Buprenorphine patches – safety briefing


Since the patent expired for BuTrans®, the original buprenorphine patch, several generic patches have become available. Patches are now available that deliver the drug over three, four and seven days. There have been medication incidents reported recently in which patients have received the wrong patch. To reduce the risk of this it is recommended that buprenorphine patches are prescribed by brand name.
Butec® is the recommended brand of seven day buprenorphine patch for primary care, replacing Butrans®. It is identical in formulation to Butrans® and available in 5, 10, 15 and 20 micrograms/hour strength. It is also lower in price, offering significant savings.

Codeine and morphine remain the first- choice opiates in the Sunderland primary care pain guidance (available on the CCG website). However, if a seven day buprenorphine patch is needed, please prescribe Butec® for any new patients. Also please consider switching existing patients on Butrans® or to use buprenorphine seven day patches to Butec®. Buprenorphine patches should be prescribed as Butec® brand to ensure continuity of supply.

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UKMi have produced a Q&A on reducing the risk of medication errors with buprenorphine patches; this is shown below, at the request of the Sunderland Medicines Optimisation Group, to support safe prescribing and dispensing of buprenorphine patches.

How can you minimise the risks of medication errors with buprenorphine patches?

Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals

Before using this Q&A, read the disclaimer at https://www.sps.nhs.uk/articles/about-ukmi-medicines-qas/

Date prepared: 10/10/2016

Background

Transdermal buprenorphine patches are widely prescribed and available from a variety of manufacturers1,2. They are not appropriate for patients with acute pain and those who need rapid dose escalationThere are two groups of buprenorphine patches, lower strength and higher strength as detailed in table 1.  

Table 11, 2

Strength of patch Licensed indication Frequency of patch application

Lower strength –

5microgram, 10microgram, 15microgram and 20microgram per hour

Treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia Apply a new patch every 7 days

Higher strength  –

35microgram, 52.5microgram and 70microgram per hour

Treatment of moderate to severe cancer pain and severe pain which does not respond to non-opioid analgesics

Either (depending on brand) –

Apply a new patch every 72 hours (3 days)

or

Apply a new patch after up to 96 hours (4 days). SPCs suggest bi-weekly dosing e.g. Tues and Friday1,2

There are at least 8 different brands and 21 individual preparations in each of the low and high strength categories mentioned in the above table. Details of available transdermal buprenorphine patches can be found in the Electronic Medicines Compendium1 and the MHRA website2.

A number of incidents have occurred in the use of transdermal opiate patches3 and concerns have been raised nationally about errors seen with these products. Errors include –

  • Initiating a patient on too large a dose of transdermal buprenorphine. Outcome – patient drowsiness due to inappropriately high dose of transdermal buprenorphine.
  • Applying a buprenorphine patch licensed to be changed every 72 hours (3 days) and leaving it in situ for 7 days. Outcome – breakthrough pain for patient.
  • Applying a buprenorphine patch licensed to be changed every 72 hours (3 days), leaving it in situ for 96 hours (4 days). Outcome – potential breakthrough pain for patient and unlicensed use of the buprenorphine patch.
  • Prescribing a higher strength patch in error to a patient previously on a 20microgram per hour patch. Outcome – patient drowsiness due to large increase in buprenorphine dose.
  • Failure to remove a buprenorphine patch when applying a new buprenorphine patch. Outcome – patient drowsiness due to increase in buprenorphine dose.
  • Administering fentanyl patches in error for buprenorphine patches. Outcome – patient receives incorrect medication.
  • Increased release of buprenorphine from the patch due to excessive heat. Outcome – patient drowsiness due to increase in buprenorphine dose.

This Q&A aims to cover a number of topics in order to improve the safety of buprenorphine patch prescribing and administration, as well as highlighting some of the concerns. This Q&A does not compare the costs of the various transdermal buprenorphine products.

Dosing information

Conversion rates between transdermal buprenorphine and oral morphine vary with transdermal buprenorphine 70-115 times more potent than oral morphine4. Standard resources including palliativedrugs.com4 and the BNF5 have tables which give comparative doses based on specific dose conversion ratios which are a useful guide. Dosing instructions including conversion from a different opioid, initiation in opioid naïve patients and titration to the effective dose are included in the summary of product characteristics for all buprenorphine products and should be followed1,2.

Frequency of transdermal buprenorphine patch removal and renewal

Patients should be appropriately counselled on the frequency of patch removal and renewal dependent on the individual preparation dispensed.  They should be encouraged to keep a record of when the patch was removed and when it was replaced, for example by using the manufacturer provided record areas on the product packaging. Some clinical teams use transdermal patch application forms to record where a patch has been placed, confirm that the old patch has been removed and ensure that patches are changed at appropriate times on a new area of skin 4. Errors have occurred in primary and secondary care because of confusion in the correct renewal frequency between 3 day, 4 day and 7 day patches. Labelling should make the frequency of patch removal and renewal clear e.g.

