THE EFFECT OF AN INTENSIVE EDUCATIONAL INTERVENTION ON THE DOCUMENTATION OF OTC MEDICATION BY PHYSICIANS IN OUTPATIENT CLINICS

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THE EFFECT OF AN INTENSIVE EDUCATIONAL INTERVENTION ON THE DOCUMENTATION OF OTC MEDICATION BY PHYSICIANS IN OUTPATIENT CLINICS

Name: James Lei

E-mail: J.lei@students.uu.nl

Research site: Erasmus MC Rotterdam Research period: 7 feb 2022 – 1 july 2022

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1. Samenvatting

Introductie

Patiënten worden vaak met meer dan een geneesmiddel en door meer dan een beroepsbeoefenaar in de gezondheidszorg behandeld. Dit maakt het voor artsen moeilijk om het precieze gebruik van over de counter (OTC) medicijnen door patiënten te achterhalen. CPOE wordt tegenwoordig gebruikt om artsen te helpen bij de documentatie van geneesmiddelen en om te controleren op geneesmiddel- geneesmiddel interacties. Echter, worden er nog steeds te weinig OTC-geneesmiddelen via CPOE in het medisch dossier gedocumenteerd. Het doel van deze studie was dan om het effect van een intensieve educatieve interventie op de documentatie van OTC-medicatie te bepalen.

Methode

De gegevens die voor deze studie waren gebruikt, waren afkomstig uit de MEDUCATE-trial van van Stiphout (2015). De studie was een multicenter, cluster gerandomiseerde gecontroleerde trial. Artsen van de afdeling interne geneeskunde en andere afdelingen werden geselecteerd van het Erasmus Universitair Medisch Centrum Rotterdam (EMC) en Universitair Medisch Centrum Utrecht (UMC). De intensieve onderwijsinterventie bestond uit een e-learning cursus en een discussiebijeenkomst. De uitkomst was de discrepantie tussen OTC medicijnen geregistreerd door artsen in het medisch dossier en het daadwerkelijke gebruik van OTC medicijnen door patiënten. De gegevens werden geanalyseerd door middel van een chi-kwadraat toets in SPSS om het medisch dossier van patiënten in de interventiegroep te vergelijken met de patiënten in de controlegroep.

Resultaten

Er werden 775 patiënten in deze studie opgenomen. Het totale aantal OTC-geneesmiddelen dat bij deze patiënten werd gevonden, bedroeg 1245. Van de 1245 OTC-geneesmiddelen waren er slechts 70 (5.6%) gedocumenteerd in het medisch dossier. Van de 70 OTC-geneesmiddelen waren 41 (58.6%) afkomstig uit de interventiegroep en 29 (41.4%) uit de controlegroep. Er werd geen statistisch significant verschil gevonden tussen beide groepen in de documentatiegraad (p=0.51).

Conclusie

De intensieve educatieve interventie had geen effect op de documentatiegraad van OTC-geneesmiddelen door artsen. Er werd geen verschil gevonden tussen de interventiegroep en de controlegroep wat betref de documentatie van OTC-geneesmiddelen. De totale documentatie van OTC-geneesmiddelen was laag in beide groepen.

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2. Abstract

Introduction

Patients are ofen treated with more than one drug and by more than one healthcare professional. This makes it difficult for physicians to find out the exact use of over the counter (OTC) medicines by patients.

CPOE is used nowadays to assist physicians in the documentation of medicines and to monitor for drugdrug interactions. However, there are still too little OTC medicines documented in the medical record through CPOE. Thus, the aim of this study was to determine the effect of an intensive educational intervention on the documentation of OTC medication by physicians.

Method

The data used for this study was obtained from the MEDUCATE-trial by van Stiphout (2015). The study was a multicenter, cluster randomized controlled trial. Physicians from the internal medicine department and other departments were selected from Erasmus University Medical Centre Rotterdam (EMC) and University Medical Centre Utrecht (UMC). The intensive educational intervention consisted of an elearning course and a discussion session. The outcome was the discrepancy between OTC medication registered by physicians in the medical record and the actual use of OTC medication by patients. The data was analyzed through chi-square test in SPSS to compare the medical record of patients in the intervention group to the patients in the control group.

Results

There were 775 patients included in this study. The total amount of OTC medicines found within these patients were 1245 OTC medicines. Out of the 1245 OTC medicines, only 70 (5.6%) of them were documented in the medical record. Out of the 70 OTC medicines, 41 (58.6%) were from the intervention group and 29 (41.4%) were from the control group. There was no statistical significant difference found between both groups in the documentation rate (p = 0.51).

Conclusion

The intensive educational intervention did not have an effect on the documentation rate of OTC medicines by physicians. No difference was found between the intervention group and the control group on the documentation of OTC medicines. Overall documentation of OTC medicines was low in both groups.

