A core facet of patient safety and pharmacovigilance that tends to be relegated to an afterthought is medication errors.
That is an error by itself.
Back in 2001, a young teenager, Wayne Jowett, suffering from leukemia and admitted to a hospital in Nottingham (UK), was injected intrathecally with a dose of vincristine instead of the recommended intravenous route. 1
He experienced respiratory failure, fell into a coma, and was transferred to the intensive care unit.
A few weeks later, he died.
Investigations showed that in the previous 15 years in the UK alone, 14 patients had either died or been left paralyzed as a result of the same error. Despite the packaging and informational insert stating clearly that vincristine injected intrathecally can be fatal,.
It was later concluded that the healthcare providers had confused the drug with methotrexate, which can be administered through the spine.
This is just one of many stories that show how devastating the impact of medication errors could be.
What is a medication error?
The National Coordinating Council for Medication Error Reporting and Prevention defines 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 professional, patient, or consumer.” 2
Although not all errors lead to death, as was the case with young Wayne, they can still have harmful consequences.
- Increased length of hospital stays
- High treatment costs
- Disability
- Birth defects
- Hospitalization
A lot can be done to both prevent and reduce the number of medication errors patients are exposed to. However, any success requires that all key stakeholders play their roles.
National Medicines Regulatory Authorities
A key function of a country’s national medicines regulatory authority (NMRA) is to implement the appropriate guidelines and policies to achieve the highest standards of safety for medical products consumed by those in their territory.
Firmly anchored on this function is the reporting and prevention of medication errors.
Before granting market authorization, regulatory agencies should analyze the drug name, packaging (including color), labeling, and overall product design to identify aspects of
the product that could potentially contribute to errors. 3
The NMRA should look at;
- The color and design of the packaging. If this is similar to a known and registered product, to the extent that it may lead to confusion, the authority can reduce potential medication errors by tasking the company in question to make necessary changes.
- The proposed brand names so as to limit confusion. The authority can use their in-house officers, technology and key stakeholders-including patients and healthcare workers to determine acceptability of proposed proprietary names in relation to existing products.
- The product labels. Drugs like prednisone that are available in various strengths are a potential source of confusion and medication errors. Available in 1mg, 5mg, 10mg and even 20mg it is important to have a distinct look for the different strengths. Ideally, the color pattern should be distinctively different and the strengths written in large font sizes.
After granting market authorization, regulatory authorities should be keen on monitoring and reviewing submitted medication error reports and subsequently instituting immediate and appropriate action.
Manufacturers
Drug manufacturing companies have a crucial role to play in reducing medication errors.
They can ensure that tablets and capsules have a distinct design and imprint that highlights their unique identity. An imprint ensures that a healthcare provider who is administering the drug or a patient taking the drug can clearly distinguish it from the next.
Manufacturers can also include on the packaging unique identifiers, such as a barcode, that provide complete information about the medicine.
In this way, the pharmacy personnel are able to scan the product and quickly ascertain whether it’s the right product, the right strength, the right route of administration, and to be administered to the right patient.
They should ensure the dosing devices co-packaged with particularly oral liquid dosage forms are for the appropriate doses to be measured. Measuring spoons, cups, and syringes should not be labeled in milligrams if the doses are normally prescribed in milliliters.
There are reported cases in Kenya where mothers applied chlorhexidine gel (recommended at the time for cord car) into their newborn’s eyes due to similarities in package design to tetracycline eye ointment.
So, manufacturers should protect patients against incorrect use by ensuring the packaging for different dosage forms is distinctively different so as to avoid confusion.
READ ALSO: The 3As That Will Drive Africa’s Pharmaceutical Agenda (2024) – African Pharmaceutical Review
Consumers
Many patients tend to be reserved when it comes to questioning doctors and other healthcare workers about what drug has been prescribed to them and what the purpose of the same is.
To minimize medication errors, patients should always seek clarity from their health providers on the medicines they are putting in their bodies, ensuring they are taking the right drug, strength, dosage, route, and duration.
They should ask whether the drug should be stored in the refrigerator or not.
Additionally, patients should be extremely careful before taking any medicine, ensuring to countercheck the label to confirm whether they are consuming the right one (particularly when
they are on multiple drugs).
Disclosure of all types of medicine, supplements, and herbal products to doctors and pharmacists is also crucial. This will inform the prescriber’s decision on the choice of therapy, factoring in potential drug-drug and food-drug interactions.
Finally, patients should always report all suspected medication errors.
The Institute of Safe Medicines Practices (ISMP) has helpful tools and resources to help patients protect themselves from medication errors. 4
Healthcare providers (HCPs)
Those who prescribe, dispense, and administer medicines to patients play a significant role in ensuring that harm doesn’t fall on patients due to medication errors.
Firstly, HCPs should continuously update themselves with treatment guidelines, whether they have changed or not. This ensures they are armed with current knowledge on the ideal therapeutic management strategies.
Secondly, they should report all medication errors both in-house and to the national pharmacovigilance centers.
Healthcare workers struggle to remain consistent with reporting due to 3 key reasons;5
- Many don’t consider it as a priority especially when it was caught and corrected before harm came to the patient.
- Lack of psychological safety. Healthcare workers are not confident to report on errors if the perception is that it may get them or their colleagues into trouble.
- They perceive it as “extra work not worth their time” if they don’t stand to gain anything from reporting the errors.
Sensitization to encourage reporting should be increased by creating an open, fair, and learning culture deep rooted in trust. Those who do report should be recognized, and efforts should be made to make the reporting process easy and fast for all healthcare workers.
Conclusion
Although many medication errors may go unnoticed and not result in any substantial harm to patients, it is clear there are situations where the consequences can be devastating.
It is important for all key stakeholders, including regulatory agencies, patients, manufacturers, and healthcare workers, to join forces and prevent these errors from occurring.
And if they do occur, report on the same to allow learning and mitigate future occurrences.
References
Guardian. https://www.theguardian.com/society/2001/feb/03/health.uknews. Published February 3, 2001. Accessed February 22, 2024.
2. Medication Error Definition. Accessed February 22, 2024. https://www.nccmerp.org/about-medication-errors
3. Research C for DE and. Working to Reduce Medication Errors. FDA. Published online August 23, 2019. Accessed February 22, 2024. https://www.fda.gov/drugs/information-consumers-and-patients-drugs/working-reduce-medication-errors
4. Home. Accessed February 22, 2024. https://www.consumermedsafety.org/
5. Pump Up the Volume: Tips for Increasing Error Reporting and Decreasing Patient Harm | Institute For Safe Medication Practices. Published August 25, 2021. Accessed February 22, 2024. https://www.ismp.org/resources/pump-volume-tips-increasing-error-reporting-and-decreasing-patient-harm
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About the Author
Bevin Likuyani is a Pharmacist with a MPharm (Pharmacoepidemiology & Pharmacovigilance) and MBA (Strategic Management) from School of Business, University of Nairobi). He is a Certified Supply Chain Pharmacist. (American Association of Supply Chain Management) and content writer on pharmaceutical related topics. Email: bevin@africanpharmaceuticalreview.com LinkedIn