Evaluation of user’s perspective on readability and understanding of medicine package inserts

Momin, Sarosh; Shaikh, Noor; Jadhav, Pallavi; Sajith, Manjusha; Pawar, Atmaram

doi:10.18203/2394-6040.ijcmph20232363

Original Research Article

DOI: https://dx.doi.org/10.18203/2394-6040.ijcmph20232363

Evaluation of user’s perspective on readability and understanding of medicine package inserts

Sarosh Momin, Noor Shaikh*, Pallavi Jadhav, Manjusha Sajith, Atmaram Pawar

Department of Clinical Pharmacy, Poona College of Pharmacy, Pune, Maharashtra, India

Received: 04 January 2023

Revised: 25 June 2023

Accepted: 30 June 2023

*Correspondence:

Dr. Noor Shaikh,

E-mail: shaikhnoor80@yahoo.com

Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

ABSTRACT

Background: Aim of this study was to evaluate the user’s perspective on readability and understanding of Medicine package inserts (MPIs).

Methods: A cross-sectional study was conducted in the community pharmacy settings, encompassing participants from urban and rural areas of Pune, Mumbai, and Thane districts. The user’s ability to read and understand was assessed using a 3-point Likert scale and was correlated to their socio-demographic characteristics using Pearson’s coefficient. Also, the difference in the means between the groups was analysed using the student’s test. A p-value ≤0.05 was considered statistically significant.

Results: Out of 502 respondents, most of the participants had the habit of reading MPI (51.3%). Although, on correlating the level of difficulty to the participant's socio-demographic characteristics, a little difficulty in reading (57.8%) and understanding (60%) of instructions respectively were reported in participants of the age group: 38-57 years (57%; 60%), who were graduate (70.2%; 69.8%), and was significantly associated to their area of residence (p<0.5). Addressing the language barrier and providing MPI in their native language increased participants’ readability by a whopping 57%, who earlier stated ‘difficulty to read (70.49%)’ as the major factor to not refer MPIs.

Conclusions: More than half the respondents (51.4%) usually read the MPI. Nonetheless, people stated that they faced difficulty in reading and understanding it. Diversifying this data by age and level of education can help policymakers ensure a user-directed upgrade of the package inserts and implement patient education in the users’ native language by healthcare providers such as pharmacists.

Keywords: Barriers, Misinterpretation, MPI, Readability, User centred approach

INTRODUCTION

Package inserts are usually the first printed source of information for the user. European Medical Agency, National Agency for Food and Drugs (NAFDAC) and the United States Food and Drug Administration have published detailed rules and guidelines, stating the requirements and format of labelling for human prescription and biological products.^1-3

A medication package inserts (MPI) primary goal is to encourage proper medication usage and prevent medication errors. Also, it should be free from any misleading or diverting promotions, and be in a form that the patient will understand to prevent adverse drug reactions or irrational use of drugs. Many of the studies indicated that more than half of the patients (63%) misunderstand one or more drug-related instructions which leads to hospitalisation (12%).⁴ Thus, medicine package inserts can prove to be an essential tool in preventing such health hazards by providing crucial drug-related information.

In India, the structure of PIs is regulated by the Drugs and Cosmetics Act (1940) and Rules (1945), Schedule D (II) sections 6.2 and 6.3, mandating the package inserts to be printed in ‘English’.⁴ However, due to illiteracy, most of the patients do not refer them and subsequent studies have shown that even physicians do not discuss some aspects of drug therapy with their patients. About 25-30% don’t receive counselling from pharmacists, while 47% do not receive any verbal or pictorial information about the drug or its use.^2,5 There exists a paucity of studies from Eastern countries that focus on patient centred approach, rather than merely evaluating the quality of package insets. Through our study, we aim to not only identify the challenges faced by users but also conduct interventions to discover the crux of the problem causing it. We aspire to publish our findings in an international community-based journal, to draw attention to problems faced by medication users from developing countries.

