Attitudes of consumers and healthcare professionals towards the patient package inserts - a study in Palestine
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Abstract
Reading the patient package inserts (PPIs) is a key source of information about medications for patients. They should be clear and understandable to the general population.
Objectives: The aims of this study were to obtain base-line data on the extent of reading PPIs by consumers and possible factors that might affect this; to explore the attitude of the Palestinian public and healthcare professionals towards the patient package inserts (PPIs); and to review a random sample of PPIs for the availability of different information.
Methods: The first part of the study was a cross-sectional self-administered questionnaire. The questionnaire for consumers included 15 items. The questionnaire for healthcare professionals included 10 items and it was very similar to that of consumers with some modifications. In the second part, a random sample of PPIs was reviewed. In our community pharmacies, where medications are arranged according to their producing company, a researcher was asked to choose randomly 10-15 medications for every company to check for the availability of pharmacological, pharmaceutical and clinical information.
Results: A total of 304 healthcare professionals out of 320 (95.0%) and 223 consumers out of 240 (92.9%) accepted to answer the survey. Forty five percent consumers reported that they always read the PPIs, and 29.3% said that they read the PPIs most of the times. Increased rate of reading the leaflet was found among females (P = 0.047). The preferred language for the PPIs was Arabic for most of the consumers (89.6%) while it was English for most of the healthcare professionals (80.8%). 35.9% of the consumers and 43.6% of the healthcare professionals found the font size suitable. 42.3% of the consumers and 25.5% of the healthcare professionals said that they found the information in the PPIs useful and enough. The PPIs of 135 randomly sampled medications were reviewed. Many important sections were not found in the PPIs' sample.
Conclusion: A high percentage of consumers read the PPIs, but still this needs to be improved. People would appreciate a more detailed and clear PPI. Pharmacists should advocate reading the PPIs but they need to provide consumers with detailed counseling to compensate for the missing information in some of the PPIs. Authorities and manufacturers should implement appropriate measures to regulate the quality and quantity of information in the PPIs.
Keywords: Drug Labeling. Comprehension. Information Dissemination. Middle East.
References
2. Watson KT, Barash PG. The new Food and Drug Administration drug package insert: implications for patient safety and clinical care. Anesth Analg. 2009;108(1):211-218.
3. Bernardini C, Ambrogi V, Perioli L, Tiralti MC, Fardella G. Comprehensibility of the package leaflets of all medicinal products for human use: a questionnaire survey about the use of symbols and pictograms. Pharmacol Res. 2000;41(6):679-688.
4. 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. Pharmacol Res. 2001;43(5):437-444.
5. Fuchs J, Hippius M. Inappropriate dosage instructions in package inserts. Patient Educ Couns. 2007;67(1-2):157-168.
6. Gebran 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):192-199.
7. Shivkar YM. Clinical information in drug package inserts in India. J Postgrad Med. 2009;55(2):104-107.
8. Raynor DK, Svarstad B, Knapp P, Aslani P, Rogers MB, Koo M, Krass I, Silcock J. Consumer medication information in the United States, Europe, and Australia: a comparative evaluation. J Am Pharm Assoc (2003). 2007;47(6):717-724.
9. Sansgiry S S, Cady PS, Patil S. Readability of over-the-counter medication labels. J Am Pharm Assoc (Wash). 1997;NS37(5):522-528.
10. Nabors LA, Lehmkuhl HD, Parkins IS, Drury AM. Reading about over-the-counter medications. Issues Compr Pediatr Nurs. 2004;27(4):297-305.
11. Sweileh WM, Zeid AN, Jaradat NA. Drug informational value of patient package insert (PPI): A sample study in Palestine. Journal of The Islamic University of Gaza, (Natural Sciences Series). 2004;12:59-68.
12. 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):181-185.
13. Nathan JP, Zerilli T, Cicero LA, Rosenberg JM. Patients' use and perception of medication information leaflets. Ann Pharmacother. 2007;41(5):777-782.
14. Savas S, Evcik D. Do undereducated patients read and understand written education materials? A pilot study in Isparta, Turkey. Scand J Rheumatol. 2001;30(2):99-102.
15. Horwitz A, Reuther L, Andersen SE. Patient information leaflets seen through the eyes of patients in a general practice. Ugeskr Laeger. 2009;171(8):599-602.
16. Raynor DK, Knapp P, Moody A, Young R. Patient information leaflets-impact of European regulations on safe and effective use of medicines. Pharm J. 2005;(275):609-611.
17. Koo M, Krass I, Aslani P. Enhancing patient education about medicines: factors influencing reading and seeking of written medicine information. Health Expect. 2006;9(2):174-187.
18. Miller MJ, Schmitt MR, Allison JJ, Cobaugh D J, Ray MN, Saag KG. The role of health literacy and written medicine information in nonsteroidal antiinflammatory drug risk awareness. Ann Pharmacother. 2010;44(2):274-284.
19. Wogalter MS, Vigilante WJ Jr. Effects of label format on knowledge acquisition and perceived readability by younger and older adults. Ergonomics. 2003;46(4):327-344.
20. Svarstad BL, Mount JK, Tabak ER. Expert and consumer evaluation of patient medication leaflets provided in U.S. pharmacies. J Am Pharm Assoc. 2005;45(4):443-451.
21. Jambert E, Kopp C, Montane E, Rago L, Rocchi F. Prescribing information in 26 countries. A comparative study. Eur J Clin Pharmacol. 2003;59(4):263-270.
22. Zaid AN, Al-Ramahi R, Abu Ghoush A. Appropriate use of oral drops: perception of health professionals and assessment of package insert information. Int J Clin Pharmacol Ther. 2010;48(12):854-859.
23. Fuchs J, Hippius M, Schaefer M. Analysis of German package inserts. Int J Clin Pharmacol Ther. 2006;44(1):8-13.
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