28th June 2007

Response of the National Pharmacy Association to consultation letter MLX 337 - proposals to restrict the availability of medicines containing pseudoephedrine and ephedrine by a change to legal status from pharmacy (P) to prescription only (POM) together with a restriction in pack size

Introduction

The NPA represents the interests of community pharmacies. We have, in voluntary membership, over 12,000 community pharmacies, which comprises virtually all the community pharmacies in the UK. The NPA provides a representative voice for its members as well as a range of services to help them with both commercial and professional aspects of running their businesses. 

The NPA strongly opposes the reclassification of ephedrine and pseudoephedrine containing medicines from P to POM.  We believe that healthcare professionals across the UK are united in the view that the proposed reclassification will be not achieve its stated aims of preventing widespread methylamphetamine abuse but instead will have serious consequences by depriving the public of a safe and effective medicine as well as increasing NHS workload and costs.  We also wish to raise in this response our grave concerns about the misleading representation of evidence during the consultation process.

Evidence for reclassification

The NPA shares the MHRA and Home Office’s concerns about the potential risks to public health posed by the threat of increased methylamphetamine manufacture in the UK.  However there is currently little evidence of widespread methylamphetamine manufacture or use in the UK and the limited current demand is being met by importation from overseas.  There is also little evidence that methylamphetamine is being produced in the UK from products purchased over the counter in pharmacies.  Concerns appear to be based on reports from other countries such as the US and Australia where pseudoephedrine has been more freely available to the public than in the UK.  It is important to note that some of the conditions that enabled the illicit manufacture of methylamphetamine in clandestine laboratories to become widespread in other countries do not exist in the UK. For example, until recently in the US, pseudoephedrine was widely available in non-pharmacy outlets in doses of 240mg and in packs containing up to 250 tablets. Despite this, at the height of illicit manufacture on home soil in the US, only 10% of the pseudoephedrine used came from over-the-counter sources and much of this was obtained by theft. The majority of methylamphetamine consumed in the US is produced by organised criminals in Mexico.  In 2005, the US Federal Government passed the Combat Methamphetamine Epidemic Act which brought in controls on the sale of pseudoephedrine. However, these controls are not as strict as the controls that already exist in the UK as pseudoephedrine is still available in non-pharmacy outlets in the majority of states. In the UK, all medicines containing ephedrine or pseudoephedrine are Pharmacy medicines, which means that they may only be sold by or under the supervision of a pharmacist from registered pharmacy premises. In addition, the Royal Pharmaceutical Society’s Code of Ethics requires Pharmacy medicines to be unavailable for self-selection by the public and for all medicines counter assistants to have undergone a programme of approved training. Furthermore, evidence from the US shows that when pseudoephedrine was restricted to pharmacy sale, the number of small domestic illicit laboratories decreased but the amount of the drug available on the street remained the same.  Production switched to organised criminals abroad or raw materials were obtained by ram raids and burglaries of pharmacies and wholesalers.  It is likely that reclassification in the UK to POM status would have similar consequences and the availability of methylamphetamine would not be reduced by the proposed reclassification. 

 

We understand that it takes around 200 x 60mg pseudoephedrine tablets to manufacture around 8g of methylamphetamine, enough for a couple of ‘hits’ for personal use. We disagree with the assertion that it will be ‘easy to amass enough pseudoephedrine for manufacture of sizeable quantities of methylamphetamine’. It will not be straightforward to obtain this quantity, even by visiting a number of different pharmacies, nor will it be cheap. If methylamphetamine abuse becomes widespread in the UK, we do not believe that it will be made in small domestic illicit laboratories when simple economics dictate that it is cheaper to manufacture abroad.

The Serious Organised Crime Agency (SOCA) notes that pseudoephedrine is not the only precursor that can be used for the manufacture of methylamphetamine.  Products containing ephedrine may also be used and these are widely available over the internet where they are sold for weight loss or body building.  There are also other methods of manufacture which use precursor chemicals such as benzylmethylketone.  This means that even if pseudoephedrine was unavailable for legitimate purchase, criminals would still be able to produce the drug from other freely available ingredients.

