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Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature

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A Correction to this article was published on 13 July 2021

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Abstract

Published reviews of written medicine information (WMI) have mainly drawn on studies published in high-income countries, including very few Asian or African studies. We therefore set out to scope the research literature to determine the extent and type of studies concerning WMI for patients/consumers across these two continents. We sought empirical studies published between January 2004 and December 2019, conducted in any Asian or African country, as defined by the United Nations, in English or with an English abstract. The majority of the 923 papers identified were from high-income countries. We retained 26 papers from Africa and 99 from Asia. Most African studies (n = 20) involved patients in the development of PILs, in the assessment of the effectiveness of PILs or in surveys. In contrast, the highest proportion of Asian studies concerned the content of WMI (n = 42). WMI is desired, but needs to be in local languages, and there needs to be more use made of pre-tested pictograms. Existing WMI frequently does not meet local regulatory requirements, particularly locally manufactured products. A number of studies reported potentially positive impacts of providing WMI on knowledge and medicine use behaviours. Provision of medicine information is essential for safe use of medicines in all countries. Internationally agreed guidelines, incorporating good design principles, are needed to ensure the optimal content and design of WMI. The World Health Organization should support African and Asian regulatory bodies to share best practice in relation to WMI for patients/consumers and to develop and implement pan-continental guidelines that take into account consumer needs and preferences.

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References

  1. Raynor DK, Blenkinsopp A, Knapp P, Grime J, Nicolson DJ, Pollock K, Dorer G, Gilbody S, Dickinson D, Maule AJ, Spoor P. A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines. Health Technol Assess. 2007;11(5):1–98.

    Google Scholar 

  2. Yuan HT, Raynor DK, Aslani P. Comparison of international regulations for written medicine information (WMI) on prescription medicines. Ther Innov Regul Sci. 2019;53:215–26. https://doi.org/10.1177/2168479018776949.

    Article  PubMed  Google Scholar 

  3. European Commission. Guideline on the readability of the labelling and package leaflet of medicinal products for human use. Revision 1. 2009. https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-2/c/2009_01_12_readability_guideline_final_en.pdf. Accessed 30 Nov 2020

  4. Raynor DK, Svarstad B, Knapp P, Aslani P, Brooke Rogers M, Koo M, Krass I, Silcock J. Consumer medication information in the United States, Europe, and Australia: A comparative evaluation. J Am Pharm Assoc. 2007;47:717–24. https://doi.org/10.1331/JAPhA.2007.06141.

    Article  Google Scholar 

  5. Kumana CR, Ma JT, Kung A, Kou M, Lauder I. An assessment of drug information sheets for diabetic patients: only active involvement by patients is helpful. Diabet Res Clin Pract. 1988;5:225–31.

    CAS  Google Scholar 

  6. Savas S, Evcik D. Do undereducated patients read and understand written education materials? A pilot study in Isparta, Turkey. Scand J Rheumatol. 2001;30:99–102.

    CAS  PubMed  Google Scholar 

  7. Young A, Tordoff J. ‘What do patients want?’ Tailoring medicines information to patients’ needs. Res Soc Admin Pharm. 2017;13:1186–90.

    Google Scholar 

  8. Kusch KP, Haefeli WE, Seidling HM. How to meet patients’ individual needs for drug information—a scoping review. Patient Pref Adher. 2018;12:2339–55.

    Google Scholar 

  9. Mullen RJ, Duhig J, Russell A, Scarazzini L, Lievano F, Wolf MS. Best-practices for the design and development of prescription medication information: a systematic review. Patient Educ Couns. 2018;101(8):1351–67.

    PubMed  Google Scholar 

  10. van Beusekom MM, Kerkhoven AH, Bos MJW, Guchelaar H-J, van den Broek JM. The extent and effects of patient involvement in pictogram design for written drug information: a short systematic review. Drug Discovery Today. 2018;23:1312–8.

    PubMed  Google Scholar 

  11. World Health Organization. Medication without harm. WHO. 2017. https://www.who.int/patientsafety/medication-safety/en/. Accessed 23 June 2020.

  12. World Health Organization. Essential Medicines and Health Products: prequalification of medicines. https://extranet.who.int/prequal/key-resources/prequalification-reports/whopars. Accessed 23 June 2020.

  13. Dowse R, Ehlers M. Medicine labels incorporating pictograms: do they influence understanding and adherence? Pat Educ Couns. 2005;58(1):63–70.

    Google Scholar 

  14. Mansoor LE, Dowse R. Medicines information and adherence in HIV/AIDS patients. J Clin Pharm Ther. 2006;31:7–15.

    CAS  PubMed  Google Scholar 

  15. Mansoor L, Dowse R. Written medicines information for South African HIV/AIDS patients: does it enhance understanding of co-trimoxazole therapy? Health Educ Res. 2007;22:37–48.

    PubMed  Google Scholar 

  16. Dowse R, Barford K, Browne SH. Simple, illustrated medicines information improves ARV knowledge and patient self-efficacy in limited literacy South African HIV patients. AIDS Care. 2014;26:1400–6.

    CAS  PubMed  PubMed Central  Google Scholar 

  17. Browne SH, Barford K, Ramela T, Dowse R. The impact of illustrated side effect information on understanding and sustained retention of antiretroviral side effect knowledge. Res Soc Admin Pharm. 2019;15(4):467–73.

    Google Scholar 

  18. Wrench W, van Dyk L, Srinivas S, Dowse R. Outcome of illustrated information leaflet on correct usage of asthma-metered dose inhaler. Afr J Prim Health Care Fam Med. 2019;11(1):a2079.

