Medication Errors and Exploring Risk in Primary Care

Lack of knowledge by healthcare professionals is the most common cause of medication errors. As a means of promoting awareness of the issues surrounding medication errors, the Irish Centre for Continuing Pharmaceutical Education (ICCPE) recently held a national education day in Tullamore, titled Medication Errors and Exploring Risk in Primary Care. Julie Cronin reports from the event.

The changing and complex environment within which pharmacists operate has had a significant effect upon the occurrence and management of risk. The increasing volume of available drugs, modifications in corporate branding, changes in business and professional practices, a multiplicity of sources of information on health and pharmaceuticals, a popular trend towards complementary medicines and ongoing changes in patient lifestyles are all potential contributory factors to the incidence of medication errors in the community pharmacy or doctor's surgery.

The core message delivered during the day was that enhanced communication - particularly between healthcare professionals - is critical to succeeding to reduce medication errors. According to ICCPE Director, Orla Sheehan, enhanced communication must be accompanied by a drive towards joint education. "If we are going to communicate together and work together, we need to learn together," she says. "We must promote joint learning, joint education and training." The theme of the role of education in preventing medication errors was continued in the presentation given by Robert Naylor, Professor of Pharmacology and Neuropharmacology at the University of Bradford and author of the book Medication Errors: Lessons for Education and Healthcare.

Medication Errors: Lessons for Education and Healthcare
PROFESSOR ROBERT NAYLOR
A lack of awareness among medical students of their capacity to make errors was Robert Naylor's impetus for writing a book on medication errors. "My own students didn't seem to have a clue that they ever made errors," he says. Since he set out to write Medication Errors, Professor Naylor has observed an increased willingness to publicly acknowledge medication error and to regard it as an area which merits in-depth scrutiny and analysis. "Four years ago when I talked to people about medication error, people would talk to me but it was always on a confidential basis. It was not talked about in public," he says. His rationale for the continued study of medication errors is a simple one: "Until we know what's wrong, we're really not in with much of a chance to correct errors," he says.

According to Professor Naylor, there are five stages in the processing of medicines where errors may potentially occur. These are detailed in table 1. Early detection of errors is crucial to rectifying them says Professor Naylor: "The earlier it starts, the greater the chance of correcting the error," he says.

Table 1: Five Stages Available to Create Medication Errors

1. PRESCRIBING
2. TRANSCRIBING
3. DISPENSING
4. ADMINISTRATION of the drug
5. The patient who may take or frequently does not take the medicine according to INSTRUCTIONS

When dealing with stages one, two and three in this chain (prescribing, transcribing and dispensing), a critical factor in preventing errors is to acknowledge one's limitations and the limitations of others. According to Professor Naylor this is true of all professions. "A primary cause of errors may begin in the culture of any profession through self-deceit, arrogance, deference or ignorance as to professional (in)competence," he says. Being deferential to the perceived eminence of other healthcare professionals is particularly problematic. "Deference is deadly," says Professor Naylor. "By all means we should respect each other's abilities but the minute we start being deferential we end up in trouble."

Stages four and five of the chain of potential medication errors provide a more complex challenge. Professor Naylor believes that treating the total patient is essential. Firstly, this involves a considered approach to all aspects of the patient's lifestyle when assessing possible medical interactions. "It is important to note that an adverse drug reaction is seen from the patient's perspective who may also be taking other prescribed and over the counter medicines, alcohol, other recreational drugs, unusual foods or health products or may be smoking!" says Professor Naylor. Commonly used herbal and complementary medicines should be noted for "pharmacological effects and potentially deleterious effects on surgery," he says. To illustrate this point, Professor Naylor points out that there are over 53 chemicals contained in St. John's Wort. "Interact all that lot with drugs that have been prescribed for therapeutic reasons by doctors, surgeons, pharmacists and you can see where problems can arise," he says. "No matter how many times we tell people, they do not realise that drugs are chemicals," he notes.