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3. Introduction

Patients are ofen treated with more than one drug and by more than one healthcare professional. In addition, patients can obtain prescribed and non-prescribed medicines through various pharmacies, drugstores and supermarkets. This may lead to discrepancies between the actual used medication by patients and what is recorded in the medical record [1].

To support physicians in improving their documentation and communication and ultimately to reduce adverse drug events (ADEs) and drug-drug- interactions (DDIs), information technology (IT) for medication management can be used. IT for medication management refers to the combination of computerized physician order entry (CPOE) and clinical decision support systems (CDSS) [1].

CPOE allows physicians to enter prescriptions directly into a computer system instead of writing the prescriptions by hand. It provides physicians and other healthcare professionals an platform that is more accessible than the paper-based prescriptions [2]. CPOE has had one of the biggest impacts on reducing medication errors. Bates et al. reported a 55% and 83% decrease in the incidence of serious errors in 1998 and 1999, respectively [3, 4].

CPOE can be beneficial for physicians in several ways. First of all, there is a fixed structure to this system, meaning the dose, administration route, dose frequency and prescriber name should be stated when writing a prescription. Secondly, the prescriptions are legible. This is can be difficult with a paper prescription. Thirdly, relevant information about the patient can be found in the system. Finally, all prescriptions are checked for a number of problems that can arise, including allergies, drug interactions, overdose, risk factors for taking certain drugs, and whether the dose is appropriate for the patient’s liver and kidney function. This is supported by CDSS [5].

Since 2002, many medicines previously only available through prescription, became available for purchasing in pharmacies, drugstores and on the internet [6]. This change has been well regulated and was based on clear criteria from the EU directive that guides UK and EU practice [7]. This decision was based on evidence of safety studies. The problem, arising from freely purchased OTC medicines, is that those medicines are not systematically registered and are not linked to other healthcare information about the purchaser or patient. Therefore, physicians ofen do not have a complete overview of the current use of medicines by patients. This can lead to two problems. First, it is difficult to evaluate whether the purchased OTC medicine are suitable for the indication. Secondly, the safety of the use of OTC medicines alone and combined with prescribed medicines cannot be monitored [6]. This can then lead to potential ADEs and DDI’s. A study by Schiemdl et al. (2014) investigated ADEs related to OTC medicines. Out of the 6887 patients who had ADEs, of whom in 266 self-medication was involved . Of these 266, 143 ADEs were due to the use of OTC medicines. In addition, in 102 patients (38,3%) of the 266 patients with selfmedication-related ADEs, a relevant interaction was found between an OTC medicine and a prescription medicine. The most common interaction found was between aspirin (taken as an OTC medicine) and prescribed diclofenac [8].

According to Sleath et al. (2001), physicians only asked patients about their OTC medication use during 37% of encounters [9]. In addition, OTC medicines are generally considered safe and effective when used properly according to the package labeling [10]. However, some OTC medicines can be dangerous when used for too long, at a higher frequency, or combined with contraindicated medicines [11, 12]. In addition, OTC medicines are most likely to be documented in the medical record if the patient report it to the physicians. Therefore, OTC medicines may be less accurately documented in the medical record than prescribed medicines [10].

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Utilizing CPOE can help physicians identify potential interaction with prescribed medicine when documenting OTC medicine in the medical record. The system can monitor for interactions and other problems that can arise from using OTC medicines with prescribed medicine [1]. However, the amount of OTC medicines registered by physicians is still insufficient. To better instruct physicians on the documentation of OTC medication, an e-learning course and a discussion session about CPOE and the documentation of OTC medication might be able to improve the low documentation rate. Thus, the aim of this study was to determine the effect of an intensive educational intervention for physicians in an outpatient clinic on the documentation of over-the-counter medication.

To help physicians on the documentation of OTC medication, it is also necessary to look into the medical education, specifically at OTC medicines. The OTC education in the medical curriculum is not well defined. There is not an overall overview of the OTC education. Medical students do get a lesson on CPOE and CDSS. Both systems are explained through an e-learning course and through a lesson where they can practice. In addition, they learn about CPOE during their internships throughout their masters.

However, it remains unclear what the effect of this educational strategy is. Thus, this study also look into the OTC education in the medical curriculum and what medical students think about the OTC education in the medical curriculum.

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4. Method

4.1 Data collection

The dataset, used in this research, was obtained from a previous study by van Stiphout (2015). Internal medicine physicians and physicians from the cardiology, pulmonology, geriatrics, gastroenterology and rheumatology with more than 4 consultation hours per week of the University Medical Center Utrecht (UMCU) and Erasmus University Medical Center Rotterdam (EMC) were asked to participate in the study.

Patients who visited these physicians were asked to participate in the telephone questionnaire and were asked for permission to access their medical records. Patients who could not speak or understand Dutch were excluded from the study [1].

