Source · Prevention of Future Deaths

Christine Stevenson

Ref: 2016-0123 Date: 10 Mar 2016 Coroner: Joanne Kearsley Area: Manchester (South) Responses identified: 2 / 1 View PDF

Large volumes of Oramorph solution, despite containing less than 0.2% morphine, are prescribed without sufficient control. This poses a serious and potentially fatal risk to naive users due to the high total dosage.

Date 10 Mar 2016

56-day deadline 5 May 2016 est.

Responses identified 2 of 1

Alcohol, drug and medication related deaths

Coroner's concerns

AI summary

View full coroner's concerns

The concerns noted by the Court the course of the Inquest are as follows: Concerns were raised at the Inquest as to the lack of control for Oramorph medication. per Sml solution does not fall under the controlled requirements in the BNF It is noted that whilst the Misuse of Drugs Act 1971 lists morphine as a Schedule 2, Part 1, Class A Controlled Section 5 gives and exemption for preparation that cortain not mnore than 0.2% morphine Oramorph (10 mg per 5 millilitres) has a morphine content that is under the 0.2% (as the 10 mg is present as morphine sulphate). However even though the solution at this strength is not to be subject of control, should there be restrictions on the amount of the solution which can be This lady was prescribed SOOmls (a total available dose of 1000 mg of this solution which poses as a dose a serious risk to health: The Court heard evidence that in naive user SOmls of the solution at this strength can be a risk to life. Given that Oramorph has an increasing street value and is commonly abused whilst the strength of the solution may not require control the issuing of s0dmls without control seems a matter which requires consideration

Responses

2 respondents

Christine Stevenson

22 Apr 2016 PDF

Action Planned

Greater Manchester will raise concerns about volumes/strengths of prescribed controlled drugs and provide guidance to prescribers, as well as examine its reporting system to identify high-volume prescribers. They will highlight prescribing volumes in the national Care Quality Commission "Controlled Drugs Vigilance Newsletter" and use local newsletters, with some CCGs already working with practices to reduce high doses. (AI summary)

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Dear Miss Kearsley Re: Christine Marie Stevenson (deceased) Your ref: JKIERI01806-2015 Thank you for copying me into the Regulation 28 Report you sent to the Chief Executive of the Medicines and Healthcare Products Regulatory Agency: Karen OBrien, the Controlled Drug Accountable Officer for Greater Manchester has prepared a response on my behalf: You have raised a number of issues that would Iike to respond to The first concerns the Home Office regulation of controlled drugs Morphine (Oramorph) regulation is currently dependent on the potency (strength) of morphine present within each type of preparation, e.g: tablets, solution, injection, etc. and not the itself; i.e. morphine. Under the 2001 Misuse of Drugs Regulations, controlled drugs were classified into five Schedules: Schedule 1 Drugs belonging to this schedule are thought to have no therapeutic value and therefore cannot be lawfully possessed or prescribed: These Include LSD, MDMA (ecstasy) and cannabis: Schedule 1 drugs may be used for the purposes of research but a Home Office license is required.

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Schedule 2 & 3 The drugs in these schedules can be prescribed and therefore legally possessed and supplied by pharmacists and doctors. They can also be possessed lawfully by anyone who has a prescription: It is an ffence contrary to the 1971 Act to possess any drug belonging to Schedule 2 or 3 without prescription or lawful authority: Examples of schedule 2 drugs are methadone and diamorphine (heroin): Schedule 3 drugs include subutex and most of the barbiturate family: The difference between Schedule 2 and Schedule 3 drugs is limited to the application of the 2001 Regulations concerning record keeping and storage requirements in respect of schedule 2 drugs. Schedule (i) & (ii) Schedule 4 was divided into two parts by the 2001 Regulations [as amended by the Misuse of Drugs (Amendment No. 2) Regulations 2012]. Schedule 4(i) controls most of the benzodiazepines. Schedule 4() drugs can only be lawfully possessed under prescription. Otherwise , possession is an offence under the 1971 Act: Schedule 4(ii) drugs can be possessed as long as are clearly for personal use . Drugs in this schedule can also be imported or exported for personal use where a person himself carries out that importation or exportation. The most common example of a schedule 4(ii) drug is steroids. Schedule 5 Schedule 5 drugs are sold over the counter and can be legally possessed without a prescription: This control by schedule was based on evidence of the potential of a drug to cause harm, to be abused or to be available illegally; therefore the potency of a is important as this is a contributory factor: In your report you raise concerns about the lack of control for Oramorph 1Omglsml solution as it is not treated as a controlled but good practice would expect the drug to be stored and usage recorded appropriately- There are unfortunately a number of drugs that would fall into the same category as Oramorph 1Omg/sml oral liquid such as codeine containing products that can actually be purchased over-the- counter from pharmacy: The second issue you raise is concerning the volume of Oramorph prescribed which in this instance was 500ml and whether this could restricted: Prescribers are aware are responsible for all prescriptions they sign (EL(91)127). This Executive Letter states clinical responsibilities lies with the clinician who signs the prescription. This means they should prescribe appropriately for each patient and this has been reinforced to all new prescribers and existing prescribers since 1991

