NPSA Alert 03: Reducing the harm caused by oral Methotrexate. Implementation Progress Report July Learning and Sharing

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1 NPSA Alert 03: Reducing the harm caused by oral Methotrexate Implementation Progress Report July 2006 Learning and Sharing

2 CONTENTS Page 1 Background 3 2 Findings 4 Appendix 1 Summary of responses 6 Appendix 2 NPSA Alert 03: Reducing the Harm 12 Caused by Oral Methotrexate

3 1 Introduction and Background One of the key additional responsibilities given to NHS Quality Improvement Scotland (NHS QIS) at the time of its establishment was that of supporting and developing patient safety throughout NHSScotland. As a result, NHS QIS now has an important opportunity to support NHS Boards in relation to the delivery of safe and effective care and continuous improvements in the quality of healthcare. One element of this new function relates to the patient safety alerts and information produced by the National Patient Safety Agency (NPSA). At present, NHS QIS has no involvement in the topic selection or content development of these alerts. NHS QIS responsibility is to distribute the information produced by the NPSA to NHSScotland in order to raise awareness of the issue and reduce the incidence of risk. NHS QIS intends to follow up key alerts that have been distributed to determine the extent of implementation across NHSScotland. This report is the first in a series in which to do so. On 30 th July 2004, the NPSA issued a patient safety alert to NHS England and Wales in relation to the use oral methotrexate, and NHS QIS distributed this information (on behalf of the NPSA) to NHSScotland. Oral Methotrexate is a safe and effective medication if taken at the right dose and with the appropriate monitoring. However, by 2004, the NPSA was aware of 137 patient safety incidents in the last ten years in England alone due to problems with taking this medication. The alert recommended that NHS Boards take the following action to reduce this problem: Agree a local risk reduction plan through their Drugs and Therapeutic Committees (D&T Committees). Representatives from clinical teams, pharmacy, risk management, IT and communications should be included in the review. Provide patient information before and during treatment. Update prescribing and dispensing software to include methotrexate alerts and prompts. Ensure that drug purchasers buy the 10 mg and 2.5 mg tablets which are visually distinguishable from each other. The NPSA recommended that these actions were to be implemented in England and Wales by March In Scotland, it was agreed that NHS QIS would review progress against this in partnership with NHSScotland. In October 2005, NHS QIS asked NHS Boards to provide assurance that their area has arrangements in place in line with the recommendations contained within the alert. All NHS Board have now provided this information and as part of learning from experience, we have produced this report which summaries the arrangements and approaches that have been put in place across NHSScotland. 3

4 2 Findings and Conclusions NPSA recommendation Agree a local risk reduction plan through their Drugs and Therapeutic (D&T) Committees. Provide patient information before and during treatment. Update prescribing and dispensing software to include methotrexate alerts and prompts. Ensure that drug purchasers buy the 10 mg and 2.5 mg tablets which are visually distinguishable from each other. NHSScotland response Every NHS Board (with the exception of one) has reported taking action to develop and agree a risk reduction plan, strategy or a good practice checklist, or current practice has been reviewed to ensure existing arrangements in place are in line with the recommendations contained within the alert. In numerous NHS Boards, shared protocols are also in place. Patient information (developed in many cases following wide consultation) is being provided before and after treatment in a high number of NHS Boards. The majority use patient information leaflets and booklets and further information is given through consultation with the appropriate clinician or pharmacist. Electronic monitoring and patient held information cards are used in many areas and counselling sessions are also made available. Every NHS Boards has reported that they have updated their software systems and the appropriate warnings/alerts are now in place (in both GP and pharmacy systems). NHS National Services Scotland reported that the have updated the GPASS system with the appropriate safety measures defined in the alert. In the majority of NHS Boards, both 2.5 mg and 10 mg tablets are still available however both strengths are visually distinguishable. Other NHS Boards have chosen to no longer stock 10 mg tablets and limit purchasing to the 2.5 mg strength. Additional safety measures in place include practice pharmacists and clinical pharmacists assisting in checking and monitoring prescriptions of this drug. The information provided by NHS Boards provides NHS QIS with reasonable assurance that every NHS Board has either implemented, or is working toward implementing, the recommendations contained within the NPSA Alert 03: Oral Methotrexate.

