A medical practice in the Hartlepool area

5. Mr R complains that a medical practice in the Hartlepool area (the Practice) reduced and stopped his fentanyl medication too rapidly, between December 2019 and February 2020. He says this was done without properly discussing this with him. He complains that this was medically inappropriate and caused him pain and the trauma of withdrawal. He also complains about failings in the Practice’s handling of his complaint.

6. Mr R states the lack of consultation caused him panic and distress. He says the rapid reduction and stoppage of fentanyl caused him to suffer recurrent and acute stabbing pains in his eye. He also states he went through the trauma of withdrawal and has ‘never been so ill’. He was nauseous, sweating, shivering, and unable to sleep. He states the complaints process caused him significant frustration and inconvenience.

7. Mr R wants an explanation and apology from the Practice, together with service improvements to stop this from happening to someone else. Mr R also wants the Practice to review their complaints handling process and to put in place service improvements.

8. The following is a brief background to put the complaint into context. We have not provided all detail as both parties are aware of the circumstances of the complaint.

9. Following surgery on his eye in 2015, Mr R was left with constant right sided globe pain. In January 2017, a pain clinic at hospital A (the Pain Clinic) suggested opioid pain relief by way of fentanyl patches (Matrifen Transdermal Patch), at a dose of 25 micrograms/hour (mcg/hour), over 48 hours. Fentanyl is a synthetic opioid and is 50–100 times more potent than morphine. Opioids are substances that act on opioid receptors to produce morphine-like effects. Medically, they are primarily used for pain relief.

10. Mr R’s GP practice, at that time, prescribed this medication on a weekly basis from January 2017. On 10 December 2019, he was prescribed four 25mcg/hour patches, one patch per 48 hours.

11. On 12 December 2019, Mr R registered with the Practice.

12. The same day, he had an initial appointment with the Practice Nurse. The Nurse completed a new registration check and noted Mr R’s current medications.

13. On 18 December 2019, an internal Practice task was generated to ‘see if we can issue Matrifen patches’.

14. On 20 December 2019, the Practice issued fourteen 25mcg/hour Matrifen patches.

15. On 10 January 2020, Mr R had an appointment with Dr A. Dr A reduced the strength of Mr R’s fentanyl patch from 25mcg/hour to 12mcg/hour. Five patches were issued, one patch every 72 hours.

16. No opiate pain relief was prescribed to Mr R from 25 January 2020 to 13 February 2020.

17. On 13 February 2020, 40 mg Zomorph modified release capsules were prescribed in accordance with the tapering plan from the Pain Clinic.

Fentanyl discussion

22. Mr R complains the Practice reduced his fentanyl medication without properly discussing this with him. He says he told the Practice he was on regular pain medication when he applied to register, and again at his initial appointment with the Practice Nurse. He says on neither of these occasions did the Practice tell him there would be any issue with continuing to prescribe the weekly fentanyl patches.

23. Dr A states they were called in to speak with Mr R regarding his prescribed medication at his new patient registration appointment. They confirm Mr R advised he was taking Gabapentin and Matrifen Transdermal Patch 25mcg/hour. They say they offered to refer Mr R to the eye specialist, and then referred him to the Pain Clinic. No dates have been given for when these were offered.

24. The records show the initial consultation with the Practice Nurse took place on 12 December 2019. The notes show that Mr R informed them of his fentanyl medication. The notes do not record that Dr A was called in to this consultation, nor do they record any discussion concerning this medication. There is no record of a referral to the Pain Clinic at this time.

25. Our adviser confirmed there are no professional standards or guidelines governing the processes for checking a new patient’s medication. Standard practice procedure is often as follows:

· The patient’s medications from their old practice will be put onto a new record on the clinical practice system by administration staff.

· The patient will see the Practice Nurse for a new patient medical.

· A more detailed review of medications takes place when the patient is seen by a GP.

26. The records show this procedure was followed with Mr R’s transfer. Mr R’s medications from his previous practice were imported to the system on 10 December 2019. He attended a new patient medical with the Practice Nurse on 12 December 2019. His medications were then put on to the system by administrative staff. On 18 December 2019, a check was made as to whether Matrifen patches could be issued. On 20 December 2019, Matrifen Transdermal Patches 25mcg/hour were dispensed.

27. Mr R says the first time the Practice raised an issue with his fentanyl prescription was in a consultation with Dr A. Mr R was unable to recall the precise date of this consultation.