Option 1 – no action until the threat is proven

We agree that this is not an effective response.

Option 2 – a package of non-statutory controls on the sale of ephedrine and pseudoephedrine containing products.

We believe that option 2, originally proposed by the Proprietary Association of Great Britain (PAGB), is the most viable of the four options and is likely to be the most effective in preventing the illicit manufacture of methylamphetamine from legitimate sources of pseudoephedrine.

Pharmacists are well placed to spot misuse of OTC medicines. In fact, in 1998 when soft gelatin capsules of diphenhydramine were withdrawn, it was pharmacists who first noticed the potential for abuse and rapidly highlighted the issue.

 

Cleveland test purchases

The MHRA published additional information in May 2007 including a report of the “Cleveland test purchases”.  The NPA believes the publication of this report by the MHRA to be extremely misleading and is concerned that such a course of action was undertaken during the public consultation period.  The MHRA report suggests that despite a local awareness campaign 13 pharmacies in the Cleveland area sold 45 boxes of decongestants to two 15 year olds.  This report is misleading for several reasons.  Firstly, the exercise was organised by a local police officer (who was unaware their report had been published by the MHRA until we contacted them) as part of a baseline study.  The objective was to discover the existing level of awareness amongst local businesses of the sale of chemicals (not specifically pseudoephedrine) and then to repeat the test purchases following an awareness campaign.  On contacting pharmacies in the area we found that none of them were actually aware of any local awareness campaign that had already been conducted suggesting that the campaign had not been effective or widespread.  The police officer stated that the awareness campaign conducted so far had taken the form of personal visits to raise awareness of requests for chemicals following the arrest of a local person and concerns that this may divert requests for chemicals for illegal purposes to local businesses.  It is difficult to see how this could be interpreted as raising awareness of the misuse of pseudoephedrine as suggested by the MHRA report.  Secondly, the report states that 45 packs of decongestants were purchased by the teenagers.  However the teenagers requested “Sudafed” which is the brand name for a range of products that contain several different active ingredients and in fact only 12 packs of medicines containing pseudoephedrine were purchased from the 13 pharmacies in total.  The remaining 33 packs purchased contained other ingredients including phenylephrine which pharmacy staff would correctly treat as a non-suspicious purchase. The NPA believes that publication of this misleading report as ‘additional evidence to be considered as part of the public consultation’ to be contrary to the Cabinet Office Code of Practice on Consultation and we have written to the MHRA separately on this issue.

Suggested measures

Pharmacists are highly trained healthcare professionals who are bound by a strict Code of Ethics from the Royal Pharmaceutical Society of Great Britain (RPSGB).  Pharmacists are ideally placed to manage the sale of these products and are already used to monitoring and limiting the sale of several other OTC products with abuse or misuse potential.  The NPA believes that the pharmacy profession can ensure that products containing ephedrine or pseudoephedrine are sold responsibly and that sales are controlled and monitored. 

The NPA recommends that sensible precautionary measures be adopted by pharmacists voluntarily to minimise the risk of OTC ephedrine and pseudoephedrine-containing products being used for methylamphetamine manufacture whilst ensuring that the products are still available to patients who need them. 