5 Recommendations NHS Board Risk reduction plan Patient Information Update software Review purchasing NHS Argyll and Clyde NHS Ayrshire and Arran NHS Borders Local action plan developed, ensuring all areas where oral methotrexate (OM) is likely to be used are informed of the alert, determine arrangements currently in place, and determine shared-care arrangements where appropriate. Local risk reduction plan agreed through D&T Committee. Areas determined where OM is used; determined local arrangements currently in place and current shared care agreements for monitoring and review of patients on OM. Shared care in place but no written formal agreements. Laboratory results available electronically (more formal arrangements to be developed by rheumatology pharmacist). Ensured all areas informed of the alert and local action taken (via Community Pharmacy bulletin, Prescribing bulletin and Hospital Pharmacy Information notice). Further safety measures include a no supply policy for all hospital in-patients until dose, frequency and prescription are reviewed by a clinical pharmacist. Only one dose supplied at a time. This is recorded in registers in the hospital dispensaries. Local work plan agreed. Continue to draw to the attention of all clinicians especially doctors and pharmacists. Series of briefings undertaken. A working group has been established to formalise shared-care agreements. Developed locally adapted information packs, pre-treatment information packs, and locally adapted patient-held monitoring and dosage records for rheumatology. This is being adapted for gastroenterology and dermatology. Paediatrics are developing their own patient information documentation. Current patient information provided was reviewed. ARC leaflet used in rheumatology, dermatology used their own leaflet. Leaflets contain appropriate information as per NPSA standard and continue to be used. Gastroenterology (rarely use OM) use the manufacturer's leaflet. New leaflets and hand held records will be developed once further information is provided by the NPSA and BSR - rheumatology pharmacist taking this forward. Patient information leaflets and protocols to be advised at a later stage once further information is released from the NPSA. Professionals advised to continue to use a patient information leaflet and hand-held dosage and monitoring card. Ensured the distribution and dispensing systems flag all appropriate warnings and controls. All requests are clinically checked prior to issue. Work done on the hospital JAC electronic prescribing system (Ayr Hospital) to ensure the correct warning appears on the screen before proceeding to prescribe - default frequency weekly. Considering whether warning stickers useful on in-patient sheets at other sites. Work done to ensure correct warning is produced while dispensing OM. Community pharmacists advised directly by letter to update their computer systems. GPASS updated centrally. All community pharmacists and dispensing doctors advised to ensure their software has been updated to include the alerts. GPASS has been updated nationally. Some sites only stock 2.5 mg. Appropriate cautionary wording determined and warning is now on all supplies dispensed. Hospital sites have only stocked and dispensed 2.5mg tablets for some time now. All community pharmacists also now advised directly by letter to also only stock and dispense 2.5mg tablets. All manufacturers packaging contains the correct warnings. Recommended only 2.5mg tablets are stocked, dispensed and prescribed. Ensured brand purchased has dose/frequency warning. 5

6 NHS Board Risk reduction plan Patient Information Update software Review purchasing NHS Dumfries and Galloway NHS Fife Risk reduction plan agreed and approved by D&T Committee. Local practices are in place aimed at reducing the risk of patient overdose and confusion about the strengths of tablets. In general a single dose is dispensed at a time to named individual patients (inpatients or in the community). These practices have been drawn into local policy which has been approved by the D&T Committee. Information provided before and after treatment (ARC leaflet for rheumatology patients and BAD for dermatology). An online system is used for patient-held monitoring and dosage records maintenance. Results available on the lab computer system and can be accessed by consultants and GPs. The majority of prescriptions are to rheumatology patients and there are well developed patient information leaflets within clinical areas which are supplied to patients starting OM. Further information is provided by pharmacy at the time of prescribing. JAC system includes relevant OM alerts. Community pharmacists ensure their own dispensing software is appropriate. Prescribing and practice software have also been updated. The Ascribe pharmacy dispensing software has alerts and interactions imbedded for OM tablets. In the community the majority of prescribing is done on GPASS 2.5 mg and 10 mg tablets are purchased and the strengths are visually distinguishable. Advice has been given and reinforced to dispensing doctors and pharmacists. Processes have been reviewed and wherever possible purchasing is limited to 2.5 mg to avoid confusion. NHS Forth Valley Action plan developed approved and implementation overseen by the D&T Committee. Plan was a tool to support good practice at operational level. Staff were made aware of the issue in a newsletter attached to which was a safe prescribing and dispensing checklist. Shared-care protocols have been developed. Patient hand-held records for OM are being used which provide valuable information on the treatment and processes involved. Existing patient information has been reviewed and patients are now provided with leaflets as recommended by the NPSA. Ensured that IT systems are compliant with the guidance both (GP and pharmacy) Ensured there are distinguishable supplies of 2.5 mg and 10 mg. NHS Golden Jubilee National Hospital As the Board treats patients on an elective basis, the specialties covered means that no patients are commenced on this treatment whilst in the GJNH. All clinical areas are supported by a clinical pharmacist who ensures that patients admitted on this therapy are aware of key issues and given the opportunity to ask any questions The chief pharmacist is currently in discussion with software suppliers regarding updates to the software (currently a warning alert is displayed if this drug is prescribed. All prescriptions for OM are checked for appropriateness by the clinical pharmacists. All OM tablets are visually distinguishable. 6