4.2 Intervention

The control group received the usual approach. This consisted of a standard instructional lesson that is currently given to physicians who participated in the study. The lecture consisted of a teacher demonstrating the main features of the IT system. The intervention group received the usual approach with an additional intensive educational intervention. The intervention consisted of an e-learning module and a small discussion session. Physicians attended the small discussion sessions to discuss about the advantages and disadvantages of IT-mediated medication management. In the e-learning course, physicians were informed about the benefits and limits of the IT-system. The training gave step- by-step instructions and information about the system. Video’s where experts explained certain aspects of the ITsystem were also provided. The training was self-directed, which meant that physicians could choose their starting level from easy to difficult. They could practice a case over and over again until they felt like going to the next level of difficulty. Documentation of OTC medication was discussed briefly in the e-learning module in the intervention group [1].

4.3 Outcome

Patients of the participated physicians were called to ask about their current use of OTC medicines. This was then compared to the medicines registered in CPOE. The outcome measure used for this study is discrepancy between registered OTC medication by physicians in CPOE and the actual use of OTC medicines by patients, obtained by the telephone questionnaire. Our focused for this research were on OTC medicines. That is why patients who did not use at least one OTC medicine were excluded from this research.

4.4 Data coding

The dataset initially contained all the medication used by patients. For this research, only OTC medicines were included. First, all other medicine that aren’t OTC medicines were excluded from the SPSS dataset.

This was done by looking at the substance names. In addition, the origin of the drugs was also examined to determine whether the medicine was an OTC medicine or not. When physicians didn’t prescribe the medicine to the patients, then it was also considered an OTC medicine. In SPSS a new variable was created with the name “is it an OTC drug?”. The OTC medicines were then coded into numbers. The answers from the questionnaire were largely typed differently for the same answer. For this, all OTC medicines were coded into the same answers and then coded into a number. Many different OTC drugs had been used. Therefore, the OTC medicines were grouped into larger groups to make the analyzing process easier.

In addition to coding the OTC medicines, the origin of the OTC medicines was also coded. First, the origin of the OTC medicines were grouped into larger groups and then coded into numbers. This was done mainly because the origins of the OTC medicines were too dispersed. Other variables that were also coded were: place of consultation, intervention status, and the age of the patients.

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The link between the medical record and the actual use of OTC medicines by patients was already coded in SPSS. There were three scenarios existed for this coding. If the physician registered the OTC medicine in the medical record and the patient indicated the use of those OTC medicines during the telephone questionnaire, it was then considered linked or no discrepancies. If the physician did register the OTC medicines in the medical record, but the patient did not take the OTC medicine, then this was seen as

“addition”. Finally, there was also “omission”. This meant that OTC medicines were taken by patients, but were not registered in the medical record.

4.5 Data analysis

The variables contained in the dataset were categorical or discrete variables. The data used for this research were nominal variables. The intervention group and control group were separate and independent of each other, which meant that the data, used in this study, was unpaired data. Thus, a chisquare test was used to compare the two groups with each other. To assess the intervention, discrepancies between the actual use of OTC medicine and the medical record of the patients were compared to each other in the two groups. In addition, the difference between the origin of the OTC medicines, between the used OTC medicines, and between the two academic hospitals were also examined. The data were analyzed using IBM SPSS Statistics for Windows, Version 28 [13].

4.6 Medical school education

For further investigation of the current medical curriculum of the Erasmus Medical Centre, Rotterdam, a survey was made (see appendix). We distributed this among medical students, who were in their final year, to assess what their thoughts were on the pharmacotherapy education, especially about OTC medicines.

The survey included nine questions and was held during the lessons on April 29^th and May 20^th 2022 (see appendix). These students had almost completed their last internship. Therefore, they had followed all lectures on pharmacotherapy education in the medical curriculum. The survey was provided at the end of the lesson so that students did not feel obliged to complete it. The survey was voluntary and was conducted anonymously using a QR-code.

The results of the survey were put into SPSS. Similar answers on open-ended questions were grouped into one overarching answer. The answers were coded into numbers.

5. Results

5.1 Characteristics of the OTC medicines 5.1.1 Origin of OTC medicines

As mentioned earlier, patients can buy OTC medicines from various pharmacies, drugstores and supermarkets. In this study, most of the patients got their OTC medicine at the drugstore. This was 953 (76.5%) out of the 1245 OTC medicines (Fig. 1).

