Specialist Surveyor Report on PSI Guidance ‘Non-prescription medicinal products containing codeine’

Background

The Pharmaceutical Society of Ireland (PSI), the pharmacy regulator, is a public body established under the Pharmacy Act 2007 (‘the Act’) to protect the health, safety and wellbeing of patients and the public by regulating pharmacists and pharmacies in Ireland. There are 1988 pharmacies registered with the PSI (accessed 2nd May 2023). The PSI (Pharmaceutical Society of Ireland), the pharmacy regulator, published its 5th revision guidance, ‘Non-Prescription Medicinal Products Containing Codeine: Guidance for Pharmacists on Safe Supply to Patients’ in October 2019[1]. 

IQVIA, a human data science company, collates the Top 100 Over the Counter (OTC) products using the total value of wholesale sales data. The most recent data is for the period May 2021 to April 2022. Since 2017, Solpadeine™ is consistently the top OTC product sold, followed by Nurofen Plus™ [2]. The Primary Care Reimbursement Service published data for 2021 and lists codeine combination products (excluding psycholeptics) in the top 20 most commonly prescribed products accounting for over 900,000 prescriptions in 2021[3].

In September and October 2022, the PSI undertook a specialist surveyor exercise to gain insight into the compliance of community pharmacies with the published PSI guidance on the safe supply of non-prescription medicinal products containing codeine (hereafter called ‘codeine medicine’) to patients. The expected outcome of this exercise was that a pharmacy, acting in compliance with PSI guidance, would refuse to sell a codeine medicine under the circumstances on the basis that other analgesia, such as paracetamol, ibuprofen or aspirin, had not yet been tried for a presenting headache.

Codeine products

Codeine phosphate is a mild to moderate opioid (narcotic) analgesic and has weak cough suppressant activity. Codeine, due to its potential for misuse, is a controlled drug under the Misuse of Drugs Acts 1977 and 1984. Low dose preparations are regulated as a Schedule 5 controlled drug. As a painkiller, it is most often used in combination with other analgesics such as paracetamol or ibuprofen and is currently authorised in Ireland in such non-prescription products for pain relief. These authorised products are available without a prescription through retail pharmacy businesses (pharmacies) only. Because of the particular characteristics of those medicines containing controlled drugs (i.e., codeine), further restrictions are imposed, which require that those medicinal products would not be accessible to the public for self-selection (regulation 5(1)(e) of the Regulation of Retail Pharmacy Businesses Regulations 2008 (S.I. No. 488 of 2008). Therefore, self-selection of medicinal products containing controlled drugs without the provision of appropriate 3 supervision, professional support, advice and information by the pharmacist is not appropriate.

Solpadeine™

Pain relief products (including tablets, soluble tablets and capsules) are currently authorised for sale without prescription through retail pharmacy businesses in Ireland. Each tablet/capsule contains paracetamol 500 mg, caffeine 30 mg, and the Schedule 5 controlled drug codeine phosphate hemihydrate 8 mg. Solpadeine™ products are authorised for the treatment of patients over 12 years in the management of headache, migraine, toothache, backache, common cold, influenza, menstrual pain and musculoskeletal pain which has not been relieved by other analgesics such as ibuprofen or paracetamol.

A number of other pain relief medicines containing codeine are available for sale without a prescription through retail pharmacy businesses in Ireland. Similar to Solpadeine™, these products include additional active ingredients such as paracetamol, ibuprofen and caffeine. Examples include Maxilief™ and Nurofen Plus™.

Codeine medicines should only be supplied when the pharmacist deems such a supply is necessary and only when a non-opioid analgesic, e.g., paracetamol, aspirin or ibuprofen, has not proven sufficient to relieve the patient’s symptoms. If recommended, codeine medicines should be used for the shortest time possible and for no longer than three days without medical supervision.

Objectives of the specialist surveyor exercise

Pan Research, an external specialist surveyor company, was provided with a 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™.

The purpose of the scenario was to determine the following:
1. If a codeine medicine (Solpadeine™) was being supplied in accordance with published guidance Non-Prescription Medicinal Products Containing Codeine: Guidance for Pharmacists on Safe Supply to Patients’ and legal requirements

2. If pharmacists were adhering to published guidance; i.e., that they ensure that codeine medicines are only supplied under their supervision

a. We asked the specialist surveyor to take particular note of pharmacist involvement, guidance questions asked, and dosage instructions given to the specialist surveyor;

b. We asked the specialist surveyor to take note of the following guidance questions asked:

  • What are your symptoms?
  • Are you currently taking any other medication?
  • How long have you had the headache?
  • Have you tried anything for this headache already?
  • Do you have any medical conditions?
  • Do you understand how to take this product?

c. Where Solpadeine™ was supplied, we asked the specialist surveyor 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 not take Solpadeine™ with other paracetamol-containing products,
  • 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™ for more than three days,
  • That prolonged use of codeine can cause tolerance and dependence,
  • To see their doctor if the headache persists.