7 NHS Board Risk reduction plan Patient Information Update software Review purchasing NHS Grampian Shared care protocols have been drawn up for prescribing and monitoring of OM between those specialities initiating therapy and GPs. An enhanced GP services contract for all disease modifying drugs in Grampian means that GPs take responsibility for monitoring of methotrexate patients. The only exception being renal and haematology patients, where the secondary-care physicians retain the responsibility for monitoring. Patient information leaflets have been developed for use in secondary care for patients when discussing initiation of therapy. Leaflets are available for rheumatology, dermatology and paediatrics. Leaflets specific to renal medicine and gastroenterology are currently under development. The leaflet will either be supplied by the initiating clinician or the clinical pharmacist. Work is being undertaken to develop a NHS Grampian patient held monitoring record. With regard to the practice computer systems GPASS, Emis and Vision all show OM in red and have a caution box that appears when selected stating 'this is a high risk process do you wish to proceed'. This update has been undertaken by the individual software providers. With regard to the hospital pharmacy computer system JAC, a pop-up warning box alerts the user to check strength and frequency. Both strengths of oral methotrexate are stocked within the pharmacy at Aberdeen Royal Infirmary but are of different shapes. NHS Greater Glasgow A risk reduction strategy has been developed, agreed and distributed. There is a local enhanced scheme for GPs which acts as a substitute and covers the use of all OM regardless of diagnosis. A draft patient information booklet (PIB) has been developed following wide consultation including all potential users of once-weekly OM. Rheumatology wish to maintain their current system; other specialists are working to develop a Glasgowwide PIB for use across nonrheumatology specialties. Systems have been updated to ensure OM alerts and prompts are in use. All requisitions/prescriptions for OM are now clinically checked and confirmed prior to supplies being issued to wards/departments. OM suppliers reviewed to ensure 2.5 mg and 10 mg tablets procured were easily distinguishable. Community pharmacists have also been alerted to this requirement. NHS Highland Done through the Area D&T Committee and the D&T Committee. Alert widely distributed and local specialist teams contacted. Monitoring and follow-up systems are in place. Information provided to rheumatology, dermatology and some oncology patients meets the standard and there are patient held information cards on monitoring and dosage. For other areas suitable information is being progressed. Prescribing and software programmes in primary and secondary care have been updated to include alerts and prompts. All tablets meet the requirements on distinct shapes. 7