28. The records show a consultation with Dr A on 10 January 2020. The consultation record states, ‘only to see me for drug reduction, slowly to reduce gabapentin slowly’ and shows 5 Mezolar Matrix 12 mcg/hour patches were prescribed, one to be applied every 72 hours. Mezolar is another brand name for fentanyl patches.

29. We asked the Practice to confirm if this represents the full consultation record for this appointment. The Practice confirmed it was and Dr A does not have a clear memory of anything different.

30. The relevant guidance when reducing or stopping opioids in primary care is The Faculty of Pain Medicine, Opioids Aware guidance (FPM Guidance). This states, ‘the decision to taper/stop an established opioid regimen needs to be discussed carefully with the patient including:

· explanation of the rationale for stopping opioids including the potential benefits of opioid reduction (avoidance of long-term harms and improvement in ability to engage in self-management strategies) · agreeing outcomes of opioid tapering · arrangements for monitoring and support during opioid taper · documented agreement of tapering schedule.

31. The Practice provided us with the County Durham and Tees Valley APC Position Statement (APC Position Statement) on prescribing in persistent pain. This sets out the aspiration to reduce the prescribing of opioids in the region, and states that the prescribing of opioids for non-cancer persistent pain is not routinely recommended.

32. The APC Position Statement sets out that: ‘the risks of long-term opioid use should be discussed with the patient, including opioid induced hyperalgesia. The benefits of opioid reduction should also be discussed and the patient offered a personalised, flexible reduction plan. Joint decision making is essential. If the patient agrees to opioid reduction, they should be provided with alternative options to help manage their pain. They should be fully supported throughout the reduction plan.’

33. The consultation record for 10 January 2020, includes no rationale for the reduction of fentanyl. There is no evidence to show why Dr A planned to reduce the fentanyl dose, or that the reasoning for this was explained to Mr R. There is also no evidence to show that the reduction, or the rate at which it was to be reduced, was discussed with Mr R, or agreed to by him.

34. Mr R says Dr A reviewed all his medications and told him he could not have the fentanyl patches as the Practice only prescribe opiates for palliative care. He says Dr A refused to discuss this further with him. He recollects Dr A prescribing a half dose for one week.

35. We recognise the need for the Practice to reduce the number of patients being prescribed opioids. We also understand the Practice had targets to work towards, in this regard, set from a patient safety perspective. From the evidence, on balance we think it is more likely than not that on 10 January 2020, the Practice did not discuss the reduction of fentanyl with Mr R. This is because Mr R does not recall a conversation and there is no evidence in the records to show any discussion was held. This is not in line with the FPM Guidance that the Practice referred to, or the approach to reduction outlined in the APC Position statement. We saw no evidence of agreeing outcomes of opioid tapering, or arrangements for monitoring and support during the opioid taper at this time.

36. We understand the anxiety and distress Mr R felt to have his medication reduced without discussion. The need to discuss and agree an individual approach for reduction with patients, as set out in both the FPM Guidance and APC Position statement is vital. We view the lack of consultation and discussion with Mr R regarding his individual circumstances as a failing.

Fentanyl Reduction

37. Mr R complains that his fentanyl was reduced too quickly. He says at the medication review with Dr A, they cut his prescription by half and only issued him with one week’s supply.

38. The Practice says it referred Mr R to the Pain Clinic for a managed programme of withdrawal.

39. We can see from the records that Mr R’s previous GP practice prescribed Matrifen 25 mcg/hour transdermal patches on 10 December 2019. When he was registered at the Practice, we have seen on 18 December 2019, an administrative task was generated by the Practice to check if Matrifen patches could be issued. On 20 December 2019, the Practice issued fourteen Matrifen patches at the same 25 mcg/hour dosage.

40. The records show, at the consultation on 10 January 2020, Dr A changed the dosage to 12 mcg/hour patches. Five patches were prescribed, with one patch to be applied every 72 hours. This represented fifteen days’ supply, or until 25 January. Mr R’s recollection that he was provided with only one week’s supply, at half dose, does not appear to be correct.

41. The South Tees Patient Guidance on reducing and stopping your Opioid medication (South Tees Guidance) advises a fentanyl 37mcg patch is equivalent to 120mg of morphine. A 25mcg patch (two thirds dose) would be 80mg, so 12mg (one third dose) would be roughly equivalent to 40mg morphine. This change of dosage on 10 January 2020 equates to a reduction by half, from the equivalent of 80 mg/day of oral morphine, to 40 mg/day.

