Intro

Fredrik Brounéus 0:16

Welcome to Drug Safety Matters , a podcast by Uppsala Monitoring Centre , where we explore current issues in pharmacovigilance and patient safety . Today , we'll be talking about medication errors . What are they , how big is the problem , why do they occur and , perhaps most importantly , how can we prevent them from occurring ? This and much more is what Drug Safety Matters host Federica Santoro will be discussing with guests Ghita Benabdallah and Loubna Alj from the National Pharmacovigilance Centre of Morocco , along with Uppsala Monitoring Centre's own , Alem Zekarias . My name is Fredrik Brouneus and you'll be hearing more from me as I'll be filling in for Federica during the upcoming months .

Fredrik Brounéus 0:59

But now,

Welcome

Fredrik Brounéus 1:09

over to Federica and her guests for an in-depth discussion on medication errors .

Federica Santoro 1:16

Hi all , and welcome to Drug Safety Matters . I'm delighted to have you all on the show to talk about medication errors today and , more broadly , about how to prevent adverse drug reactions .

What is a medication error?

Federica Santoro 1:25

So I think we start with a definition , just to get everyone on the same page . And , Loubna , I would start with you . What is a medication error ?

Loubna Alj 1:36

So there are several definitions of medication errors , but I will state the European Medicine Agency's one . Medication errors is defined as an unintended failure in the drug treatment process that leads to , or has the potential to lead to , harm to the patient . This definition has the advantage to point out two important characteristics of medication errors . First of all , the fact that medication errors are unintended . This term is key to highlight the non-intentional aspect of medication errors , in contrast to other drug-related problems that are intentional , such as misuse , abuse or off-label use . The second characteristic is that not all medication errors lead to harm . Some of them are not associated with adverse reactions . Others are potential , meaning that there are circumstances that could lead to their happening . Obviously , all medication errors should be reported to pharmacovigilance centers .

Federica Santoro 2:48

So not all medication errors automatically lead to harm , but obviously we will try to focus on those that do harm patients , because they have an impact and we want to prevent those especially . It's

Common causes

Federica Santoro 3:02

not always easy to pinpoint exactly why people make mistakes , but has anyone looked into this when it comes to medication errors ? So what are their most common causes ?

Loubna Alj 3:15

Studies show that there are five most common causes of medication errors . First , look-alike and sound-alike medicines are a leading cause . They can occur during all the stages of the medication use: prescribing , transcribing , dispensing and also administering . Medication e rrors could occur when medicines have similar looking or similar sounding names , look-alike boxes , look-alike tablets or look-alike blister packaging . Second , medication errors occur when protocols and guidelines for safe use of medications are lacking in healthcare settings , especially those related to high-alert medications . Third , when communication is unclear , medication errors could happen , of course . For example , illegible handwriting orders could lead to dispensing errors and the use of error-prone abbreviations may also result in those errors .

Loubna Alj 4:21

I can give an example of a misinterpreted trailing zero after a decimal . This could lead to a tenfold drug dose administration error . Fourth , interruptions or distractions to nurses during administration may also result in giving a drug by an incorrect route or giving a drug to another patient . Last but not least , lack of allergy documentation in medical records contribute to prescribing errors , as well as a lack of pharmacist medication orders review . In oncology prescription review by pharmacist is important to intercept medication errors related to those calculation errors for weight based medication . In addition , receiving complex medication regimens in cancer patients may also lead to medication errors .

Federica Santoro 5:26

So there's a few different causes , and obviously that helps then understand how one can intervene to try and prevent those errors from happening , and we'll go into that later on . But first I'd like to talk about frequencies , and I understand just as it's difficult to pinpoint causes . It can be even harder then to determine frequencies . But , lem , you might have some numbers for us .

Frequency of medication errors

Federica Santoro 5:51

How often do medication errors occur ?

Alem Zekarias 5:55

So medication errors can happen throughout the use of medicines , as just Lubna mentioned , which usually includes the prescribing , dispensing administration , but also the monitoring stages .

Alem Zekarias 6:06

According to the report "Global Burden of Preventable Medication-Related Harm in Healthcare that was published in 2023 by the World Health Organization , where they have done a systematic review and meta-analysis of 100 studies globally , so in this studie was both studies from high income settings but also low-income countries , and the pool prevalence of medication areas that actually have led to harm was 5% , which is basically one in 20 patients , and one-fourth of the harm was severe or potentially life-threatening .