A second factor involved in treating the total patient concerns the 'specialisation' of the various medical professions. Professor Naylor puts forward the following conundrum: "Specialisms narrow and greatly restrict authority; yet patients receive attention from an ever greater number of specialists. So who looks after the TOTAL patient?"

An increase in the numbers of drugs prescribed to individual patients and the various interactions that they may have heightens the possibility of adverse drug reactions. Citing one US study which gave the mean number of drugs received in the twenty-four hour period before an adverse drug reaction as 9.3 for non-ICU patients and 15 for ICU patients, Professor Naylor underlined the enormity of the task faced by healthcare professionals. "Stockley's Drug Interactions - to my mind the best text on drug interactions in the world - gives the interactions between only two drugs. To think you can begin to predict the interactions between 9 or 15 drugs! The permutations run into millions," he says.

Rather than supplementing this trend of increased prescribing with a drive to increase the knowledge base of health professionals, Robert Naylor observes what he terms a "dumbing down" of education. "The basic knowledge of pharmacology is disappearing to two sides of an A4 sheet of paper that can be quickly remembered," he says. "We've got to at all costs improve the education of our medical students."

"There are no easy answers - but identification of the nature of the problem is the essential prerequisite to error reduction," Professor Naylor concludes.

Building a Safer Practice
MS. WENDY HARRIS
Patient safety refers to the processes by which an organisation reduces the risk and occurrence of harm to patients as a result of their healthcare. In 2001, the National Patient Safety Association (NPSA) was founded to coordinate efforts throughout Britain to identify and learn from patient safety incidents. Ms Wendy Harris, Senior Pharmacist with the NPSA's Safe Medication Practices in Primary Care unit, is quick to point out that everyone working in the healthcare sector makes medication errors. "I know the gut-wrenching reaction inside when you realise what you have done and what might have happened to that patient," she says.

According to Ms. Harris, it is essential that healthcare professionals move away from a culture of blame in order to learn about how and why patient safety incidents occur and what can be done to prevent them in future. "Being open refers to open discussion of incidents that resulted in unintended harm or unexpected harm to one or more people due to a system failure or human error or a combination of both," she says. "It's not to say you must try harder. It's not to change practices. It's to try and put something there that makes people work in a safer direction."

In its objective to assist health professionals to work in a safer direction, a primary activity of the NPSA is to collect and analyse information on adverse events from NHS organisations, staff, patients and carers through the National Reporting and Learning Systems (NRLS). These reporting procedures are completely anonymous. "Our information is about the incident, about the what not the who so we have no names of practitioners," says Wendy Harris. Gathering information about patient safety incidents is elementary in establishing measures to tackle unsafe practices. "One of the most fundamentally important things is to know how you get down to the bottom of why things go wrong because you have to be able to understand this before you can put things right," Ms. Harris says.

Information reported to the NPSA through the National Reporting and Learning Systems channel is assimilated with international safety-related information and reporting systems and the lessons learned are fed back into practice through the production of solutions to prevent harm and of mechanisms to track progress. Such mechanisms include the provision of Root Cause Analysis training events and a Root Cause Analysis e-learning programme for NHS staff, as well as an Incident Decision Tree, which provides a framework for the reporting of patient safety incidents within the NHS.

Wendy Harris believes that healthcare professionals may have varying attitudes to the provision of a safety culture, attitudes which are reflected in the manner in which an individual/organisation responds to a medication error. Ms. Harris summarises these attitudes as follows in Table 2:

Table 2: Healthcare Professionals' Attitudes to Safety Culture

Waste of time = PATHOLOGICAL
React every time an incident occurs = REACTIVE
Put systems in place to manage risk = CALCULATIVE
Always alert, prospectively assessing risk = PROACTIVE
Risk management is integral to everything = GENERATIVE

According to Ms. Harris, "most pharmacists are, at best, reactive when it comes to patient safety." She notes that familiarity and routine are a particular danger for the pharmacist, who may be processing similar prescriptions on a daily basis. "If something becomes more automatic, less consciousness is involved. This is a problem when it comes to making errors," she says. As well as implementing meticulous checking procedures, the pharmacist has a duty of care to keep him/herself abreast of developments in therapeutics and the management of medicines. "If you've qualified 5, 10, 20, 30 years ago and not kept your knowledge up-to-date then that is an intentional unsafe action," says Ms. Harris.