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Fig. 1 Origin of OTC medicines

*others refers to the following things: family, doctor, dietician, homeopathic doctor, naturopathic doctor, self-made and unknown

**retail contains the following things: company, online store, supermarket and market

***combination refers to the combination of some of the components in the other categories which didn’t fall into one category

5.1.2 Types of OTC medicines

The OTC medicine groups are summarized in table 1. There were different kind of OTC medicines used by patients, which did not all have a known mechanism of action. Thus, the OTC medicines were grouped into mechanism of action or target location. Painkillers included NSAID’s, paracetamol and other kind of painkillers. The most used OTC medicine group were the painkillers with 639 (51.3%) and vitamins 338 (27.1%) out of the 1245 OTC medicines. Out of the 639 painkillers, 550 (44.2%) were paracetamol and 51 (4.1%) were NSAID’s. Out of the 70 OTC medicines with no discrepancy, 57 (81.4%) of them were paracetamol and 7 (10%) were vitamins.

Table 1 OTC medicines grouped into mechanism of action or target location

OTC groups Discrepancy No discrepancy Total

Painkillers 570 60 639

Vitamins 331 7 338

GI-tract 37 2 39

Others 93 1 94

Nutritional supplements

83 0 83

Respiratory tract 25 0 25

Herbal supplements 36 0 36

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Total 1175 70 1245 5.2.1 Discrepancies

The main outcome of this research was the discrepancy between OTC medicine registered in the medical record by a physician and the actual use of OTC medicines by patients, obtained via a telephone questionnaire. If the medical record did not match with the actual use of OTC medicines by patients, then this was defined as “discrepancy”. On the contrary, if the medical record and the actual use of OTC medicines did match, then it was defined as “no discrepancy”. The total amount of “no discrepancy”

found in the intervention group and control group was 70. Out of the 70 no-discrepancies, 41 (58.6%) of them were in the intervention group and 29 (41.4%) of them were in the control group. There was no statistically significant difference found between the two groups (p = 0.51) (Fig. 2).

Fig. 2 Discrepancies in OTC medicines among the intervention group and control group

5.2.2 Type of discrepancies

The two scenarios that could occur when there was a discrepancy, were addition and omission. Addition meant that the OTC medicine was registered in the medical record, but the patient didn’t use the OTC medicine. Omission was the opposite of addition, which meant that the patient took the OTC medicine, but it wasn’t registered in the medical record. The total amount of omission versus addition found was 1172 (99.7%) versus 3 (0.3%). There were 2 additions found in the control group and 1 addition found in the intervention group. The amount of omission in the control group was 536 (45.7%) and 636 (54.3%) in the intervention group (Fig. 3).

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538

637

29 41

0 100 200 300 400 500 600 700

Control group Intervention group

OTC medicines

Discrepancy No discrepancy

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5.3 Patients demographic and characteristics

The patient characteristics and demographics are summarized in table 2. The intervention group and the control group were similar. Rotterdam had a larger intervention group than Utrecht (53.4% vs 42.3%, P

<0.05). There were 775 patients included from the 1094 patients in this study. The amount of OTC medicines found in the dataset was 1245 OTC medicines. There was a total of 567 OTC medicines registered in the control group and 678 OTC medicines registered in the intervention group.

Table 2 Patients demographics and characteristics

Variable

Intervention group [N = 365]

Control group

[N = 410 ] P-value

Patient characteristics Male sex, n [%]

169 [46.3] 191 [46.6] 0.57

Female sex, n [%] 196 [53.7] 219 [53.4] 0.57

Age, mean years ±SD 55.3 [±16.9] 54.2 [±16.3] 0.87

Age category, n [%] 0.26

0-40 years 80 [47.3] 89 [52.7] -

41-60 years 128 [45.2] 155 [54.8] -

61-80 years 133 [46.7] 152 [53.3] -

≥81 years 21 [63.6] 12 [36.4] -

Consultation site, n [%] 0.002

Rotterdam 179 [53.4] 156 [46.6] -

Utrecht 186 [42.3] 254 [57.7] -

5.4 Questionnaire

The questionnaire was made to evaluate the view of medical students on OTC medicine education during their master’s program. The questions can be found in the appendix. Out of the 46 students, 27 students (65.5%) have completed the whole questionnaire and 5 students have done it partly. The answers of each question are grouped and will be briefly described in the following paragraphs.

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536

636

2 1

0 100 200 300 400 500 600 700

Control group Intervention group

OTC medicines

Omission Addition Fig. 3 Types of discrepancies

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5.4.1 Attention paid to OTC medicines and DDIs

Out of the 27 students, 18 students (66.7%) felt that there wasn’t enough attention paid to OTC medicines during the classes in the master’s program (Fig. 4). They said that they did not hear much of it during the lessons or it does not fall into the category “prescribing medicines”, which the curriculum paid more attention to. On the other side, 7 students (25.9%) who thought there was enough attention paid, said that the attention was particularly paid during the pharmacy final exam.

Students were asked about whether there was enough attention paid to DDIs with OTC medicines during their master’s program. Opinions among students were divided evenly with 13 students (48.1%) believing there was enough attention paid to DDIs and 13 (48.1%) students believing that there was not (Fig. 4). Students, who thought that there was enough attention paid, said that it was paid during the pharmacy final exam and most of the relevant interactions were mentioned during the lectures.