Alem Zekarias 6:39

A nd the highest prevalence rates globally for preventable medication-related harm are for patients managed in geriatric care units , as well as among patients in surgical care . So , if we focus on the avoidable medication-related harms on a global level , about half of them occurred during the ordering prescribing stage and about 30-40% at the monitoring reporting stage . It is important , though , as you just mentioned , that these are just approximate numbers , so there is no really uniform collection of data or harmonized definition , which , of course , makes it harder to estimate how often medication errors can occur or occur . So they happen everywhere and we do have challenges with underreporting due to different reasons , including lack of capacity to detect and report these types of problems .

Federica Santoro 7:31

So , even though the figures are an approximation , they still give an idea of the degree of the problem and obviously we're talking about a pretty intense burden on health care . Let's go into that a little more, Alem . What

Impact on patients, healthcare and communities

Federica Santoro 7:46

is exactly the impact of medication errors on healthcare ? So, how do they affect patients ? But how do they affect communities as well ?

Alem Zekarias 7:57

So the direct impact is , of course , the harm , pain and suffering for the individual patient and its family . The patient may experience emotional , but also psychological discomfort and , as a consequence to this , of course , lose trust and confidence to the healthcare system . Except this , another important aspect is the financial impact , which it's also important to remember . As previously mentioned , one-fourth of the harms due to preventable medication errors were severe or potentially life-threatening , which require resources from the healthcare systems .

Federica Santoro 8:34

Let's move on to the nitty-gritty , so to say . I'd like to talk about data collection and analysis now , which I'm sure will interest all the pharmacovigilance professionals out there listening to this episode . So , Ghita

Data collection and analysis

Federica Santoro 8:50

, how is data on medication errors collected ? And , specifically , I'm wondering , does it end up in the same pharmacovigilance databases that we use to collect regular reports of adverse drug reactions ?

Ghita Benabdallah 9:05

Thank you , Federica .

Ghita Benabdallah 9:13

Data on medication errors could be collected from healthcare professionals and patients once they are familiar with the culture of reporting medication errors , and , in the second way , preventable ADRs that are called also medication errors with harm could be detected through individual case safety reports that are received at pharmacovigilance centers by using a tool which is enabling to identify preventable ADRs .

Ghita Benabdallah 9:38

This is the preventability method , called P method , which enables the identification of any well-known risk factors that will increase the likelihood of ADR occurrence , which are leading to understand the root causes of this medication error and will help to be able to put in place the right risk minimization actions . The P method is used only by pharmacovigilance staff within pharmacovigilance centers and it comes after the step of causality assessments , which enables to confirm the link between the adverse event and the medication that is taken . Regarding these data that are collected , yes , they are all sent to the same pharmacovigilance database we use to collect a regular ADR report . So medication error with harm and without harm have to be sent to pharmacovigilance databases , so the national one that we have in our countries and also the international one , VigiBase .

Federica Santoro 10:49

And we'll dive into that distinction between the national and the global perspective a little bit later

Listener question: Efficiency of P-method

Federica Santoro 10:54

. I'm glad you brought up the P method because we actually got a question about that on social media from one of our listeners . Mohamed in Egypt asks: is this method effective in keeping healthcare professionals proactive and helping them prevent any potential risks ?

Ghita Benabdallah 11:14

Yes , so the question is very interesting . So at the individual level , in a case-by-case analysis , it is not a proactive tool because when there is an error it is already there . So this tool will enable to prevent in the future the recurrence of medication errors that have been detected . And at a public health level , it is part of an overall medication error prevention strategy . For example , when we are looking for preventable ADRs in the global database , we are acting to be proactive .

Listener question: Facilitating patient reporting

Federica Santoro 11:52

Thank you very much . I have another question for you from our social media followers . Sudarshan , who is based in India , asks how we can simplify the identification and reporting of medication errors from a patient's perspective . So I guess he means basically , how can we make it easier for patients to identify and report those errors ?

Ghita Benabdallah 12:16

Yes , so a patient can report medication errors if there is a reporting system in place .

Ghita Benabdallah 12:25

So they have to be aware of that and then they need to be sensitized on that field . So the reporting system in place needs to be adapted to the culture of the country and , for example , in countries with an oral culture , the reporting system could be the phone call and it could be a solution and this will be easier for patients to report medication error by calling , and this way of reporting has also some benefit for healthcare professionals from pharmacovigilance centers because it allows them to gather all information that is needed in one time . So , regarding the identification of medication errors by patient , it depends first on the engagement in their own health care , because they shouldn't solely rely on health care professionals and they should know that they are able to identify medication errors and for that they should be aware about the five R's . When they are starting the treatment they always have to check that this is the right patient with the right drug at the right dose and at the right route of administration and at the right moment .