METHODS

The cross-sectional study included participants from Pune, Mumbai and Thane districts. The study was carried out for a duration of 6 months; from October 2020 to March 2021. The participants who were included in our study were of 18 years of age or older, provided their consent and used medicines dispensed with secondary packaging.

A pilot study involving 50 participants was conducted to generate feedback on problems to be addressed using the questionnaire. Electronic informed consent was obtained for each participant once they were informed about the study's purpose, process, and benefits. The use of MPI was evaluated using a bipartite questionnaire, where the participants were asked if they used MPI; and, if not, what the reasons were for the same. Participants who replied affirmatively on MPI usage were then asked whether they found the package inserts necessary, and if yes, then to state the reasons for it. The respondents were then evaluated regarding their difficulties in reading and understanding the MPI using a 3-point Likert scale (very difficult, little difficult, not difficult). A few participants who found the language barrier to be a major cause were provided with instructions translated to their native language, printed in the same font size as the original (to avoid bias), and were asked if it reduced their level of difficulty in interpreting the instructions or not.

The data were then tabulated, indicating the frequency of each type of response, and presented in tables and charts. Pearson’s χ² test was used to compare proportions between participants’ socio-demographic characteristics such as age, gender, level of education, area of residence, etc, and the level of difficulty in reading and understanding instruction printed on MPIs. The continuous variables were presented as mean±SD (standard deviation), and the difference in the means between the groups was analyzed using the student’s “t” test. The qualitative variables were presented as numbers and percentages. The statistical analysis was done using SPSS statistical software version 20. The p value of <0.05 was considered significant.

RESULTS

Total 514 responses were collected, of which 502 met the inclusion criteria. Among the 502 participants, more than half of the respondents were females 269 (53.59%), and were significantly higher (p<0.001) in the age group of 38-57 years of age (57.97%). 25.29% of respondents had primary education or lower, proving to be a statistically significant parameter in participants’ readability and understanding of printed instructions. The majority of users were employed (42.03%) and residing in the urban area (57%). An outline of socio-demographic data has been presented in Table 1.

Table reproduced from source PDF page 2, part 1 of 2 — **Table 1: Socio-demographic details of the respondents.**

Table reproduced from source PDF page 3, part 2 of 2 — **Table 1: Socio-demographic details of the respondents.**

The majority of the participants suffered from diseases like diabetes (27.5%), hypertension (23%), and respiratory disorders/diseases (10.5%) along with other diseases as depicted in Figure 1. Figure 2 illustrates the use of medicine package inserts, which was highly observed for tablets (25.7%), aerosol (20%) and droplet preparations (9.5%).

Figure 1: Participant’s medical condition. | 27% 23% 11% 39% Diabetes Hypertension Respirtory diseases Other medical conditions — **Figure 1: Participant’s medical condition.**

Figure 2: Use of medicine package inserts. | 27% 21% 10% 42% Tablets Aerosol Droplet Other — **Figure 2: Use of medicine package inserts.**

Out of 502 participants, 258 (51.4%) stated that they had the habit of reading medicine package inserts dispensed with their medication and found them necessary (Figure 3). Of the 244 (48.6 %) who did not refer to package inserts, most of them found it difficult to read (70.5%), among other reasons listed below under Figure 4.

Figure 3: Reasons for considering medicine package inserts necessary (n=258). | 167 162 153 152 27 0 50 100 150 200 Shows indication of medicine Gives information on dosage and administration of medicine Shows composition of the medicine Shows general information on medicine Other reasons No.ofresponses — **Figure 3: Reasons for considering medicine package inserts necessary (n=258).**

Figure 4: Reasons for not reading MPI. | 172 136 83 77 0 50 100 150 200 They are difficult to read They are too long Don’t use medicine They are too confusing No.ofresponses — **Figure 4: Reasons for not reading MPI.**

The extent of readability and understanding of the user was assessed using a three-pointer scale which evaluated the level of difficulty faced by them. While evaluating the readability of package inserts by the participants, it was found that almost half of them found it a little difficult (48.21%), which was highly observed in participants within the age group 38-57 years, males, who were graduate, employed and residing in the urban area. A similar observation was seen in understanding medicine package inserts (40.84%), where participants could not understand medication package inserts. The participants found that readability and understanding were found to be significantly little difficult, than high or no difficulty (p<0.001) (Figure 5 and Figure 6 respectively).