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This patient was unlikely to be opioid naive as she was released from hospital on a reducing dose of slow release oral morphine 2Omg (Schedule 2) twice daily and tramadol (Schedule 3) drugs Tramadol is sometimes substituted by Oramorph solution as currently there is a significant problem with abuse and addiction to tramadol: The prescriber may have decided that the Oramorph was more appropriate option. All prescribers are advised to keep the prescribed volume of drugs to a minimum especially with controlled drugs: Patients taking drugs such as morphine do find that over time need increasing doses to control their symptoms and this varies greatly between patients. Limiting the volume of Oramorph prescribed may disadvantage some patients who are legitimately on a high dose at the end of their life_ We take the following actions: Greater Manchester along with all areas of NHS England has established Local Intelligence Networks where information is shared across a network of healthcare providers such as hospitals, hospices, private hospitals, clinics, the police, the Care Quality Commission; and regulators such as the General Pharmaceutical Council: The Network meets twice a year to share learning concerning controlled drugs and more recently "Iegal highs" , We are going to raise the issue concerning the volumes and strengths of controlled drugs prescribed and provide guidance to prescribers Greater Manchester has a web based reporting system where all providers report incidents involving controlled drugs: This means we have real time data of incidents across the Network so early warnings can be distributed. We will examine the system to identify high volume prescribers and question reasons for prescribing high volumes. We have shared your letter with the Local Intelligence Network (LIN); one of the recommendations from the group was to highlight the issue of prescribing high volumes of controlled drugs in the next national newsletter from the Care Quality Commission "Controlled Drugs Vigilance Newsletter" , which is a published every two months; Karen O'Brien will take this recommendation forward as a member of this group: The LIN also suggested that we use local newsletters to highlight the issues especially around volume of prescribing: Some of the Clinical Commissioning Groups are working with their GP practices already to reduce high doses and volumes being prescribed. The Network felt there is a significant problem in that patients could travel around practices, out-of-hours services and A&E departments in order to obtain controlled drugs Since the controlled drug reporting tool was introduced we have seen a great

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deal of this behaviour and we now have an alert system to inform providers of possible abuse. The system is not full proof but it does provide a safety net: trust this replies to your query in respect of local learning; if | can be of further assistance please do not hesitate to contact me_

Home Office Central Government

5 Jun 2016 PDF

Action Taken

The Home Office notes the concerns and states information from the investigation has been added to the Yellow Card Scheme to monitor substances suspected of being misused. The Home Secretary has commissioned the ACMD to explore potential medical and social harms arising from the illicit supply of medicines. (AI summary)

