Analysing potential harm in Australian general practice: an incident-monitoring study

Abstract

Introduction

Following the success of incident monitoring in anaesthetics,^4,5 in 1993 the Commonwealth Review of Professional Indemnity Arrangements for Health Care Professionals initiated pilot incident-monitoring studies in six medical specialties. The aim of this study was to test the incident-monitoring method in general practice.

An important difference between studies such as the Harvard Medical Practice Study and incident-monitoring studies is that no claims of generalisability are made in the latter. Incident monitoring cannot estimate prevalence. It provides detailed contextual information about specific processes and situations that can lead to adverse patient outcomes. Such information is then used to make specific recommendations.

The objectives of this study were to test a mechanism for obtaining incident reports from GPs; to gain an understanding of the type of incidents occurring in general practice and hence areas of potential harm; and to identify areas which might benefit from intervention.  

Method

All GP members of the Australian Sentinel Practice Research Network and the Central, Southern, Western and Wentworth Area Health Sentinel Networks in Sydney were asked by letter to participate. Others volunteered when reporting was offered as a Quality Assurance option through the Royal Australian College of General Practitioners (RACGP). Reports were anonymous and information was protected from subpoena by the Health Insurance Act 1973 (Cwlth).⁷

The reporting form included both free text and fixed-response questions. Information requested included GP characteristics and the patient's age, sex and health problems associated with the incident. Free text descriptions were elicited of the incident, its consequences, and contributing and mitigating factors; the outcome; and the GP's opinion of the incident's preventability. Fixed-choice responses included the type of incident, contributing factors, mitigating factors, potential for harm, immediate consequences, and predicted long term outcomes. All fixed-choice questions included an "other" category to allow continuing development of categories.

Quantitative descriptive analysis was used to describe the main features of the data for all 805 incidents received, using SAS.⁸ No significance testing was carried out as it would have been invalid because of the nature of the study and sample. Qualitative analysis of textual data was carried out for 500 incidents. This analysis involved examination of groups of events for common causes, situations and contributing factors.  

Results

GP response

The proportion of each sex and the proportion from rural practices among the respondents were equivalent to the overall GP population at that time.⁹ However, only 16% of respondents had less than 10 years' experience, whereas in a national sample in 1990-1991 about 30% of GPs had less than 10 years' experience.¹⁰ 

Patients

Age and sex of patients involved in reported incidents.

Incidents

GPs thought 76% of the incidents were preventable (Box 2) and 11% were unpreventable. They were undecided about the remaining 13%. More than one-third of the incidents resulted in additional use of resources. While pharmacological incidents were most often reported, they were also largely considered preventable (79%) and the least harmful potentially and in the long term. In contrast, diagnostic events were less preventable and more harmful (Box 2). Of the 38 deaths reported, 30 involved a diagnostic incident.

Mitigating and contributing factors

Ineffective communication and problems in coordination between healthcare services were frequent contributing factors (Box 4). Actions or involvement of others in caring for patients were also frequently cited. Assessment-related mistakes constituted another cluster of contributing factors (eg, errors in judgement, failure to recognise significant signs and symptoms, and inadequate patient assessment). Insufficient use of standard resources and protocols by the GP was also recognised. GPs reported being tired, rushed or late in 10% of incidents, but GP memory lapses and stressful situations were least frequently cited as contributing factors.

There were no obvious associations between specific contributing factors and incident type.  

Qualitative analysis

Communication problems: Most communication problems between GPs and patients occurred when patients did not understand some aspect of their condition, the management plan or the treatment. Patients with mental health problems or lacking English language skills were particularly at risk. Some serious pharmacological incidents occurred when patients misunderstood instructions and took newly prescribed drugs in addition to, rather than instead of, a previously prescribed medication. Poor communication also manifested as clinical error in inadequate history taking.

There were also problems with communication between healthcare providers. Clinical information about the outcomes of hospital referrals or admissions, the expected role of the GP in post-discharge care, specialists' recommendations for management and results of tests or investigations was often not communicated between GPs and other healthcare providers, or was too late to be of use.

Unclear or uninformative medical records caused a number of incidents, and inadequate records resulted in poor communication within practices. Incorrect or unclear labelling of drugs resulted in administration of the wrong drug, and inappropriate drugs were dispensed because of poor handwriting on prescription forms. Such errors were often compounded by similar medication names (eg, Teldane/Feldene, Microlax/ Murelax).

Procedural problems: The main procedural error was failure to check medical records. Diagnostically, procedural error manifested in poor application of the differential diagnosis, when the correct diagnosis was inappropriately rejected because of insufficient or incorrect examination, or was not included in the differential diagnoses and was therefore not evaluated. In non-pharmacological incidents, treatment procedures may have been neglected (eg, not checking for anaesthesia before an excision). In equipment incidents, machines were not properly checked before use (eg, leads or tubes were disconnected) or were not well maintained (eg, unfilled emergency oxyviva equipment).

Lack of protocols for ensuring action on results of tests and investigations meant that important results were filed unseen or left until the GP who ordered the test was next in the surgery. Recall systems were often inadequate, preventing recall of patients for follow-up tests and investigations and resulting in missed or delayed diagnosis or management.

Clinical problems: These consisted of incidents that could only be attributed to human error. In pharmacological incidents, clinical errors occurred where an inappropriate drug was chosen; in non-pharmacological incidents, where the wrong treatment was chosen; in diagnostic incidents, where symptoms and signs were not recognised (eg, chest pain considered to be musculoskeletal); and in equipment incidents, where equipment was used inappropriately.

