Risks associated with sublingual buprenorphine prescribing, dispensing and administration

We write in relation to the article by Wilson et al. that was published in the June 2025 issue, discussing medicines used in the treatment of opioid dependence.¹ We wish to highlight medication safety risks associated with sublingual buprenorphine products.

In addition to the formulations of buprenorphine listed by Wilson et al.,¹ in Australia there is also a 200 microgram sublingual tablet that is indicated for the short-term management of severe pain when other treatment options have failed or are unsuitable.² This formulation is not approved for opioid dependence treatment.²

Buprenorphine, being an opioid, is a high-risk medicine. Our health service has identified 11 incidents involving sublingual buprenorphine that occurred due to a selection error at the point of prescribing, dispensing or administration between 1 July 2022 and 30 June 2025. Errors occurred in both digital and paper-based prescribing systems. Two incidents occurred where prescribing was performed within the hospital and supply occurred within a community setting. In response to incidents with these medicines, some health jurisdictions have published safety notices for health professionals.^3,4

Review of these incidents highlighted the following key learning points for health professionals:

• There are multiple brands (Subutex, Suboxone and Temgesic), strengths (from 200 micrograms to 8 mg), formulations (tablets and films), and indications for sublingual buprenorphine products.
• Most selection errors involved buprenorphine 2 mg (Subutex) and buprenorphine 200 micrograms (Temgesic) – a 10-fold difference in dose.
• Caution is needed when prescribing and dispensing buprenorphine in electronic medication management systems to avoid product selection errors.⁵
• When prescribing buprenorphine, specify the brand name in addition to the generic name, and state the indication.⁶
• Consider medicine storage strategies to minimise look-a-like and sound-a-like medication errors, for example with Subutex and Suboxone for opioid dependence (e.g. storage within original packaging, physical separation).⁷
• Utilise bar code scanning when dispensing buprenorphine products.⁷
• Ensure interfacing between clinical information systems is accurate.
• Ensure timely clinical handover of prescription details and the indication for treatment between hospital and primary care providers.

Correct product selection is important for patients on buprenorphine for opioid dependence treatment, acknowledging the importance of therapeutic trust in the success of opioid dependence programs. For patients prescribed buprenorphine for pain, correct selection is critical to avoid inadvertent overdose.

The risks associated with sublingual buprenorphine may be reduced through adherence to the key learning points outlined above, and the use of mandated real-time prescription monitoring tools.

Martin Canning
Consultant Safety and Quality Pharmacist, Metro North Clinical Governance, Metro North Health, Brisbane

Benita Suckling
Medicines Strategy and Outpatients Team Leader Pharmacist, Surgical Treatment and Rehabilitation Service, Metro North Health, Brisbane

Mika Varitimos
Safety and Quality Pharmacist, The Prince Charles Hospital, Metro North Health, Brisbane

Conflicts of interest: none declared

 

References

1. Wilson HH, Kanck J. Medicines used in the treatment of opioid dependence. Australian Prescriber 2025;48:98-105.
2. Therapeutic Goods Administration. Australian Product Information - TEMGESIC buprenorphine 200 microgram (as hydrochloride) sublingual tablet blister pack. Department of Health and Aged Care; 2025. [cited 2025 Jul 16]
3. Medication Services Queensland. Patient Safety Notice 02/2025: Buprenorphine sublingual products – Ensure correct dose and product selection for the required indication. Queensland Health; 2025.
4. NSW Health. Potential for errors with buprenorphine sublingual products. Safety notice 013/25. 2025. [cited 2025 Jun 16]
5. Koppel R, Metlay JP, Cohen A, Abaluck B, Localio AR, Kimmel SE, et al. Role of computerized physician order entry systems in facilitating medication errors. JAMA 2005;293:1197-203.
6. Feather C, Appelbaum N, Darzi A, Franklin BD. Indication documentation and indication-based prescribing within electronic prescribing systems: a systematic review and narrative synthesis. BMJ Qual Saf 2023;32:357-68.
7. Australian Commission on Safety and Quality in Health Care. Principles for the safe selection and storage of medicines: Guidance on the principles and survey tool. Sydney: ACSQHC; 2020. [cited 2025 Aug 18]

 

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