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Karen Bradley MP Minister for Preventing Abuse, Exploitatlon and Crime Home Office 2 Marsham Street; London SWIP 4DF wwwgovuk/home-office Ms Joanne Kearsley Coroner's Court 16 #79 Mount Tabor Street C Stockport H: SK1 3AG 1 5 JUN 2016 Keasles INQUEST INTO THE DEATH OF CHRISTINE MARIE STEVENSON REGULATION 28 REPORT Thank you for your letter of 15 April to the Advisory Council on the Misuse of Drugs (ACMD) about the tragic death of Christine Marie Stevenson the combined toxic effects of a number of prescribed and controlled substances. am replying as the Minister for Preventing Abuse, Exploitation and Crime, with responsibility for policy including the Misuse of Drugs Regulations 2001. note your request for action regarding the prescribing of products such as oramorph, which have a morphine content of less than 0.2%. As you stated in your report, there were many factors around the prescribing of the amounts of morphine to Ms Stevenson that led to her death and am grateful to you for raising these issues. My officials have consulted with other departments and agencies who have responsibility for prescribing opiate medicines for severe pain relief;, including the Department of Health and the Care Quality Commission: The amount of morphine needed to give relief from severe pain varies enormously according to the needs of each individual: It is not possible to set a daily maximum dose: If a limit to the amount of oramorph which can be prescribed were set; it may have unintended consequences and could have a negative impact on sore patients' care: All professionals who prescribe any medicines should act within their scope of practice and comply with their Regulators' standards: All prescribers are required to accept clinical and professional responsibility for their prescribing decisions. Following the Shipman Inquiry the governance requirements for the safe management of controlled drugs, including the prescribing, requisitioning, supply and storage of controlled drugs were strengthened and guidance was issued by the Department of Health and the National Prescribing Centre. Most recently NICE published guidance on the safe use and management of controlled drugs in April 2016 (https IlWnice org uklguidanceING46): Ac> from drug

The response from the Medicines and Healthcare products Regulatory Agency confirms that information from your investigation has been added to the Yellow Card Scheme which is the scheme used to monitor substances suspected of misused, including low concentrations of morphine in the future_ also note your point about the missing 30Omls of morphine sulphate. The diversion of prescription drugs into the illicit supply is taken seriously, which is why the Home Secretary has commissioned the ACMD to "explore the potential for medical and social harms arising from the illicit supply of medicines predominantly controlled drugs' The scope of this work includes: whether diversion and illicit supply displaces the misuse of classic drugs; the prevalence of misuse of medicines obtained through these means; demographics of users; and the most prevalent drugs being misused We expect the ACMD to report their findings this year: Already a considerable number of prescription-only medicines are controlled under the Misuse of Drugs Act 1971, where there has been evidence on misuse and harms sufficient to justify additional controls over and above those provided by medicine laws. This includes morphine and tramadol. hope that this letter addresses your concerns: Lc> KAREN BRADLEY MP being very

