Specialist Surveyor Report on PSI Guidance: Non-Prescription Medicinal Products Containing Codeine
In March and April 2024, the PSI undertook a specialist surveyor exercise to gain an insight into the compliance of community pharmacies in accordance with the published PSI guidance on the safe supply of non-prescription medicinal products containing codeine to patients.
Published: 10 October 2024
Background
In October 2019, we published the 5th revision of our guidance, Non-Prescription Medicinal Products Containing Codeine: Guidance for Pharmacists on Safe Supply to Patients.
In March and April 2024, the PSI undertook a specialist surveyor exercise to gain an insight into the compliance of community pharmacies in accordance with the published PSI guidance on the safe supply of non-prescription medicinal products containing codeine to patients.
In 2022, PSI conducted a similar specialist surveyor exercise at 100 pharmacies. The exercise resulted in the sale of a codeine containing medicinal product at 81% of pharmacies. Due to the level of non-compliance with PSI guidance identified in 2022 and to ensure results were statistically significant, a larger specialist surveyor exercise was conducted in 250 pharmacies throughout March and April 2024.
The expected outcome of this exercise was that a pharmacy, acting in compliance with PSI guidance, would not sell a Codeine medicine to the specialist surveyor on the basis that other pain-relieving medication, such as paracetamol, ibuprofen, or aspirin, had not yet been used for the treatment of a presenting headache.
The codeine containing medicine, Solpadeine™, was selected as the medicine to be requested by the specialist surveyor for this exercise, as it is consistently the top over-the-counter (OTC) product sold in pharmacies in Ireland, and has been since 2019, based on data from IQVIA, a human data science company.
Objectives of the specialist surveyor exercise
The objective of the specialist survey exercise was to:
- Evaluate whether the sale and supply of Codeine medicinal products (Solpadeine™) is in accordance with published guidance Non-Prescription Medicinal Products Containing Codeine: Guidance for Pharmacists on Safe Supply to Patients and legal requirements.
- Ensure that Codeine medicinal products are appropriately stored and supplied under the supervision of a pharmacist.
For this exercise, the PSI requested that 250 pharmacies be visited in person, as part of the specialist surveyor exercise. The PSI provided Pan Research with a random list of 375 pharmacies to choose from and 229 pharmacies were randomly selected by Pan Research to reflect the demographics of the registered pharmacies on the PSI register. The remaining 21 pharmacies selected received a low compliance score in the codeine exercise conducted in 2022. Full results of the 2022 exercise can be accessed on the PSI website here.
Pan Research, an external specialist surveyor company, was provided with a specific scenario by PSI. The scenario required the specialist surveyor to present with a headache, state they had not taken any other painkillers if asked, and request Solpadeine™.
As part of the exercise, we asked the specialist surveyors to take a note of the following
- The pharmacist involvement in the request of a codeine medicinal product;
- The information gathering on the request of a codeine medicinal product.
- The counselling provided about codeine medicinal products.
- Decision to sell or not to sell a codeine medicinal product and the alternative medicinal product options provided for treatment.
A total of 250 pharmacies were visited. One hundred pharmacies (100) did not sell Solpadeine™ to the specialist surveyor based on the scenario provided. One hundred and forty-nine (149)* pharmacies sold Solpadeine™ to the specialist surveyor with varying levels of compliance with the guidance observed. From the 149 pharmacies that did supply Solpadeine™, only 13% (20) of these involved the specialist surveyor speaking directly to the pharmacist on duty.
Of the twenty-one (21) pharmacies that were revisited following low compliance findings in the 2022 specialist surveyor activity, ten of these pharmacies did not sell Solpadeine™ to the specialist surveyor, meaning eleven of these pharmacies did sell Solpadeine™ to the specialist surveyor.
*Note: In one case, the specialist surveyor deviated from the scenario provided, and this result has not been included in the report.
Key Findings
Pharmacist Involvement
In total, out of the 249 pharmacies visited:
- In 89 (36%) pharmacies, the Pharmacist was involved in the sale, which involved either the specialist surveyor speaking directly to the pharmacist, or the pharmacist being involved in the interaction at some point via the sales assistant.
- In 157 (63%) pharmacies, the Pharmacist was not involved in the sale at any point.
- For 3 (1.2%) of the pharmacies visited, the specialist surveyor stated they were unsure if the Pharmacist was involved in the sale.