In conjunction with the other major pharmacy bodies, the NPA proposes the following robust package of non-statutory controls as an alternative to reclassification:

• Reduction of pack size to a maximum of 12 x 60mg tablets (or equivalent)

• Royal Pharmaceutical Society of Great Britain (RPSGB) to make it a professional requirement to sell a maximum of one pack per transaction

• Products containing pseudoephedrine or ephedrine to remain unavailable for self-selection

• An awareness raising programme for pharmacists and pharmacy staff. (In fact, the NPA and RPSGB have already written jointly to all pharmacy owners in the UK to alert them to the potential for misuse of pseudoephedrine and ephedrine and a copy of this letter is attached as Appendix 1)

• Pharmacists and pharmacy support staff to undertake an awareness training programme.  Details of expected content and learning objectives for a UK pharmacy educational awareness programme have been developed jointly with the UK pharmacy bodies and further information is attached as Appendix 2

• Pharmacy trade press to maintain high profile awareness campaigns

• Pharmacists and pharmacy staff to monitor sales of pseudoephedrine and ephedrine closely and to report suspicious behaviour to local drugs squad officers

• Wholesalers, manufacturers and pharmacies to monitor sales patterns and trends in order to identify any unexplained change to sales or trends so that this can be further investigated. We are aware that sales of pseudoephedrine are decreasing so any changes to the long term trend UK-wide, or the appearance of a local sales peak should merit investigation. 

The NPA, together with the other pharmacy bodies, is willing to explore the possibility of record keeping with the MHRA. However, after much discussion with the other pharmacy bodies and consumer representatives, we do not believe this will add any value to the process unless photographic identification is also presented and this has serious implications for civil liberties and data protection, as well as timely access to medicines. However, it may be useful in certain circumstances, for example, where police officers in a particular area have suspicions about the behaviour of certain individuals or where pharmacy staff wish to refuse a sale. The NPA would be happy to work with other stakeholders, particularly the Home Office and the police, to explore how record keeping could add value to the overall programme of controls.

Options 3 and 4 – POM control

The NPA does not believe that these options will be any more effective in controlling the potential threat from methylamphetamine abuse than option 2. In addition, for the reasons outlined below, we believe these options will increase costs to patient and to the NHS and will impact heavily on GP workload.

The NPA does not agree that these options will ‘ensure that the illicit manufacture of methylamphetamine from these products would cease in the UK, possibly almost immediately’. This assumes that illicit manufacture uses, in the main, OTC medicines when, in fact, all the evidence from comparator countries shows that the majority of pseudoephedrine used is from bulk supplies of raw chemical.  Information on the control of pseudoephedrine sales in other countries is attached as Appendix 3.  This information demonstrates that the proposals for reclassification in the UK go far beyond the measures introduced in other countries.

These options are disproportionate to the extent of the problem and are no more likely to prevent widespread methylamphetamine abuse than the other options.  The NPA opposes the reclassification of ephedrine and pseudoephedrine containing medicines from P to POM as there is no evidence that this would reduce methylamphetamine manufacture in the UK.  It is important to remember that the overwhelming majority of requests for products containing pseudoephedrine are from patients needing relief from their symptoms rather than from the theoretical minority of individuals who may try to purchase the product for illegal drug manufacture.  In fact there is little evidence that OTC purchases have been used in this way in the UK. 

Impact on patients

Reclassification will severely restrict consumer access to a range of safe, effective medicines.  These ingredients are contained in over 100 licensed OTC products in the UK including many popular cough and cold remedies.  These products are used for the short-term treatment of self-limiting illnesses such as colds.  Patients will find it difficult and inconvenient to have to wait for a GP appointment to obtain these products.  Many of the affected products are included on the “blacklist” and are therefore not even eligible for supply on NHS prescription. Many consumers will have to pay a prescription charge to receive these products if the reclassification goes ahead. As this charge is much greater than the retail price of the products, patients will be disadvantaged.  We do not believe it is justified for consumers to pay a higher price for their medicines when there is no evidence that the reclassification will achieve its stated aims.

We are also concerned that if pseudoephedrine containing products were no longer available through pharmacies this could have a significant impact on patients health and GP workloads during the peak cold and influenza season and could lead to serious capacity problems within the NHS.  Restricting patients’ access to a safe, effective medicine could also have potentially disastrous consequences when the expected influenza pandemic occurs. 