    Google Scholar 

  19. Patel SP, Dowse R. Understanding the medicines information-seeking behaviour and information needs of South African long-term patients with limited literacy skills. Health Expect. 2013;18:1494–507.

    PubMed  PubMed Central  Google Scholar 

  20. Dowse R, Ramela T, Browne SH. An illustrated leaflet containing antiretroviral information targeted for low-literate readers: development and evaluation. Patient Educ Couns. 2011;85:508–15.

    PubMed  Google Scholar 

  21. Mwingira B, Dowse R. Comprehension and acceptability of a patient information leaflet (PIL) for antiretroviral therapy. Health SA Gesondheid. 2006;11:49–61.

    Google Scholar 

  22. Mansoor L, Dowse R. Effect of pictograms on readability of patient information materials. Ann Pharmacother. 2003;37:1003–9.

    PubMed  Google Scholar 

  23. Dowse R, Ehlers M. Pictograms for conveying medicine instructions: comprehension in various South African language groups. S Afr J Sci. 2004;100:687–93.

    Google Scholar 

  24. Dowse R, Ramela T, Barford K-L, Browne S. Developing visual images for communicating information about antiretroviral side effects to a low-literate population. Afr J AIDS Res. 2011;9:213–24.

    Google Scholar 

  25. Ankrah DNA, Ofei CN. The effect of advice to read the medicine/patient information leaflet among patients in Ghana: A cross-sectional study. J Pharm Health Serv Res. 2010;1:91–6.

    Google Scholar 

  26. Kyei S, Ocansey S, Asumeng Koffuor G, Abokyi S, Adu FK. Patients’ information leaflets: its’ influence on ophthalmic patient education and medication compliance. Br J Med Med Res. 2014;4:1217–30.

    Google Scholar 

  27. Opare-Addo MN, Buabeng KO, Marfo AF, et al. Source of medicines and medicine information by self-reported persons living with hypertension and diabetes in rural and urban Ghana. Pharm Pract. 2018;16(3):1151.

    Google Scholar 

  28. Afreh ES, Akoto OY, Adam-Moses K. Hedging strategies in health discourse: a study of pharmaceutical leaflets. J Asia TEFL. 2017;14:515–31.

    Google Scholar 

  29. Afolabi MO, Akinwale VO, Akinyemi OA, Irinoye AI. Patient use and perception of medicine information leaflets. Pharmacoepidemiol Drug Saf. 2012;21:111.

    Google Scholar 

  30. Auta A, Shalkur D, Banwat SB, Dayom DW. Readability of malaria medicine information leaflets in Nigeria. Trop J Pharm Res. 2011;10:631–5.

    Google Scholar 

  31. Joseph B, Asiegbu OU, Aya BM, Nyam MN, Umar DM, Jimam NS, Dapar LPM. Usability of medicine package inserts for chronic diseases: a survey of the pharmaceutical market in Jos, Nigeria. J Pharm Res Int. 2017;17:1–10.

    Google Scholar 

  32. Mbuagbaw L, Ndongmanji E. Patients’ understanding of prescription instructions in a semi-urban setting in Cameroon. Patient Educ Couns. 2012;88:147–51.

    PubMed  Google Scholar 

  33. Amin MEK, Chewning BA, Wahdan AMH. Sources of drug information for patients with chronic conditions in Alexandria, Egypt. Int J Pharm Pract. 2010;19:13–20.

    PubMed  Google Scholar 

  34. Gebreyohannes EA, Bhagavathula AS, Abegaz TM, Abebe TB, Belachew SA, Tegegn HG, Mansoor SM. The effectiveness of pictogram intervention in the identification and reporting of adverse drug reactions in naïve HIV patients in Ethiopia: a cross-sectional study. HIV/AIDS Res Palliat Care. 2019;11:9–16.

    Google Scholar 

  35. Mwingira B, Dowse R. Development of written information for antiretroviral therapy: comprehension in a Tanzanian population. Pharm World Sci. 2007;29:173–82.

    PubMed  Google Scholar 

  36. Kunutsor S, Walley J, Muchuro S, Katabira E, Balidawa H, Namagala E, Ikoona E. Improving adherence to antiretroviral therapy in sub-Saharan African HIV-positive populations: an enhanced adherence package. AIDS Care. 2012;24:1308–15.

    CAS  PubMed  Google Scholar 

  37. World Health Organization. Product information supplied with selected antiretrovirals in five African countries. WHO Drug Inf. 2018;32:1.

    Google Scholar 

  38. Sillo HB, Masota NE, Kisoma S, Rago L, Mgoyela V, Kaale EA. Conformity of package inserts information to regulatory requirements among selected branded and generic medicinal products circulating on the East African market. PLoS ONE. 2018;13(5):e0197490.

    PubMed  PubMed Central  Google Scholar 

  39. Gupta U, Sharma S, Sheth PD, Jha J, Chaudhury RR. Improving medicine usage through patient information leaflets in India. Trop Doct. 2005;35(3):164–6.

    PubMed  Google Scholar 

  40. Arul Kumaran KSG, Yohannan JK, John J, Palanisamy S, Jacob S. Development and implementation of patient information leaflet on hypertension and to assess its effectiveness. Int J Pharm Res. 2009;1(3):712–9.

    Google Scholar 

  41. Arul Kumaran KSG, Palanisamy S, Rajasekaran A. Development and implementation of patient information leaflets in diabetes mellitus. J Pharm Health Serv Res. 2010;1(2):85–9.

    Google Scholar 

  42. Thawani VR, Gharpure KJ, Sontakke SD. Impact of medicine-related information on medicine purchase and use by literate consumers. Ind J Pharmacol. 2014;46(4):420–4.

