Authors: Schellack N, Maimin J, Malan SF, Moodley S and Eksteen MJ
Medication errors (MEs) often elicit guilt and fear in pharmacists, thereby resulting in under-reporting and further compromising patient safety. Pharmacists do not report adverse events due to a number of reasons. It might be that they fear embarrassment, or potential punishment or litigation. Or it might be because they do not believe that reporting will lead to any improvements. This is commonly referred to as a “blame culture”, where the individual responsible for the error is blamed for the consequence.
– this article aims to highlight common errors and provide guidance for pharmacists and the industry to mitigate the situation.
Research in reporting the number of medication errors is relatively understudied in South Africa. The US National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) defines a medication error as ‘any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labelling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use’.(1)
Most medications used in paediatrics are used off-label when adult dosage forms are used, which may increase opportunities for medication errors with subsequent risks for the patient.(2) Most medication errors occur during the prescribing and dispensing steps of the process.(3) Dosing errors are the leading cause of medication errors, especially in the paediatric and elderly population and more so in the intensive care unit (ICU).(3) Vulnerable populations require individualised prescribing of medications based on their age, body weight and comorbid conditions together with the need for the interpretation of the therapy outcome.(4)
Where do medication errors occur?
There are five stages of the medication process where medication errors can occur, called the origin of medication errors.(5,6) The five stages include the following: prescribing of medication by an authorised prescriber; transcribing of the documentation of an order by someone other than the prescriber for ordering and processing; dispensing is the process where a pharmacist assesses a medication order and releases the product for use by another health care professional; administering is the process where the medication is administered to the patient, which includes giving the right medication to the right patient at the right time and labelling the current intravenous medication that the patient is receiving; and monitoring to evaluate the patient’s response to medication and recording the findings.(5,6)
Pharmacists are mostly involved in stage three namely dispensing and stage five, monitoring. Statistically dispensing errors are low, but due to the large volumes of medicines dispensed by pharmacists, it translates into a large number of errors.(5,6) Different types of medication errors can occur when the pharmacist does not perform a final product check or fails to perform proper patient counselling.(15) The following types of medication dispensing errors are identified and described by various studies: incorrect medicine, incorrect dose, incorrect preparation, expired product, incorrect time, incorrect route, unauthorised medication, omission, wrong patient, mislabelling, incorrect dispensing, incorrect duration of treatment, extra dose, deteriorated medication and contraindication.(5,7-10)
Part of the dispensing process is patient counselling where the pharmacist provides verbal instructions to the patient on how to administer the medication. These instructions, aimed at reducing medication errors and advance patient safety, include how medication would be used, potential side-effects, drug-food interactions, and potential adverse reactions. Patient education and counselling, and the provision of appropriate written information or pictograms are important strategies for empowering patients to self-manage their medications on a daily basis and ensure that they are using their medications safely and appropriately.(9)
Dispensing can also occur in the absence of a prescription from the prescriber. Patients may request access to medication through self-care. The World Health Organization (WHO) defines self-care as the ability of individuals, families and communities to promote health, prevent disease, maintain health, and to cope with illness and disability with or without the support of a healthcare provider.(11) These days, where patients turn towards the internet for their health information, medication errors can occur just as easily. The WHO report has identified several risks including:(11)
- Incorrect self-diagnosis;
- Failure to seek appropriate medical advice promptly;
- Incorrect choice of therapy;
- Failure to recognise or self-diagnose contraindications, interactions, warnings and precautions;
- Failure to recognise that the same active substance is already being taken under a different name;
- Failure to recognise or report adverse drug reactions;
- Incorrect route of administration;
- Inadequate or excessive dosage;
- Excessively prolonged use;
- Risk of dependence and abuse;
- Food and drug interactions;
- Storage in incorrect conditions or beyond the recommended shelf life.(11)
Pharmacists have the responsibility that even when patients seek medication that is not scheduled or that is available ‘over the counter’, they must still ensure that it is suitable for the patient to use.
