Pseudoephedrine

The CCA partially supports the proposal contained within MLX 343. We would agree that packs containing more than 720mg pseudoephedrine or 180mg ephedrine should become subject to prescription control. This would give effect to the support given by the national pharmacy bodies in response to the earlier MLX 337 to proposals from the manufacturers to reduce the pack sizes of pseudoephedrine and ephedrine-containing products available for OTC sale, as part of the mechanism to further reduce the likelihood of OTC medicines being the source of precursors in the illicit manufacture of methylamphetamine (“crystal meth”). However, we would argue that amending the Prescription Only Medicines (Human Use) Order 1997 to make the sale of such quantities at any one time a criminal offence would remain a disproportionate response.

The national pharmacy bodies proposed and have implemented a voluntary “one pack per transaction” rule in response to MLX337, supported by the development of awareness materials promoting it. All CCA member companies are now in the process of implementing awareness programmes, and are committed to ensuring that all staff involved in the sale of medicines to the public complete a programme. However, we believe that, in the interests of the public health, there may be a number of occasions, notably where a consumer wishes to buy effective medicines for both adults and children in a family, that it would be appropriate, at the discretion of a pharmacist, for the sale of two packs of different formulations to be made, without having to resort to a ruse to get around a “one pack per transaction” legal position.

We would therefore ask the MHRA to consider, if a maximum “per visit” limit is to be imposed, that the quantities be set at a level that allows the supply of a quantity of less than two packs of solid dose form – ie less than 1440mg pseudoephedrine (or equivalent) – but more than one pack – 720mg pseudoephedrine (or equivalent) – so this specific circumstance might be met, without unduly inconveniencing the public, or causing them to lose confidence in the services of their pharmacist or pharmacy. We would additionally suggest that such a move could be supplemented by the addition of pseudoephedrine and ephedrine as Controlled Drugs to the Misuse of Drugs Regulations in order to criminalise possession or supply of more than a quantity deemed appropriate for normal use, a move that would also bring sanctions regardless of the source of the pseudoephedrine or ephedrine.
 

BACKGROUND
In its response to MLX 337, the CCA fully recognized and accepted the legitimate concerns of the Commission on Human Medicines that given the physical, psychological, social and economic harms associated with consumption of methylamphetamine, the overall risk to UK public health of an escalation in its use, and indeed from the home production process, would be substantial.
The Association supported, along with the other pharmacy bodies, the implementation of a robust, but balanced package of measures, including:

  • A restriction on sales of pseudoephedrine and ephedrine products to one pack per transaction.
  • All pharmacists and staff involved in the sales of OTC medicines to complete an awareness programme covering the issues and the agreed actions.
  • A reduction in the pack size of pseudoephedrine and ephedrine containing products, so that only packs containing a maximum 720mg pseudoephedrine or equivalent, are available for pharmacy sale.
  • Monitoring of sales patterns and trends by manufacturers and the supply chain.
  • Reclassification of pseudoephedrine and ephedrine as Controlled Drugs under the Misuse of Drugs Regulations to limit the quantities available to the public, and criminalising possession or supply of unexplained quantities of the medicines.


We therefore welcome the outcome to the consultation delayed reclassification of the products in all forms and quantities to POM until July 2009, allowing the opportunity for the measures proposed by pharmacy to be implemented as the means to contain the illicit manufacture of methylamphetamine through misuse of OTC medicines.
 

Pharmacists and pharmacies: existing controls
As we explained in our response to MLX337, Pharmacy medicines sales are restricted to pharmacies, where personal control is exercised by a registered pharmacist, operating under professional codes of practice and local standard operating procedures. Pharmacists are specifically trained in the use of medicines and are used to dealing with medicines that are liable to being abused. Staff given delegated authority to sell medicines under a protocol, and under the supervision of a pharmacist, must have undertaken or be undertaking an accredited training course relevant to their duties.