Federica Santoro 13:49

Thank you , and that leads nicely into my next question . I wanted to ask you , Ghita , about the barriers to reporting medication errors in general . You mentioned , obviously , that a system has to be in place , that people have to be aware that it exists and have to be aware of how to report . But let's consider it not just from a patient's perspective . Underreporting of adverse drug reactions is a well-known and a pretty big issue in the pharmacovigilance world , and we've discussed it on the podcast before .

Reasons for under-reporting

Federica Santoro 14:25

Do medication errors go unreported for the same reasons as regular adverse drug reactions , or are there additional factors at play here ?

Ghita Benabdallah 14:38

Thank you , Federica , for this question and , as you just mentioned , yes , at the basis all countries are facing underreporting of adverse event and , of course , also of medication errors as well . For the latter , for medication errors , this is mostly due to the culture of patient safety , with the concept of non-blame that is not implemented everywhere . So this leads to a fear to report because there is a fear of repercussion . And , on the other hand , we still have patients who do not know that they are allowed to report because there is still this lack of culture of patient safety and of reporting .

"Errors" - a blaming name?

Federica Santoro 15:28

And going back to that blame issue , is it a problem that we call them errors ? Does that just feed into the blame and shame ? And is that then stopping people from documenting these issues even more ?

Ghita Benabdallah 15:48

Yes , definitely , the term error would be an element that could stop the process of reporting , because it's referring to the blame , to the shame , and there is a repercussion on the career of the healthcare professional . So, it's very important to implement a culture of non-blame that focuses on the fact that errors are not due to the human but rather to the system in which the human works . And regarding that point , there is a very famous psychologist , James Reason , who stated already in 1995 , that we cannot change the human condition , but we can change the conditions under which humans work . And this is how we moved from this individual approach to the systemic approach .

Federica Santoro 16:43

Absolutely, it's a very interesting and very positive , constructive way to frame it . Thanks for sharing that . Now I'll let you rest your voice for a little bit , Ghita . I'll move over to Alem .

Coding medication errors

Federica Santoro 16:56

Let's talk about coding . So what should healthcare or pharmacovigilance professionals keep in mind when they're coding medication errors into their database ?

Alem Zekarias 17:09

It's exactly the same thing as you should actually think about when you report suspected adverse drug events . Try to report everything and try to describe what happened . So if you don't have the information needed , contact the primary reporter , especially when it comes to medication errors , and ask the additional questions . So the report try to code as correct , clear and complete as possible , which is important for the root cause analysis , because understanding what caused the error and how the error can be avoided is important to prevent future unnecessary patient harm . The more accurate data that has been collected , the higher are the chances for a successful root cause analysis and appropriate risk minimization actions relevant to your own setting can be suggested and implemented . There are coding guidelines , as the one being provided by the Medical Dictionary for Regulatory Activities , also referred as MedDRA , which can be used as a support for the coding of adverse event terms .

Federica Santoro 18:13

Okay , I'd like to move on to data analysis now , and we've touched on this here and there . We've mentioned the P method . You mentioned root cause analysis , so we've hinted at it so far , but I'd really like to explain for our listeners how the analysis of medication error reports happens . So

Signal detection and assessment

Federica Santoro 18:36

how are signals detected and assessed for these types of reports ? Are there any special methods ? Do regular pharmacovigilance methods apply ? Is it a combination ? Loubna , take it away .

Loubna Alj 18:51

Thank you , Federica . Yes , the regular pharmacovigilance pipeline does apply , although there are some particularities . So detecting signals related to medication errors may be qualitative or quantitative . However , when pharmacovigilance centers have small medication error databases , the qualitative approach is more applicable . So the pharmacovigilance staff proceed to a manual screening of medication errors reported to them and look for those that draw their attention .

Loubna Alj 19:27

I can here give you examples of triggers of medication error signals . We can consider serious medication reports , potentially serious medication error reports and also clusters of medication errors . Please note that only one serious medication error is enough to trigger a signal . For example , if you receive , as a PV center , a fatal outcome with paracetamol in a child that was administered adult formulation instead of pediatric one , how would you consider this ? Is it a signal or not ? I'm sure you will consider it as a signal and you will investigate the case to understand how and why the error occurred and what should be done to prevent it . Now , when it comes to signal validation , medication errors are , by definition , preventable . That is why there is no need to conduct epidemiological studies to validate medication errors signals in contrast to adverse drug reactions which occur under normal conditio n of use

The VigiBase global perspective

Loubna Alj 20:55

.

