Executive summary

This document covers the definitional aspects and nature of medication errors and adverse drug events (ADEs) affecting hospitals in New Zealand and Australia. The document contains the clinical aspects of medication errors prevention via an elaborate evidence-based approach that takes into account the role and involvement of all relevant stakeholders. The documents also contain details for the assessment, features, investigation, management, and discharge of medication error cases.

This guideline applies to all hospital staff. Some of the people it applies to include;

Medical Staff

Nursing and Midwifery staff

Pharmacy staff

All the Allied Health Care Professionals as well as Health Care Scientists who are involved in the administration of medication.

This policy also affects the operation of Pre-registration Healthcare Professionals Students such as Pharmacy, Nursing and Medical students who are directly or indirectly involved in any given medication process while under direct supervisions.

The policy also affects the operations of all staff members who are involved in the prescription, dispensing as well as administration of drugs.

Any staffs who take the initiative to promptly report any case of medication error will not in any way be subject to any form of disciplinary action unless of course it’s under any of the following conditions.

Where the staff member behaved in a malicious or criminal manner

Where the staff is guilty of gross negligence and carelessnes

Introduction

The development of elaborate clinical procedure guidelines for use in reducing medication errors is important for the assurance of quality health care and safety within the medical health facilities. According to Grober and Bohnen (2004,p.39), medication errors are a major source of public health concern and pose a great threat to the safety of patients. As healthcare institutions seek to contain the “errors” as a matter of both research and clinical priority, the answer to one of the most daunting clinical equations still remain: What set of clinical procedures exists for handling or reducing medical errors? In order to reduce medication errors, a systematic measurements of its various incidents on the basis of a clear and yet consistent definitions of its constituents are a necessary prerequisite for an effective and holistic solution to be devised.

The definition of the concept of medication error has remained elusive. In this regard, we shall roughly define it as any event that is preventable but could cause or lead to the prescription and taking of inappropriate medication that mat lead or cause inappropriate use of medication or harm to patient while in the control of a given health application or patient harm while under control of a health care professional, consumer or patient (Porché , 2008, p. 16)

The issue of patient safety is of utmost importance in health care. Its importance is further amplified by a growing number of literature showing high incidence of medication errors (Brennan et al,1994; Leape et al, 1991; Wilson et al, 1995; Wilson et al,1999; Thomas et al.,1999).This is coupled with the rising number of highly publicized cases of medical errors that have raised the level of public concern on the very safety of our modern healthcare delivery systems.

According to Nichols et al (2008, p.276) adverse drug events (ADEs) are at the moment associated with between 2.4 % to 3.6 % of all admissions to Australian health care facilities. Preventable errors in prescribing, dispensing, as well as administration of drugs in the Australian hospitals contribute to 24% of ADEs (Runciman et al, 2003; Bates et al,1995; Barber & Dean,1998). In a study conducted in the UK, close to 1.5 percent of medication orders had clearly identifiable errors out of which 0.4 percent were deemed to be potentially serious (Dean et al, 2002).

Types of medication errors

According to Nichols et al (2008, 277), three types of medication errors are the most common. They include errors due to slips in intention in memory lapse, errors of judgment in medication planning (also called rule-based errors), and finally, errors due to a general lack of knowledge (commonly referred to as knowledge-based errors) (Reason, 1990). According to Reason (1990), the systems approach to cases of human errors clearly distinguishes between the active mistakes committed by hospital staff and the latent (related to the system) conditions that inherently makes mistakes more likely like fatigue and busy workload. All in all, medication-related activities in health care facilities are usually carried out within very busy and quite potentially distracting environments, a scenario that seemingly increases with latent conditions that may further predispose medical staff to errors.

In order to reduce cases of medical errors, healthcare providers must accurately identify their main causes, come up with solutions, as well as measure the success of the installed improvement initiatives. At the same time, accurate evaluations of the incidents of medication errors on the basis of clear and yet consistent definitions are necessary for the best route of action to be taken.

Scope and purpose of this document

This guideline applies to all hospital staff. Some of the people it applies to include;

Medical Staff

Nursing and Midwifery staff

Pharmacy staff

All the Allied Health Care Professionals as well as Health Care Scientists who are involved in the administration of medication.

This policy also affects the operation of Pre-registration Healthcare Professionals Students such as Pharmacy, Nursing and Medical students who are directly or indirectly involved in any given medication process while under direct supervisions.

The policy also affects the operations of all staff members who are involved in the prescription, dispensing as well as administration of drugs.

Any staffs who take the initiative to promptly report any case of medication error will not in any way be subject to any form of disciplinary action unless of course it’s under any of the following conditions.