Action taken by the CCA to date
The CCA has played a leading role within pharmacy is agreeing and promoting the robust package of measures. As part of the implementation of the solution the CCA has made developed and made available across pharmacy an awareness programme – Methguard UK – working with LearnSomething Inc, a US training provider with extensive experience of methylamphetamine awareness programmes in the US and Canada. Methguard UK is available as an online programme and in CD-ROM and paper versions, through a variety of providers to both chain and independent pharmacy owners, while LearnSomething’s experience with credentialing means that completion is tracked at the individual level, a feature particularly important within the multiple environment.

At the same time, the CCA has used its increasing professional press profile not only initially to ensure the importance of this issue was communicated to pharmacists and medicines counter assistants, but continues to do so to ensure pharmacy teams complete awareness programmes and implement effectively the agreed actions.
 

PROPOSAL

1. Reclassification of products containing more than 720mg pseudoephedrine or 180mg ephedrine as POM (paragraphs 9 and 10 of MLX343)

The CCA supports this part of the proposal, but would wish to ensure that sufficient time is given in order to avoid pharmacists being left with stocks of larger packs. The movement of packs through the supply chain will to some extent be dependent on the severity or otherwise of the winter colds season. At this stage we would suggest that in order to avoid unnecessary costs to pharmacy and to manufacturers a slightly longer period is given for this exercise, recognising that in their correct use, products containing pseudoephedrine and ephedrine are safe and effective medicines, and would suggest that the transitional period for implementation be 1 July 2008.

2. Underpinning controls making sale of more than one pack illegal (paragraphs 12 and 13 of MLX 343)

The CCA does not support this proposal. As we have stated above, pharmacists are healthcare professionals well used to handling medicines that are liable to be misused. The CCA contributed to the development of the voluntary “one pack per transaction” agreement from all the pharmacy bodies, and continues to work for its implementation across the profession. As MHRA knows, this voluntary restriction is supported by professional guidance from the professional bodies, the Royal Pharmaceutical Society of Great Britain and the Pharmaceutical Society of Northern Ireland. Our start point, therefore, is that the voluntary agreement should be implemented, and compliance monitored, and we believe the use of criminal sanctions to enforce it is disproportionate at this time.
However, in the light of the substantive proposal from MHRA to enforce a voluntary restriction with criminal sanctions for non-compliance, we have had the opportunity to examine this issue further, we believe there are a small, but significant, number of occasions where the purchase is sought of different formulations of pseudoephedrine and/or ephedrine products for use by different members of a family. We think it is not in the best interests of patient care, nor would it support patient confidence in their pharmacy for pharmacists to have to refuse such requests so as not to break the law, or resort to some elaborate means to provide both products in what might be classed as two separate transactions.

If MHRA were to amend the POM Order to impose a daily limit on sales, we foresee considerable difficulty in explaining to patients that they need to visit another pharmacy or return on another day to obtain the second medicine, and make a choice on which to buy at the time.

We would therefore suggest that, rather than impose a one pack limit, if the POM Order is to be used, then the maximum sale per transaction be calculated as quantities such as to prevent the sale of two packs of solid dose form pseudoephedrine (or equivalent) but allow the sale of packs of different formulations (the liquid packs contain less total pseudoephedrine that the solid dose packs) without breaking the law. Were such an approach to be allowed, we would be happy to enter into discussions, through the Commission on Human Medicines’ Expert Advisory Group on whether such exceptional sales should be subject to some form of record keeping.

We would finally submit that there may be an alternative or additional route to the use of the POM Order to provide a criminal sanction that would be useful in the prosecution of those who would seek to be involved in the illicit manufacture of methylamphetamine, whatever the source of pseudoephedrine. In our response to MLX337, we suggested that pseudoephedrine and ephedrine be scheduled under the Misuse of Drugs Act to criminalise possession of quantities in excess of an amount that would be considered appropriate in normal use. We still consider this worth pursuing.