Journal of Isfahan Medical School

Journal of Isfahan Medical School

Patients' Medication Information: Current Situation, Challenges and Information Technology

Document Type : Review Article

Authors
Tahereh Eteraf-Oskouei 1
Vahideh Zarea- Gavgani 2
Taha Samad-Soltani 3
Moslem Najafi 4
Mina Mahami-Oskouei 5
1 Professor, Department of Pharmacology and Toxicology, School of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran
2 Professor, Tabriz Health Services Management Research Center, School of Management and Medical Informatics, Tabriz University of Medical Sciences, Tabriz, Iran
3 Assistant Professor, Department of Health Information Technology, School of Management and Medical Informatics, Tabriz University of Medical Sciences, Tabriz, Iran
4 Professor, Medical Education Research Center, Health Management and Safety Promotion Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran
5 PhD Candidate in Medical library & Information Science, Student Research Committee, School of Health Management & Information Sciences, Iran university of Medical Sciences, Tehran , Iran
10.48305/jims.v41.i707.0069
Abstract
Background: The Patient package inserts are officially published by pharmaceutical companies and authorized by the food and drug administration. The purpose of the package inserts is to provide complete, reliable and safety information about the drug to the consumer. Drug catalogues are another drug information sheet that is made available to physicians due to time constraints and busy schedules to update their knowledge about the existing and novel drugs. Of course, today the digital world has faced tremendous changes in the provision and consumption of pharmaceutical services. Internet of things, artificial intelligence, block chain and cloud computing are new technologies that will revolutionize the future of drug therapy. Digital transformation will lead to accurate drug therapy, cost reduction, saving time and manpower, access to more flexibility and better efficiency in all processes. This review article was about the current situation, challenges and promotion of information provided in the patient package inserts, also the importance of new technologies in the field of medication information.
Keywords
Drug labeling
Pamphlets
Consumer health informatics
Patient education handout