Pharmacists are also involved in monitoring patients’ medication use in order to improve patient and medication safety. The first step will be to access the patient history to check for potential drug-drug interactions, drug-condition interactions or potential duplication of therapy.(12) Another example where patients’ medication use is monitored is through review of prescribed medication and therapeutic drug monitoring where the pharmacist identifies potential medication-related problems, patient and medication risk factors that can compromise patient safety, and opportunities for optimising therapy.(12) This role can be optimized by working in a multidisciplinary collaborative healthcare team which will facilitate the pharmacist’s role and achieve a timelier, more optimal outcome for the patient. This multidisciplinary approach has the primary objective of patient safety and optimal medicine use which includes the detection of early stages of adverse drug reactions and medication toxicity.(13)
Classes of drugs where medication errors occur, listed by several authors, include anti-infectives, sedatives, analgesics, bronchodilators and cardiovascular drugs.(11-13)
How do medication errors occur?
The causes of medication errors in general clinical practice can be divided into human and system errors. Human errors consist of performance deficit, procedure or protocol not followed, miscommunication, inaccurate or omitted transcription, improper documentation, knowledge deficit, miscalculations, missing or misplaced zero and decimal points, use of non-standard abbreviations, lack of patient information and lack of patient understanding of their therapy.(5) Human errors are compounded when wards are overcrowded as it leads to an increase in workload, generation of more stress, tiredness and sleep deprivation in the health care professional, facilitating the occurrence of more medication errors.(4,5) Factors that contribute to system errors include medications with similar names, similar packaging for different medicines, complex or poorly designed technology, access to medication by non-pharmacy personnel, drug distribution system errors, computer entry error, lack of system safeguards, and work place environmental problems that include the daily occupancy rate and the workload of the health care professionals.(5)
Look-alike and sound-alike medication names pose a great risk for potential medication errors as it could result in selecting the incorrect medicine item in the prescribing, transcribing, prescription interpretation or picking of the medicinal product. Certain dispensing errors are seen on a regular basis and Textbox 1 highlights these regular and potentially dangerous dispensing errors as part of the cautionary tale.
Sound-alike brand names: Cytotec® and Cyclogest®
The first cautionary tale involves the substitution of Cyclogest® 200mg pessaries with Cytotec® 50mg tablets per vagina. The former intended to maintain a pregnancy and the latter an abortifacient. This particular complaint has been seen more than once at the Committee for Preliminary Investigation and in both cases the outcome was the loss of the pregnancy.
Other sound-alike brand names: Lasix® (furosemide – diuretic) and Losec® (omeprazole – proton pump inhibitor) – to avoid confusion, brand name for omeprazole has been changed to Prilosec in the USA
Other look-alike brand names:
- Topraz® (montelukast) 4mg tablets and Pantoprazole 40mg tablets and
Look-alike and sound-alike brand names:
- Pulmicort® Turbohaler (budesonide – oral inhalation) and Rhinocort® (budesonide – nasal inhalation)
Look-alike and sound-alike generic names:
- hydroxyzine and hydralazine
- tramadol and trazodone
The second cautionary tale involves errors around warfarin. Pharmacists confuse the 1mg and 5mg strength, or dispense the 5 mg where the strength is not specified, with life threatening consequences associated with a five times too high dose of this blood thinning agent.
Further examples where dosage errors occur:
- Eltroxin® 100 µg (0.1 mg) and Eltroxin® 50 µg (0.05 mg)
The last cautionary tale involves Methotrexate® 2,5mg tablets, a potent cytotoxic agent not usually intended for daily dosing. However, a number of cases have been reported to Council where a weekly dose was given daily with very serious adverse events.
