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MHRA: Safety of OTC products containing codeine ‘under review’

MHRA: All opioid-based painkillers could be reclassified if necessary
MHRA: All opioid-based painkillers could be reclassified if necessary

The Medicines and Healthcare products Regulatory Agency (MHRA) is keeping the “safety and availability” of codeine-based products “under review”, it has told C+D.

The MHRA will consider the possibility of reclassifying all opioid-based painkillers as prescription-only medicines (POMs) “as necessary”, a spokesperson told C+D last week (March 5).

The medicines regulator was responding to C+D’s question as to whether it would consider reclassifying codeine linctus from a pharmacy (P) medicine to POM, following an increase of enforcement notices placed on pharmacies for the “high purchase numbers of codeine linctus”.

Several regulatory restrictions have already been imposed on over-the-counter (OTC) products containing codeine over the last few years, the MHRA said.

These include recommending the use of OTC painkillers containing codeine and paracetamol, ibuprofen, or aspirin for a maximum of three days.

OTC medicines containing codeine have been limited to 32-tablet pack sizes or less, and they “carry prominent label warnings to highlight the potential for addiction and the fact they contain opioids”, according to the MHRA.

The medicines regulator told C+D it has received “a very small number of queries relating to the OTC status of codeine-containing medicines and is taking these into consideration in its ongoing monitoring of these medicines”.

C+D reported last month that the GPhC had placed conditions on the practice of 38 pharmacies between April 1 last year and January 31, with the majority chastised for “the online, over-the-counter supply of codeine linctus and promethazine-containing medicines”.

Result

Do you think codeine linctus should be reclassified from a P medicine to POM?
Yes
70%
No
15%
N/A, we don't really stock this product anymore
15%
Total votes: 150
4 Comments
Question: 
Do you regularly supply codeine linctus in your pharmacy?

Ranj Locum, Locum pharmacist

Ok, long rant, but very important. I don’t ever post here, but this is something that really gets me and I struggle to deal with the relaxed nature of codeine sales. ALL codiene products should be POM!

One of the benefits of being a locum is that I get to operate in lots of different areas. If you honestly believe there's no problem with selling opioids otc, then you are either burying your head in the sand or you have only worked in those rare areas where there are very few sales.

I get phone calls once, sometimes twice a week in different areas, asking if we sell codeine linctus. "what it is man. I have this dry cough, yeah. And the dokta, says this is the best thing for me"

All of these articles also act like the problem is limited to codiene linctus. I’m finding more and more that College and University age students are trying to buy codeine and Phenergan products (which should also be taken off otc!) Educate yourselves here and ask yourself why they want these? I hear horror stories of youngsters these days, mixing this stuff to make the recreational drug "sizzurp" aka"purple drank" aka "lean" or whatever else they want to call it. Why is this not something we’re addressing?!

Every time I sell co-codamol otc, I ask all the correct questions. However, like a robot, most people answer the questions before I finish my sentence and end with "I've not used it in months though and know not to use it regularly." 

Now, this is where the problem of being a locum lies. I don’t see the same customers regularly, so can’t really track who’s buying more often than they should. I could refuse the sale, but an adult has met the criteria based on their response. If I say no, then I get a complaint about prejudice (this has happened several times). All I can do is remind the staff to take a mental note of who’s buying codeine proudcts and reiterate to the patient, the 3 day rule and that it is highly addictive. Occasionally I get lucky and the counter assistant remembers a repeat customer and informs me to refuse the sale (and I try call the local pharmacies to be vigilant and try to signpost the customer).

Customers all know the answers by this point and know they can go elsewhere. When a patient asks what the strongest painkiller is, I will always recommend Ibuprofen and or paracetamol (and a rub too) if suitable. I will tell them that codeine is in theory the strongest, but it is a highly addictive opioid and that there are lots of people addicted and they don't even realise it. This gives them the info, so they can make an informed decision. At this point, you’ll be surprised by how many people will say "oh no, I don't want that". When this happens, I feel like I have a small victory. Those who decide to proceed, I will stress the 3 day rule (while selling them a box of 32 which lasts up to 4 days at the max dose. Work that one out!) and the addiction potential.

 

I don’t think it’s helpful telling patients that at otc doses codeine isn’t even a good painkiller. This will just make them want to buy solpadeine max! Thank god, in over a decade, I’ve never met a single patient who’s clocked on that they can get higher than POM doses codeine, if they went to two pharmacies bought both solpadeine max and neurofen plus (not to mention linctus), but there are no doubt people out there that are aware of this.

Things that need doing:

Pharmacists being extra vigilant with otc sales and giving counter staff a refresher. Reiterate the importance of short term use and highly addictive nature (I even tell them why it’s addictive! If they are better informed they will think twice).

 

We seriously need to an otc sale of opioids product Audit. Yes clinical audits are annoying, but they’re all about patient safety. This may reveal some startling figures and may potentially reveal an opioid epidemic! Until we get data, nothing will happen.

 

Perhaps have leaflets/sign posting information for people we refuse sales to.  Over 99% will chuck these away and leave in huff, but if we get through to some people it’s worth it. Often people come to buy for their partners, so it may be easier to give the info to them and let them have the hard talk.

Tell GPs and dentists to not recommend otc co-codamol regularly (why does this still happen?!)

 

Stop advertising these products! If we are going to sell them make cigarette-style packaging a legal requirement (yes I’m serious here). White box, with a warning label, pack size 24 and factual information about codeine addiction.

Conor M, Community pharmacist

We do not stock the linctus for OTC sale in my Pharmacy. It should be reclassified as a POM.
It is a little extra work to sort out the abusers vs. those in genuine short term need of something a little stronger than Paracetamol, but I would like to still see Co-codamol/Solpadeine MAX etc. kept as P medicines. They shouldn't be advertised all over the place though.

Bob Dunkley, Locum pharmacist

I too would like to see codeine removed from sale - my only worry is - what is going to replace it? There exists a body of people outside of the people who frequent heroin cocaine circles, but nevertheless have a substance use disorder based exclusively on codeine, nothing stronger. These are the "Respectable Addicts" whose life revolves around codeine etc. Whilst for the greater good it is imperative that codeine is controlled, this move will cause distress to these people.

Kevin Western, Community pharmacist

The sooner its all reclassified the better. I'm tired of sorting the few genuine people needing codeine from the masses of abusers.... the marketing/advertising of this needs to be halted as a minimum.

 

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