Report sections

Investigation and inquest

On the 11th January 2016 I concluded the Inquest into the death of Christine Marie Stevenson date of birth 27.01.1969 who died on the 21.07.2015. The cause of aeath was la) Combined Toxicity (from prescribed and illicit use) I recorded an open conclusion. CIRCUMSTANCES OF THE DEATH The Court heard evidence that the deceased had of illicit use. In addition she had number of medical issues and undergone right amputation in February 2015. At the time of her death she was residing with her Mother and was effectively housebound: The deceased had been admitted to hospital in February 2015 and was released from hospital on reducing dose of slow release oral morphine, initially x2 day and tramadol: At the time of her discharge she was registered with Heaton Moor Medical Practice. She attended her GP practice on the 24th February when her Tramadol mnedication was changed to Oramorph. She is seen by Heaton Moor on the 3"d March when she was also prescribed Tramadol, Mirtazapine and Pregabalin. On the 4t March 2015 the deceased changed medical practice to the Brinnington Surgery where she was a temporary patient until the 29th June 2015. Throughout this time Brinnington Surgery only had summary of her medical records Drug drug history drug leg 90mg again they did not receive all her medical records. She attended at this practice on the 6th March requesting Oramorph. It was noted that she had been discharged from hospital on Zomorph but that the advice from the hospital was that the dose should be gradually reduced and if their advice was followed then use of Zomorph should have been stopped by the time she registered with the Brinnington Practice. On this initial visit the deceased requested Oramorph: However; on this date she was issued with prescription for Tramadol but not Oramorph: She was on also on pregabalin. On the 20th March she advised that her was not controlled and she was prescribed Oramorph (lOmg/ Smls; on an as required basis hours) , it was discussed that this should be for short term use. The initial prescription on the March was for per 5 ml solution and 300 mls were issued. This was increased in June to 10 mgs per ml solution and 500 mls were prescribed on 5th then further 500 mls on 19th (suggesting averaging doses daily, when advise was every 4 hours thus maximum of 6 doses daily): At the time this was increased she was overdue a medication review. On the June 2015 she returned to the Heaton Moor practice. Again the medical records from Brinnington were now not immediately available to the Heaton practice. She had further prescription of Oramorph issued on the 29.06.15 (10Omls), 03.07.15 (280mls). On the 20*h July she telephoned the practice requesting more morphine and a prescription of 500 mls was issued. This prescription was collected from the pharmacy on the same the 20th It was usual practice for her Mother to collect her prescriptions but the evidence to the Court was that her Mother did not collect this prescription. It could not be established who collected this prescription. The pharmacy were able to confirm that SOOrls of 'Sml morphine sulphate were dispensed in two 1OOmls bottles and one 300 mls bottle_ Whilst there is an illegible signature on the back of the prescription there was no name OT address printed. You will be aware that Morphine 'Sml is a Schedule 5 Controlled and therefore not subject to any requirements to check the identification of the person collecting it: The deceased was at home on the 20th July, she was seen by her Mother when she returned home from work at Zpm. She went to her room around 6pm and was later discovered deceased in bed. The police attended out at the time of the police attendance were not advised pain being every 20th 1Omgs 29th Moor day July. Omg 1Omg/ drug they of any medication which may be missing from the property They seized some medication which was also issued on the 20"h July but were not aware that Morphine Sulphate was also issued: Later two empty 1OOmls bottles of morphine sulphate were found by her Mother in the handbag of the deceased. The bottle containing 300mls which was issued on the of the deceased' s death has never been located, CORONER'S CONCERNS The concerns noted by the Court the course of the Inquest are as follows: Concerns were raised at the Inquest as to the lack of control for Oramorph medication. per Sml solution does not fall under the controlled requirements in the BNF It is noted that whilst the Misuse of Drugs Act 1971 lists morphine as a Schedule 2, Part 1, Class A Controlled Section 5 gives and exemption for preparation that cortain not mnore than 0.2% morphine Oramorph (10 mg per 5 millilitres) has a morphine content that is under the 0.2% (as the 10 mg is present as morphine sulphate). However even though the solution at this strength is not to be subject of control, should there be restrictions on the amount of the solution which can be This lady was prescribed SOOmls (a total available dose of 1000 mg of this solution which poses as a dose a serious risk to health: The Court heard evidence that in naive user SOmls of the solution at this strength can be a risk to life. Given that Oramorph has an increasing street value and is commonly abused whilst the strength of the solution may not require control the issuing of s0dmls without control seems a matter which requires consideration ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe you have the power to take such action: YOUR RESPONSE You are under a duty to respond to this report within 56 of the date of this report, namely by 2iytn pi6 1, the coroner; may extend the period Your response must cortain details of action taken or proposed to be taken; setting out the timetable for action. Otherwise you must explain why no action is proposed. day during Omgs drug drug; prescribed? drug days Aay

COPIES and PUBLICATION Ihave sent a copy of my report to the Chief Coroner and to the following Interested Persons namely, the family of Mrs Stevenson. I am also under a to send the Chief Coroner a copy of your response. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest: You may make representations to me, the coroner; at the time 0f your response, about the release or the publication of your response by the Chief Coroner. 110.03.2016 Joanne Kearsley Area Coroner (lesc1 duty

