Statement From The Irish Medicines Board In Relation To Codeine16/08/2005


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9869260_OTC_Codeine_press_rel.pdf The Irish Medicine Board (IMB) today confirmed that it has requested companies producing over-the-counter codeine containing medicinal products to amend the product information leaflets to state that there is a possibility of physical and psychological dependence associated with prolonged use of these products. The IMB have taken this action in the interest of public health following a process of consultation with its expert committee to address anecdotal concerns expressed about the potential misuse/abuse of codeine containing analgesic products. It is expected that all products will carry these updated warnings before year end. The IMB acknowledges that these products are beneficial for the treatment of short term pain and is taking this action to avoid patients using these products on a long term basis for which they are not appropriate. This course of action was initiated by the IMB in July 2005.
According to the IMB, reports of codeine abuse in Ireland appear to have mainly arisen in the context of multisubstance drug abuse, with a very small number of isolated cases of codeine abuse reported compared to the volume of sales for these products. Since 1980, the IMB has received a total of 10 reports of dependence in association with codeine containing products, all of which arose with prolonged use, which is not recommended, or use of a higher than recommended dose. In order to maintain the availability of controlled, yet accessible and appropriate analgesia to patients, the IMB considers that the continuing availability of these medicinal products, without prescription, in pharmacies only and subject to the limitations outlined, should be maintained. However, in the interest of consistent patient information, the Marketing Authorisation Holders for these products, which include Nurofen Plus and Solpadeine, have been requested to implement explicit standard warning statements regarding the risk of physical and psychological dependence (addiction).
The IMB would like to re-emphasise the importance of doctors and pharmacists discussing the use of all medications, including non-prescribed medicinal products, with patients/consumers, including the need to strictly adhere to the recommended dosage and duration of use and to avoid prolonged use, which is associated with dependence. In addition, in July 2005 the IMB called for all healthcare professionals to report on suspected cases of tolerance, dependence or addiction associated with the use of these products and it continues to actively encourage continued reporting on these issues.
The IMB stresses that no more than the recommended dose of codeine containing products should be taken in any 24-hour period. The IMB advises patients that while these products are beneficial in short term pain relief they should not be used for longer than the recommended three day period. Patients with symptoms persisting for more than three days should contact their healthcare professional for best advice on a course of treatment. Consumption of quantities in excess of the recommended dose, or for a prolonged period of time, may lead to tolerance and physical and psychological dependence and may result in symptoms such as restlessness and irritability upon cessation of the medicine.
In addition to the amendments to the patient information leaflets in relation to the risk of dependency, codeine containing products which are available without prescription in pharmacies only are currently subject to the following restrictions:
- They must contain a low dose of codeine (as per the Medicinal Products [Prescription and Control of Supply] Regulations 2003);
- They must be dispensed under expert pharmaceutical guidance;
- Their pack size/ bottle volume is restricted;
- Their advertising is restricted to healthcare professionals only;
- At a minimum, their product information leaflets must all contain warnings regarding the fact that the recommended dose should not be exceeded and that the product is not suitable for prolonged use.
The IMB will continue to monitor the situation in conjunction with healthcare professionals and relevant professional bodies and will take whatever further regulatory action deemed necessary.