Figure 5: Difficulty in readability of MPI. | 241 199 62 0 50 100 150 200 250 Little difficult Very difficult Not difficult No.ofresponses Level of difficulty — **Figure 5: Difficulty in readability of MPI.**

Figure 6: Difficulty in understanding of MPI. | 204 194 104 0 50 100 150 200 250 Little difficult Very difficult Not difficult No.ofresponses Level of difficulty — **Figure 6: Difficulty in understanding of MPI.**

Table reproduced from source PDF page 4 — **Table 2: Difficulty in readability characterised by socio-demographic details of participants.**

Table reproduced from source PDF page 4, part 1 of 2 — **Table 3: Difficulty in understanding characterised by socio-demographic details of participants.**

Table reproduced from source PDF page 5, part 2 of 2 — **Table 3: Difficulty in understanding characterised by socio-demographic details of participants.**

Upon co-relating socio-demographic characteristics of participants with readability (Table 2) and understanding (Table 3), it was observed that people with lower educational levels and residing in rural areas had more difficulty in reading and understanding medication package inserts.

DISCUSSION

To avoid serious adverse events due to misinterpretation and to aid the correct interpretation of MPIs, developed countries have reduced their complexity by the inclusion of pictograms, complemented with verbal instructions.^6,7 In developed countries, medicine package inserts are majorly referred to and understood by the well-literate population. However, in developing countries like India, we did not see much awareness about medication package inserts and their use. Most studies in India have shown that about 6.3% of medicine package inserts show information about adverse drug reactions.⁸ The patient-to-doctor ratio in India is 1:1700 which is lesser than the recommended fraction of 1:1000, and thus instances occur where doctors are unable to provide complete information about the therapy. Also, studies carried out in India only focus on the completeness or quality of information provided, by use of the Flesch reading ease (FRE) score and internationally accepted Baker Able leaflet design (BALD) criterion.⁹ It is equally important to apply the user-centred approach to bridge the gap leading to incompliance.

Our study aimed at the people in urban and rural areas, concerning their socio-demographic characteristics being a barrier faced while referring to the medicine package inserts. Educational background plays an important role in understanding information, and therefore our prime objective was to identify all the barriers and difficulties faced by users. The majority of respondents in our study were under the age group of 38-57 years of age (58%), with 36% undergraduate and 42% employed. The age group of 38-57 show a significant difference between the rest of the groups in reading and understanding medication package inserts. The age group mostly consisted of educated, employed and participants from urban areas. Even though coming from an educational background, the participants could not understand the medicine package inserts completely. This is mainly due to the complex nature of medicine package inserts, with small font size, and too confusing. Thus, the respective regulatory bodies can consider the factors mentioned above to make package inserts more readable and thus be understood by every age group to improve patient compliance.

The study conducted in developing countries shows a lack of awareness of medication package inserts and their understanding of patients was not satisfactory. Our study assessed that a total of 167 respondents considered medication packages insert necessary as they can show indication for the prescribed drug. On the other, 172 participants stated that the medication package inserts are difficult to read and understand. This shows that the general population taken in our study rely on medication labels but faced some complications in understanding them. European Commission has proposed guidelines on the readability of medicine package inserts and considered factors like the type of font and font size to improve the patients' readability.¹⁰ For instance, a study conducted in Iran shows that 70% of the medicine package inserts are difficult to read.¹¹