Labelling and packaging issues
Labelling and packaging issues can cause up to 33 percent of medication errors.(14) Professional Information (PI) and Patient Information Leaflets (PILs) are compulsory for each dossier when pharmaceutical manufacturers want to register their product with SAHPRA, according to the General Regulations to the Medicines and Related Substances Act, 101 of 1965.(14) PILs are used to improve patients’ knowledge about the medication and therefore adherence to the treatment.(14,15) However, patient safety can be compromised and avoidable medication errors realised when the PIL does not reach the patient as found when PILs are attached to the manufacturer’s original packaging, so a patient may not receive the PIL if they have not been supplied a whole pack. Patient safety could be further compromised by a slow turnaround time at the medicine’s regulatory authority when changes to the PIL and PI are requested, notably when changes are made to the list of the medication’s side effects.(16) Importantly, patient safety can be impacted when the PIL contains information that the patient cannot understand or act on (that is, where information has been written at a higher level than the average patient’s health literacy), or the patient is unable to find the relevant information in the PIL.(16)
Severity of medication errors
The severity of medication errors can be categorised (Categories A to I) based on the effect it has on the patient as constructed by the NCC MERP.(1,6,14) Currently, in South Africa, a standardised medication error database to identify and quantify medication errors in hospitals is not available. Voluntary reporting systems, as part of pharmacovigilance programmes are available in South Africa to ensure ongoing safety and effectiveness of medicines.(15)
Role of pharmacovigilance
Pharmacovigilance attempts to detect, assess, manage and prevent drug-related problems as part of a voluntary reporting system.(15) Health care workers do not report adverse events due to a number of reasons. It might be that they fear embarrassment, or potential punishment or litigation. Or it might be because they do not believe that reporting will lead to any improvements. This is commonly referred to as a “blame culture” where the individual responsible for the error is blamed for the consequence. The result is that errors or mistakes sometimes get covered up out of fear of retribution instead being reported for future improvements.(15-18) Linking with the image of a plane, planes are perceived as one of the safest modes of travel due to high-level Aviation Safety Reporting systems. In the unfortunate event of a plane crash, a whole investigation is launched to determine the cause of the crash. Medication errors occur nearly every day and similarly require an investigation to prevent future fatalaties through understanding of the error and taking corrective action where applicable. It is crucial for pharmacists to adopt the concept of “just culture” which focuses on identifying system flaws that can be resolved in order to promote patient safety and move away from a “pathological culture”, where failures are punished, covered up, or ignored and individuals who fall short during the patient care process are punished.(14-19)
The role of pharmacists in medication errors
The importance of pharmacists working in dispensaries to monitor their drug treatment and prevent medication errors is well established in some countries.(7,9,16) Pharmacists monitoring medication orders might prevent more than half (58%) of all errors, including 72% of potentially harmful errors. Furthermore, they may improve doctor-pharmacist communication preventing 47.4% of all errors.(16) The pharmacist should thus be involved in double-checking all drug administrations to reduce medication errors and for preventative measures to be successful, there needs to be collaboration between all health care professionals.(13)
Traditionally, the contribution by pharmacists towards safety in the medication use process was limited to the medicine supply chain such as ensuring proper storage, dispensing and compounding. However, during the past few decades, the pharmacists’ role evolved toward patient-orientation which includes evaluation of prescribing of medication with appropriate dose regimes and dosage forms, clarifying instructions on medication use, patient counselling, prevention of potential drug-condition, drug-drug and/or drug-food interactions, avoiding preventable harm to patients due to medication use, adherence to treatment regimens and reduction of over-prescribing.(16)
A number of guidelines exist for South African pharmacists to assist in avoiding medication errors. The GPP clearly describes the three phases of dispensing, which is developed and prescribed in the rules to prevent medication errors.(13) Utilising the skill set of each member of the dispensary team in the dispensing process ensures a team approach, task appropriate action, a triple checking system and a cost-effective outcome.(17) Added electronic mechanisms such as the electronic prescription and robotic picking are useful tools but may be cost probative in LMIC.(17) The introduction of the low-cost item-scanning devices using the already allocated bar code on most medicine packs is an alternative model that ensures the correct picking and verification process against the captured items. Furthermore, it allows for the monitoring of each phase of dispensing for correctness and for training purposes, an essential component of error reduction described above.(17,18) A further caution is the introduction of a strict workflow programme that ensures that those involved in this process are focused on the task at hand without having to multi-task which adds to potential errors.(18)
There are substantial tools available to pharmacist that extend beyond the dispensing function to bolster their role in the harm reduction envisaged by the WHO. Ensuring that patient understands their disease together with the appropriate use of new medicines (New Medicine Service), reducing the polypharmacy, offering a medicine therapy management (MTM), and ensuring a full medicine use review(MUR) listing in transition of care (patient being admitted to hospital, visiting a specialist) will enhance the critical role of the pharmacist in error reduction.(11)
As a considerable number of medication errors that serve before the South African Pharmacy Council were preventable, it is important to develop and implement strategies that are unique to the South African environment to try to overcome such errors in the future. We highlighted these medical errors for pharmacists on the ethical basis to alert them regarding the potential for errors. It is however critical that medication errors be mitigated in the total value chain, from manufacturer to the end user – the pharmacist’s intervention at the dispensing point needs to be enhanced by the appropriate naming of both pharmaceutical substances and products and good prescribing practices. This paper serves to draw pharmacists’ attention to these possible errors, to emphasise the importance of prevention of errors, and to minimise pharmacy based medication errors in the future. In this way, pharmacists can effectively contribute towards patient safety.