The pharmaceutical industry also has a role to play in patient safety. The role that packaging plays in the safe administration of medicines must seriously considered. "It's not just our own needs in pharmacies but also the patient's needs, the end user, the carer dispensing the medicine. What are their needs in order to use the medication safely?" she asks.

Another key NPSA undertaking has been to set out a seven-step approach to ensuring patient safety. These steps are outlined in Table 3.

Table 3: Seven Stept to Patient Safety

1. Build a safety culture
2. Lead and support your staff
3. Integrate your risk management activity
4. Promote reporting
5. Involve and communicate with patients and the public
6. Learn and share safety lessons
7. Implement solutions to prevent harm

Wendy Harris translates these seven steps to the following practical advice for pharmacists: "When you have a moment, stand and look around you. Look at the layout of your pharmacy; does it work in the way that you need it to? Is there a separate area where the drugs can be checked after they've been dispensed, are the drugs easily accessible K Then discuss the area of risk management with your staff. Your staff are a huge and brilliant resource in help towards improving safety."

Health professionals must be willing to acknowledge mistakes and, above all, to learn from them. Quoting Sir Liam Donaldson (Chief Medical Officer at the British Department of Health), Wendy Harris points to the importance of this ongoing learning process: "To err is human. To cover up is unforgivable. To fail to learn is inexcusable."

Root Cause Analysis: What are the root causes of medication errors?
DR. PAUL GRASSBY
Dr. Paul Grassby, Principal Lecturer at Anglia Polytechnic University, asserts that in the area of medication errors, "a lot of problems are about understanding and communication issues." Dr. Grassby observes that the miscellany of similar sounding drugs, indistinguishable liveries and drugs which carry different names in different countries has done little to promote patient safety. "Everything we've done has resulted in the patient being utterly confused about their medicines," he says. "We assume that everybody understands the world as we do and this leads to poor compliance."

The need to enhance communication with patients is particularly pertinent in a society which is inundated with different therapies. Dr. Grassby gives the following statistic: in 1960, there were approximately 650 licensed drugs in use. Today, there are over 8,000 licensed drugs on the market. "We're all taking a greater variety of drugs and we're taking a greater number of drugs," says Dr. Grassby. "We have become a lot more pharmalogical, a lot more therapeutic but we haven't put the systems in there to deal with it; we haven't put the training there to cope with this," he says.

Paul Grassby believes that the perception of what constitutes a medication error is often limited to the dramatic event, where the cause and effect are easy to track. He compares the treatment of the relatively small number of cases where vincristine has been injected intrathecally with the widespread mismanagement of cardiovascular disease. "It's much easier to deal with 23 incidents of vincristine that have happened around the world than the 235,000 deaths a year caused by CVD," he says. "I would argue that we need to do root cause analysis on the processes which cause medication errors on a large scale rather than the small number of dramatic errors which are dealt with on an emotional level," Dr. Grassby says.

Problems with drug therapy are another area cause for concern. "I would argue that it is a significant medication error that patients are not self-administering their drugs in the way they are supposed to and that should be treated as any other medication error," says Dr. Grassby. This is a problem that must be tackled with at the time of prescribing and dispensing of medicines. "Why can we not influence patients at that level before we get to the level of medicines reviews? It's a case of closing the gate after the horse has bolted," says Dr. Grassby.

According to Dr. Grassby, there are many causes of drug therapy problems. Some of these are outlined in Table 4 below:

Table 4: Suggested causes of drug therapy problems

- Failed communication
- Poor health literacy
- Poor compliance
- Poor prescribing practices
- Poor training
- Poor drug distribution practices (verbal orders, transcription)
- Dose miscalculations
- Drug and device-related problems (name, labelling, design)
- Poor follow-up or monitoring procedures
- Lack of patient education
- Preparation errors
- Multiple agencies/prescribers
- etc, etc.