Federica Santoro 20:55

That's very helpful, thank you . Alem, could we talk a little bit about the global perspective ? So obviously here at UMC we're looking into a global database , VigiBase . So what happens when we want to analyze medication error reports like that, that are coming from all over the world ? Is something different ?

Alem Zekarias 21:05

So , as Loubna just mentioned , there are two approaches to do signal detection: it's the quantitative or the qualitative approach . For databases with a large number of reports of suspected adverse drug events , the quantitative approach , with support of different statistical methods that we also apply here at UMC , can be used . And what's mainly different between regular pharmacovigilance and signal detection , but also assessment on suspected medicationary reports , is actually what type of data you collect and report . In general pharmacovigilance , the reported data is primarily for causality assessment purposes . You want to understand if there is a possible causal relationship between the reported medicinal product and the reported adverse event , while for medicationary related problems , the main purpose is actually to understand the reasons and factors behind this inappropriate medication use . It's first when you actually fully understand what happened you have the possibility to prevent it from occurring again .

Federica Santoro 22:05

And , on that note , let's talk about prevention . Now, as we said at the beginning , we are talking about this ultimately because we want to try and prevent those mistakes from happening again . And now, while I appreciate that achieving zero mistakes and zero harm is an impossible feat , we're only human after all,

Strategies for prevention

Federica Santoro 22:36

what are the most effective strategies , though , to try and prevent those errors ? Back to you , Ghita , for this one .

Ghita Benabdallah 22:41

So, there are many strategies and it depends on the country where it will be implemented , but it always starts by creating a culture of patient safety . To be able to report in this non-blame atmosphere , having a good communication with the healthcare professional , between them, and between healthcare professional and patient is also very important important . Having a very well implemented vigilance system that will react and act quickly is also the key element for putting in place this strategy . Regarding the training , it's very important to strengthen training; general training , but also specific training , as , for example , training in prescribing . And within the health system, it's important to be proactive and implement therapeutic protocols for clinical management and also focus on high alert medications . And finally , it's very important to be part of medication error networks to share prevention strategies .

Federica Santoro 23:59

How about patient engagement ? We mentioned this earlier , but how can it specifically help to prevent medication errors ? Do you have any real life examples of how that can work ?

Ghita Benabdallah 24:11

So, there are some examples, but patient engagement is very importantit's not possible to rely important, because, as I said before, it's on healthcare professionals . And when the patients are engaged in their own healthcare , they could , for example , by the double-check of the five R's , prevent the occurrence of medication errors . And , as a real-life example , I could say that the prevention of an immunoallergic reaction by the double-check of the patient just before the administration of ibuprofen at the hospital . Here, the patient was allergic to ibuprofen and it wasn't mentioned before .

Federica Santoro 24:55

We have a couple of more questions from our social media followers . This clearly was a topic that resonated very much with our audience; when we advertised it on social, we got quite a few responses . So ,

Listener question: Technological innovations

Federica Santoro 25:10

Ghita , here's another question from Sudarshan in India . He asks about technological innovations and can you imagine how they could help prevent medication errors . He cites an interesting example of a medication packaging that , for example , could change color if stored incorrectly .

Ghita Benabdallah 25:31

Yes , yes . So, there are many actions to be implemented to prevent medication errors , as having the Tall Man lettering on the boxes of medicines to avoid medication errors that are due to look- alike or sound-a like drug names . We can use the pictograms , we could have adapted storage , we could use different storage , and this is an action that is easy to implement and is efficient to prevent medication errors . The barcodes , when available , will help to reduce medication error , as well as some artificial intelligence tools as e-prescribing , that can be used to decrease medication errors and prevent human errors

Listener question: AI

Ghita Benabdallah 26:23

.

Federica Santoro 26:23

Great that you mentioned AI , because another listener , Paula in the UK , had a question on that . So can artificial intelligence help both patients and healthcare professionals reduce these errors ?

Ghita Benabdallah 26:37

The use of AI for medication management and in reducing medication errors would help identify potential medication errors that could happen during the whole delivery process . Regarding the AI , it is important that the tools to be used have to be validated and that they will be used in a rational way , without outpassing the role of healthcare professionals . The AI used to prevent medication errors needs to stay a tool to help and could not replace the role of healthcare professionals .