The PSI provided the specialist surveyor company with a list of pharmacies to visit, which reflected the demographics of the registered retail pharmacy businesses on the PSI register. The specialist surveyor had to be aged 18 and over and could be either gender. The specialist surveyor could visit the pharmacy at any time of the day.

Results

We categorised the pharmacies according to their compliance with the 12 criteria outlined in the PSI published guidance which was reflected in the proforma:

  • low compliance: 0-3
  • medium compliance: 4-6 high
  • compliance: >7

A total of 100 pharmacies were visited. Nineteen pharmacies did not sell Solpadeine™ to the specialist surveyor. Eighty-one pharmacies sold Solpadeine™ to the specialist surveyor with various levels of compliance with the guidance observed. In twenty-one pharmacies where the pharmacist did not personally supply Solpadeine™, low compliance with the guidance was reported.

Compliance with the guidance Total number of Pharmacies
Solpadeine™ sold 81
a. Pharmacist sale – High compliance with the guidance criteria 31
b. Pharmacist sale – Medium compliance with the guidance criteria 7
c. Pharmacist sale – Low compliance with the guidance criteria 2
d. Non-pharmacist sale (sold under pharmacist supervision) - High compliance with the guidance criteria 13
e. Non-pharmacist sale (sold under pharmacist supervision) - Medium compliance with the guidance criteria 9
f. Non-pharmacist sale (sold under pharmacist supervision) - Low compliance with the guidance criteria 19

Follow up

The PSI corresponded with each pharmacy surveyed and provided them with the outcome of the exercise. Where Solpadeine™ was not sold, no return response was required.

Where Solpadeine™ was sold, the PSI requested four actions from each of the 81 pharmacies involved:
1. Provide assurances that you have reviewed the supply of non-prescription codeine-containing medicines from your pharmacy,
2. Provide assurances that all pharmacy staff members, including pharmacists, have been re-trained on the sale and supply of codeine-containing medicines,
3. Provide details of the steps you have taken or are taking to ensure your pharmacy’s ongoing compliance with the PSI Guidance,
4. 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.

Pharmacy responses

All 81 pharmacies responded, confirming the requested actions and providing the required assurances.

Fifteen pharmacies requested additional detailed information, which the PSI provided.

Summary

This small sample of pharmacies provided insight into compliance with the ‘Non-Prescription Medicinal Products Containing Codeine: Guidance for Pharmacists on Safe Supply to Patients’[1]. Eighty-one pharmacies sold Solpadeine™ to the specialist surveyor. The first-line recommended treatment for headache in the scenario provided is paracetamol, ibuprofen or aspirin.

The PSI has contacted all pharmacies that supplied Solpadeine™ to the specialist surveyor. All pharmacies have provided assurances to PSI, including:

  • They have reviewed the supply of non-prescription codeine-containing medicines from their pharmacy,
  • All pharmacy staff members, including pharmacists, have been re-trained on the sale and supply of codeine-containing medicines,
  • Details of the steps they have taken or are taking to ensure their pharmacy’s ongoing compliance with PSI guidance,
  • Confirmation that the sale and supply of codeine-containing medicines at their pharmacy is now being carried out in accordance with legislation, marketing authorisations and PSI Guidance.

The PSI has published a reminder to all registrants in the March 2023 PSI newsletter concerning the sale of codeine medicines and the PSI guidelines[4]. The PSI will share the findings of this survey with the Health Products Regulatory Authority (HPRA) and the Department of Health. In 2023, we will carry out a further, more extensive surveillance exercise, including those pharmacies that sold Solpadeine™ in circumstances where the sale of paracetamol, ibuprofen or aspirin was the recommended treatment for headache in the scenario presented.

References

  1. Pharmaceutical Society of Ireland. 2019. ‘Non-prescription medicinal products containing Codeine: Guidance for Pharmacists on safe supply to patients’.
  2. Irish Pharmacy News. 2022 (14) 8. ‘Focusing on growth- The OTC Market in Ireland’.
  3. Health Service Executive Primary Care Reimbursement Services Report 2021. 
  4. Pharmaceutical Society of Ireland Newsletter, March 2023: Issue 1. ‘Non-prescription Medicinal Products containing Codeine’.