These were the main messages at a recent webinar hosted by the South African Health Products Regulatory Authority (SAHPRA) on the identification of MEs, their impact on patients and healthcare costs, and the importance of reporting them so that HCPs can learn from them to ensure better prevention.
“To err is human and while most errors are harmless, some result in harm to patients and have the potential to cause disability, death, a reduction in quality of life, hospitalisation, and sometimes prolonged hospitalisation,” explained Dr Sarisha Singh from Frere Hospital in the Eastern Cape.
“MEs increase costs to patients, health institutions and the healthcare system as a whole. The cost is not necessarily incurred in terms of monetary value but also in patients’ loss of trust in healthcare professionals or by patients and HCPs in the healthcare system.”
Dr Singh is responsible for ME-reporting at Frere hospital and is a member of SAHPRA’s pharmacovigilance committee. In the past few years, she has worked intensively with staff at the hospital in implementing an efficient reporting system where the emphasis is on identifying the types of errors, their causes and contributing factors, analysing them, and putting in place mitigating systems to improve the quality and safety of care.
Research cited by the webinar presenters showed that in the US, most hospitals experience MEs every 22.7 hours while two to five per 100 admissions at these hospitals are blamed on MEs, costing the American health system between $17 billion and $29 billion annually. Research also shows that globally between 45% to 95% of MEs are not reported with Africa reporting the lowest number at only 1% because of inadequate reporting systems.
Data about the prevalence of MEs in South Africa are not readily available. According to Prof Marc Blockman, Chair of SAHPRA’s pharmacovigilance committee and Professor: Clinical Pharmacology at UCT and Groote Schuur Hospital, work they have done in four medical wards in South Africa has shown that up to 8.4% of all admissions in these wards were due to adverse drug reactions and medication errors. Fifty percent of cases of severe adverse drug-related events (ADEs) were found to have been preventable. Drugs used in HIV and TB were implicated in one-third of ADEs.
SAHPRA’s Busisiwe Mosane who is responsible for pharmacovigilance awareness throughout the country noted that of 67 000 MEs reported in South Africa, 6% of the patients had died, 31% were hospitalised for prolonged periods while 10% of the events were life-threatening. She said the top errors reported related to incorrect doses, inappropriate schedules, product prescribing errors and medication administration errors.
What causes MEs?
Describing a medication error as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in control of the HCP or patient, Dr Singh explained that these events may be related to professional practice, healthcare products and systems, and include prescribing -, dispensing – dosing -, distribution – and compounding errors, poor communication, product packaging or labelling problems and a lack of education monitoring.
“Most errors are not the result of an individual, but arise more from systemic organisational failures that include systems, processes and conditions that exist within the organisation that lead to HCPs making mistakes,” Dr Singh pointed out.
She named illegible handwriting of prescribing healthcare providers, confusion of products with similar names or similar packaging, interfering noise when information is conveyed, and lack of education or updates on new guidelines and policy procedures as some of the reasons why these mistakes are made.
Non-punitive reporting system
But, Dr Sing stressed, identification of errors is not enough. There should be a system-based approach where the impetus shifts from the individual making the error to the characteristics of the system wherein they function.
At Frere Hospital ME reporting forms have been designed that staff are required to complete when errors occur. The three main areas of focus are the type error, its cause and contributing factors. However, it is a no-blame system. Only the name of the reporting person is included on the form, because, Dr Singh asserted, reporting should be non-punitive.
“We are not trying to blame or put anyone down. It is not about one profession trying to catch out the other one. Reporting is about working as a team to ensure the safety of patients.”
Prof Blockman and Mosane also stressed the importance of a non-punitive reporting system.
“When errors are reported, we (SAHPRA) can see what the problems are and act accordingly. We need to enable collaboration between all role players so that we can implement proactive rather than reactive strategies to mitigate errors,” Mosane said.
She added that SAHPRA was considering the drafting of similar reporting forms to those used at Frere Hospital. Some of the information required when the tick-box forms are filled in include whether the error reached the patient if harm was caused and how severe it was, what type of error it was (dose omission, improper dose, wrong drug, wrong administration route, wrong patient, wrong strength), followed by contributing factors ( poor handwriting, confusing packaging, etc), and the setting of the error (hospital ward, consultation room, pharmacy).
Safety tools
According to Prof Blockman electronic medical records and cheat sheets are invaluable for doctors when prescribing.
“Asking doctors to rely on memory when prescribing is like asking a travel agent to memorise airline schedules. In 1980 medical students were required to know 60 drugs well, in 2006 it was 700 and now it’s far over 1000 and the increase in these numbers, has also caused an exponential increase in drug-drug interactions,” Prof Blockman said.
“Memory, guesswork and educational information such as Dear Doctor Letters and package labelling are insufficient because people don’t read them. We need safety tools such as Cheat Sheets or Apps that will allow us to quickly check if we are going to cause potential harm.”
Asked what SAHPRA is doing to manage doctors whose illegible handwriting on prescriptions is causing errors or problems, Mosane said while the regulator can’t manage HCPs’ practices, it does bring it to the attention of the HPCSA to deal with the relevant professional.
“Our mandate is to ensure that we make medicines safe and when we identify issues that pertain to or have an impact on drug safety, we are obliged to communicate it to the relevant organisation to ensure collaboration across all organisations involved in patient care and safety,” she elaborated.
“Reporting is not an admission of guilt. Our (SAHPRA’s) goal is to increase awareness regarding MEs and how to understand, identify and report it to improve patient care and to ensure that these errors are routed to SAHPRA so that we can improve our systems as well,” Mosane concluded.
For more
information on the reporting of medical errors go to https://www.sahpra.org.za/safet-information-and-updates/
or download the Med Safety App at https://medsafety.sahpra.org.za/