42. The Practice complaint register shows Mr R complained verbally to the Practice on 20 January about Dr A not being willing to prescribe the Matrifen medication. After discussion with Dr A, the Practice Manager telephoned Mr R on 23 January. They offered a further appointment with Dr A to discuss alternative pain medication, such as codeine, ibuprofen, or paracetamol. We understand Mr R declined this appointment as he felt it did not meet his needs and his concern was that the medication should not just be stopped. The complaint register does not show if the Practice Manager discussed a referral to the Pain Clinic in this telephone conversation. There is no evidence of a referral at this time.

43. The records show no further opiate pain relief was prescribed for Mr R between 10 January until 13 February 2020. On 13 February, and 21 February, Mr R was prescribed 40mg of Zomorph oral morphine in line with the Pain Clinic reduction plan, dated 11 February. Mr R then left the Practice, returning to his previous surgery.

44. Our adviser confirmed clinical guidance for safe dosage levels, when tapering down to reduce opioids, is provided at a local level. This is generally based on national guidance amended for local circumstances by Medicines Management Groups in an area, so areas will have similar advice. We asked the Practice to provide any local guidance they relied on in their area. It has not sent us any guidance.

45. The South Tees Guidance suggests that while a personalised plan for reduction will be created, a daily dose of opioid medication can be reduced by roughly 10% every one to two weeks. The dose may be reduced more slowly when the patient nears the end of their reduction plan.

46. The records show Mr R’s patches were reduced from 25mcg to 12mcg for a fifteen day period. After this fifteen day period the 12mcg patches were stopped. Our adviser confirmed that the sudden drop of Mr R’s patches from 12mcg to nothing was equivalent to a drop from 40mg morphine to nothing. This does not comply with safe dosage levels when tapering down opioid medication.

47. We asked our adviser what should have happened. Our adviser confirmed from 25 January 2020, Mr R should have been prescribed oral morphine at a slowly reducing level. As shown above, 12mcg equates to 40mg/day of oral morphine. An appropriate reduction plan in line with the South Tees Guidance would be to reduce this down by roughly 10% every one to two weeks.

48. We consider the actions of the Practice in stopping Mr R’s dose from a level of 12mcg without any tapering, to be a failing and not in line with local guidance.

49. The Practice states it referred Mr R to the Pain Clinic for a programme of managed withdrawal. Mr R disputes that the Practice made this referral. Given this difference we have considered this carefully.

50. We asked the Practice to provide confirmation of its referral. It directed us to a telephone call and email from the Pain Clinic on 11 February 2020. There are no records of the Practice contacting the Pain Clinic prior to 11 February 2020.

51. We also obtained the nursing notes from the Pain Clinic, for the period in question. These records show the Pain Clinic initiated contact with the Practice on 11 February after speaking to Mr R. It was from this contact that a plan of gradual opiate reduction was agreed.

52. We recognise Mr R found the contact with the Practice difficult once his medication was reduced. From the evidence, we are satisfied that on 10 January 2020, when Mr R’s fentanyl was reduced by half, there was no tapering plan in place from the Pain Clinic. The evidence also shows when Mr R’s fentanyl ran out on 25 January, there was no tapering plan in place from the Pain Clinic. While there is evidence the Practice spoke to the Pain Clinic on 11 February, during which a tapered reduction plan was formulated, by this time Mr R had already experienced two weeks with no opiate medication. This is a failing.

Complaint Handling

53. Mr R complains about the handling of his written complaint. He says the responses he received were not true when Dr A said he had referred him to the Pain Clinic. He complains he did not receive any proper answers to his questions and was upset by the dismissive attitude of the responses he received. He also says he was not advised how he could take his complaint further.

54. We do not underestimate the impact of the Covid pandemic on the workload and working practices of all staff at the Practice at the time. We also recognise that many health organisations suspended its complaint processes at this time, so we commend the Practice for dealing with Mr R’s complaint in the period of March to October 2020.

55. The Practice provided us with its Complaints and Comments Leaflet, revised in November 2020. It is not clear if Mr R had access to the Complaints and Comments Leaflet when he made his complaint. The leaflet provides details and relevant contact information for complaining to other authorities. It also sets out how to complain to the Practice, the timescales for doing so and how the Practice will approach any complaint.