Subjects

  1. Bawazir SA, Abou-Auda HS, Gubara OA, Al-Khamis KI, Al-Yamani MJ. Public attitude toward drug technical package inserts in Saudi Arabia.
    J Pharm Technol 2003; 19(3): 209-18.
  2. 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.
  3. Sawalha Af, Sweileh W, Zyoud Sh, Jabi S. Comparative analysis of patient package inserts of local and imported anti-infective agents in Palestine. Libyan J Med 2008; 3(4): 181-5.
  4. 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.
  5. Wulfovich S, Meyers A. Digital Health Entrepreneurship. Berlin, Germany: Springer; 2020. p. 207-13.
  6. Bublitz FM, Oetomo A, Sahu KS, Kuang A, Fadrique LX, Velmovitsky PE, et al. Disruptive technologies for environment and health research: an overview of artificial intelligence, blockchain, and internet of things. Int. J. Environ. Res. Public Health 2019; 16(20): 3847.
  7. Singh M. Revolutionizing healthcare through artificial intelligence and virtual reality. Int J Educ
    Manag Stud 2018; 8(4): 406-10.
  8. Kurtz MM, Baker E, Pearlson GD, Astur RS. A virtual reality apartment as a measure of medication management skills in patients with schizophrenia: a pilot study. Schizophr Bull 2007; 33(5): 1162-70.
  9. Chan HCS, Shan H, Dahoun T, Vogel H, Yuan S. Advancing drug discovery via artificial intelligence. Trends Pharmacol Sci 2019; 40(8): 592-604.
  10. Heggde G, Shainesh G. Social media marketing: Emerging concepts and applications: Berlin, Germany: Springer; 2018.
  11. 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): 433-8.
  12. Raynor DK, Blenkinsopp A, Knapp P, Grime J, Nicolson DJ, Pollock K, et al. 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): 1-160.
  13. Shivkar YM. Clinical information in drug package inserts in India. J Postgrad Med 2009; 55(2): 104.
  14. Mahatme MS, Dakhale GN, Hiware SK, Wankhede SS, Salve AM, Mahatme SR. Comparison of Indian package inserts in public and private sector: an urgent need for self regulation. Int J Basic Clin Pharmacol 2013; 2(2): 165-9.
  15. Ramdas D, Chakraborty A, Swaroop H, Faizan S, Kumar P, Srinivas B. A study of package inserts in southern India. J Clin Diagn Res 2013; 7(11): 2475-7.
  16. Maat HP, Lentz L. Improving the usability of patient information leaflets. Patient Educ Couns 2010; 80(1): 113-9.
  17. Shiffman S, Gerlach KK, Sembower MA, Rohay JM. Consumer understanding of prescription drug information: an illustration using an antidepressant medication. Ann Pharmacother 2011; 45(4): 452-8.
  18. Genale C, Issa A, Negash B, Wondu K. Assessing the readability of medicine information materials: the case of tikur anbessa specialized hospital-mixed approach. Patient Prefer Adherence 2021; 15: 635-44.
  19. Zarea Gavgani V, Mirzadeh-Qasabeh S, Hanaee J, Hamishehkar H. Calculating reading ease score of patient package inserts in Iran. Drug Healthc Patient Saf 2018; 10: 9-19.
  20. Frye LJ, Kilfedder C, Blum J, Winikoff B. A cross-sectional analysis of mifepristone, misoprostol, and combination mifepristone-misoprostol package inserts obtained in 20 countries. Contraception 2020; 101(5): 315-20.
  21. Wongtaweepkij K, Corlett S, Krska J, Pongwecharak J, Jarernsiripornkul N. Patients’ experiences and perspectives of receiving written medicine information about medicines: a qualitative study. Patient preference and adherence 2021; 15: 569-80.
  22. Fuchs J, Hippius M, Schaefer M. Analysis of German package inserts. Int J Clin Pharmacol The 2006; 44(1): 8-13.
  23. Sudha MJ, Viveka S, Remya S, Udupa AL. Drug package inserts: how accessible is the information? Int J Bas Clin Pharmacol 2015; 4(6): 4.
  24. Ved J. Package inserts in India: need for a revision. Int J Pharm Sci Res 2010; 1(11): 454-56.
  25. Bouayad-Agha N, Power R, Scott D, Belz A. ITRI-02-04 PILLS: Multilingual generation of medical information documents with overlapping content. Proceedings of LREC 2002; 22-31.
  26. Momeni K, Janati A, Imani A, Khodayari-Zarnaq R. Barriers to the development of medical tourism in East Azerbaijan province, Iran: A qualitative study. Tourism Management 2018; 69: 307-16.
  27. Commission E. Guideline on the readability of the label and package leaflet of medicinal products for human use. Brussels (Belgium): European Commission Directorate-General 1998; 3: 22.
  28. Botta M. Unlike all of the European Union countries where braille is mandatory on pharmaceutical packaging, the U.S. still considers it to be an optional guideline. Pharmacutical Processing. [Online 2017]. Available from:

https://www.pharmaceuticalprocessingworld.com/braille-in-pharma-differing-views-in-the-u-s-and-europe/

