Applying the principles of PINCER to learn from patient medicines safety incidents to improve the prescribing and monitoring of oral methotrexate in general practice

Aim:

• To improve blood monitoring frequency of oral methotrexate to facilitate the development of a robust pathway for the safe prescribing oral methotrexate in general practice.

Objectives:

• To identify contributory factors preventing regular blood monitoring of oral methotexate (NG5 1.1.3), defined as full blood count (FBC), (ii) liver function test (LFT), and (ii) urea and electrolytes (U&Es) at least every three months.

• To reduce variation in the interpretation of local and national oral methotrexate guidelines (NG5 1.1.11).

• To develop a strategy to improve regular blood monitoring for oral methotrexate (NG5 1.1.8).

At a general practice with a list size of approximately 11,000 patients, 23 patients were prescribed oral methotrexate.

From February to June 2018, three significant events identified, (i) 1 patient prescribed oral methotrexate did not have blood monitoring for 9 months, (ii) 2 patients with deranged blood test results whose blood results fulfilled the criteria for stopping were prescribed with no clinical review prior to authorisation by signature.

In August 2018, a baseline audit identified 41% (9/22) of patients were prescribed oral methotrexate and had not blood monitoring: (i) full blood count (FBC), (ii) liver function test (LFT), and (ii) urea and electrolytes (U&Es) within the past three months.

In September 2018, the Care Quality Commission (CQC) inspected the practice and in November 2018 the report determined that the prescribing and monitoring of high-risk medicines was an area that required improvement.

Reasons for suboptimal monitoring:

• No clinician review of oral methotrexate and blood monitoring prior to authorising by clinician signature.
• Oral methotrexate NPSA alerts integrated into electronic prescribing systems were overridden by non-clinical staff processing repeat prescriptions to facilitate authorisation by clinician signature.
• Patients were not aware of the requirement for on-going blood monitoring or frequency.
• Blood test monitoring and location unclear in patient records.

Stakeholders were involved as follows:

Clinical engagement: the GP Prescribing lead and Practice Manager were engaged at the start and throughout the project. The proposal of an audit and development of a pathway was agreed. GPs were engaged at clinical practice meetings to gain feedback on the proposed strategy to improve oral methotrexate monitoring and updated on project progress.

Process mapping: current process of managing prescription requests for oral methotrexate was reviewed was mapped to inform development of more robust pathway with input from both clinical and non clinical staff involved in processing repeat prescription requests.

Patient stories: a practice patient participation meeting with a focus on high risk medicines of which patients prescribed oral methotrexate were targeted: (i) to clarify patients understanding of blood monitoring requirements, (ii) ascertain current patient experience when submitting repeat prescriptions for oral methotrexate, (iii) identify potential solutions to overcome suboptimal blood monitoring.

Between December 2018 and May 2019, three Plan, Do Study, Act cycles including a phased roll out of the proposed pathway to improve blood monitoring for oral methotrexate were undertaken.

*Less than 100% to allow for patients prescribed oral methotrexate by the GP where hospitals continue blood monitoring and are responsible for updating patient held information and/or sharing blood test results in clinic letters

PDSA 1: Information leaflet developed to advise patients about their responsibilities under the shared care agreement for oral methotrexate including requirement to attend blood tests with an opportunity for telephone consultation with the practice pharmacist to develop patient-specific exceptions for those prescribed oral methotrexate by the GP and monitored in secondary care

PDSA 2: Review patient clinic letters to:

1. Identify recommended blood testing frequency and include the directions for use e.g. Methotrexate 2.5mg tablets, 15mg (Six Tablets) To Be Taken Weekly (you need a blood test every X months), emails sent to clinics where this information was not clear
2. Add patient alerts e.g. FBC, U&Es & LFTs every X months, bloods monitored at hospital, practice, and walk-in clinic to each patient record.
3. If patients did not have up-to-date blood test results and no recent clinic visit confirming bloods tests undertaken with results communicated, the result would be declined and a GP telephone consultation required

PDSA 3: Full implementation of a robust pathway to improve blood monitoring for oral methotrexate that involves continuing actions from PDSA 2 to include the following:

1. Clinical review of blood monitoring to ensure regular blood testing and results are within acceptable limits for safe prescribing from GPs or practice pharmacists of patients prescribed oral methotrexate prior to authorising by signature
2. Texting patients to advise on the next blood test result once the prescription is issued to nominated pharmacy
3. Contacting patients who request oral methotrexate and the blood results have not been made available to the practice
4. The main challenge with implementation was engaging GPs with adding the blood test frequency to the directions for use, adding and/or reviewing alerts to include blood test frequency and location of blood tests. Also obtaining up-to-date information about blood test frequency for patients attending clinics other than the local hospital was another challenge. Non clinical staff supported with contacting patients as advised by the clinician.

Between December 2018 and May 2019, the total number of patients prescribed oral methotrexate with recommended 3 monthly blood monitoring for oral methotrexate increased from 59% to 85%. Table 1 shows the percentage of total prescribed oral methotrexate with recommended regular blood monitoring. The positive trend shows that the full implementation of a robust pathway resulted in improved blood monitoring.

The time lag between PDSA 1 and PDSA 2 is accounted for by pathway development, reviewing clinic letters, contacting clinics and updating patient records with alerts with blood testing frequency and the location of blood tests and including blood test frequency on the directions for use. Where information was not available patients and specialists were contacted. Staff gained greater appreciation for clinical risk and risk management and awareness to comply with patient safety alerts.

Table 1. Oral methotrexate prescribed as a percentage total of all methotrexate prescribed at the practice baseline compared with PDSA 1, 2 and 3

An important lesson learnt was the need to understand the patient experience and mapping the existing process. Engagement with a more robust pathway required involvement from all team members both clinical and non-clinical throughout by incorporating feedback gathered from group and individual meetings.

The project highlighted the benefits of stakeholder engagement with both clinical and non clinical staff. The project could have been improved by directly engaging community pharmacists to help identify patients who are not attending regular blood monitoring at the practice and have oral methotrexate prescribed by the GP. I would have prioritized this group if the project were to be undertaken again. This project applied the principles of pharmacist led interventions using technology to drive improvement; subsequent projects should be done using PINCER or equivalent tool methodology and resources.