5.4.2 Knowledge on OTC medicines and DDIs

Students were also asked about what their thoughts were on their own knowledge on OTC medicines.

Out of the 27 students, 14 students (51.9%) believed that their knowledge on OTC medicines was not enough (Fig. 4). They said that they do not know all the interactions or only the relevant ones. On the other side, 10 of the students believed that they know enough about OTC medicines. Some of them said that they learned it during the lessons or internship, looked it up in articles, and searched it on the website “Farmacotherapeutisch kompas” [14].

Fig. 4 Attention paid to and knowledge on OTC medicines and DDI

5.4.3 Responsibility of asking about the use of OTC medicines

Students were ask about the responsibility of asking about the use of OTC medicines by physicians. Out of 27 students, 19 (70.4%) felt like this was the responsibility of the physician. They said that it is important to get an overview of all the medicines used by patients, but that patients are also responsible for notifying the physicians about it. There were 7 students (25.9%) who did not think it was always necessary for physicians to ask about the use of OTC medicines (Fig. 5). According to them, the pharmacist is also responsible and it is not always relevant for each disease.

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7

13

10 9

18

13 14 14

2 1

3 4

0 2 4 6 8 10 12 14 16 18 20

Attention for OTC meds

Attention for DDIs Knowledge on OTC meds

Knowledge on DDIs

Students

Yes No Don't know

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5.4.4 Responsibility of documenting the use of OTC medicines

Whether physicians had the responsibility to document OTC medicines was also asked in the questionnaire. Out of the 27 students, 16 students (59.3%) answering “yes”, 9 students (33.3%) answering “sometimes”, 1 student (3.7%) answering “no”, and 1 student (3.7%) answering ”I don’t know”

(Fig. 5). Most of the students answering “yes”, said that it was the task of the physician to document the use of OTC medicines if the OTC medicines came up for discussion during the consultation or to get a better overview of what a patient is using, because of the electronic prescribing system that can monitor for interactions. Students who answered with “sometimes”, said that it is not always relevant or there is not always time for it. The student, who answered “no”, did not give any explanation.

Fig. 5 The job of the physicians to ask about the use and documenting OTC medicines

5.4.5 Usefulness of doing an e-learning course

The last question about the usefulness of participating in an e-learning course about OTC medicines and DDIs that can occur with OTC medicines, was predominantly answered with a “yes”. Out of the 27 students,

25 students (92.6%) found it useful and 2 students (7.4%) did not (Fig.6). The students, who answered

“yes”, found it useful and helpful, with 1 student finding an e-learning course not the best way to learn more about OTC medicine. The 2 students, who answered “no”, did not give any explanation.

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19

16

7

9

1 1

0 1

0 2 4 6 8 10 12 14 16 18 20

Physician's job to ask about OTC meds Physician's job te document OTC meds

Students

Yes Sometimes No Don't know

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30

25 25

20 15

10

5

0

Usefull to do a e-learning about OTC meds and DDIs Yes No

Fig. 6 Usefulness of participating in an e-learning course

6. Discussion

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As mentioned before, there are more and more medicines available for purchasing at different stores, pharmacies and even on the internet. This makes it difficult for physicians and other health professionals to find out which OTC medicines patients are taking, because OTC medicines are not systematically registered in the medical record [6]. In addition, some OTC medicines can have interactions with prescribed medicines, potentially causing adverse drug events. To avoid this, it is important that physicians ask about the use of OTC medicines during a consultation and also document them correctly in the medical record.

There are still too little OTC medicines documented in the medical record. Possibly, physicians are not properly trained in the documentation of OTC medicines. An e-learning course and a discussion meeting on the use of CPOE and on the documentation of OTC medicines could possibly improve the documentation of OTC medication. Therefore, the purpose of this research was to examine the effect of an intensive educational intervention on the documentation of OTC medicines by physicians in outpatient clinics.

The primary outcome of this research was the discrepancy of OTC medicines in medical records of physicians who did and did not follow the educational intervention. Of the 1245 OTC medicines in our dataset, only 70 (5.6%) were coupled in this study. This was not a lot. There was no statistically significant difference found between the intervention group (6.0 % vs. 94%) and the control group (5.1% vs 94.9%) in the documentation of OTC medicines (p = 0.51) The P-value exceeded 0.05 (Fig. 1).

There were more omissions than additions. Meaning it was more likely that patients were taking OTC medicines, but the physicians did not document those in the medical record rather than the opposite.

NSAIDs are one of the relevant medicines which can have interactions with prescribed medicines. The amount of NSAID with no discrepancy was two and the amount of NSAID with discrepancy was 49, which meant that NSAIDs are not registered a lot in the medical record by physicians.