    Google Scholar 

  43. Bansal V, Dhamija P, Medhi B, Pandhi P. Package inserts-do they have any role? JK Pract. 2006;13(3):152–4.

    Google Scholar 

  44. Kaikade SB, Jha RK. Assessment of awareness and attitude towards package inserts amongst rural population. Res J Pharm Biol Chem Sci. 2011;2(4):982–5.

    Google Scholar 

  45. Dawoodi I, Bhosale UA. Evaluation of knowledge and awareness of patients about prescribed drugs and their package inserts: a cross-sectional study. Asian J Pharm. 2016;10(2):S96–9.

    CAS  Google Scholar 

  46. Singh KR, Munshi R, Arora D. Assessment of the degree of awareness among physicians and patients about drug package inserts. Int J Pharm Sci Res. 2016;7(3):1258–62.

    Google Scholar 

  47. Rajesh R, Vidyasagar S, Varma DM, Sharma. Design and evaluation of pictograms for communicating information about adverse drug reactions to antiretroviral therapy in Indian human immunodeficiency virus positive patients. J Pharm Biomed Sci. 2012;16(10):1–11

  48. Mathew EM, Rajiah K, Sharma KK. Consumer’s perception on design and layout of consumer medical information leaflets on obesity and lipid lowering drugs. J Clin Diagn Res. 2013;7(12):2800–2.

    PubMed  PubMed Central  Google Scholar 

  49. Patel SV, Ganguly B. Audit of patient information leaflets available with topical medicines for patient use. Int J Pharm Res. 2014;6(4):50–5.

    Google Scholar 

  50. McDonald J, Vaillancourt R, Mishra P, Puliot A. HIV-TB treatment pictogram tool designed from semiotic analysis for community pharmacists in India. Ind J Pharm Sci. 2019;81(2):373–9.

    Google Scholar 

  51. Pawar M, Chakraborty P, Biswas P. Comparison of patient information leaflet (PIL) of cardiac drugs marketed by Indian companies with the original SmPC. Drug Saf. 2008;31(10):942.

    Google Scholar 

  52. Shivkar YM. Clinical information in drug package inserts in India. J Postgrad Med. 2009;55(2):104–7.

    CAS  PubMed  Google Scholar 

  53. Singh UP, Biswas PN. Comparison of patient information leaflet (PIL) of CNS drugs marketed by Indian companies with the original SmPC. Pharmacoepidemiol Drug Saf. 2009;18:S248.

    Google Scholar 

  54. Mehndiratta C, Biswas P. Comparison of 6 patient information leaflets (PILs) of anti-diabetic drugs marketed by Indian companies with the original SmPC from innovator companies. Pharmacoepidemiol Drug Saf. 2011;20:S217–8.

    Google Scholar 

  55. Biswas AK, Biswas PN. Comparison of 7 patient information leaflets (PILs) of narcotic pain medications marketed by Indian generic companies with original SmPC from innovator companies. Pharmacoepidemiol Drug Saf. 2013;22:86.

    Google Scholar 

  56. Justice N. Comparison of seven patient information leaflets (PILs) of anesthetic drugs marketed by Indian generic companies with original SmPC from innovator companies. Pharmacoepidemiol Drug Saf. 2013;22:92.

    Google Scholar 

  57. Ramdas D, Chakraborty A, Swaroop HS, Faizan A, Praveen K, Srinivas BN. A study of package inserts in Southern India. J Clin Diagn Res. 2013;7(11):2475–7.

    PubMed  PubMed Central  Google Scholar 

  58. Narzaree P, Gupta MC. Critical appraisal of patient package inserts and “the need.” Ind J Pharmacol. 2014;46:S85.

    Google Scholar 

  59. Wankhede SY, Pardeshi ML, Ghongane BB. Critical evaluation of drug package inserts in Maharashtra. Res J Pharm Biol Chem Sci. 2015;6(5):277–81.

    Google Scholar 

  60. Agharia MAM, Gawali UP, Kesari HV, Shah KU. A critical appraisal of package inserts in India. J Evol Med Dent Sci. 2016;6(5):2885.

    Google Scholar 

  61. Shruti DA, Sarala N, Bhuvana K. Analysis of package inserts of drugs utilized in a tertiary care hospital. J Young Pharm. 2016;8(3):275–8.

    Google Scholar 

  62. Prasad NS, Revankar SP, Vedavathi H, Manjunath H, Hegde S. Analysis of completeness of drug package inserts available in India. Natl J Physiol Pharm Pharmacol. 2017;7(11):1139–43.

    Google Scholar 

  63. Rahim N, Rafiq K, Iffat W, Nesar S, Shakeel S. Patients comprehension of pharmaceutical package inserts information in Karachi, Pakistan. Trop J Pharm Res. 2015;14(12):2307–11.

    Google Scholar 

  64. Saleem H, Ghoto MA, Memon N, Dayo A, Suheryani I, Shafique S, Khan M, Arain MI. Assessment of patients’ awareness towards pharmacotherapy and their sources of drug information in different areas of Hyderabad, Pakistan. Int Res J Biol Sci. 2015;4(8):56–9.

    Google Scholar 

  65. Rahim N, Rafiq K. Judgement of pharmaceutical package insert available in Pakistan from local and multinational companies. Asian J Pharm Health Sci. 2013;3(1):597–600.

    Google Scholar 

  66. Arsalan A, Qureshi S, Alam M, Ahmed S, Shakeel O, Ali A, Jabeen W. Errors in patients’ information leaflets of marketed medicines in Pakistan. J App Pharm Sci. 2015;5(5):68–74.

