Response of the National Pharmacy Association (NPA) to the All Party Parliamentary Inquiry on proposals to restrict the availability of medicines containing ephedrine and pseudoephedrine

1. From your perspective, how much of a problem is methylamphetamine abuse?

We share the MHRA and Home Office 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.  Concerns appear to be based on reports from other countries such as the US and Australia where pseudoephedrine was more freely available to the public than in the UK.  In the US pseudoephedrine was previously available for self selection by customers in non-pharmacy outlets, in large pack sizes of 250 tablets (not in blister strips as in the UK) and in higher strengths than in the UK.  However despite this wide availability in the US only 10% of illicit methylamphetamine was produced from OTC medicines and of this the majority was acquired by theft.  Measures have since been taken in the US to restrict supply to pharmacy sale but similar restrictions already exist in the UK.

2. Do you feel there is a need for reclassification of ephedrine and pseudoephedrine containing medicines?

The NPA opposes the reclassification of ephedrine and pseudoephedrine containing medicines from P to POM.  We feel that reclassification would deprive many people of a safe, effective medicine and there is no evidence that reclassification would reduce methylamphetamine use in the UK.  Evidence from the US shows that even when pseudoephedrine was restricted to pharmacy sale the amount of methylamphetamine available on the street remained the same, proving that the major source of pseudoephedrine was not from non-prescription medicines.

3. Do you feel pharmacists are well placed to manage the sale of ephedrine and pseudoephedrine containing medicines?

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, for example, codeine-containing analgesics. 

4. What impact do you think reclassification will have on consumers’ accessibility of medicines containing ephedrine and pseudoephedrine?

Reclassification will severely restrict consumer access to these 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 short term treatment of self-limiting illnesses such as colds and coughs.  Patients will find it difficult and inconvenient to have to wait for an appointment to see their doctor to obtain these products.  Many of the affected products are included on the “blacklist” and are therefore not eligible for supply on NHS prescription.

5. What impact do you think reclassification will have on doctor’s workload and NHS costs?

Reclassification will inevitably increase both GP 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.  This is in direct contradiction of Government policy to encourage self care.

6. Consumers will be forced to pay a higher price for their medicines if the reclassification goes ahead, do you think this is justified?

No, we do not believe it is justified to expect consumers to pay a higher price for their medicines when there is no evidence that the reclassification will achieve its stated aims.  Many consumers will have to pay a prescription charge (£6.85 in England) to receive these products if the reclassification goes ahead.  This will encourage prescribing of larger quantities of these products which could lead to increased amounts of these products available in the community for misuse.  In addition, as many of the products are not allowed on NHS prescription it is likely that patients will not be able to receive the most effective product.  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 borne by the NHS.

7. What measures would you recommend?

We recommend that sensible precautionary measures should be adopted to minimise the risk of OTC pseudoephedrine products being used for methylamphetamine manufacture.  For example:

• pack sizes could be reduced to contain a maximum of 720mg (this is sufficient for short-term treatment of symptoms)

• pharmacists should limit sales to one pack per patient

• the NPA would support additional professional guidance from the RPSGB for pharmacists and their staff to ensure the sale of these products is closely monitored and controlled.

8. Do you believe that OTC products are readily available to replace those that contain ephedrine and pseudoephedrine?

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 unproven .  Topical decongestants are also unsuitable for many patients and use for periods longer than 7 days can cause rebound symptoms of congestion.