Not many studies have been done on the documentation of OTC medicines by physicians. The study by Oborne et al. (2005), like this study, found a low documentation rate of OTC medicines by physicians. Out of the 268 OTC medicines, only 13 (4.9%) were found in the medication history before hospitalization.

During hospitalization, 26 (9.7%) OTC medicines were used, but only 8 (31%) were documented in the medical record [15]. This is comparable to our study because they were also looking at the documentation rate of physicians.

In contrast to our study, Jaski et al. (2000) found that 68% of physicians reported documenting OTC medicines during a consultation. In addition, 99.8% of the physicians reported reviewing prescription medicines before prescribing a new prescription, but only 86% of them reviewed OTC medicines before prescribing a new prescription [16].

Another study, mentioned before, by Kokaly et al. (2020) found that in 30% of the patients, who visited the nephrology department, an incorrectly documented OTC medicine was found in their medical record afer medication reconciliation. Thus, there was no discrepancy found among 70% of the patients about the actual use of OTC medication and what was documented in the medical record [10]. This percentage, like the study by Jaski et al. (2000), was much higher than the 5.6% found in our study.

In contrast to the study by Jaski et al. (2000) and Kokaly et al. (2020), our study found a much lower rate (5.6%) of documenting OTC medicines by physicians in outpatient clinics. This may be due to several reasons. First of all, the intensive educational intervention, consisting of an e-learning course and a small discussion session, was not solely focused on documenting OTC medicines. The documentation of OTC medicines was only a part of the intervention. Secondly, the percentage of the documentation rate of 14

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OTC medicines seemed high, but the response rate in the study by Jaski et al. was low. The results they found were probably an overestimation of the actual extent of documentation of OTC medicines. Thirdly, the documentation rate relied on self-report of the physicians. This may be biased. Finally, the studies by Jaski et al. (2000) and Kokaly et al. (2020) were American studies. Education for documenting OTC medicines may be different in the United States compared to the Netherlands.

The documentation rate of OTC medicines was very low (5.6%) in this study in the two outpatient clinics in the Netherlands. This shows that not enough OTC medicines are documented by physicians. More research should be done on this since there was no difference found in the documentation of OTC medicine afer implementing the intensive educational intervention. Better documentation of OTC medicines might reduce ADEs and DDIs. However, not all OTC medicines have interactions with prescribed medicines. Most of the common interactions of OTC medicines with prescribed medicines are between NSAID’s and ARB’s or NSAIDs with ACE inhibitors. In addition, co-administering NSAIDs with (Selective Serotonin Reuptake Inhibitors (SSRIs) or antithrombotic can cause higher risk of gastro- intestinal bleeding [17]. Another interaction that is commonly known is the interaction with St. John’s wort. When combined with SSRIs, serotonin syndrome might occur. St. John’s wort is also a CYP3A4- and a P-glycoprotein inductor, which means that medicines metabolized through these routes may have an increase in concentration when co-administered with St. John’s wort [18]. Thus, documenting OTC medicines in the medical record might not always be relevant if no interaction will occur.

Another aspect about the documentation of OTC medicines is that it might be questionable whether it is the job of the physician to document OTC medicines. Physicians tend to not have a lot of time during a consultation. Would it not be better to delegate this task to the pharmacy? The questionnaire showed that most of the medical students felt like it was the job of the physician to document OTC medicines , but some of them also felt that the pharmacy had a responsibility in documenting OTC medicines.

Furthermore, patients are also responsible for reporting the use of OTC medicines to physicians.

It might be beneficial if it is not only the job of the physician to document OTC medicines. The pharmacy could certainly help with this. However, it has to be done together since the physician does not prescribe medicines at every consultation. Patients also have the responsibility to self-report the use of OTC medicines. This does not happen a lot. The study Dieringer et al. (2011) showed that out of the 771 respondents, only 7% of them responded using OTC medicines [17]. Patients need to be made aware that some OTC medicines can cause ADE’s and even DDI’s with some prescribed medicines. They need to be aware that it is important that the consulted physician should be informed about the use of OTC medicines.

If we look at the medical education, there was not enough attention paid to OTC medicines during the master program, according to last year medical students. This was felt by 66.7% of the students. For both the knowledge on OTC medicines and DDIs, there were the same amount of students (51.9%) who felt that they did not have enough knowledge about these two topics. Furthermore, the majority of the students 70.4% and 59.3% felt that physicians had the job to ask about the use of OTC medicines and had the job to document them in the medical record, respectively. Lastly, there were 92.6% of the students who felt that taking an e-learning course was helpful to learn more about OTC medicines and possible DDIs that can occur with prescription medicines.