  1. 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.
  2. Fuchs J, Hippius M. Inappropriate dosage instructions in package inserts. Patient Educ Couns
    2007; 67(1-2): 157-68.
  3. Al-Aqeel SA. Evaluation of medication package inserts in Saudi Arabia. Drug Healthc Patient Saf; 2012; 4: 33-8.
  4. Najafi M, Dindar-Oskouei H, Eteraf-Oskouei T. Awareness and Satisfaction of Patients with Iranian Patient Package Inserts [in Persian]. J Mazandaran Univ Med Sci 2021; 31(196): 82-91.
  5. Eteraf Oskouei T, Vatankhah E, Najafi M. The Status of Potentially Inappropriate Medication Prescription by General Physicians for The Elderly in Tabriz (Iran) According to Beers Criteria [in Persian]. Salmand: Iranian Journal of Ageing 2021; 16(2): 274-87.
  6. Mendes D, Alves C, Batel-Marques F. Number needed to treat (NNT) in clinical literature: an appraisal. BMC Med 2017; 15(1): 112.
  7. Eteraf-Oskouei T, Mohammadi Y, Najafi M. Evaluating the Causes of Non-Standard Prescription and Drug Use in Iran and Its Improvement Strategies from the Viewpoint of Pharmacy Students of Tabriz University of Medical Sciences. Depiction of Health 2019; 10(3): 180-8.
  8. Fuchs J, Hippus M, Schaefer M. A survey of package inserts use by patients. Hosp Pharm 2005: 29-31.
  9. da Silva Dal Pizzol T, Moraes CG, Dourado Arrais PS, Bertoldi AD, Ramos LR, Farias MR, et al. Medicine package inserts from the users' perspective: are they read and understood? Rev Bras Epidemiol 2019; 22: E190009.
  10. Lal A. Pharmaceutical drug promotion: how it is being practiced in India? J Assoc Physicians India 2001; 49: 266-73.
  11. Kakasaniya GG, Mer RJ, Chhaiya SB, Mehta DS. Perception of resident doctors regarding promotional drug literature. Natl J Physiol Pharm Pharmacol 2021; 12(8): 1151-4.
  12. Sareetha AV, Gore SR, Sandeep B. Critical appraisal of drug promotional literature: Educative or misleading for second year MBBS students. Natl J Physiol Pharm Pharmacol 2021; 11(7): 710-4.
  13. Sharma S, Akhoon N, Moe HW, Nair DR, Shashidhar V. A study of perceptions and exposure of drug promotional literature among clinicians in a teaching hospital. Perspect Clin Res 2021; 12(3): 140-5.
  14. Randhawa GK, Singh NR, Rai J, Kaur G, Kashyap R. A critical analysis of claims and their authenticity in Indian drug promotional advertisements. Adv Med 2015; 2015.
  15. Mikhael EM. Drug promotion in Iraq and its negative effect on both personal and country budget. Int J Pharm Pharm Sci 2015; 7(1): 1.
  16. Singh KR, Munshi R, Arora D. Assessment of the degree of awareness among physicians and patients about drug package inserts. Int
  17. J Pharm Sci Res 2016; 7(3): 1258-62.
  18. Bharti D, Ganguly A, Katiyar D, Kumar A. Evaluation of the rationality of the drug promotional literature distributed among the physicians using the WHO guidelines. Eur J Mol Clin Med 2022; 9(3): 2831-6.
  19. Mistry VR, Kanani NJ, Thacker KS. A critical evaluation of promotional drug literatures available with prescribers at a tertiary care teaching hospital in Gujarat, India. International Journal of Basic & Clinical Pharmacology 2022; 11(2): 167.
  20. Roughead EE. The Australian Pharmaceutical Manufacturers Association code of conduct: Guiding the promotion of prescription medicines. Aust Prescr 1999; 22: 78-80.
  21. FaD. Bad Ad Program. to help health care providers detect, report misleading drug ads. USA: FDA; [online 2010]. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm211611. [Last accessed on 2019 Mar 04].
  22. Programme PS. Medicines (Advertisement and Sale) Act 1956. Ministry of Health Malaysia. [online 2019] Available from:

https://www.pharmacy.gov.my/v2/en/documents/medicines-advertisement-sale-act-1956-and-regulations.html

  1. Goh CF, Chan MY, Ali AM, Rashid SM. The Complementary and Alternative Medicine (CAM) Product Information Brochure: How is Generic Structure Used to Persuade Potential Users? GEMA Online Journal of Language Studies. 2019;19(4): 219-42.
  2. Jadav SS, Dumatar CB, Dikshit RK. Drug promotional literatures (DPLs) evaluation as per World Health Organization (WHO) criteria. J Appl Pharm Sci 2014; 4(6): 84-8.
  3. Sah P, Sah AK, Jha RK. Evaluation of the rationality of psychotropic drug promotional literatures in Nepal. Journal of Drug Delivery and Therapeutics 2012; 2(6).
  4. Othman N, Vitry A, Roughead EE. Quality of pharmaceutical advertisements in medical journals: a systematic review. PloS One 2009; 4(7): e6350.
  5. Khakhkhar T, Mehta M, Shah R, Sharma D. Evaluation of drug promotional literatures using WHO guidelines. J Pharm Negat 2013;4(1): 33-8.
  6. Understanding and Responding to Pharmaceutical Promotion- A Practical Guide. Netherland: HAI; [2010]. Available from:

http://www.haiweb.org/11062009/ drug-promotion-manual-CAP-3-090610.pdf. [Last accessed on 2019 Mar 4]

