Primary Care Pharmacy March 2000 Vol 1 No 2 p46-47

Audit

Monitoring treatment of hypothyroidism

By Sheila Duncan MRPharmS, BSc

How auditing therapeutic drug monitoring of patients with hypothyroidism can improve quality of care

Audit is one of the principal means by which clinical practice can be improved. This article looks at the process of undertaking an audit of the monitoring of hypothyroid patients within a general practice. Hypothyroidism may not be considered by some to be a high priority area to target but putting simple procedures in place can ensure high quality care for patients with this disorder.
Audit requires an appropriate structure and a clear objective, otherwise the information collected may be of poor quality or of little use, which leads to failure of the audit process. Consequently, before starting this project, a checklist was drawn up and used to avoid omissions (see Table 1).

Audit design

Using the checklist, the audit for this practice was agreed by all participants.
Was there a need for the audit? The correct dose of thyroxine is assessed by measurement of thyroid stimulating hormone (TSH). However, a recent needs assessment within the practice highlighted that there was no agreed protocol for therapeutic drug monitoring (TDM) of patients on thyroxine.
A published study that investigated the monitoring of hypothyroid patients in general practice found that, despite elevated TSH levels, thyroxine doses failed to be adjusted.¹ More recently, a consensus statement for good practice, with associated audit measures for patients with thyroid disease, was published by a national expert working group and it was felt that the prescribers within the practice should be adhering to this statement.²
What was the objective of the audit?
The objective was to audit the monitoring of hypothyroid patients in the practice in accordance with the consensus statement.
Who would be involved? A good audit requires the involvement of all appropriate staff. This study was carried out in a general practice with 10,100 patients and six full-time-equivalent general practitioners (GPs). The audit team included a GP, a pharmacist, practice and district nurses and the reception staff involved in the patient recall process.
How would data be gathered and from where? Patients were identified using a computerised search for those who had been prescribed thyroxine. Data was collected from computerised and paper patient records.

Table 1 Audit check list

Audit design

Does a need exist for the audit?
What is the objective of the audit?
Who will be involved?
How will data be gathered and from where?
Setting standards
Length of data collection

Audit process

Pilot data collection sheet/method
Data collection and analysis

Results

Compare results with standards
Findings and recommendations
Set date of re-audit

Setting standards

Standards were set based on the national consensus guidelines and agreed by the pharmacist and GP. These standards stated that:

90 per cent of patients receiving thyroxine replacement therapy should have their TSH levels measured annually
90 per cent of patients should be entered into an adequate recall system

Additional standards were agreed, which stated:

90 per cent of patients with TSH levels outside of the normal range should have adequate follow up
The period for which data should be collected
The audit was to be carried out over a one-month period

Audit process

Pilot data collection sheet/method A pilot was carried out on 10 patients to check the validity of the data collection sheet and its ease of use.
Data collection and analysis The pharmacist carried out data collection and analysis. Data relating to the date TSH was last sampled, the TSH level and whether the patient was on a recall register were recorded.

Results

Compare results to standards The audit found that 153 patients (1.5 per cent of the practice population), average age 61 years (range 16-96), were prescribed thyroxine replacement therapy. Of these, two had left the practice since the start of the audit and four sets of medical notes were unobtainable during the one-month period. Review of the remaining 147 medical notes identified that measurement of TSH levels within the last year had been undertaken in 135 (92 per cent) patients. Twenty three patients had an elevated TSH level and a further TSH level was requested in 22 (96 per cent) patients.
Despite the request for a second sample, an increased dose of thyroxine was recommended in only five patients, three of whom were suspected of poor compliance. No action was taken with 14 patients, despite the fact that the TSH level remained elevated.
Twelve patients had not had their TSH levels checked in the previous year, four were overdue by one month, one was overdue by more than one month and seven had no record in the notes of the TSH level ever having been checked. Formal recall systems were established for 130 (88 per cent) patients, 40 of which were on a computerised, centralised thyroid disease register and 88 were on a paper-based register within the practice.

Findings and recommendations The audit demonstrated that the practice met the standard for yearly TSH level checks but, although 96 per cent of patients with elevated TSH levels had further checks made, no action was taken in 64 per cent of these patients, despite continuing elevated levels.
Although these results were better than those achieved in the published study,¹ it was thought to be important that follow-up procedures following return of TSH levels were improved, since they were regarded as being a sensitive measure of thyroid disease.
A formal paper-based recall system had been established for 88 per cent of patients, which was slightly less than the standard set for the audit. One reason for this might have been that information on recall systems within the medical notes was missing. Despite this standard being lower than ideal, results from the study showed that patients continued to be well monitored within the practice, although adequate follow-up procedures needed to be enforced.
Limitations of this study were that only one partner was consulted when the standards were set, and drug therapy that might have affected TSH levels was not documented.
Although the audit has shown that there is little room for improvement in the frequency of monitoring these patients, further work is required to ensure that thyroxine doses are adjusted in accordance with elevated TSH levels.
Pharmacists have a role to play in helping to achieve this standard by improving patient education on the long-term management of hypothyroidism, thus improving compliance.
The main recommendation arising from the audit was to develop and implement an agreed protocol for the TDM of patients on thyroxine. This would include standard documentation, the use of only one recall system and the follow-up of patients with TSH levels above the normal range. The practice agreed to the recommendations made and the pharmacist will play a major role in helping to develop, implement and monitor the protocol.

Set date of re-audit Re-audit is an essential part of the process and helps to establish good clinical practice. It was decided by the team that a re-audit should be carried out every three years.
A meeting was arranged with GPs and nurses in the practice to discuss outcomes of the project. Initially recommendations will increase workload, but, once systems are set in place for TDM, management of hypothyroid patients should be simplified and their clinical outcomes should improve.

Mrs Duncan is the pharmacy manager at Aberdeen West local health care co-operative

References

1. De Whalley P. Do abnormal thyroid stimulating hormone level values result in treatment changes? A study of patients on thyroxine in one general practice. Br J Gen Prac 1995;45:93.

2. Vanderpump MPJ, Ahlquist JAO, Franklyn JA, Clayton RN. Consensus statement for good practice and audit measures in the management of hypothyroidism and hyperthyroidism. BMJ 1996;313:539.