Where the staff member behaved in a malicious or criminal manner

Where the staff is guilty of gross negligence and carelessness

This document covers the definitional aspects and nature of medication errors and adverse drug events (ADEs) affecting hospitals in New Zealand and Australia. The document contains the clinical aspects of medication errors prevention via an elaborate evidence-based approach that takes into account the role and involvement of all relevant stakeholders. The documents also contain details for the assessment, features, investigation, management, and discharge of medication error cases.

Definitions of a Medication Error

The following list gives examples of scenarios where medication errors can occur. Near Misses in any of the sections below should also be considered. The definitions have been divided into sections according to the National Patient Safety Agency (NPSA) Safety in doses: medication safety incidences in the NHS (2007).

This is not a conclusive list, therefore managers, clinicians, and Clinical Governance

Managers must use professional judgment before addressing the issue at hand.

Prescribing Errors

• Deviation from Policy and Guidelines relating to Management of Medicines

• Medication prescribed to the wrong patient

• Transcription errors

• Prescribing without taking into account the patients clinical condition

• Prescribing without taking into account patients clinical parameters e.g. weight

• Prescription not signed

• wrong medication/rate/dose/route prescribed to the patients

Dispensing Errors

• Dispensation of medication to the wrong patient

• Patient dispensed wrong medication / dose / route

• Patient dispensed an out of date medicine

• Deviation from Policy and Guidelines relating to Management of Medicines

• Incorrect labeling of medication

Preparation and Administration Errors

• Wrong infusion rate

• Patient administered an out of date medicine

• Medication administered to the wrong patient

• Medication omitted without a clinical rationale

• Medication incorrectly prepared

• Patient administered the wrong medication / dose / route

• Wrong timing of medication administration

• Deviation from Policy and Guidelines relating to Management of Medicines

Monitoring Errors

•Deviation from policy and guidelines relating to management medicine

•Failure to provide the patient with correct information regarding their medication e.g. when to take, what it is for, side effects

• Failure to monitor therapeutic levels

• Failure to monitor patient / carer who is undertaking self medication

• Patient allergic to medication but the medication was prescribed and/or dispensed and/or administered

Actions to be taken on discovery of a medication error

Immediate actions to be taken

Assess the condition of the patients ad then take the necessary actions for maintaining their stability (see appendix)

Immediate reporting of the error to the nurse in-charge/ person in-charge or line manager

Seek immediate advise from the institution’s Pharmacy on the possible outcomes of the given medication error

In case of a dispensing error, the manager of the local pharmacy must be informed and the incorrect medication should be returned to the pharmacy for correct re-dispensing.

The incident report form must then be completed following the hospital’s policy for the management of staff and patient safety. All relevant charts must be photocopied and statements obtained. The incident must then be documented in the facility’s patient case notes

The line manager must ensure that the incident form is appropriately completed and the situation/case escalated appropriately (such as to the Clinical Governance manager, Matron or Education and Practice Development Teams). It is necessary that this take place in an expeditious manner in order to allow for a more timely investigation in cases of more serious events.

The out of hours facility Duty Manager must then be informed.

Medium Term Actions

Medium term actions involve the systematic review of the main or root causes of the medication error. The necessary Root Cause Analysis checklist must be used with the involved staff available. For errors that are of moderate nature, the Patient Safety Team as well as Senior Pharmacy staff must be involved.

After the Root Cause Analysis and by means of an incident tree, the line manager may deem it necessary to stop the involved staff member from taking part in any medication prescribing, dispensing as well as administration duties until thorough critical incident reflective exercise has been conducted.In such a case, the Head Nurse must be consulted by the line manager.

Suspension of affected staff and ways of addressing competency concerns

There are instances when it becomes necessary to stop staff from prescribing, dispensing or administration of medication. This issue must be respected and taken care of within the existing the critical incident reflective exercise.

The line manager while working with the Clinical Tutors and Matron must undertake a thorough critical incident reflective exercise with the affected medical, clinical or pharmaceutical member of staff. This must be carried out in less than a week after the error is reported.

A signed copy of the agreed actions as indicated in the critical incident reflective exercise must be kept on the affected staff member’s personal record/file and then reviewed according to the laid down appraisal procedures

Long Term Actions

As a major part of the long term actions after medication error, the Directorate Senior Management team comprising of the Clinical Director , Clinical Governance Manager and Head of Nursing must put in place clear proicedures for reviewing information on medication errors (obtained from Datix) to be used for the identification of common trends and themes. Any concerns regarding medication errors must then be pointed out and then be appropriately escalated.

A copy of the Root Cause Analysis Checklists must then be mailed/sent to the Principal Pharmacist in charge of Clinical Governance. The results will then be entered in special database and then appropriately analyzed for common themes and trends. The outcome would then be reported to Australia Medicines management Board.

Informing the affected Patient

The hospital acknowledges that open communication is important whenever things go wrong.