  1. Eteraf Oskouei T, Najafi M, Savadi Oskouei D, Herizchi Ghadim H, Rouhani Z, Vahedi N. The attitude of medical students of Tabriz University of Medical Sciences towards the necessity of clinical pharmacology. Future Med Edu J 2012; 2(1): 32-5.
  2. World Health Organization. Programme on Traditional Medicine. WHO traditional medicine strategy 2002-2005. World Health Organization. [online 2002] Available from: https://apps.who.int/iris/handle/10665/67163
  3. Leitch S, Smith A, Zeng J, Stokes T. Using an information package to reduce patients’ risk of renal damage: protocol for a randomized feasibility trial. JMIR Res Protoc 2021; 10(4): e29161.
  4. Najafi M, Eteraf-Oskouei T. Pharmacy Students’ Attitude in Tabriz University of Medical Sciences toward Using Computerized Simulations in Teaching [in Persian] Iranian J Med Edu 2011; 11 (4) :308-17.
  5. Li P, Nelson SD, Malin BA, Chen YJBiht. DMMS: a
    decentralized blockchain ledger for the management of medication histories. Blockchain Healthc Today 2019; 2: 38.
  6. Fetooh HM, Youssef H, Ali AH, Yusuf M, Adel S, Zaki AAE, et al. A future vision for digital transformation in pharmacy and drug system. Egyptian J 2022; 8(8): 140-54.
  7. Varshney U. Mobile health interventions for opioid epidemic. AMCIS 2019.
  8. Ding H, Fatehi F, Russell AW, Karunanithi M, Menon A, Bird D, et al. User experience of an innovative mobile health program to assist in insulin dose adjustment: outcomes of a proof-of-concept trial. Telemed J E Health 2018; 24(7): 536-43.
  9. Ram KG, Harisha H. Healthcare System using LoRa and Mysignals based Communication Technology. Ir Interdiscip J Sci Res 2021; 5(2): 7-13.
  10. Saif S, Saha R, Biswas SJWPC. On Development of MySignals based prototype for application in health vitals monitoring. Wirel Pers Commun 2021: 122(2):1599-616.
  11. Strand NAW, Vinther S, Horwitz H. [Information and misinformation about adverse drug reactions] [in Danish]. Ugeskr Laeger 2021; 183(2):
  12. Rodriguez-Nava G, Trelles-Garcia DP, Yanez-Bello MA, Imani-Ramos T, Trelles-Garcia VP, Bustamante-Soliz DS, et al. MMR Vaccine Adverse Drug Reactions Reports in the CDC WONDER System, 1989-2019. Open Forum Infect Dis 2020; 7(8): ofaa211.
  13. Li S, Da Xu L, Zhao S. 5G internet of things: a survey. J Ind Inf Integr 2018; 10: 1-9.
  14. Islam SMR, Kwak D, Kabir MH, Hossain M, Kwak K-S. The internet of things for health care: a comprehensive survey. IEEE Access 2015; 3: 678-708.
  15. Moise MV, Niculescu AM, Dumitraşcu A. Integration of Internet of Things technology into a pill dispenser. 2020 IEEE 26th International Symposium for Design and Technology in Electronic Packaging (SIITME); [21-24 October 2020]. Available from: https://ieeexplore.ieee.org/document/9292283
  16. Zweig SE. From smart tags to brilliant tags: Advances in drug stability monitoring. BioPharm International 2005; 18(11).
  17. Goffredo R, Accoto D, Santonico M, Pennazza G, Guglielmelli E. A smart pill for drug delivery with sensing capabilities. Annu Int Conf IEEE Eng Med Biol Soc 2015; 1361-4.
  18. Abdul Minaam DS, Abd-ELfattah M. Smart drugs: Improving healthcare using smart pill box for medicine reminder and monitoring system. Future Computing and Informatics Journal 2018; 3(2): 443-56.