There are a number of limitations tied to this study. First of all, it was not entirely known to what extent the documentation of OTC medicines was addressed in the intensive educational intervention. In the elearning course, documenting OTC medicines was not discussed elaborately. There were two small modules that dealt with that. It was mostly about the CPOE itself and where information about the patient could be found in the system. In addition, it was not known to what extent the discussion 15

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sessions were about documenting OTC medicines either. Thus, the focus of the intervention was not entirely on documenting OTC medicines. This could have meant that the effect of the intervention could have been increased if the intervention was focused on the documentation of OTC medicine.

Secondly, it was sometimes not clear whether a medicine was an OTC medicine or not. This may have caused more or less OTC medicines to be included in this study. For example, paracetamol was dosed as 1000mg, but it was unknown where the patient had bought it from. Other paracetamol, also dosed 1000 mg , were bought from the drugstore. It was thus assumed that if paracetamol 1000 mg was used by patients and the origin was unknown, it was considered an OTC medicine. This could have biased the results.

Thirdly, there was a possibility that patients did not mention every OTC medicines used during the telephone questionnaire. The information about the actual use of OTC medicines is subjective. The study van Stiphout et al. (2015) did mention that they had an early version of the questionnaire which they validated with the medication history of patients during home visits. Subsequently, improvements were then made to the questionnaire [1]. However, it is possible that patients did not mention every OTC medicine used during that time.

Lastly, there was a possibility of information bias. The physicians were not blinded to the intervention.

Thus, the physicians who received the intervention knew they were in the intervention group. This could have caused them to possibly pay closer attention when asking about the use of OTC medication and document them in the medical record. The patients, however, were blinded to the intervention status of the physician they visited.

The strength of this study are: (1) confounding bias was unlikely to occur in this study. Physicians were randomized into two study arms evenly. (2) the documentation rate of OTC medication of this study was based on the link between the medical record and the telephone questionnaire rather than physicians who self-report the percentage of OTC documentation rate. (3) the source of data came from a previous study done by van Stiphout et al. (2015) where they had quite a high response rate of the patients.

As mentioned earlier, there have not been many studies on interventions that would improve the documentation of OTC medicines by physicians. The intervention used in this study was not completely focused on documenting OTC medicines. It may be beneficial to create an intervention that mostly focuses on this aspect. This may provide a better view of the effect of the intervention on the outcome measure than what was done in this study.

In addition, future research should look at the difference in the documentation rate of OTC medicines between older, more experienced physicians, versus the younger, newly graduated physicians. If the documentation rate in the younger generation is higher or lower than the older generation, then we could look at the differences in the two groups and find possible explanations why the younger generation does it better than the older generation or vice versa. Furthermore, research should look into master of medicine students, who are in their final year and who are allowed to prescribe medicines during their internships, whether they do a better job at documenting OTC medicines during a consultation. Ultimately, we train medical students through education focused on OTC medication, on common DDIs with OTC medication and on documenting these.

Conclusion

The intensive educational intervention did not have an effect on the documentation rate of OTC medicines by physicians. No difference was found between the intervention group and the control group on the documentation of OTC medicines. Overall, the documentation of OTC medication was low. If OTC 16

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medication was documented, it was mainly paracetamol. Future practice could be improved by implementing an intervention where the focus should be on the documentation of OTC medicines.

7. Reference

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1. van Stiphout, F., et al., MEDUCATE trial: effectiveness of an intensive EDUCATional intervention for IT-mediated MEDication management in the outpatient clinic - study protocol for a cluster randomized controlled trial. Trials, 2015. 16: p. 223.

2. Kuperman, G.J. and R.F. Gibson, Computer physician order entry: benefits, costs, and issues. Ann Intern Med, 2003. 139(1): p. 31-9.

3. Bates, D.W., et al., Effect of computerized physician order entry and a team intervention on prevention of serious medication errors. JAMA, 1998. 280(15): p. 1311-6.

4. Bates, D.W., et al., The impact of computerized physician order entry on medication error prevention. J Am Med Inform Assoc, 1999. 6(4): p. 313-21.

5. Bates, D.W., Using information technology to reduce rates of medication errors in hospitals. BMJ, 2000. 320(7237): p. 788-91.

6. Bond, C. and P. Hannaford, Issues related to monitoring the safety of over-the-counter (OTC) medicines. Drug Saf, 2003. 26(15): p. 1065-74.

7. Potts, M. and C. Denny, Safety implications of transferring the oral contraceptive from prescription-only to over-the-counter status. Drug Saf, 1995. 13(6): p. 333-7.

8. Schmiedl, S., et al., Self-medication with over-the-counter and prescribed drugs causing adversedrug-reaction-related hospital admissions: results of a prospective, long-term multi- centre study. Drug Saf, 2014. 37(4): p. 225-35.

9. Sleath, B., et al., Physician-patient communication about over-the-counter medications. Soc Sci Med, 2001. 53(3): p. 357-69.