The study contains a total of 21% of the participants who only had primary education, whereas 48.21% of participants found medication package inserts a little difficult to understand. Although, Fuchs et al in their study, state that educational level wasn’t associated with participant’s degree of understanding.¹² In developing countries, users tend to understand better with pictograms, verbal communications and one-to-one interaction, where there is a scarcity of independent sources of medical information. The study conducted in Sudan shows that package inserts from developed countries tend to contain more information when compared to package inserts from developing countries.¹³ A study from Brazil by Pizzo et al observed that 60% of participants read the medicine package inserts which is similar to our finding states as 51.4% and nearby to the study conducted in Portugal by A. cavaco which was 53%.^6,14 This indicates that developing countries have a lower rate of readability and comprehensibility towards medication labels.

Our study also found that a total of 258 participants (51.4%) refer to medication package inserts, out of which 167 say they prefer it for indication and 162 refer it for understanding dosage and administration of the medicine. This is significantly lower compared to a study from Belgium where 71% read it for all medications, supporting the hypothesis indicating restricted use of PIs in developing countries.¹⁵

The findings from “Analysis of package inserts orally administered in Indian Market” concluded that 95% of medicine package insert contains contraindication and side effects, which contradicts the patient perspective as they state that only 59% show general medicine information.¹⁶ This difference and gap in opinion can be ascribed to a lack of understanding of medicine package inserts which can be improved in the future. The factors associated with lack of understanding were mainly stated as, too long to read by 136 participants and difficult to read by many 172 participants.

Most of the users are in the criteria of not reading the medication package inserts because they found the MPI difficult to read (70%); The study from Brazil, observed that 57% found it difficult to read and 54% found it difficult to understand under another study from Brazil.¹⁴ A similar finding was observed when the doctor’s perspective was taken on their patient’s level of comprehensibility where they claimed that about 61.5% did not understand the instructions.¹³ In comparison to our study, the finding claimed a much higher level of difficulty in readability (88%) and understanding (79%). Again, this can be linked to the socio-demographic factors of education and employment status or the lack of literacy, awareness, and complexity of the medicine package inserts.

A study by Gibbs et al, concluded that verbal advice complemented with package inserts leaflet greatly enhanced the knowledge level of the patient up to 67% for understanding its uses and side effects of the medication, compared to 40% of patients at entry-level.¹⁷ But in India, verbal advice is preferred when compared to medication package inserts. This results in imparting half the information and can result in medication errors. Thus, implementing a proper strategy can change this scenario where the patient will get up-to-date information along with understanding the given instructions.

During our study, we also addressed the language barriers as a probable cause for users being unable to read and understand information. Our hypothesis was confirmed when 68% of participants stated that with the provision of package inserts in regional language, their ease to interpret somewhat increased. Although there no measures or steps are taken for medicine package inserts in India concerning a pharmacovigilant approach to assist in readability and improve leaflets, decreasing the incorrect use of medication.¹⁸ Implementing such a system will improve the quality of information of medicine package inserts, and change the complex nature of medicine package insert into a simple format that will be easy to read and understand by the general population.

CONCLUSION

The study concluded that medicine package inserts were mostly used by participants who were literate and employed. A larger portion of the users from Pune, Mumbai and Thane usually read the medicine package inserts. Nonetheless, people stated that they have difficulty reading and understanding it, especially those of a lower educational level and residing in rural areas. The majority of the problems encountered were the font size, length of package inserts and complexity of reading the labels and medicine package inserts.

It is important to address the above factors and also the difficulties arising due to the language barrier.

Hence there is a need for change in designing the medication package inserts and medication labels by the respective bodies where users’ perspectives should be considered according to their needs. By focusing on the patient’s perspective and not just the qualitative analysis, problems such as patient compliance could be addressed and adverse events or medication errors could be avoided. Our findings can be useful for manufacturers and drug regulatory agencies to produce more readable and understandable medicine package inserts.