  19. Le DN, van Le C, Tromp JG, Nguyen GN. Emerging technologies for health and medicine: virtual reality, augmented reality, artificial intelligence, internet of things, robotics, industry 4.0: John Wiley & Sons; 2018.
  20. Steuer JJJoc. Defining virtual reality: Dimensions determining telepresence. Journal of Communication 1992; 42(4): 73-93.
  21. Weiss PL, Rand D, Katz N, Kizony RJJon. Video
    capture virtual reality as a flexible and effective rehabilitation tool. J Neuroeng Rehabil 2004; 1: 12.
  22. Bin S, Masood S, Jung Y. Virtual and augmented reality in medicine. Biomedical Information Technology. Elsevier; 2020. p. 673-86.
  23. Schmitt YS, Hoffman HG, Blough DK, Patterson DR, Jensen MP, Soltani M, et al. A randomized, controlled trial of immersive virtual reality analgesia, during physical therapy for pediatric burns. Burns 2011; 37(1): 61-8.
  24. Spiegel BM. Virtual medicine: how virtual reality is easing pain, calming nerves and improving health. Med J Aust 2018; 209(6): 245-7.
  25. Gustafsson M, Englund C, Gallego G. The description and evaluation of virtual worlds in clinical pharmacy education in Northern Sweden. Curr Pharm Teach Learn 2017; 9(5): 887-92 .
  26. Nuffer W, Smith SM, Trinkley K. Integrating virtual reality to expand the public health role of community pharmacists. J Am Pharm Assoc (2003) 2013; 53(2): 152-8.
  27. Fox BI, Felkey BG. Virtual reality and pharmacy: opportunities and challenges. Hosp Pharm 2017; 52(2): 160-1.
  28. Lai C, Chang YM. A testing case of simulation learning in nursing by virtual reality-subcutaneous injection training. International Conference on Innovative Technologies and Learning 2020; 109-18.
  29. Liang CJ, Start C, Boley H, Kamat VR, Menassa CC, Aebersold M. Enhancing stroke assessment simulation experience in clinical training using augmented reality. Virtual Reality 2021; 25: 575-84.
  30. Lo CK, Chang SS, Chuang CH, Chen H-C. A mobile nursing app applying to the wound care and drug administration of patients. 2015 9th International Conference on Innovative Mobile and Internet Services in Ubiquitous Computing; 08-10 July 2015: Santa Catarina, Brazil.
  31. Zhang W, Zhang J, Ma R, Chen H, Huang J, Xu B. Patient expectations and awareness of information regarding adverse reactions in drug labelling in China. Int J Clin Pharm 2021; 43(1): 174-80.
  32. Jara AJ, Alcolea AF, Zamora M, Skarmeta AG, Alsaedy M. Drugs interaction checker based on IoT. 2010 Internet of Things (IOT); 2010: IEEE.
  33. Alabdulhafith M, Sampangi RV, Sampalli S, editors. NFC-enabled smartphone application for drug interaction and drug allergy detection. 2013 5th International Workshop on Near Field Communication (NFC); 2013: IEEE.
  34. Guerrero E, Lu MH, Yueh HP, Lindgren H. Designing and evaluating an intelligent augmented reality system for assisting older adults’ medication management. Cognitive Systems Research 2019; 58: 278-91.
  35. Dedeu T. Medicine Adherence & Augmented Reality. 2014. Available from: https://strathprints.strath.ac.uk/65955/1/Dedeu_DHCI2014_Medicine_Adherence_Augmented_Reality.pdf
  36. Ingeson M, Blusi M, Nieves JC. Smart augmented reality mHealth for medication adherence. Joint Workshop on Artificial Intelligence in Health, Stockholm, Sweden, July 13-14, 2018.
  37. Benjamens S, Dhunnoo P, Meskó BJNdm. The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database. NPJ Digit Med 2020; 3: 118.