External problems: External problems involved factors outside the GP's control, such as actions of other healthcare providers, equipment faults or unavailability, disease-related factors, and unpredictable drug effects. Patient-related factors included non-compliance, age, level of comprehension, and psychological condition.  

Discussion

Pharmacological incidents were most frequent and could be prevented through clearer prescription writing, double-checking of doses and potential interactions, and improved patient understanding. Unexpected drug reactions (eg, to previously well-tolerated drugs) and idiosyncratic complications were largely beyond GPs' control. However, compilation of this information may be useful to reinforce or add to data collected elsewhere.

Diagnostic incidents had the most serious outcomes. While management of test results and lack of recall systems contributed to these incidents, many occurred while the patient was under another medical practitioner's care, or were caused by the diagnostic decision-making processes of GPs.

Patient misunderstanding was a factor in many incidents. This might be addressed by improved GP awareness to ensure full patient understanding. However, information management problems require "hard-wired" solutions -- structures and systems that ensure better outcomes. In particular, opportunities for errors may be reduced by better recall systems for follow-up and for regular tests and screening,¹³ better transfer of medical information between healthcare providers, clearer writing of prescriptions, and better maintenance and use of medical records. Information technology could help by streamlining some of the administrative functions, particularly prescription writing, which appears to be adversely affected when GPs are tired, rushed, or running late.

Limitations to the validity of our data include the non-random nature of the sample, limited recognition of incidents, selectivity in reporting incidents, and the lack of an alternative perspective. (We did not seek the patients' perspective because of the controversial nature of the data.) However, issues we identified as important have been described by other researchers. Many of the issues pertaining to pharmacological incidents have been described in a study of adverse drug events in United States hospitals.¹⁴ Similarly, the problems of multiple prescribing in the elderly have been well summarised, and opportunities for improvement in the management of polypharmacy have been identified.¹⁵ Prescription clarity has also been recognised as an area of potential misunderstanding.¹⁶

In critical incident studies, incidents are sampled until "saturation" (until no new incident types are reported).¹⁷ While these 805 incidents may not reach saturation, they demonstrate at least some of the types of incidents occurring in Australian general practice. Logically, where inadequate systems are widely used, similar events are likely to occur regularly rather than being related to individual characteristics or techniques. Continued collection and classification of events will elucidate more causal factors, particularly for the less common types of incidents.

This study also resulted in a number of suggested interventions.¹⁸ Incident monitoring studies are intended to be continually used in improving systems. It is important to use the data for formulating interventions. This study has shown that such data can be collected in general practice, but the translation of findings into active change remains to be addressed.  

Acknowledgements

References

1. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. N Engl J Med 1991; 324: 370-376.
2. Leape LL, Brennan TA, Laird NM, et al. The nature of adverse events in hospitalized patients: results of the Harvard Medical Practice Study II. N Engl J Med 1991; 324: 377-384.
3. Wilson RM, Runciman WB, Gibberd RW, et al. The Quality in Australian Health Care Study. Med J Aust 1995; 163: 458-471.
4. Williamson JA, Mackay P. Incident reporting. Med J Aust 1991; 155: 340-343.
5. Webb R, Currie M, Morgan CA, et al. The Australian incident monitoring study: an analysis of 2000 incident reports. Anaesth Intensive Care 1993; 21: 520-528.
6. Britt H, Miller G, Steven I, et al. Collecting data on potentially harmful events: a method for monitoring incidents in general practice. Fam Pract 1997; 14: 101-106.
7. Commonwealth of Australia. Health Insurance Act 1973. Declaration under section 106L. Commonwealth of Australia Gazette 1993; GN 31: 2269-2272.
8. SAS [computer program]. Version 6.11. Cary, North Carolina: SAS Institute, 1995.
9. General Practice Branch. Commonwealth Department of Health and Family Services. General Practice in Australia: 1996. Canberra: Commonwealth of Australia, 1996.
10. Bridges-Webb C, Britt H, Miles DA, et al. Morbidity and treatment in general practice in Australia 1990-1991. Med J Aust 1992; 157 Suppl: S1-S56.
11. Miller G, Britt H, Steven I, et al. Incident monitoring in general practice: a pilot study. Report to the Professional Indemnity Review, Commonwealth Department of Human Services and Health. Sydney: Royal Australian College of General Practitioners, 1995.
12. Bhasale AL. Collecting data on potentially harmful events: evaluation of an incident monitoring technique in Australian general practice [master's thesis]. Sydney: University of Sydney, 1997.
13. Bhasale AL, Norton KJ, Britt H. Tests and investigations. Indicators for better utilisation. Aust Fam Physician 1996; 25: 680-694.
14. Leape LL, Bates DW, Cullen DJ, et al. Systems analysis of adverse drug events. JAMA 1995; 274: 35-43.
15. Teng Liaw S. Drug interactions among the elderly. Aust Fam Physician 1997; 26: 355-357.
16. Liddell MJ, Goldman SP. Attitudes to and use of a modified prescription form by general practitioners and pharmacists. Med J Aust 1998; 168: 322-325.
17. Flanagan JC. The critical incident technique. Psych Bull 1954; 51: 327-359.
18. Bhasale AL, Britt H, Miller G. Developing interventions which could reduce the occurrence of adverse patient incidents in general practice. Report to the Taskforce on Quality in Australian Health Care, Department of Human Services and Health, Canberra. Sydney: Family Medicine Research Unit, University of Sydney, 1995.