8 NHS Board Risk reduction plan Patient Information Update software Review purchasing NHS Lanarkshire NHS Lothian National Services Scotland A multidisciplinary short-life working group was established via the AD&TC to agree a plan. The group acted to ensure that areas where OM is used were informed and involved. The group concentrated on information leaflets, how they should be used, shared-care arrangements and patient held records. A Safer Practice Checklist for OM has been developed (approved by D&T Committee) and is available on the Lothian Joint Formulary website ( ate.pdf). It is for use by all healthcare professionals prescribing, dispensing and supplying OM. Prescribing information is available on the internet ( and intranet. The Lothian Prescribing Bulletin also contained a detailed awareness raising article in Issue 15. Patient-held information and monitoring cards used in rheumatology and dermatology.. Rheumatology patients cared for via shared-care arrangements, prescriptions may be dispensed via community pharmacists, dispensing doctors and hospital pharmacies. Systems in place support pre-treatment counselling; a prompt sheet is used to ensure a structured approach. GPs and patients are provided with an information sheet. Dermatology all OM supplies are received via hospital pharmacies, staff follow a pretreatment prompt sheet prior to initiating therapy. Patients receive information leaflets Patient information has been and is currently being developed for patients prescribed OM. There is also a shared-care monitoring card that a patient should keep as a record. There is no electronic prescribing of OM within the managed service. The pharmacy dispensary service has been updated to include a prompt to staff involved in the dispensing process. The electronic prescribing system on GPASS has been set to default onceweekly prescribing and this also applies to the LJF electronic formulary. The current GPASS system and the new clinical system under development have the appropriate safety requirements in place. Hospital pharmacies now only purchase 2.5mg tablets. It has been recommended to community pharmacies and dispensing GPs to concentrate on 2.5 mg only. NHS Lothian now issue 2.5 mg tablets for all prescriptions and no longer stock 10 mg. 8

9 NHS Board Risk reduction plan Patient Information Update software Review purchasing NHS Orkney Any patient receiving OM is provided with written information about the drug along with comprehensive counselling from the pharmacist. The ASCRIBE dispensing software programme has been updated and the safety enhancements installed. A review of purchasing has taken place and only 2.5 mg OM tablets are now stocked. NHS Shetland Risk reduction strategies agreed by the Area Drug and Therapeutic Committee. Patient information booklets are based on the NPSA s for the use of methotrexate which allows patients to be introduced to the drug before use, and allows the maintenance of a monitoring record explaining why tests are performed and encourages the patient to ask when blood tests are due. Pharmacy computer software used for dispensing is regularly updated. No electronic prescribing has started yet in Shetland hospitals. Only 2.5 mg tablets are purchased (this is the only strength that has ever been used). The State Hospitals Board Clinical pharmacy and medicine supply services are provided by NHS Lothian; the State Hospital has therefore adopted all relevant Lothian prescribing guidelines through the local Medicines Committee. OM has not been prescribed to date but there has been distribution of the Lothian Prescribing Bulletin (Jun/Jul 05) which includes a safe practice checklist for the use of OM. As per NHS Lothian. Not relevant. As per NHS Lothian. NHS Tayside Through the D&T Committee local arrangements have been reviewed. Arrangements put in place by various specialties are broadly in line with the recommendations. The concerns of the British Association of Dermatologists and the British Association of Rheumatologists were raised locally and it has been agreed that a further review will be undertaken with new guidance issued. Patient information leaflets are well developed within the specialities in line with the national professional groups. These are issued to patients when OM treatment is commenced. Laboratory results are available to all prescribers (hospital and general practice) through a web-based system. The Ascribe dispensing software has alerts re OM. In general practice the majority of prescribing is through GPASS which has been update centrally. Hospital pharmacy purchases only 2.5mg tablets which have a warning highlighting that they are normally once weekly dosing. 9

10 NHS Board Risk reduction plan Patient Information Update software Review purchasing NHS Western Isles A protocol for monitoring, prescribing and dispensing OM was developed and approved by the Area D&T Committee then issued to all pharmacists for comment and circulated to all GPs. A Newsletter was circulated to all practices, pharmacists and doctors with an action plan and information sheets on required action to be taken. Pharmacists in tertiary centres (Glasgow, Highland and Lothian) contacted to compare approaches (most referrals come from tertiary centres therefore it is important to dovetail our response to theirs if possible). Investigated the possibility of a standard national booklet for information and recording through various government agencies and publishers of similar booklets e.g. Anticoagulant Booklet. Information given to patients at outpatient clinics by visiting consultants was identified. We identified funding for the production of a local booklet produced from the available information following on from contact with other hospitals and finding out their progress. (more info included) Investigated the range of computer systems held by GPs and Pharmacists to check for compliance with this alert. The IT department was informed of future requirements this was particularly an issue with the GPASS system. All IT companies where contacted to check their timetable for compliance. It has been endeavored to restrict the supply to only 2.5mg tablets in foil strips for safety. 10

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