Tuesday is HEALTHplus supplement day with the IT. Yesterday there was two pieces in it relating to the recent codeine guidelines.
The first related to the drop in sales of codeine products.
Default Pharmacy guidelines halve sales of codeine drugs
Irish Times Health Supplement
The pharmacy union says the new rules are misleading customers and creating a stigma regarding the use of certain painkillers
THE IRISH Pharmaceutical Union (IPU) has said that sales of products containing codeine have fallen by up to half since new guidelines governing their use came into effect.
Under the new Pharmaceutical Society of Ireland rules, the products must only be supplied under the personal supervision of a pharmacist. The pharmacist must advise customers to use them only when necessary and for the shortest time possible. All advertising and window display of codeine-containing medicines, which include Solpadine and Nurofen Plus, is also prohibited.
“Sales are half of previous levels,” said Darragh O’Loughlin, president of the IPU. “There’s almost a stigma attached to asking for these products now. The legislation is supposed to be about stopping addiction, not stopping sales altogether.”
Mr O’Loughlin said there were other impacts. “The pharmacist has to be involved in every sale, which means patients are left waiting,” he said. “If you start talking about the dangers of addiction, it can feel like an accusation.”
Rory O’Donnell, vice president of the IPU and owner of two pharmacies in Donegal, said there was a misconception that codeine was no longer available because it was no longer visible. “Some now think they can’t get it, even though it may be the most appropriate thing for them to take.”
On the positive side, however: “In some cases, patients were taking codeine for pain that wouldn’t respond to it so they are happy to be prescribed something more appropriate.”
Kathy Maher a pharmacist in Meath said: “the codeine issue did need to be addressed, but taking the products out of view has stigmatised them”.
Patrick McCauley, managing director of Sam McCauley chemists, which has 24 stores, said sales of codeine products had almost halved: “Half of codeine sales would not reflect those with an addiction.”
He said there had been an increase in sales of non-codeine alternatives such as paracetamol and that the numbers treated for overuse of this was far greater than those treated for codeine addiction. Describing the new rules he said, “it’s like trying to swat a fly with a sledgehammer.”
Kate O’Flaherty, head of communications at the Pharmaceutical Society of Ireland said: “There may be a misunderstanding about the role of the pharmacist in the public eye – the pharmacist has to be satisfied the supply is safe and appropriate.”
Regarding the increased counter time required of pharmacists, Ms O’Flaherty said: “the act increases the role of the pharmacist and some may need to ask if they have enough pharmacists in the store.”
To anybody involved with pharmacy the article it was old news. However I picked up on a comment by Kate O’Flaherty of the PSI. “…and some may need to ask if they have enough pharmacists in the store.”
So as far as the PSI is concerned we have gone from being community pharmacy to being a “Retail Pharmacy Business” to a “store”. In a way I am not surprised by their lack of respect for the skills of the pharmacist but I never thought that they could go as far as misunderstanding the role of a pharmacy. Well at least they didn’t call us hucksters.
The second piece questions the recent trend by the PSI to try and legislate by guidelines. I cannot find much wrong with this piece.
Default Has the regulator overstepped its powers?
Irish Times – Supplement 26/10/10
ANYONE WHO has been to their pharmacy recently and asked for a packet of Solpadeine, Nurofen Plus or other painkiller containing codeine will have noticed that these products are no longer displayed where they used to be. They are also likely to have been asked about the symptoms they were looking to treat and may have been refused supply.
The Irish Medicines Board has licensed these products for sale in pharmacies over the counter (OTC) in other words, without a prescription. However, the law requires chemists to ensure that codeine-containing products “are not accessible to the public for self-selection”.
Until recently, guidance issued by the Pharmaceutical Society of Ireland – the pharmacy regulator – required that such medicines be sited in an area inaccessible to customers and obliged pharmacists to ensure they were in a position to intervene in the decision to supply them. It has long been the practice to display such products behind the counter, so the customer would not have access but could see what was available.
So what has changed? While the law has remained the same, new guidance issued by the regulator, effective since August 1st, requires that medicines containing codeine be stored out of view and that they be sold only through the pharmacist. Effectively, such medicines – which have until now been available to the public to take on a self-medicating basis – are now being treated as prescription medicines.
The regulator has argued that these products must be kept out of view to ensure that they are not accessible. It has also indicated that displaying them constitutes an advertisement and that it is an offence to advertise medicines containing codeine, as they are controlled drugs. Both of these suggestions are legally questionable.
The removal of these products from view is not necessary to ensure their safe and rational use. A product which is visible but which cannot be physically accessed (as in the past) is not, according to ordinary canons of construction, “accessible to the public for self-selection”.
This interpretation is supported by the well-established presumption against unclear changes in the law. If the legislation intended to prohibit display, it was required to have done so in unambiguous language. An example of this can be seen in the legislation governing the sale of tobacco under which retailers must “ensure that tobacco products are kept in a closed container or dispenser that is not visible or accessible to any person other than the [retailer] or a person employed by him or her”.
Apart from providing a clearly worded prohibition on the visual display of tobacco products, the above supports the view that accessibility and visibility are distinct concepts.
While the regulator has certain defined statutory powers, it does not have the power to legislate. Codes of practice, guidelines and other “soft law” documents cannot displace established law. Their function is to regulate how things are to be done in a particular legal context.
The regulator’s guidance also flies in the face of community legislation and a 2003 decision of the European Court of Justice which held that a national law could not prohibit the advertising or sale by mail order of medicines not subject to prescription. As a result, Irish law was amended to allow the sale by mail order of OTC medicines containing codeine.
Thus, it is arguable, the regulator has exceeded its powers, rendering the guidance invalid and unenforceable. Mark Ryan is a partner in Whitney Moore Solicitors, specialising in pharmaceutical regulation