Alem Zekarias 27:15

There are some existing support already, AI to support , like barcode scanning , for example , but also this robotic dispensing errors , which basically using AI that accurately dispense medications , which studies have seen reduces the risk for human error in dosage and labeling . Then we have something called clinical decision support system , of course , that provide real-term alerts , reminders to the healthcare professionals about dosage errors , incorrect prescriptions , also called automated prescription verification . That can basically an AI algorithm that can cross -check prescriptions against patient records , medical history and known drug interactions, to flag potential errors before medications are being dispensed . But also there are ways you know , if you look at the analysis part , how AI can support . One way could be using machine learning for pattern recognition , which can be applied to analyze reported safety data to identify patterns of medication errors and suggest interventions or processes to the healthcare providers .

Federica Santoro 28:15

Thank you both for that . I hope that answers our listeners questions and gives them an idea of where technology is headed in this field

Reflections on a UMC course on medication errors

Federica Santoro 28:26

. Now, we're nearly at the end of the interview , but before I let you go , I'd like to hear your reflections from a course on medication errors that you recently led . So this was a course that you developed with some other colleagues of mine here at UMC , and it was designed to help pharmacovigilance center staff, who maybe lack procedures for collecting and analyzing medication errors , to get them started on that journey . So I was just wondering what did you , as instructors , learn from them , the participants , regarding the needs and the knowledge gaps in this particular field of pharmacovigilance ? And I'd say we start with you , Loubna .

Loubna Alj 29:12

I think that additional efforts are needed to remind the pharmacovigilance community that medication errors are part of the pharmacovigilance scope . The medication errors course organized by the UMC was a great opportunity for national PV centers to remind them, and to stress the fact that they should implement or enhance their medication errors activity to better contribute to medication safety . Moreover , there is still some confusion to distinguish medication errors from other drug-related problems . Always remember that medication errors are not deliberately made by healthcare professionals or patients . As stated in the definition, they are unintended . I would like also to add that looking for causes of medication errors should be systematically performed and keep in mind that it is important to learn from errors , regardless of their seriousness . Indeed , every medication error is an opportunity to improve medication safety and patient safety worldwide .

Federica Santoro 30:22

Thank you . Ghita, is there any other reflection you'd like to add ?

Ghita Benabdallah 30:26

Thank you very much, and thank you Loubna . I believe that Loubna said everything , so I will just add that we have seen that participants know that the burden of the problem is there . They are aware about that and I would like just to say that all the tools are available and the participants need more training and they need training, specific training, workshops, and working groups to be able to implement the tools that were presented .

Federica Santoro 31:06

Thank you for that . And finally , Alem, any last thoughts ?

Alem Zekarias 31:11

I can just agree with both my colleagues , Loubna and Ghita , because medication errors are part of pharmacovigilance, but despite that , we still lack quite a lot of suspected or virtual medication- related reports from several parts of the world in VigiBase . So working with the medication area requires a different type of mindset , different processes and guidelines , and it's not easy as you may think , which was evident during the course . There was definitely a curiosity and an interest to start tackling these types of problems as part of the pharmacovigilance mission , which is great , especially if you manage to do this in close collaboration with relevant stakeholders , including the patients . But it may be hard to know how and where to start . So I hope this course has enabled and motivated healthcare professionals working in different settings around the world to start to identify , report , analyze and communicate medication errors as part of their responsibility to ensure safe use of medicinal products for their patients .

Federica Santoro 32:10

Thank , you very much . I'm sure the course has helped and I hope that this podcast , where we tried to give an overview of the field of medication errors , will do the rest and set people on a course to start collecting and analyzing medication errors more and more . Thank you very much , all three of you , for sharing your time with me . It was such a pleasure to talk to you .

Alem Zekarias 32:36

Thank you so much . Loubna Alj: Thank you , Federica .

Ghita Benabdallah 32:39

Thank you , Federica , thank you so much .

Outro

Fredrik Brounéus 32:51

And if you'd like to learn more about medication errors and preventable adverse drug reactions , we've put together some useful links for you in the episode show notes . Apart from these conversations with experts , we offer a series of audio stories from Uppsala Monitoring Center's pharmacovigilance news site called Uppsala Reports Long Reads , so why not check that out too ? That's all for now , but we'll be back soon with more on medicines safety . In the meantime , we'd love to hear from you . Reach out on Facebook , LinkedIn and X , send comments or suggestions for the show or questions for our guests next time we open up for that . And visit our website to learn more about what we do to promote safer use of medicines and vaccines for everyone everywhere . If you like the podcast , please subscribe to make sure you won't miss an episode and spread the word so other listeners can find us too . For Drug Safety Matters . I'm Fredrik Brouneus . Thanks for listening .