    Google Scholar 

  67. Perera T, Ranasinghe P, Perera U, Perera S, Adikari M, Jayasinghe S, Constantine GR. Knowledge of prescribed medication information among patients with limited English proficiency in Sri Lanka. BMC Res Notes. 2012;5:658.

    PubMed  PubMed Central  Google Scholar 

  68. Saheeha MMS, Piumanthe MHS, Perera SP, Samaranayake NR, Fernando GH. Quality of medicine information in product information leaflets: a retrospective audit. Ther Innov Regul Sci. 2018;52:656–60.

    CAS  PubMed  Google Scholar 

  69. Islam MS, Farah S. Availability and characteristics of information on drug-drug interactions in the drug package inserts: an experience from Bangladesh. Internet J Health. 2007;6(1):9.

    Google Scholar 

  70. Taibanguay N, Chaiamnuay S, Asavatanabodee P, Narongroeknawin P. Effect of patient education on medication adherence of patients with rheumatoid arthritis: a randomized controlled trial. Patient Pref Adher. 2019;13:119–29.

    Google Scholar 

  71. Jarernsiripornkul N, Chaipichit N, Chumworathayib P, Krska J. Management for improving patients’ knowledge and understanding about drug allergy. Pharm Pract. 2015;13(1):513.

    Google Scholar 

  72. Phueanpinit P, Jarernsiripornkul N, Pongwecharek J, Krska J. Experiences of and attitudes towards receiving information about non-steroidal antiinflammatory drugs: a cross-sectional survey of patients in Thailand. Expert Opt Drug Saf. 2016;15(4):417–26.

    Google Scholar 

  73. Pongpunna S, Pratipanawatr T, Jarernsiripornkul N. Survey of outpatients’ use and needs of patient medicine information leaflets in Thailand. Int J Clin Pharm. 2019;41(1):141–50.

    PubMed  Google Scholar 

  74. Jarernsiripornkul N, Phueanpinit P, Pongwecharak J, Krska J. Development and evaluation of user-tested Thai patient information leaflets for non-steroidal anti-inflammatory drugs: effect on patients’ knowledge. PLoS ONE. 2019;14(1):e0210395.

    CAS  PubMed  PubMed Central  Google Scholar 

  75. Phueanpinit P, Pongwecharek J, Krska J, Jarernsiripornkul N. Medicine information leaflets for non-steroidal anti-inflammatory drugs in Thailand. Int J Clin Pharm. 2016;38(1):25–9.

    CAS  PubMed  Google Scholar 

  76. Ho CH, Ko Y, Tan M-L. Patient needs and sources of drug information in Singapore: is the Internet replacing former sources? Ann Pharmacother. 2009;43:732–9.

    PubMed  Google Scholar 

  77. Liu LST, Goh BQ, Tang WP, Lo FL, Khoo RSY, Lim CJF. Drug information needs and concerns of primary care patients with newly prescribed chronic medications. Proc Singap Healthc. 2018;27(4):294–8.

    CAS  Google Scholar 

  78. Malhotra R, Bautista MAC, Tan NC, Tang WE, Tay S, Tan ASL, Puillot A, Saffari SE, Vaillancourt R. Bilingual text with or without pictograms improves elderly Singaporeans’ understanding of prescription medication labels. Gerontologist. 2019;59(2):378–90.

    PubMed  Google Scholar 

  79. Ng GQ, Sclar GE, Chng HT. An evaluation of the completeness of drug-drug interaction-related information in package inserts. Eur J Clin Pharmacol. 2017;73:165–74.

    CAS  PubMed  Google Scholar 

  80. Dawood OT, Hassali M, Saleem F, Ibrahim IR. Assessment of self-reporting reading of medicine’s labels and the resources of information about medicines in general public in Malaysia. Pharmacol Res Perspect. 2018;6(2):e00387.

    PubMed  PubMed Central  Google Scholar 

  81. Mittal P, Gan XY, Sim AY, Yeo JQ, Cheng J. Adherence of safety information on over-the-counter product labels and leaflets to the regulatory guidelines in Malaysia. J Pharm Pract Res. 2018;48:204–11.

    Google Scholar 

  82. Karuniawati H, Putra ON, Wikantyasning ER. Impact of pharmacist counseling and leaflet on the adherence of pulmonary tuberculosis patients in lungs hospital in Indonesia. Ind J Tuberc. 2019;66:364–9.

    Google Scholar 

  83. Yamamoto M, Doi H, Yamamoto K, Watanabe K, Sato T, Suka M, Nakayama T, Sugimori H. Adaptation of the European Commission-recommended user testing method to patient medication information leaflets in Japan. Drug Healthc Patient Saf. 2017;9:39–63.

    PubMed  PubMed Central  Google Scholar 

  84. Hirata-Koizumi M, Saito M, Miyake S, Hasegawa R. Adverse events caused by drug interactions involving glucuronoconjugates of zidovudine, valproic acid and lamotrigine, and analysis of how such potential events are discussed in package inserts of Japan, UK and USA. J Clin Pharm Ther. 2007;32(2):177–85.

    CAS  PubMed  Google Scholar 

  85. Watanabe S, Misu T, Kurihara T, Suzuki S, Sakurada T, Satoh N, Ueada S. Regulation of the statements in the information on drug metabolizing enzyme in the package insert—the present regulation and its history in Japan, the U.S and the U.K. Yakushigaku Zasshi. 2008;43(2):175–80.