- National Coordinating Council for Medication Error Reporting and Prevention. NCCMERP, 2014. [http://www.nccmerp.org/] (accessed 28 January 2014).
- Ghaleb MA, Barber N, Franklin BD, Wong ICK. The incidence and nature of prescribing and medication administration errors in paediatric inpatients. British Medical Journal 2010; 95(2):113-118. [http://dx.doi.org/10.1136/adc.2009.158485]
- Jain S, Basu S, Parmar VR. Medication errors in neonates admitted in intensive care unit and emergency department. Indian Journal of Medical Science 2009; 63(4):145-151. [http://dx.doi.org/10.4103/0019-5359.50763]
- Lerner RB, de Carvalho M, Vieira AA, Lopes JM, Moreira MA. Medication errors in a neonatal intensive care unit. Jornal de Pediatria 2008; 84(4):166-170. [http://dx.doi.org/10.1590/S0021-75572008000200013]
- Jhanjee A, Bhatia MS, Srivastava S. Medication Errors in Clinical Practice. Delhi Psychiatry Journal 2011; 14(2):205-210.
- Hicks RW, Becker SC, Krenzicheck D, Beyea SC. Mediation Errors in the PACU: A Secondary Analysis of MEDMARX Findings. Journal of Peri-Anaesthesia Nursing 2004; 19(1):18-28. [http://dx.doi.org/10.1016/j.jopan.2003.11.007]
- Chua SS, Chua HM, Omar A. Drug administration errors in paediatric wards: a direct observation approach. European Journal of Paediatrics 2009; 169(5):603-611. [http://dx.doi.org/10.1007/s00431-009-1084-z]
- Cheung KC, Bouvy ML, De Smet PA. Medication errors: the importance of safe dispensing. British journal of clinical pharmacology. 2009;67(6):676-80.
- College of Pharmacists of Bristish Columbia. Pharmacy Matters – Reducing Errors and Increase Patient Safety by Following the Standards of Practice [Internet ]. 2014 [Available from: https://www.bcpharmacists.org/readlinks/pharmacy-matters-reducing-errors-and-increase-patient-safety-following-standards-practice.
- International Pharmaceutical Federation (FIP). Patient safety. Pharmacists’ role in delivering medications without harm. The Hague: International Pharmaceutical Federation (FIP); 2020.
- World Health Organization, Regional Office for South-East Asia. Self-care for health.: WHO Regional Office for South-East Asia; 2014.
- World Health Organization. Guidelines for the regulatory assessment of medicinal products for use in self-medication Internet. 2000 25 June 2019.
- South African Pharmacy Council. Rules relating to good pharmacy practice. Internet. 2004.
- Sustersic M, Gauchet A, Foote A, Bosson JL. How best to use and evaluate Patient Information Leaflets given during a consultation: a systematic review of literature reviews. Health expectations: An International journal of public participation in health care and health policy. 2017;20(4):531-42.
- Khalili H, Farsaei S, Rezaee H, Dashti-Khavidaki S. Role of clinical pharmacists’ interventions in detection and prevention of medication errors in a medical ward. International Journal of Clinical Pharmacy and Pharmaceutical Care 2011; 33(2):281-284. [http://dx.doi.org/10.1007/s11096-011-9494-1]
- Medicine I, Services BHC, Errors CIPM, Cronenwett LR, Bootman JL, Wolcott J, et al. Preventing Medication Errors: National Academies Press; 2006.
- Leape LL. Reporting of medical errors: time for a reality check. Western Journal of Medicine. 2001;174(3):159-61.
- Kapur N, Parand A, Soukup T, Reader T, Sevdalis N. Aviation and healthcare: a comparative review with implications for patient safety. JRSM open. 2016;7(1):2054270415616548.