56. Mr R complained in writing to the Practice on 11 March 2020. He sought an explanation for his concerns and answers to three specific questions: 1) Why did Dr A stop the medication prescribed by his previous surgery? 2) Why was a different pain relief option not offered? 3) Why did Dr A suggest he half the dose and then stop taking them completely?

57. The Practice responded to Mr R by letter dated 10 July 2020. The response stated that according to Practice guidelines, and guidelines from the CCG, it does not prescribe opiates for long-term chronic non-palliative conditions. It confirmed it had referred Mr R to the Pain Clinic and attached copies of the Pain Management guidance for non-cancer pain in primary care.

58. On 27 August 2020, Mr R wrote again seeking answers to two of his original three questions: 2) Why was a different pain relief option not offered when the opiate medication was removed? 3) Why did Dr A suggest he half the dose and then stop taking them completely? He also stated it was untrue that Dr A referred him to the Pain Clinic as he himself had contacted it.

59. The Practice responded on 12 October 2020, repeating it does not prescribe opiates for chronic non-palliative conditions. It stated again it had referred him to the Pain Clinic for opiate reduction in a planned way.

60. The Practice policy states that when looking into a complaint the Practice aims to:

· Ascertain the full circumstances of the complaint · Make arrangements for you to discuss the problem with those concerned, if you would like this · Make sure you receive an apology, where this is appropriate · Identify what the practice can do to make sure the problem does not happen again

61. Mr R says the responses he received were not true in stating Dr A had referred him to the Pain Clinic. We have set out above our analysis of the referral to the Pain Clinic. While the Practice did have a discussion with the Pain Clinic, from which a reduced tapering plan resulted, this happened after Mr R had already been taken off the opioid medication. On this basis, we consider the Practice in both of its responses, did not meet its own policy aim of ascertaining the full circumstances of the complaint.

62. The Ombudsman’s Principles for Good Complaint Handling (our Principles) set out the importance of being open and accountable. It says the organisation should ensure that complaints are investigated thoroughly and fairly to establish the facts of the case. Complaints should also be reviewed by someone not involved in the events leading to the complaint. The evidence we have seen shows the Practice did not do this when addressing Mr R’s complaint.

63. Mr R complains he did not receive any proper answers to his questions and was upset by the dismissive attitude of the responses he received. The Practice response dated 10 July 2020, explained its stance of not prescribing opiates for non-cancer care. This was in answer to Mr R’s first question as to why it stopped the medication, and we note Mr R did not raise this question again. The response did not address or refer to Mr R’s remaining questions about how the stoppage was dealt with. Mr R raised these questions again. The Practice response from 12 October 2020 did not refer to or address these questions.

64. We consider the questions Mr R asked were not unreasonable. Our Principles state that an important part of getting it right when dealing with complaints is to listen to complainants to understand the complaint and the outcome they are seeking. As both Practice responses failed to acknowledge the questions asked, we do not feel the Practice did this. We believe this will have contributed to Mr R’s perception that the responses he received were dismissive in attitude.

65. Mr R complains he was not advised how to take his complaint forward. Our Principles state the importance of signposting to the next stage of the complaint procedure, in the right way, and at the right time. Although we have referred to the Complaints Leaflet above, it is not clear that Mr R was given this. In its written responses, we would expect the Practice to signpost Mr R as to how to go forward if he was not satisfied with the response. This should include reference to the role and function of the Parliamentary and Health Service Ombudsman. The Practice did not do this.

66. For the reasons set out, we consider there were failings in the way the Practice dealt with Mr R’s complaint.

Impact

67. We have considered the impact of the failings we have identified on Mr R.

68. He said the lack of consultation caused him panic and distress. We can understand how distressing it was for Mr R to be told his medication would be stopped given the pain he previously experienced. His distress is recorded in the Practice Complaint register on 20 January.

69. We next considered the impact of the failing to appropriately taper the medication down. Mr R had been on a 25mcg dose of fentanyl over 48 hours, since January 2017. He states that the rapid reduction and stoppage of fentanyl caused him to suffer recurrent and acute stabbing pains in his eye. He also states he went through the trauma of withdrawal and has ‘never been so ill’. He says he was nauseous, sweating, shivering, and unable to sleep.