    PubMed  Google Scholar 

  86. Nabeta K, Kimura M, Ohkura M, Tsuchiya F. Analysis on descriptions of precautionary statements in package inserts of medicines. Drug Healthc Patient Saf. 2012;4(1):19–25.

    PubMed  PubMed Central  Google Scholar 

  87. Shimazawa R, Ikeda M. Differences in pharmacogenomic biomarker information in package inserts from the United States, the United Kingdom and Japan. J Clin Pharm Ther. 2013;38(6):468–75.

    CAS  PubMed  Google Scholar 

  88. Kanda A, Kawasaki A, Morita R, Musha M, Sakurada T, Kobayashi E, Satoh N. Survey on “renal function” information in the package inserts of prescription drugs. Jpn J Clin Pharmacol Ther. 2013;44(4):313–8.

    CAS  Google Scholar 

  89. Jayaputra K, Ono S. Differences between the United States and Japan in labels of oncological drugs. Pharmacoepidemiol Drug Saf. 2017;26(2):143–51.

    PubMed  Google Scholar 

  90. Shimazawa R, Ikeda M. Safety information in drug labeling: a comparison of the USA, the UK, and Japan. J Clin Pharm Ther. 2013;38:468–75.

    CAS  PubMed  Google Scholar 

  91. Kin H, Ahn S. Consumers’ medication scheme for package inserts. Arch Des Res. 2014;27:57–71.

    Google Scholar 

  92. Song S, Lee S-M, Jang S, Lee YJ, Kim N-H, Sohn H-R, Suh D-C. Mediation effects of medication information processing and adherence on association between health literacy and quality of life. BMC Health Serv Res. 2017;17(1):11.

    Google Scholar 

  93. Lee I-H, Lee HW, Je NK, Lee S. Examining the readability of two package inserts for self-medication in South Korea. Pharmacoepidemiol Drug Saf. 2012;21(Suppl 3):452.

    Google Scholar 

  94. Lee SH, Shin J-U, Park M-J, Park B-J. Agreement of label information of cardiovascular drugs in pregnancy among Korea, the USA, the UK, and Japan. Regul Tox Pharmacol. 2014;68:363–9.

    Google Scholar 

  95. Zhang N, Wang L, Ouyang Y-Q, Redding S. Survey on medication information literacy and influencing factors among pregnant Chinese women. J Matern Fetal Neonatal Med. 2019;1–8.

  96. Ying L, Yumei Z. Lexis in Chinese-English translation of drug package inserts: corpus-based error analysis and its translation strategies. Int J Biomed Sci. 2010;6(4):344–50.

    PubMed  PubMed Central  Google Scholar 

  97. Xu L, Lei J, Feng Y-F. Investigation on drug information for the elderly in 10 483 package inserts of national essential drugs. Chin J New Drugs. 2016;25(17):2036–40.

    Google Scholar 

  98. Ng AWY, Chan AHS, Ho VWS. Comprehension by older people of medication information with or without supplementary pharmaceutical pictograms. Appl Ergon. 2017;58:167–75.

    PubMed  Google Scholar 

  99. Chan AHS, Chan KWL. Effects of prospective-user factors and sign design features on guessability of pharmaceutical pictograms. Patient Educ Couns. 2013;90:268–75.

    PubMed  Google Scholar 

  100. Chuang M-H, Lin C-L, Wang Y-F, Cham T-M. Development of pictographs depicting medication use instructions for low-literacy medical clinic ambulatory patients. J Manag Care Pharm. 2010;16(5):337–45.

    PubMed  Google Scholar 

  101. Lin H-W, Ku C-H, Li J-F, Tan AC, Chou C-H. A nationwide evaluation on electronic medication-related information provided by hospital websites. J Eval Clin Pract. 2013;19(2):304–10.

    PubMed  Google Scholar 

  102. Cho IY, Choi KH, Sheen YY. How does “regulatory practice” create discrepancies in drug label information between Asian and Western countries? Different label information for direct oral anticoagulants approved in the United States, Europe, Korea, and Japan. Ther Innov Regul Sci. 2019;53(2):233–42.

    PubMed  Google Scholar 

  103. Imatoh T, Sai K, Saito Y. Pharmacogenomic information in the warning section of drug labels: a comparison between labels in the United States and those in five other countries/regions. J Clin Pharm Ther. 2018;43(4):493–9.

    CAS  PubMed  Google Scholar 

  104. Polinski JM, Kesselheim AS, Seeger JD, Connolly JG, Choudhry NK, Shrank WH. A cross-national comparison of 17 countries’ insulin glargine drug labels. Pharmacoepidemiol Drug Saf. 2015;24(2):159–65.

    PubMed  Google Scholar 

  105. Bawazir SA, Abou-Auda HS, Gubara OA, Al-Khamis KI, Al-Jamani MJMS. Public attitude toward drug technical package inserts in Saudi Arabia. J Pharm Technol. 2003;19:209–18.

    Google Scholar 

  106. Abanmy NO, Al-Quait N, Alami AH, Al-Juhani M, Al-Aqeel S. The utilization of Arabic online drug information among adults in Saudi Arabia. Saudi Pharm J. 2012;20(4):317–21.

    PubMed  PubMed Central  Google Scholar 

  107. Alhaddad MS. Patients understanding and interpretations of the instructions given by pharmacists on the dispensed medications in Saudi Arabia. Lat Am J Pharm. 2018;37(8):1632–7.

    Google Scholar 

  108. Alburikan KA, AbuAlreesh A, Alenazi M, Albabtain H, Alqouzi M, Alawaji M, Aljadhey HS. Patients’ understanding of prescription drug label instructions in developing nations: the case of Saudi Arabia. Res Soc Admin Pharm. 2018;14(5):413–7.

    Google Scholar 

  109. Al Juffali L, Al Omran O, Al AS. Saudi young patient understanding of information about side effects Verbal versus numerical expression. Saudi Pharm J. 2014;22:33–7.

    CAS  PubMed  Google Scholar 

  110. AI-Aqeel SA. Evaluation of medication package inserts in Saudi Arabia. Drug Healthc Patient Saf. 2012;4:33–8.

  111. Al-Aqeel S, Al-Obaidi N. Patient evaluation of medication package leaflets in Al Kharj City, Saudi Arabia. Ther Innov Regul Sci. 2017;51(1):45–50.

    Google Scholar 

  112. Al-Aqeel S, Abanmy N, Aldayel A, Al-Khalifa H, Al-Yahya M, Diab M. Readability of written medicine information materials in Arabic language: expert and consumer evaluation. BMC Health Serv Res. 2018;18:139.

    PubMed  PubMed Central  Google Scholar 

  113. Sukkari SR, Al Humaidan AS, Sasich LD. The usefulness and scientific accuracy of private sector Arabic language patient drug information leaflets. Saudi Pharm J. 2012;20(3):211–5.

    PubMed  PubMed Central  Google Scholar 

  114. Gabran N, Al-Haidari K. Assessment of prescribing information for generic drugs manufactured in the Middle East and marketed in Saudi Arabia. Ann Saudi Med. 2006;26(3):192–9.

    Google Scholar 

  115. Sweileh WM, Zeid AA, Jaradat NA. Drug information value of patient package insert (PPI): a sample study in Palestine. J Islam Univ Gaza. 2004;2(2):59–68.

    Google Scholar 

  116. Al-Ramahi R, Zaid AN, Kettana N, Sweileh W, Al-Jabi D. Attitudes of consumers and healthcare professionals towards the patient package inserts—a study in Palestine. Pharm Pract. 2012;10(1):57–63.

    Google Scholar 

  117. Qatmosh SA, Koni AA, Qeeno BG, Arandy DA, Abu-Hashia MW, Al-hroub BM, Zyoud SH. Comparative analysis of package inserts of local and imported antihypertensive medications in Palestine. BMC Public Health. 2017;17:741.

    PubMed  PubMed Central  Google Scholar 

  118. Zaid AN, Al-Ramahi R, Ghoush AA. Appropriate use of oral drops: perception of health professionals and assessment of package insert information. Int J Clin Pharmacol Ther. 2010;48(12):854–9.

    CAS  PubMed  Google Scholar 

  119. Sawalha AF, Sweileh WM, Zyoud SH, Jabi SW. Comparative analysis of patient package inserts of local and imported anti-infective agents in Palestine. Libyan J Med. 2008;3(4):181–5.

    PubMed  PubMed Central  Google Scholar 

  120. Eshtayeh M, Draghmeh A, Zyoud SH. A comparative evaluation of medicine package inserts for oral antidiabetic agents in Palestine. BMC Public Health. 2019;19:1037.

    PubMed  PubMed Central  Google Scholar 

  121. Arandy DA, Abu-Hashia MW, Al-Hroub BM, Qatmosh SA, Koni AA, Qeeno BG, Al-Jabi SW, Zyoud SH. Comparative evaluation of drug information leaflets for non-steroidal anti-inflammatory drugs in Palestine: local versus imported products. BMC Health Serv Res. 2019;19:892.

    PubMed  PubMed Central  Google Scholar 

  122. Nader F, Mousavizadeh K, Ghafourifar P. Patient sources for drug information in Iran: a questionnaire-based survey. Pharm World Sci. 2008;30:764–7.

    PubMed  Google Scholar 

  123. Ahmadi P, Badri S, Zargarzadeh A. An investigation on patient attitudes toward package inserts and their accessibility in Iran. J Res Med Sci. 2018;23:100.

    PubMed  PubMed Central  Google Scholar 

  124. Zarea Gavgani V, Mirzadeh-Qasabeh S, Hanaee J, Hamishehkar H. Calculating reading ease score of patient package inserts in Iran. Drug Healthc Patient Saf. 2019;10:9–19.

    Google Scholar 

  125. Zarghami M, Azari A, Ghasemi S, Hormozpour M, Hendouei N. Availability of drug key information on package inserts of psychiatric drugs manufactured in Iranian pharmaceutical companies. Iran J Psychiatr Clin Psychol. 2016;22(2):122–33.

    Google Scholar 

  126. Khamas SS, Jafari A, Zarif-Yeganeh M, Taghvaye-Masoumi H. Evaluation of medication package inserts in Iran. J Res Pharm Pract. 2019;8:45–51.

    PubMed  PubMed Central  Google Scholar 

  127. Eteraf-Oskouei T, Abdollahpour S, Najafi M, Gavgani VZ. Do drug package inserts meet the rules and regulations of Iran’s Food and Drug Administration in terms of informing patients? Health Promot Perspect. 2019;9(3):214–22.

    PubMed  PubMed Central  Google Scholar 

  128. Kheir N, Awaisu A, Radoui A, El Badawi A, Jean L, Dowse R. Development and evaluation of pictograms on medication labels for patients with limited literacy skills in a culturally diverse multiethnic population. Res Soc Admin Pharm. 2014;10(5):720–30.

    Google Scholar 

  129. Munsour EE, Awaisu A, Hassali MAA, Dabbous Z, Zahran N, Abdoun E. Impact of customized-consumer medication information on health-related quality of life among patients with type 2 diabetes mellitus. Res Soc Admin Pharm. 2020;16(6):793–9.

    Google Scholar 

  130. Munsour EE, Awaisu A, Hassali MA, Darwish S, Abdoun E. Readability and comprehensibility of patient information leaflets for antidiabetic medications in Qatar. J Pharm Technol. 2017;33(4):128–36.

    PubMed  PubMed Central  Google Scholar 

  131. Al-Saffar N, Abdulkareem A, Abdulhakeem A, Salah AQ, Heba M. Depressed patients’ preferences for education about medications by pharmacists in Kuwait. Patient Educ Couns. 2008;72(1):94–101.

    PubMed  Google Scholar 

  132. Al-Saffar N, Deshmuck AA, Carter P, Adib SM. Effect of information leaflets and counselling on antidepressant adherence: open randomised controlled trial in a psychiatric hospital in Kuwait. Int J Pharm Pract. 2005;13:123–31.

    Google Scholar 

  133. Sharif SI, Abdullah M, Yousif A, Mohamed D. Interpretation of pharmaceutical pictograms by pharmacy and non-pharmacy university students. Pharmacol Pharm. 2014;5:821–7.

    Google Scholar 

  134. Gharibyar H, Sharif Y, El Ghandour S, Saffarini M, Aden B. Measuring compliance of package inserts in the Emirate of Abu Dhabi—UAE. Health. 2013;5(5):834–7.

    Google Scholar 

  135. Kazaryan I, Sevikyan A. Patients in need of medicine information. Int J Risk Saf Med. 2015;27(Suppl 1):S21–2.

    PubMed  Google Scholar 

  136. Vinker S, Eliyahu V, Yaphe J. The effect of drug information leaflets on patient behavior. Isr Med Assoc J. 2007;9:383–6.

    PubMed  Google Scholar 

  137. Demiralay R. The effects of asthma education on knowledge, behavior and morbidity in asthmatic patients. Turk J Med Sci. 2004;34:319–26.

    Google Scholar 

  138. Raynor DK, Dickinson D. Key principles to guide design of consumer medicine information—content analysis of information design texts. Ann Pharmacother. 2009;43:700–6.

    PubMed  Google Scholar 

  139. Flesch R. A new readability yardstick. J Appl Psychol. 1948;32:221–33.

    CAS  PubMed  Google Scholar 

  140. Gunning R. The technique of clear writing. New York: McGraw-Hill; 1952.

    Google Scholar 

  141. Kincaid JP, Fishburne RP, Rogers RL, Chissom BS. Derivation of new readability formulas (Automated Readability Index, Fog Count and Flesch Reading Ease formula) for navy enlisted personnel. Memphis: Naval Air Station; 1975.

    Google Scholar 

  142. SurulivelRajan M, Joy M, Suhaj A, Rajesh V, Manu MK. Study to assess the utility of cloze test in readability assessment of patient information leaflets in English and Indian languages. Asian J Pharm Health Sci. 2013;3(4):824–9.

    Google Scholar 

  143. Al-Khalifa HS, Al-Ajlan AA. Automatic readability measurements of the Arabic text: an exploratory study. Arab J Sci Eng. 2010;35(2C):103–24.

    Google Scholar 

  144. Tongtep N, Coenen F, Theeramunkong T. Content-based readability assessment: a study using a syllabic alphabetic language (Thai). In: Pacific rim international conference on artificial intelligence 2014, pp. 863–870.

  145. Basara LR, Juergens JP. Patient package insert readability and design. Am Pharm. 1994;34(8):48–53.

    Google Scholar 

  146. Baker SJ. Who can read consumer product information? Aust J Hosp Pharm. 1997;27:126–31.

    Google Scholar 

  147. Krass I, Svarstad BL, Bultman D. Using alternative methodologies for evaluating patient medication leaflets. Patient Educ Couns. 2002;47(1):29–35.

    PubMed  Google Scholar 

  148. Adepu R, Swarmy MK. Development and evaluation of patient information leaflets (PIL) usefulness. Ind J Pharm Sci. 2012;74(2):174–8.

    CAS  Google Scholar 

  149. Matteti UV, Nagappa AN, Attur RP, Bairy M, Nagaraju SP, Mallayasamy S, Vilakkathala R, Guddattu V, Balkrishnan R. Preparation, validation and user-testing of pictogram-based patient information leaflets for hemodialysis patients. Saudi Pharm J. 2015;23(6):621–5.

    Google Scholar 

  150. Roy RT, Sekhar MS, Rodrigues GS, Rajesh V. Preparation and readability assessment of patient information leaflets for diabetic foot ulcers. J Soc Health Diabet. 2013;1(2):79–81.

    Google Scholar 

  151. Arai M, Maeda K, Satoh H, Miki A, Sawada Y. Creation new patient information leaflets with diabetes by pharmacists and assessment conducted by patients. Yakugaku Zasshi. 2016;136(10):1449–54.

    CAS  PubMed  Google Scholar 

  152. Yamamoto M, Matsuda T, Suka M, Furukawa A, Igarashi T, Hayashi M, Sugimori H. Research for the effective use of the medication guides for patients. Jpn J Soc Pharm. 2013;32(2):8–17.

    Google Scholar 

  153. Diobi K, Fakeye TO, Adisa R. Community pharmacists’ perception of the relevance of drug package insert as source of drug information in Southwestern Nigeria. Trop J Pharm Res. 2013;12(3):439–43.

    Google Scholar 

  154. Idris KAMA, Yousif MA, Elkhawad AO. Medications package inserts’ usefulness to doctors and patients: Sudanese doctors perspective. Int J Basic Clin Pharmacol. 2014;3(4):718–22.

    Google Scholar 

  155. Phueanpinit P, Jarernsiripornkul N, Pongwecharek J, Krska J. Hospital pharmacists’ roles and attitudes in providing information on the safety of non-steroidal anti-inflammatory drugs in Thailand. Int J Clin Pharm. 2014;36:1205–12.

    CAS  PubMed  Google Scholar 

  156. Phueanpinit P, Pongwecharak J, Sumanont S, Krska J, Jarernsiripornkul N. Physicians’ communication of risks from non-steroidal anti-inflammatory drugs and attitude towards providing adverse drug reaction information to patients. J Eval Clin Pract. 2017;23:1387–94.

    PubMed  Google Scholar 

  157. Olofinjana B, Taylor D. Antipsychotic drugs - information and choice: a patient survey. Psychiatr Bull. 2005;29(10):369–71.

    Google Scholar 

  158. Auyeung V, Patel G, McRobbie D, Weinman J, Davies G. Information about medicines to cardiac in-patients: Patient satisfaction alongside the role perceptions and practices of doctors, nurses and pharmacists. Patient Educ Couns. 2011;83(3):360–6.

    PubMed  Google Scholar 

  159. Parham R, Riley S, Hutchinson A, Horne R. Patients’ satisfaction with information about phosphate-binding medication. J Renal Care. 2009;35:86–93.

    Google Scholar 

  160. Krska J, Morecroft CW. Informing patients about medicines–a hospital in-patient survey in England. Patient Educ Couns. 2013;90(2):276–8.

    PubMed  Google Scholar 

  161. Krska J, Morecroft CW. Patients’ use of information about medicine side effects in relation to experiences of suspected adverse drug reactions: a cross-sectional survey in medical in-patients. Drug Saf. 2013;36(8):673–80.

    PubMed  Google Scholar 

  162. O’Donovan B, Rodgers RM, Cox AR, Krska J. Use of information sources regarding medicine side effects among the general population: a cross-sectional survey. Prim Health Care Res Dev. 2019;20(e153):1–8.

    Google Scholar 

  163. Knapp P, Raynor DK, Woolf E, Gardner PH, Carrigan N, McMillan B. Communicating the risk of side effects to patients: an evaluation of UK regulatory recommendations. Drug Saf. 2009;32(10):837–49.

    PubMed  Google Scholar 

  164. Dickinson R, Raynor DK, Knapp P, MacDonald J. Do patients use a headline section in a leaflet to find key information about their medicines? Findings from a user-test study. Ther Innov Regul Sci. 2016;50(5):581–91.

    PubMed  Google Scholar 

  165. Bersellini E, Berry D. The benefits of providing benefit information in a patient information leaflet. Int J Pharm Pract. 2007;15:193–9.

    Google Scholar 

  166. Dickinson D, Teather J, Gallina S, Newsom-Davis E. Medicine package leaflets does good design matter? Inf Des J. 2010;18(3):225–40.

    Google Scholar 

  167. Katz MG, Kripalani S, Weiss BD. Use of pictorial aids in medication instructions: a review of the literature. Am J Health Syst Pharm. 2006;63(23):2391–7.

    PubMed  Google Scholar 

  168. Wilson EA, Vaillancourt R, Pascuet E, Besançon LJ, Wolf MS. Seeking international consensus in the use of icons for medication instructions. J Commun Healthc. 2012;5(1):67–72.

    Google Scholar 

  169. Pander Maat H, Lentz L, Raynor DK. How to test mandatory text templates: the European Patient Information Leaflet. PLoS ONE. 2015;10(10):e0139250.

    PubMed  PubMed Central  Google Scholar 

  170. Young A, Tordoff J, Smith A. Regulatory agencies’ recommendations for medicine information leaflets: Are they in line with research findings? Res Soc Admin Pharm. 2017;14(2):196–202.

    Google Scholar 

  171. Way D, Blazsin H, Löfstedt R, Bouder F. Pharmaceutical benefit–risk communication tools: a review of the literature. Drug Saf. 2017;40(1):15–36.

    CAS  PubMed  Google Scholar 

  172. Academy of Medical Sciences. Enhancing the use of scientific evidence to judge the potential benefits and harms of medicines: next steps. Academy of Medical Sciences, London. 2017. https://acmedsci.ac.uk/publications. Accessed 20 Jan 2021.

  173. Holt T, Lahrichi M, Santos de Silva J. Insight into pharmaceuticals and medical products. Africa: a continent of opportunity for pharma and patients. 2015. https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/africa-a-continent-of-opportunity-for-pharma-and-patients. Accessed 17 June 2020.

  174. https://accesstomedicinefoundation.org. Accessed 17 June 2020.

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Authors and Affiliations

  1. Faculty of Pharmaceutical Sciences, Prince of Songkla University, Hatyai, Thailand

    Pitchaya Nualdaisri

  2. Medway School of Pharmacy, Universities of Kent and Greenwich, Chatham Maritime, Kent, UK

    Pitchaya Nualdaisri, Sarah A. Corlett & Janet Krska

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  1. Pitchaya Nualdaisri
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Correspondence to Janet Krska.

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This work was supported by a Royal Thai Government Scholarship for PN.

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PN conducted searches, screened titles, extracted data, categorised studies and commented on the article. SC reviewed and categorised studies and contributed to drafting the article. JK screened titles, extracted data, categorised studies and drafted the article. All authors have read and approved the final version of the manuscript.

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Nualdaisri, P., Corlett, S.A. & Krska, J. Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature. Drug Saf 44, 421–437 (2021). https://doi.org/10.1007/s40264-020-01038-8

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