Circumstances of the death

The Court heard evidence that the deceased had of illicit use. In addition she had number of medical issues and undergone right amputation in February 2015. At the time of her death she was residing with her Mother and was effectively housebound: The deceased had been admitted to hospital in February 2015 and was released from hospital on reducing dose of slow release oral morphine, initially x2 day and tramadol: At the time of her discharge she was registered with Heaton Moor Medical Practice. She attended her GP practice on the 24th February when her Tramadol mnedication was changed to Oramorph. She is seen by Heaton Moor on the 3"d March when she was also prescribed Tramadol, Mirtazapine and Pregabalin. On the 4t March 2015 the deceased changed medical practice to the Brinnington Surgery where she was a temporary patient until the 29th June 2015. Throughout this time Brinnington Surgery only had summary of her medical records Drug drug history drug leg 90mg again they did not receive all her medical records. She attended at this practice on the 6th March requesting Oramorph. It was noted that she had been discharged from hospital on Zomorph but that the advice from the hospital was that the dose should be gradually reduced and if their advice was followed then use of Zomorph should have been stopped by the time she registered with the Brinnington Practice. On this initial visit the deceased requested Oramorph: However; on this date she was issued with prescription for Tramadol but not Oramorph: She was on also on pregabalin. On the 20th March she advised that her was not controlled and she was prescribed Oramorph (lOmg/ Smls; on an as required basis hours) , it was discussed that this should be for short term use. The initial prescription on the March was for per 5 ml solution and 300 mls were issued. This was increased in June to 10 mgs per ml solution and 500 mls were prescribed on 5th then further 500 mls on 19th (suggesting averaging doses daily, when advise was every 4 hours thus maximum of 6 doses daily): At the time this was increased she was overdue a medication review. On the June 2015 she returned to the Heaton Moor practice. Again the medical records from Brinnington were now not immediately available to the Heaton practice. She had further prescription of Oramorph issued on the 29.06.15 (10Omls), 03.07.15 (280mls). On the 20*h July she telephoned the practice requesting more morphine and a prescription of 500 mls was issued. This prescription was collected from the pharmacy on the same the 20th It was usual practice for her Mother to collect her prescriptions but the evidence to the Court was that her Mother did not collect this prescription. It could not be established who collected this prescription. The pharmacy were able to confirm that SOOrls of 'Sml morphine sulphate were dispensed in two 1OOmls bottles and one 300 mls bottle_ Whilst there is an illegible signature on the back of the prescription there was no name OT address printed. You will be aware that Morphine 'Sml is a Schedule 5 Controlled and therefore not subject to any requirements to check the identification of the person collecting it: The deceased was at home on the 20th July, she was seen by her Mother when she returned home from work at Zpm. She went to her room around 6pm and was later discovered deceased in bed. The police attended out at the time of the police attendance were not advised pain being every 20th 1Omgs 29th Moor day July. Omg 1Omg/ drug they of any medication which may be missing from the property They seized some medication which was also issued on the 20"h July but were not aware that Morphine Sulphate was also issued: Later two empty 1OOmls bottles of morphine sulphate were found by her Mother in the handbag of the deceased. The bottle containing 300mls which was issued on the of the deceased' s death has never been located,

Inquest conclusion

Concerns were raised at the Inquest as to the lack of control for Oramorph medication. per Sml solution does not fall under the controlled requirements in the BNF It is noted that whilst the Misuse of Drugs Act 1971 lists morphine as a Schedule 2, Part 1, Class A Controlled Section 5 gives and exemption for preparation that cortain not mnore than 0.2% morphine Oramorph (10 mg per 5 millilitres) has a morphine content that is under the 0.2% (as the 10 mg is present as morphine sulphate). However even though the solution at this strength is not to be subject of control, should there be restrictions on the amount of the solution which can be This lady was prescribed SOOmls (a total available dose of 1000 mg of this solution which poses as a dose a serious risk to health: The Court heard evidence that in naive user SOmls of the solution at this strength can be a risk to life. Given that Oramorph has an increasing street value and is commonly abused whilst the strength of the solution may not require control the issuing of s0dmls without control seems a matter which requires consideration ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe you have the power to take such action: YOUR RESPONSE You are under a duty to respond to this report within 56 of the date of this report, namely by 2iytn pi6 1, the coroner; may extend the period Your response must cortain details of action taken or proposed to be taken; setting out the timetable for action. Otherwise you must explain why no action is proposed. day during Omgs drug drug; prescribed? drug days Aay

COPIES and PUBLICATION Ihave sent a copy of my report to the Chief Coroner and to the following Interested Persons namely, the family of Mrs Stevenson. I am also under a to send the Chief Coroner a copy of your response. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest: You may make representations to me, the coroner; at the time 0f your response, about the release or the publication of your response by the Chief Coroner. 110.03.2016 Joanne Kearsley Area Coroner (lesc1 duty

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Report details

Reference: 2016-0123
Date of report: 10 March 2016
Coroner: Joanne Kearsley
Coroner area: Manchester (South)

Responses identified

Responses identified 2 of 1

All listed responses identified

Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 5 May 2016 (estimated).

Sent to

Medicines and Healthcare Products Regulatory Agency

Source links

Judiciary.uk page → Report PDF →

Data: judiciary.uk under OGL.