Funding: No funding sources

Conflict of interest: None declared

Ethical approval: The study was approved by the Institutional Ethics Committee of Bharati Hospital and Research Centre, Pune (REF: BVDUMC/IEC/98)

REFERENCES

1. Pires C, Vigário M, Cavaco A. Factors influencing subjects’ comprehension of a set of medicine package inserts. Inter J Clin Pharm. 2016;38:888-98.
2. Shrank W, Avorn J, Rolon C, Shekelle P. Medication safety: Effect of content and format of prescription drug labels on readability, understanding, and medication use: A systematic review. Ann Pharmaco. 2007;41(5):783-801.
3. Ogundeko TO, Ogbole EA, Builders M, Akande T, Sokomba EN, Toma B, et al. Readability of drugs and chemicals package inserts information: a survey of the Nigerian market. World J Pharma Life Sci. 2017;4(5):12-6.
4. Ramdas D, Chakraborty A, Swaroop HS, Faizan S, Kumar P, Srinivas BN. A study of package inserts in southern India. JCDR. 2013;7(11):2475.
5. Law AV, Zargarzadeh AH. How do patients read, understand and use prescription labels? An exploratory study examining patient and pharmacist perspectives. Inter J Pharm Pract. 2010;18(5):282-9.
6. Pires CM, Cavaco AM. Exploring the perspectives of potential consumers and healthcare professionals on the readability of a package insert: a case study of an over-the-counter medicine. Euro J Clin Pharmacol. 2014;70:583-8.
7. Idris KA, Yousif MA, Elkhawad AO. Assessment of the readability, understandability, informational contents conformity and usefulness of medication package inserts to Sudanese patients. World J Pharma Sci. 2014;2(9):892-8.
8. Shivkar YM. Clinical information in drug package inserts in India. J Postgrad Med. 2009;55(2):104.
9. Adepu R, Swamy MK. Development and evaluation of patient information leaflets (PIL) usefulness. Ind J Pharma Sci. 2012;74(2):174.
10. European Commission Enterprise and Industry Directorate-Genera. Guideline on the readability of the label and package leaflet of medicinal products for human use, Revision 1, 2009. Available at: https://health.ec.europa.eu/system/files/2016-11/2009_01_12_readability_guideline_final_en_0.pdf. Accessed 20 December 2023.
11. Zarea Gavgani V, Mirzadeh-Qasabeh S, Hanaee J, Hamishehkar H. Calculating reading ease score of patient package inserts in Iran. Drug Healthc Pat Sa. 2018;10:9-19.
12. Fuchs J, Heyer T, Langenhan D, Hippius M. Influence of font sizes on the readability and comprehensibility of package inserts. Pharmaz Indust. 2008;70(5):584-92.
13. Idris KA, Yousif MA, Elkhawad AO. Medications package inserts’ usefulness to doctors and patients: Sudanese doctors perspective. Inter J Bas Clin Pharmacol. 2014;3(4):718-22.
14. Pizzol TD, Moraes CG, Arrais PS, Bertoldi AD, Ramos LR, Farias MR, et al. Medicine package inserts from the users’ perspective: are they read and understood?. Revi Brasil Epidemiol. 2019;22:e190009.
15. Vander Stichele RH, Van Haecht CH, Braem MD, Bogaert MG. Attitude of the public toward technical package inserts for medication information in Belgium. DICP: Ann Pharmaco. 1991;25(9):1002–6.
16. Chhaya MU. Analysis of package inserts of orally administered drugs available in the Indian market. Int J Res Med Sci. 2017;5(2):529-32.
17. Gibbs S, Waters WE, George CF. Prescription information leaflets: a national survey. J Roy Soci Med. 1990;83(5):292–7.
18. Merges F, Nasiri S, Fathi M. Package Insert Leaflet Analysis and Improvement to Reduce Patient Risk Factors: A Pharmacovigilance Approach in Computer Science. In2014 IEEE 27th International Symposium on Computer-Based Medical Systems 2014 (pp. 483-484). IEEE.