  38. Babel A, Taneja R, Malvestiti FM, Monaco A, Donde S. Artificial Intelligence Solutions to Increase Medication Adherence in Patients With Non-communicable Diseases. Front Digit Health 2021; 3: 669869.
  39. Vyas M, Thakur S, Riyaz B, Bansal K, Tomar B, Mishra V. Artificial intelligence: the beginning of a new era in pharmacy profession. Asian Journal of Pharmaceutics 2018; 12(2): 72-6.
  40. Wong CH, Siah KW, Lo AW. Estimation of clinical trial success rates and related parameters. Biostatistics 2018; 20(2): 273-86.
  41. Bain EE, Shafner L, Walling DP, Othman AA, Chuang-Stein C, Hinkle J, et al. Use of a novel artificial intelligence platform on mobile devices to assess dosing compliance in a phase 2 clinical trial in subjects with schizophrenia. JMIR Mhealth Uhealth 2017; 5(2): e18.
  42. Van Biesen W, Decruyenaere J, Sideri K, Cockbain J, Sterckx SJACB. Remote digital monitoring of medication intake: methodological, medical, ethical and legal reflections. Acta Clin Belg 2021; 76(3): 209-16.
  43. Kee T, Weiyan C, Blasiak A, Wang P, Chong JK, Chen J, et al. Harnessing CURATE. AI as a digital therapeutics platform by identifying N‐of‐1 learning trajectory profiles. Advanced Therapeutics 2019; 2(9): 1900023.
  44. Contreras I, Vehi J. Artificial intelligence for diabetes management and decision support: literature review. J Med Internet Res 2018; 20(5): e10775.
  45. Barrett M, Boyne J, Brandts J, Brunner-La Rocca H-P, De Maesschalck L, De Wit K, et al. Artificial intelligence supported patient self-care in chronic heart failure: a paradigm shift from reactive to predictive, preventive and personalised care. EPMA Journal 2019; 10(4): 445-64.
  46. Daley BJ, Ni’Man M, Neves MR, Bobby Huda MS, Marsh W, Fenton NE, et al. mHealth apps for gestational diabetes mellitus that provide clinical decision support or artificial intelligence: A scoping review. Diabet Med 2022; 39(1): e14735.
  47. Davoudi Kongsofla M, Najafi Ghezeljeh T, Saeidi A, Peyravi H, Kiaroosta N. Design and evaluation of a smartphone-based application to manage the treatment of people with heart failur. Iran J War Public Health 2019, 11(3): 125-31.
  48. Rangraz Jeddi F, Nabovati E, Hamidi R, Sharif R. Mobile phone usage in patients with type II diabetes and their intention to use it for self-management: a cross-sectional study in Iran. BMC Med Inform Decis Mak 20(1): 24.
  49. Kiyarosta N, Ghezeljeh TN, Naghashzadeh F, Feizi M, Haghani S. The effect of using smartphone applications on self-care in patients with heart failure. Nursing Practice Today 2020; 7(4): 311-21.
  50. Omidi Z, Kheirkhah M, Abolghasemi J, Haghighat S. Effect of lymphedema self-management group-based education compared with social network-based education on quality of life and fear of cancer recurrence in women with breast cancer: a randomized controlled clinical trial. Qual Life Res 2020; 29(7): 1789-800.
  51. Roosan D, Li Y, Law A, Truong H, Karim M,
    Chok J, et al. Improving medication information presentation through interactive visualization in mobile apps: human factors design. JMIR Mhealth Uhealth 2019; 7(11): e15940.
Journal of Isfahan Medical School
Volume 41, Issue 707
3rd Week, April
March and April 2023
Pages 69-82

  • Receive Date 28 September 2022
  • Accept Date 11 January 2023