Dr Grassby cites figures from the UK Department of Health document An Organisation with a Memory. According to this report 400 people die or are seriously injured annually in adverse events involving medical devices; nearly 10,000 people are reported to have experienced serious adverse reactions to drugs; and adverse events occur in around 10 per cent of admissions, or at a rate in excess of 850,000 a year. "We get bombarded with these figures but do they actually mean anything to us from an emotional point of view? Does it make us want to do something about it?" Dr Grassby asks. "We need to engage the public's emotion and our emotion in terms of medication errors."

Death by Decimals: Medical Protection Society Experience of Medication Errors
DR. TIM HEGAN
Each year in Britain, 5,700 people die as a result of medication errors. According to Dr. Tim Hegan of the Medical Protection Society, this death rate reflects a much higher degree of failures in communication between healthcare professionals than the degree of cases of professional negligence.

Dr. Hegan estimates that 70% of litigation against doctors is actually due to poor or ineffective communication. Ensuring the patient understands how and when to take medication is vital. He cites an example of a patient being told to make sure he finished a course of antibiotics by being given the following directions: 'Make sure you take all of the tablets.' The result? The patient went outside and took all of the tablets together. To avoid situations like this, clear communication is crucial. "Use language the patient can understand," says Dr. Hegan. "Then, check they really understand. Patients don't want to feel stupid. What you have to do is try to get them to talk back to you, to explain to you what it is you talked about," he says. He calls this process 'teaching back' or 'closing the loop.'

The computerisation of the medical practice and the pharmacy has also played a role in the occurrence of communication errors. Dr. Hegan points out that, while computers are a valuable prescribing tool which enhance legibility and standardisation of the format of prescriptions, they are not infallible. "Computer systems are not foolproof and should be used as a back-up warning system, not a first line of defence," warns Dr. Hegan. A recent study of GP computer systems used in the UK found that four of the most commonly used programs failed to spot unsafe prescribing scenarios. None of the programs issued an alert to more than 7 of the scenarios. Tim Hegan gives the following example of a medication error caused by over-reliance on a computer program:

"A young woman with a history of epilepsy was prescribed Efamast. She was already taking Tegretol. When Efamast was typed into the computer, no contraindications, interactions or cautions came up. Within five days, the woman had a fit and lost her driving licence. She made a claim against her doctor. The BNF states that caution should be exercised when prescribing Efamast to patients with a history of epilepsy. The computer did not pick up on this."

Even in cases where the computer generates alerts, problems can arise. "Alerts are not the only solution," says Dr. Hegan. "Some systems already produce a plethora of alerts, and getting into the habit of dismissing many of these, almost without thinking, may cause its own problems."

Tim Hegan believes that increases in litigation against doctors and other healthcare professionals do not reflect an increase in medication errors but a change in society. "Why the increase in litigation?" he asks. "It's not because doctors are getting worse but because of the 'lawyerization' of society." "The reason people sue doctors is cultural and emotional not due to negligence," says Dr. Hegan. "Patients want to prevent it happening to someone else and then they want an explanation," he says. When an adverse event occurs, Tim Hegan underlines that it is essential to "get in early" and explain the problem to the patient. "If something's gone wrong, the patient needs to know immediately," he says. He points out that a simple apology is often enough to prevent a case being taken. "An apology is not an admission of liability," he says.

Aligning Patient Safety with Empowerment
STEPHEN MCMAHON
According to Stephen McMahon of the Irish Patients' Association, the role of his organisation is to guide the Irish healthcare system towards `"the destination of a world class, patient-centred healthcare system that is built on trust." Mr. McMahon does not believe that such a system currently exists in Ireland. "Really we don't have a health system. A system is something that consistently delivers a desired result. We are only now beginning to get to a stage where we can begin to deliver," he says.

Mr. McMahon asserts that the system must recognise that patients have basic needs: dignity, access, communications, consent, complaints, and quality (including safety). "System safety needs to be addressed at all levels, everyday in every way," he says.

"No patient should leave their encounter with the healthcare system worse off for having entered it," Mr. McMahon says.