSE products to hospital pharmacies. That is a decision for the Cabinet and that is not what Cabinet has agreed to.”

To follow up with an expert quoted above, or to speak to other scientists on this topic, contact the Science Media Centre on tel: 04 499 5476 or email: