Higher Readability Levels and Suboptimal Design of Medicine Information Leaflets in Artemisinin-based Combination Therapy Antimalarial Packages: A Consequence for Over-the-Counter-Medicines Use
Abstract:
The study aimed to determine the readability level
and assess the design layout of medicine information leaflets in packages of Artemisinin-based
Combination (ACT) antimalarials used as over-the-counter medicines in Nigeria where
malaria is endemic with higher adverse events in under-five children and pregnant
women. A cross-sectional study design was adopted to evaluate thirty-two medicine
information leaflets of ACTs obtained from community pharmacies. Texts in selected
passages of the leaflets were subjected to the Flesch-Kincaid (F-K) formula to determine
the F-K score and the corresponding reading-grade level. The Baker Able Leaflet
Design (BALD) assessment tool was employed to assess the medicine information leaflets
design layout. The mean Flesch-Kincaid score for the MILs was 14.22 ±5.06. A proportion of 15.63% of the MILs were readable at the postgraduate level, 28.13%
at the undergraduate level, 37.5% at the senior secondary school level and 18.76%
at the junior secondary school level. This represented the total proportion of leaflets
readable at the junior secondary school level which is the average level of education
in Nigeria. On the BALD tool, 46.28% of the MILs were rated ‘above standard’ and
53.72% were ‘poor’ in design. The dimension of the longest MIL was 80cm by 36cm.
A large proportion of the MILs were written above the reading level of average Nigerians
and were poorly designed. Most Nigerians are not likely to be able to read these
leaflets for reference purposes and to serve as reminder for instructions obtained
during medication counselling.
References:
[1] Beusekom MM., Grootens-Wiegers P, Bos MJW, Guchelaar
H, van den Broek. J. Low literacy and written drug information:
information-seeking, leaflet evaluation and preferences, and roles for images. Int
J Clin Pharm. 2016; 38:1372–1379.
[2]
Liu F,
Abdul-Hussain S, Mahboo S, Rai V, Kostrzewski A. How useful are medication
patient information leaflets to older adults? A content, readability, and
layout analysis. Int J Clin Pharm. 2014;36(4):827-834.
[3]
Piñero-López M,
Modamio P, Lastra CF, Mariño EL. Readability Analysis of the Package Leaflets
for Biological Medicines Available on the Internet Between 2007 and 2013: An
Analytical Longitudinal Study. J Med. Internet Res. 2016;18(5):100.
[4]
Kamal AM, Ahmad I,
Mirghani AY, Abdalla OE. Medication Package inserts’ usefulness for Sudanese
Pharmacists and patients: Pharmacist’s perspective. Inter J Basic and Clin
Pharm. 2014;3(5):884.
[5]
Buck ML. Providing
patients with written medication information. Ann. Pharm. 1999;32: 962-969.
[6]
Mai A, Aslani P.
Impact of Vietnamese written and verbal medicine information on Vietnamese
speaking Australians’ knowledge and satisfaction. Brit J Clin Pharm.
2007;64(4):527-535.
[7]
Adepu R, Swamy,
MK. Development and Evaluation of Patient Information Leaflets (PIL)
Usefulness. Ind J Pharm Sci. 2012;74(2):174–178.
[8]
Munsoh EE, Awaisu
A, Hassali MAA, Darwish S, Abdoun E. Readability and Comprehensibility of
Patient Information Leaflets for Antidiabetic Medications in Qatar. J Pharm
Technol. 2017;33(4):128–136.
[9]
Jegede A, Awodun
O. The Impact of Text Readability Indices in the Learning of Physics in
Secondary Schools. Intern J Case Studies. 2013;2(2):16-22.
[10] Bernardini
C, Ambrogi V, Fardella G, Perioli L, Grandolini G. How to improve the
readability of the patient package leaflet: A survey on the use of colour,
print size and layout. Pharm Res.
2001;43(5):437–443.
[11] Hamrosi
KK, Raynor DK, Aslani P. Enhancing provision of written medicine information in
Australia: pharmacist, general practitioner and consumer perceptions of the
barriers and facilitators. Biom Comm Health Serv Res.
2014;14: 183.
[12] Orna
E, Stevens G. Managing information for research. Buckingham, Open University
Press; 1995.
[13] European
Commission. Guideline on the readability of the labelling and package leaflet
of medicinal products for human use. London; 2009. Available from: http://ec.europa.eu/health/files/eudralex/vol2/c/2009_01_12_readability_guideline_
final_en.pdf.
[14] Raynor
DK, Dickinson D. Key principles to guide development of consumer medicine
information–content analysis of information design texts. Annals of Pharm. 2009; 43:700-706.
[15] Waller
R. Technical Paper 2: What makes a good document? The criteria we use.
Simplification Center, 2011. Available at: https://www.reading.ac.uk/web/files/simplification/SC2CriteriaGoodDoc-7.pdf.
[16] DuBay
WH. The Principles of Readability. Costa Mesa, CA; 2004. 631-3309. Retrieved at
http://almacenplantillasweb.es/wp-content/uploads/2009/11/ThePrinciples-of-Readability.pdf.
[17] Watt
O., 2001. Case Study: Contrastive discussion of the structural, lexical, and
grammatical properties of the Patient Information Leaflet (PIL) genre in
British English and Russian, including cross-cultural differences, 2013.
Available at: https:\<Study%3A-Contrastivediscussion-of-the-structural-lexical-and-grammatical-properties-of-the-Patient-Information-Leaflet-(PIL)-genre-in-British-English-and-Russian,-including-crosscultural-differences.6/9/14>
[18] Yamamoto
M. Patient Drug Information Leaflets for Risk/Benefit Communication. J Pharm. 2015; 3:132.
[19] Afolabi
MO, Afolabi, ER, Ojedokun OE, Adediwura, A. Content Validity and Readability
Estimates of Selected Anti-malarial Medicine Information Leaflets Sold Over the
Counter in Nigeria. The African Symposium.
2010;10(1):34- 41.
[20] Kasesnik,
K, Kline M. Analyzing readability of medicines information material in
Slovenia. South Med Rev, 2011;4(2):80–87.
[21] Nnamani
O, Otaburuagu E. The Language of Selected Prose Texts: A Readability Study,
2013.
[22] Kern
RP. Usefulness of readability formulas for achieving Army readability
objectives: Research and state-of-the-art applied to the Army’s problem. Fort
Benjamin Harrison, ID: Technical Advisory Service, U.S. Army Res Inst. 1979.
[23] National
Bureau of Statistics. In UNESCO, 2012: High level International Round Table on
Literacy “Reaching the 2015 Literacy Target: Delivering on the promise” UNESCO,
Paris, 6-7 September 2012. 2010 Retrieved at: http://www.unesco.org/new/fileadmin/MULTIMEDIA/HQ/ED/pdf/Nigeria.pdf.
[24] UNESCO
Institute of Statistics, 2021, Literacy rate, adult total (% of people ages 15
and above). The World Bank Data. https://data.worldbank.org/indicator/SE.ADT.LITR.ZS.
[25] Universal
Basic Education Commission, 2004. Standard Action Plan based on the UBE Act.,
Nigeria, 2004.
[26] Anaduka
EO. Okafor CF. The Universal Basic Education (UBE) Programme in Nigeria:
Problems and Prospects. J Res Nat Dev.
2013;11(1):152-157.
[27] Osemene
KP, Lamikanra A. A Study of the Prevalence of Self-Medication Practice among
University Students in South-western Nigeria. Trop J Pharm Res.
2012;11(4): 683-689.
[28] World
Health Organisation. Guidelines for the regulatory assessment of Medicinal
Products for use in self-medication. WHO/EDM/QS?00.1,2000.
[29] Flesch
R. A new readability yardstick. J Applied Psych.
1948;32: 221–233.
[30] Garner
M, Ning Z, Francis J. A framework for the evaluation of patient information
leaflets. Health Expectations, Blackwell Publishing Ltd.;
2012.15:283–294.
[31] 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. Research Branch Report 8–75. Chief of
Naval Technical Training: Naval Air Station Memphis, 1975.
[32] Katz
MG, Kripalani S, Weiss BD. Use of pictorial aids in medication instructions: a
review of literature. Am J Health Sys Pharm.
2006;63(23):2391-2397.
[33] Matthew
E, Rajiah K, Sharma KK. Layout of Consumer Medical Information Leaflets. J Clin Diag Res. 2013;7(12):2800-2802.
[34] Adibe
MO, Igboeli, NU, Ubaka CM, Udeogaranya PO, Onwudiwe NP, Ita OO. Evaluation of
Information Contained in Drug Advertisement and Promotion Materials in Nigeria.
Trop J Pharm Res. 2015;14(3):539-544.
[35] Brieger
WR, Salako, L.A., Umeh, Agomo B, Afolabi M, Adeneye AK. Promoting pre-packaged
drugs for prompt and appropriate treatment of febrile illnesses in rural
Nigerian communities. Int Quart Comm Educ.
2002;21(1):19–40.
[36] Pinero-Lopez
MA, Modamio P, Lastra CF, Marino EL. Readability Analysis of the Package
Leaflets for Biological Medicines Available on the Internet Between 2007 and
2013: An Analytical Longitudinal Study. J Med Internet Res.
2016; 18(5): e100. DOI:10.2196/jmir.5145.
[37] Hill
J, Bird H. The development and evaluation of a drug information leaflet for
patients with rheumatoid arthritis. Rheum. (Oxford), 2003;42(1):66-70.
[38] Zethsen
KK, Askehave I. PIL of the month: A study of best practice in European Union
patient information leaflets. J Applied Ling Prof Pract.
2010;7(1):97–120.
[39] Fitzmaurice,
D. A. and Adams, J. L. A systematic review of patient information leaflets for
hypertension. J Human Hypert. 2000;14(4):259-62.
[40] Maat,
H. P., and Lentz, L. Improving the usability of patient information leaflets. Patient Edu Counselling 2010;80(1):113-9.
[41] Twomey
C. An analysis of patient information leaflets supplied with medicines sold by
pharmacists in the United Kingdom Library and Information Research News; 2001.
5(80):3-12.
[42] Janan
D, Wray D. Readability: The limitations of an approach through formulae. Paper
presented at the British Educational Research Association Annual Conference,
University of Manchester (2012). http://www.leeds.ac.uk/educol/documents/213296.pdf.