In total, out of the 149 pharmacies that sold Solpadeine™ :
- In 65 (44%) pharmacies, the Pharmacist was involved in the sale, which involved either the specialist surveyor speaking directly to the pharmacist or the pharmacist being involved in the interaction at some point via the sales assistant.
- In 81 (54%) pharmacies, the Pharmacist was not involved in the sale at any point.
- For 3 (2%) of the pharmacies visited, the specialist surveyor stated they were unsure if the Pharmacist was involved in the sale.
In order to verify whether a pharmacist was present in the pharmacy, the specialist surveyors were instructed to ask to speak to the pharmacist regarding an additional query.
It was confirmed that at all 249 pharmacies visited, the pharmacist was present in the pharmacy.
Questions Asked by the Pharmacy
The specialist surveyor was asked to take note if the following questions were asked by the pharmacy. These questions are considered the appropriate questions to be asked based on PSI guidance and best practice:
- What are your symptoms?
- How long have you had the headache?
- Have you tried any other medication for this headache already?
- Are you currently taking any other medication?
- Do you have any medical conditions?
Overall, the 249 reports of the specialist surveyors indicated that upon requesting SolpadeineTM they were asked:
| Number of pharmacies (%) | Number of guidance questions asked by pharmacy |
| 52 (20.8%) | 0 questions |
| 68 (27.2%) | 1-2 questions |
| 80 (32%) | 3-4 questions |
| 49 (20%) | All questions |
Advice and Dosage Instructions
Of the 149 pharmacies that supplied SolpadeineTM, the specialist surveyor was asked to take note of the following advice and dosage instructions. The surveyor was to be informed:
- That this product contains codeine
- That this product contains paracetamol
- To take one or two every 4-6 hours only when needed
- That the max dose is eight tablets in 24 hours
- To not take Solpadeine™ with other paracetamol-containing products
- To not take Solpadeine™ for more than three days
- That prolonged use of codeine can cause tolerance and dependence
- To see their doctor if the headache persists.
| Number of pharmacies (%) | Advice and dosage instructions provided by the pharmacy |
| 26 (17.3%) | 0 advice and dosage instructions |
| 58 (38.9%) | 1-2 advice and dosage instructions |
| 39 (26%) | 3-4 advice and dosage instructions |
| 21 (14%) | 5-6 advice and dosage instructions |
| 5 (3.4%) | 7-8 advice and dosage instructions |
The PSI has corresponded with the Superintendent Pharmacists of each of the 249 pharmacies surveyed and provided them with the outcome of the exercise. In pharmacies that did not sell Solpadeine™, no return response was required.
In those pharmacies that sold Solpadeine™, the PSI requested three actions from each of the pharmacies involved:
- Provide assurances that you have carried out a review of the supply of non-prescription codeine containing medicines from your pharmacy.
- Provide assurances that all pharmacy staff members, including pharmacists, have been re-trained on the sale and supply of codeine-containing medicines.
- Confirm that the sale and supply of codeine-containing medicines at your pharmacy is now being carried out in accordance with legislation, marketing authorisations, and PSI guidance.
In the eleven pharmacies that sold Solpadeine™ to the specialist surveyor, in both the 2022 and 2024 exercises, PSI has requested the Superintendent Pharmacist to provide signed undertakings on the actions they will take regarding the sale and supply of non-prescription codeine containing medicines.
This extensive exercise surveyed 249 pharmacies and provided further insight into pharmacy compliance with the Non-Prescription Medicinal Products Containing Codeine: Guidance for Pharmacists on Safe Supply to Patients, in addition to the specialist surveyor exercise conducted in 2022, which surveyed 100 pharmacies.
In the 2024 exercise, 149 sold Solpadeine™ to the specialist surveyor. The first-line recommended treatment for headache in the scenario provided to the specialist surveyors is paracetamol, ibuprofen, or aspirin.
On analysis of the results of the specialist surveyor exercise, the PSI identified the following concerns:
- Codeine containing non-prescription medicines is being sold from pharmacies otherwise than in accordance with legislation, PSI guidance, and relevant product marketing authorisations.
- Pharmacists are not, on all occasions, personally supervising such sales and/or are not in a position to determine the appropriateness of the request.
- Codeine medicines are being sold outside their therapeutic indication in circumstances where the patient has not yet tried other non-codeine analgesics.
- Codeine medicines are being sold without the provision of adequate counselling and advice.