It is difficult to see why the vast majority of patients in genuine need should be deprived of a product which provides effective relief from their symptoms when it is likely that if the products are reclassified criminals will simply turn to other sources of the raw or finished product such as via the internet, from abroad or via organised crime. 

Impact on doctors

The responsibility for ensuring that the products are not available for misuse will be transferred from community pharmacies to GPs and their staff.  There is no evidence that this will increase the level of control.  GPs and practice staff will not have the time or the resources to ensure that they are only prescribing pseudoephedrine in cases of genuine need and it is likely that larger quantities would be prescribed than would be available over the counter through pharmacies. Patients are likely to want to stockpile larger quantities to reduce the frequency of GP visits and to avoid paying prescription charges.

Reclassification will inevitably increase both GP’s workloads and NHS costs as patients will be forced to see their doctor to obtain products on prescription that were previously available for them to purchase from the pharmacy.  The Proprietary Association of Great Britain (PAGB) have calculated that if just a third of people who currently self medicate were to go to the GP, each GP would have an extra 389 visits a year and this would cost the NHS £350m.  This is in direct contradiction of the Government’s stated policy to encourage patients to treat minor ailments without accessing the GP and to encourage self care by patients.  In addition, some patients may decide not to visit their doctor at this stage which could result in increased complications and further costs and GP involvement at a later stage.  The majority of prescriptions dispensed are for patients who are exempt from prescription charges and so it is also likely that the increased cost will be paid for by the NHS.

Impact on pharmacy

Pharmacists are used to having effective treatments available to recommend to patients. There is no effective alternative OTC product to replace ephedrine and pseudoephedrine.  The most commonly used alternative is phenylephrine. However Professor Eccles of the Common Cold Centre stated in a recent review that 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 unproven1.  Topical decongestants are also unsuitable for many patients and use for periods longer than 7 days can cause rebound symptoms of congestion. Therefore, pharmacists will have no effective products that they can confidently recommend to patients suffering from nasal congestion.

In addition, we believe a move to POM would seriously undermine the important role of the pharmacist in self-care and give out negative subliminal messages about pharmacy’s ability to supply these medicines responsibly.   By retaining pseudoephedrine products under pharmacy control pharmacists will be able to monitor and control sales and in addition are ideally placed to alert the relevant authorities when suspicious requests are received.

Impact on minor ailment schemes including Scotland

The NPA has over 1000 community pharmacy members in Scotland and we are concerned about the effect reclassification would have on the successful implementation of the new pharmacy contract in Scotland.  As a core service within the new contract in Scotland the Minor Ailment Service (MAS) allows patients who are exempt from prescription charges to access a community pharmacist as a first port of call for a consultation regarding minor illness. This can lead to the pharmacist giving the patient advice, or advice and/or a prescription for any P or GSL medicine (provided it is not blacklisted) for free or referral to another healthcare practitioner.

Over 700,000 patients have registered for this service in Scotland to date and community pharmacists are conducting over 50,000 consultations a month of which a high proportion are consultations for cough and cold symptoms. Reclassifying pseudoephedrine to POM would have a severe impact on this service in Scotland driving patients back to GP surgeries instead of patients having easy access to their community pharmacist.  Reclassification would also impact on minor ailments schemes in England and Wales.

Summary

The NPA strongly opposes the proposed reclassification of products containing pseudoephedrine and ephedrine.  We believe that if the products are reclassified:

• Patients will no longer have access to safe effective remedies for symptoms of congestion, colds and flu

• Patients’ consultations with GPs for minor ailments will increase as they seek relief of their symptoms or present with later complications due to being unable to treat their symptoms at an earlier stage

• GPs and GP practices (including nurse prescribers) workload will increase

• Costs to the NHS will increase due to increased drugs bill costs when the products are prescribed rather than purchased as previously and other associated costs due to GP and other prescribers time

• There will be little effect on methylamphetamine manufacture and abuse in the UK

The NPA is happy to discuss in more detail any of the issues raised in this response.