Deal with over-the-counter requests for pseudoephedrine with confidence
With autumn upon us and winter around the corner pharmacists will start to see an increase in patients asking for medicines for colds and influenza. Are you and your staff confident in handling those requests for “two boxes of Benylin 4 flu”? In the second article in our professional judgement series produced by the Royal Pharmaceutical Society’s support service, senior legal and ethical pharmacist. Wing Tang reminds readers of the restrictions and outlines signs of misuse
Among the range of medicines that pharmacists in the UK have at their disposal for cold and influenza symptoms will be products containing ephedrine and, more commonly, pseudoephedrine.
These drugs were reconfirmed in July 2010 as retaining pharmacy-only status by the Medicines and Healthcare products Regulatory Agency — a position to be reviewed again in July 2011.
The classification of products containing pseudoephedrine or ephedrine is reviewed regularly and supply restrictions are in place because they can be used in the illicit production of the highly addictive, class A Controlled Drug methylamphetamine, also known as “crystal meth” and “ice”.
Some countries, such as Australia and the US, have major problems with methylamphetamine abuse and subsequently have tighter controls on supply than the UK. The UK currently has relatively low levels of abuse, not least because of the continued vigilance of pharmacists and pharmacy staff and the restrictions already in place (see below).
Other countries have taken various approaches to restriction. In Mexico pseudoephedrine is banned, while in Norway, Sweden and Finland both pseudoephedrine and ephedrine are prescription-only medicines.
What are the UK restrictions?
Since 1 April 2008 it has been unlawful to sell or supply any pseudoephedrine product with an ephedrine product at the same time without a prescription. It also became unlawful to supply more than 720mg of pseudoephedrine or more than 180mg of ephedrine at any one time without a prescription
So, for example, this means it is illegal to sell a bottle of Day Nurse liquid and a packet of 20 Day Nurse capsules together.
Since the restriction, some manufacturers reformulated their products to remove the pseudoephedrine. Panel 1 lists some common cold and flu preparations that contain pseudoephedrine.
The key legal points are summarised in Panel 2 (p514).
Panel 1: Examples of OTC pseudoephedrine
Panel 2: Key points
It is unlawful to supply a product or combination of products that contains more than 720mg of pseudoephedrine or 180mg of ephedrine at any one time without a prescription.
It is unlawful to sell or supply any pseudoephedrine product together with any ephedrine product without a prescription.
Sale or supplies should either be made personally by the pharmacist or by pharmacy staff who have been trained on pseudoephedrine and ephedrine issues, and who know when to refer to the pharmacist.
Even when a request is made for a lawful quantity, the sale or supply can and should be refused where there are reasonable grounds for suspecting misuse — be vigilant for signs of misuse and be aware of suspect requests even if these fall within the legal limits.
The issue for pharmacists and pharmacy staff is how to spot and handle suspect requests. There are a number of possible signs that can be used by the pharmacist or pharmacy staff to build a profile and make a professional judgement on how suspect a request is. These are described in Panel 3.
It is also important to remember that the people purchasing pseudoephedrine and ephedrine for illicit purposes may not be users of methylamphetamine and may not conform to stereotypes. They can be of any age, sex and background.
Requests considered suspect should be refused and also reported to the local police Controlled Drugs liaison officer or General Pharmaceutical Council inspector. (To find out who the inspector is for your area and how to contact them, visit www.pharmacy regulation.org)
A Royal Pharmaceutical Society quick reference guide for dealing with suspect requests of pseudoephedrine and ephedrine (“Pseudoephedrine and ephedrine: look, listen and report your suspicions”) can be downloaded and kept in the pharmacy as a reminder.
Dealing with what is thought to be a genuine request for quantities over the legal limit can, arguably, be more difficult. For example, where the purchaser wishes to obtain products for a whole family that is suffering cold or flu symptoms, the legislation can be an inconvenience.
Viable options, without breaking the law, include recommending alternative preparations containing decongestants that are not restricted, such as phenylephrine (see Panel 4 for examples) or xylometazoline. With so many similar cold and flu products, it may be advisable to check the packaging for ingredients each time.
Another option is to suggest that a family share the same packet of medicine and the person return for more once the packet is finished.
Further information, such as the MHRA annual report on pseudoephedrine and ephedrine misuse is available online, but members requiring further support and advice can contact RPS support (email: firstname.lastname@example.org; tel 0845 257 2570).
Panel 3: Signs of misuse
Nervous or guilty behaviour — the customer avoids eye contact, appears uncomfortable answering questions, or is unusually timid
Lack of symptoms — the customer is not suffering from cough, cold and flu symptoms or, if buying for someone else, is unable to describe his or her symptoms
Rehearsed answers — the customer’s answers appear rehearsed or scripted
Impatient or aggressive — the customer is in a hurry to complete the transaction
Opportunistic — the customer waits for busy periods in the pharmacy or until less experienced staff are available
Specific products — the customer wants products that contain only pseudoephedrine (eg, Contac 12 hour relief, Sudafed non drowsy 12 hour relief) or only ephedrine
Paraphernalia — the customer wishes also to purchase other items that can be used to manufacture methylamphetamine (eg, lithium batteries and acetone)
Panel 4: Examples of OTC phenylephrine
Citation: The Pharmaceutical Journal URI: 11041158
Recommended from Pharmaceutical Press
Pharmaceutical Press is the publishing division of the Royal Pharmaceutical Society, and is a leading provider of authoritative pharmaceutical information used throughout the world.Visit rpharms.com