70. The South Tees Guidance sets out withdrawal symptoms can include:

· Flu-like symptoms e.g., runny nose, aching, alternating hot and cold spells · Upset stomach and stomach ache · Nausea and vomiting · Goose bumps on the skin · Blurry vision · Rapid heartbeat, high blood pressure · Difficulty sleeping, frequent yawning · Feeling anxious or irritable · Short term increase in pain.

71. Our adviser confirmed that, given Mr R was on fentanyl for long-term pain management, a reduction from the equivalent of 40mg/day of oral morphine to nothing would give rise to the symptoms Mr R has set out. A sudden withdrawal from that level would cause both a resurgence in pain, which was otherwise effectively controlled, and lead to opioid withdrawal symptoms, as described by Mr R. Our adviser confirmed the withdrawal symptoms of effectively going ‘cold turkey’ would not have been mild and would likely have persisted until Mr R was started on 40mg of Zomorph on 13 February 2020.

72. We can link Mr R’s experience of anxiety and distress to the lack of consultation and discussion when reducing his medication. We can also link the quick reduction in medication to the symptoms that Mr R experienced. The failings we have found mean in January 2020 Mr R was not given an opportunity to agree an opioid reduction programme suitable for him. This caused him distress and concern and meant between the end of January and February he suffered significant symptoms of withdrawal over a two week period, which could have been avoided.

73. Mr R states the complaints process caused him significant frustration and inconvenience. We consider this impact would reasonably flow from the failings identified. Mr R, having taken the time to approach an advocate and pursue a written complaint would have been frustrated that the questions he specifically sought answers to were not referenced at all. This led to the inconvenience of him having to approach the Practice again and finally to bring the complaint to ourselves.

1. Mr R complains that a medical practice in the Hartlepool area (the Practice) reduced, and then stopped, his fentanyl medication too rapidly and without discussion. We understand that stopping the medication was distressing for Mr R and caused him some difficult symptoms. We have found the Practice failed to discuss and agree a suitable and individualised plan of withdrawal, before reducing Mr R’s fentanyl medication. This caused Mr R panic and distress over several weeks.

2. We have found the Practice failed to appropriately taper Mr R’s fentanyl medication, before stopping it. This meant Mr R suffered an unnecessary resurgence in his pain and withdrawal symptoms for a period of two weeks, which could have been avoided.

3. Mr R also complains about the complaint handing at the Practice. We have found the Practice failed to address Mr R’s concerns through its complaint process, causing him frustration and inconvenience.

4. We therefore uphold this complaint. We recommend the Practice acknowledges what it got wrong, apologise to Mr R for the distress, frustration, unnecessary pain, and withdrawal symptoms he experienced. We recommend the Practice makes service improvements.

74. In considering our recommendations, we have referred to our ‘Principles for Remedy’. These state that where poor service or maladministration has led to injustice or hardship, the organisation responsible should take steps to put things right.

75. Our principles say that public organisations should look for continuous improvement and should use the lessons learned from complaints to make sure they do not repeat maladministration or poor service.

76. In line with this, we recommend that within six weeks of the date of our final report, the Practice should write to Mr R and apologise for the impact its failings had on him. It should acknowledge how failing to agree a suitable and individualised plan of withdrawal caused him panic and distress. It should also acknowledge that failing to appropriately taper his medication down meant he suffered unnecessary withdrawal symptoms and a resurgence of his pain. It should also apologise for failing to address this through its complaint process.

77. We will recommend within eight weeks of our final report, the Practice develops an action plan to show how it plans to address its failings in discussing and agreeing an individualised approach to a tapered reduction of opiates. It should also show how it is going to address its failure to appropriately reduce the dosage levels of fentanyl medication. The action plan should include the reasons for the failings, where possible; the steps the Practice will take; timeframes for the actions; details of who is responsible for each one; and how the Practice will monitor the actions.

78. Finally, we will recommend within eight weeks of our final report the Practice develops an action plan to show how it plans it address its failings in the handling of the complaint. It should address the failures to ascertain the full circumstances of the complaint; to listen to the complainant, to understand the complaint, and the outcome they are seeking; to address these, and to advise the complainant how to take the complaint forward. The action plan should include the reasons for the failings, where possible; the steps the Practice will take; timeframes for the actions; details of who is responsible for each one; and how the Practice will monitor the actions.