10. Kokaly, A.N., et al., Identification of undocumented over-the-counter medications in an academic nephrology clinic. J Am Pharm Assoc (2003), 2020. 60(6): p. e236-e245.

11. Soller, R.W., Evolution of self-care with over-the-counter medications. Clin Ther, 1998. 20 Suppl C:

p. C134-40.

12. Catlin, J.R. and E.P. Brass, The Effectiveness of Nonprescription Drug Labels in the United States:

Insights from Recent Research and Opportunities for the Future. Pharmacy (Basel), 2018. 6(4).

13. IBM SPSS Statistics for Windows, Version 28.0. Armonk, NY: IBM Corp. Released 2021.

14. Nederland, Z. Farmacotherapeutisch Kompas. Available from:

https://www.farmacotherapeutischkompas.nl/ .

15. Oborne, C.A. and M.L. Luzac, Over-the-counter medicine use prior to and during hospitalization.

Ann Pharmacother, 2005. 39(2): p. 268-73.

16. Jaski, M.E., et al., Medication review and documentation in physician office practice. Eff Clin Pract, 2000. 3(1): p. 31-4.

17. Moore, N., C. Pollack, and P. Butkerait, Adverse drug reactions and drug-drug interactions with over-the-counter NSAIDs. Ther Clin Risk Manag, 2015. 11: p. 1061-75.

18. Mannel, M., Drug interactions with St John's wort : mechanisms and clinical implications. Drug Saf, 2004. 27(11): p. 773-97.

8. Appendix

Enquête

Deze enquête is bedoeld om meer inzicht te krijgen in jullie beleving van het farmacotherapie onderwijs in de master geneeskunde, met name als het gaat om Over The Counter (OTC) medicijnen. Deelname

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aan deze enquête is geheel vrijwillig. De enquête wordt anoniem afgenomen en met de ingevulde antwoorden wordt vertrouwelijk omgegaan.

1. Vind je dat er genoeg aandacht wordt besteed aan OTC medicijnen tijdens de lessen in de master? o Ja

o Nee, want _____________________________________________________ o Ik weet het niet 2. Vind je dat er genoeg aandacht wordt besteed aan mogelijke geneesmiddel-geneesmiddel interacties

met OTC medicijnen tijdens de lessen in de master?

o Ja

o Nee, want _____________________________________________________ o Ik weet het niet 3. Bij welke lessen kwamen OTC medicijnen en geneesmiddel-geneesmiddel interacties aan bod?

4. Vind je dat je genoeg kennis hebt over OTC medicijnen? (Zo ja, waar heb je deze kennis vandaan gehaald?) o Ja, _______________________________________________________________ o Nee

o Weet ik niet

5. Vind je dat je genoeg kennis hebt over geneesmiddel-geneesmiddel interacties met OTC medicijnen?

(Zo ja, waar heb je deze kennis vandaan gehaald?) o Ja,

_______________________________________________________________ o Nee o Weet ik niet

6. Vind je dat het de taak is van de arts om het gebruik van OTC medicijnen uit te vragen tijdens een consult?

o Ja o Soms, want ____________________________________________________________ o Nee, want _____________________________________________________________ o Ik weet het niet

7. Welke OTC medicijnen/OTC geneesmiddelgroepen zou jij als huisarts willen uitvragen tijdens een consult? (ongeacht de situatie)

8. Vind je dat het de taak is van de arts om OTC medicijnen in het patiëntendossier te noteren tijdens een consult?

o Ja

o Soms, want ____________________________________________________________ o Nee, want _____________________________________________________________ o Ik weet het niet

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9. Vind je het waardevol/nuttig om een e-learning module te maken over OTC medicijnen en mogelijke geneesmiddel-geneesmiddel interacties die kunnen ontstaan met OTC-middelen?

o Ja

o Nee, want _______________________________________________________________

Translation

1. Do you think enough attention is paid to OTC medicine during the classes in the master's?

2. Do you think enough attention is paid to possible drug-drug interactions with OTC medications during the classes in the master's?

3. Which classes covered OTC medications and drug-drug interactions?

4. Do you feel that you have enough knowledge about OTC medications? (If so, where did you get this knowledge from?)

5. Do you feel you have enough knowledge about drug-drug interactions with OTC drugs? (If so, where did you get this knowledge?)

6. Do you think it is the physician's job to ask about the use of OTC medications during a consultation?

7. Which OTC medications/OTC medication groups would you, as a family physician, want to ask about during a consultation? (regardless of the situation)

8. Do you think it is the physician's job to document OTC medications in the patient record during a consultation?

9. Do you find it valuable/useful to create an e-learning module about OTC drugs and possible drug-drug interactions that can occur with OTC drugs?

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THE EFFECT OF AN INTENSIVE EDUCATIONAL INTERVENTION ON THE DOCUMENTATION OF OTC MEDICATION BY PHYSICIANS IN OUTPATIENT CLINICS

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