  • Apply ONE patch every SEVEN days. Remove and discard old patch before applying new patch

Labelling added to the package during dispensing should be applied carefully so that it does not obscure useful information for the patient. When reviewing a patient using buprenorphine patches, healthcare professionals should consider the following questions –

  • Which manufacturers’ version of transdermal buprenorphine patch does the patient apply and what is the licensed frequency of removal and renewal?
  • What is the strength of the buprenorphine patch?
  • When was the buprenorphine patch last applied and when is it due for replacement?
  • Have all the old buprenorphine patches been removed?
  • Does the patient understand how to use buprenorphine patches appropriately?

National and local guidelines should be followed when choosing appropriate opiate analgesia.

Should you prescribe by brand name?

Brand name prescribing is advocated when there is a risk to the patient of a change in bioavailability of a drug leading to a potential increase or decrease in dose. This is important when the drugs involved have a narrow therapeutic index or where a change in bioavailability may have a significant clinical effect e.g.  all oral lithium products should be prescribed by brand name5,6.

Whilst switching between products of the same strength, but made by different manufacturers, should not cause a significant change in dose for the patient6, it is sensible to be aware that breakthrough pain or excessive drowsiness may occur and advise the patient and prescriber on how to manage this.

In some areas of the country, there have been formulary decisions to prescribe specific transdermal buprenorphine products. Where such local arrangements exist it is important to ensure that patients are managed appropriately in any switch programme. Prescribing systems may be employed to support safe buprenorphine patch prescribing whether specifying local formulary choices or via reminders about how and when to prescribe buprenorphine patches.

In general, brand name prescribing should not be necessary as long as the strength (release rate) and frequency of patch replacement are specified on the prescription and communicated to the patient who will be using the buprenorphine patch.

Allergy/sensitivity to patch adhesive

Some patients are sensitive to transdermal patches with reports of skin reactions at the sites of application. In such cases, the constituents of both the adhesive on the section of the patch containing active ingredients and the adhesive on the remainder of the patch should be identified from the manufacturer’s information1,2. It should be possible to identify an alternative brand of buprenorphine patches with different adhesives that is suitable for someone exhibiting sensitivity.

Effects of temperature on buprenorphine release from the patch system

It is known that increases in skin temperature may lead to increased release of buprenorphine from the patch, causing increased opiate side effects in the patient1,2.  The temperature increase may occur –

  • Internally – i.e. when a patient is febrile
  • Externally – e.g. using electric blankets, hot water bottles, heat pads, sauna, hot tubs, heat lamps and heated water beds

Patients should be advised to avoid external heat sources and be aware that fever might increase absorption.

Answer

Medication errors with buprenorphine patches can be minimised by –

  • Being aware of the wide range of buprenorphine patches, as well as other opiates that are presented in this formulation, and the range of strengths and frequency of replacement.
  • Ensuring that the doses are individualised and suitable for patients who are either
    • Opiate naïve or
    • Being transferred from another opiate.
  • Specifying the dose rate and the frequency of patch replacement on the prescription and dispensing labelling.
  • Properly advising the patient about the need to remove existing patches before replacing them at the appropriate frequency.  Patients may find it useful to keep a record of when old patches are removed and new patches applied.
  • Applying any additional dispensing labelling so as not to obscure useful patient information on the packaging.

Summary

The prescribing of transdermal buprenorphine patches in the UK is increasing as are the number of manufacturers and range of doses and duration of action. There are a number of potential errors that can occur at various points in the prescribing, dispensing and administration of transdermal buprenorphine patches. Suggestions for mitigating these errors include improving the awareness of the product range, checking the dose is appropriate, specifying the individualised dose rate and replacement frequency, effective patient advice on proper use and good record keeping.

Limitations

The list of available strengths of buprenorphine patches is up to date as of 10th October 2016, after this date readers are advised to check the current BNF, EMC and MHRA websites for any new products and strengths.

References

Quality Assurance

Prepared by

Tiffany Barrett [Senior Medicines Information Pharmacist]

Date Prepared

10th October 2016

Checked byTrevor Beswick [Director], South West Medicines Information and Training, Bristol

Date of check

26th  October 2016

Search strategy

In-house database/ resources [search term: “buprenorphine”]

BNF online [search terms: “buprenorphine” and section on prescribing in palliative care]

Electronic Medicines Compendium online [search term: “buprenorphine”]

MHRA online [search term: “buprenorphine”]

Palliativedrugs.com website [search terms: “buprenorphine” and “transdermal patch”

Specialist Pharmacy Services website [search term: “buprenorphine”]

In addition advice was sought from: David Erskine, Director Medicines Information Service for London and South East; Claire Steele Medicines Pricing and Supply Manager, Procurement, Commissioning & Facilities NHS National Services Scotland; Kevan Wind,Medicines Procurement Pharmacist, London and East of England