The affected patient must be informed by the nurse in-charge or the consultant team and an appropriate apology given. That apology must never be treated as an admission of liability

The patient’ consent must be sort before informing other mebers of the family or any other third party for that matter

If the Senior Nursing or Consultant feels that there is a compelling medical reason not to discuss the medication error event with the patient or relative, then a clear record must be made of such decision in the patient’s case notes.

There are instances when it becomes necessary to stop staff from prescribing, dispensing, or administration of medication. This issue must be respected and taken care of within the existing the critical incident reflective exercise.

The line manager while working with the Clinical Tutors and Matron must undertake a thorough critical incident reflective exercise with the affected medical, clinical, or pharmaceutical member of staff. This must be carried out in less than a week after the error is reported.

A signed copy of the agreed actions as indicated in the critical incident reflective exercise must be kept on the affected staff member’s personal record/file and then reviewed according to the laid down appraisal procedures

Discussion

Management of Medical Errors

Several empirical research suggest that error in clinical medicine results in grater harm, it is estimated that more than quarter of all medical errors around the world can be prevented. Additionally, effective error management strategies are available especially in clinical practice. This can best be done by involving individuals from all relevant professional groups.

Stakeholder Involvement

Medical stakeholders can come up with several interventions to mitigate medical errors in clinical practice. For instance, they can test existing systems to ensure they actually catch errors that injure patients; improve regulation and remove disincentives for vendors to provide clinical decision support; implement clinical decision support judiciously; make existing quality structures meaningful; consider consequent actions when designing systems; promote adoption of standards for data and systems; develop systems that communicate with each other; and use systems in new ways; to measure and prevent adverse consequences;

Specific recommendations should be; to implement bar-coding for medications, blood, devices, and patients; to implement provider order entry systems, especially computerized prescribing; and to utilize modern electronic systems to communicate key pieces of related data such as markedly abnormal laboratory values. Increases in the use of information technology appropriately, in the health care especially the introduction of clinical decision support and better linkages in and among systems, resulting in process simplification, could result in substantial improvement in the safety of patient.

References

Bates DW, Cullen DJ, Laird N, et al.1995 Incidence of adverse drug events and potential adverse drug events. Implications for prevention. JAMA; 274: 29-34. HYPERLINK “http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=7791255&dopt=Abstract” t “pubmed” <PubMed>

Barber ND, Dean BS.1998, The incidence of medication errors and ways to reduce them. Clin Risk 1998; 4: 103-106.

Dean B, Schachter M, Vincent C, Barber N. 2002Prescribing errors in hospital inpatients: their incidence and clinical significance. Qual Saf Health Care 2002; 11: 340-344. HYPERLINK “http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12468694&dopt=Abstract” t “pubmed” <PubMed>

Grober, E.D and J.M.A. Bohnen. 2005. “Defining Medical Error.” Canadian Journal of Surgery48: 39–44.

Nichols et al ,2008.Learning from error: identifying contributory causes of medication errors in an Australian hospital.Med J Aust; 188 (5): 276-279.

Reason J.1990. Human error. New York: Cambridge University Press, 1990

Runciman WB, Roughead EE, Semple SJ, Adams RJ.2003. Adverse drug events and medication errors in Australia. Int J Qual Health Care 2; 15 Suppl 1: i49-i59. HYPERLINK “http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=14660523&dopt=Abstract” t “pubmed” <PubMed>

Appendix

Assessment

Medical errors are manifested in patients as adverse medical events. Before event thinking on how to reduce medical errors, it is important for this guideline to outline ways of assessing the genuine cases of medical errors as evidenced from patients admitted as a result of adverse medical events.

What is an adverse event?

An adverse event (AE) or side effect is any unfavorable and yet unrelated change in the function, structure, as well as chemistry of a patient’s body that is temporarily associated with the use of a given drug/medicine. In other words, it is the undesired or harmful affects that result from the use of a given medication.

Serious adverse events must be treated as a matter of MEDICAL ERMERGENCY. This is because it can lead to:

Death

Hospitalization

Significant disability/ patient incapacitation

Discomfort and pain

Congenital anomaly

Cancer

Overdose

A principal investigator (trained physician) must be involved in the assessment of the nature of care that an adverse medical event patient requires. Physical symptoms must be evaluated together with laboratory results.

Treatment should never be unblinded unless under emergency conditions

The emergency unblinding procedures must be followed as prescribed in the existing hospital protocol

The unblinding process should be discussed with the sponsor if conditions allow

Subject’s safety is paramount

Documentation

The cases of adverse events must be documented. There must be;

A description of the patient’s experience

The onset, the duration as well as date of resolution

Assessment of causality

Treatment given

Outcome of the treatment

All the relevant documentations must be obtained. These include;

Hospital admissions, notes and discharge summaries

Lab reports

Medication data

Procedure reports

All these documents should always be completed and then forwarded to the relevant sponsor representatives.

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