Impact of Benefit Messages in Patient Package Inserts on Subjective Drug Perception

  • 8 Citations



To explore the impact of the inclusion of a benefit message in a patient package insert on knowledge about medicines and on subjective benefit/risk perception.


Female members of community social organizations, female relatives of psychology students, and caregivers to psychotic patients.

Nature of the study

Randomized, controlled healthy human volunteer study with three parallel experiments, involving the inserts of cisapride, itraconazol, and risperidon.


Subjects were recruited in a convenience sample and randomized to one control and two intervention groups (one with a normal insert and one with an insert with a benefit message). Material and methods: Subjects were asked to read the inserts (using mock text in the control group) in 5 to 15 minutes. Knowledge of the medication was tested with 20 simple questions (to be answered Yes/No/Don’t know) and benefit/risk perception with a five-point bipolar Likert scale. Results: In the three experiments respectively 89, 102, and 83 subjects were recruited. The provision of inserts increased the knowledge about medication in all the intervention groups. Thirty-one percent, 41%, and 54% of the subjects who read a normal insert agreed that the benefit of the medicine was greater than its risks, compared to 62%, 64%, and 70% of subjects who read an insert with a benefit message included (P < 0.05 in all 3 experiments). Discussion: A hypothesis for further research is formulated: adding a section on benefit information within a patient package insert helps to integrate increased knowledge about medication into a more balanced benefit/risk perception.

This is a preview of subscription content, log in to check access.

Access options

Buy single article

Instant unlimited access to the full article PDF.

US$ 39.95

Price includes VAT for USA

Subscribe to journal

Immediate online access to all issues from 2019. Subscription will auto renew annually.

US$ 189

This is the net price. Taxes to be calculated in checkout.


  1. 1.

    Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets. Brussels, Belgium: European Union; OJ No L 113/8, April 30, 1992.

  2. 2.

    Kenny T, Wilson RG, Purves IN, Clark J, Newton LD, Newton DP, Moseley DV. A PIL for every ill? Patient information leaflets (PILs): a review of past, present and future use. Fam Pract. 1998;15:471–479.

  3. 3.

    Vander Stichele RH, Bogaert MG. European legislation and research projects regarding patient education for medication. Drug Inf J. 1995;29:285–290.

  4. 4.

    Morris LA. The FDA approach to patient package inserts: the four phases of PPIs. In: Bogaert MG, Vander Stichele RH, Kaufman JM, Lefebvre R, eds. Patient Package Inserts as a Source of Information. Amsterdam: Elsevier Science Publishers; 1989:59–66.

  5. 5.

    Morris LA, Tabak ER, Gondek K. Counseling patients about prescribed medication: 12-year trends. Med Care. 1997;35:996–1007.

  6. 6.

    Vander Stichele RH, Van haecht CH, Braem MD, Bogaert MG. Attitude of the public toward technical package inserts for medication information in Belgium. DICP. 1991;25:1002–1006.

  7. 7.

    Nightingale SL. Written patient information on prescription drugs. The evolution of government and voluntary programs in the United States. Int J Technol Assess Health Care. 1995;11:399–409.

  8. 8.

    Vander Stichele RH. Promises of a measurement breakthrough. In: Métry JM, Meyer UA, eds. Drug Regimen Compliance. Issues in Clinical Trials and Patient Management. New York, NY: Wiley; 1999:71–83.

  9. 9.

    Leventhal H. The role of theory in the study of adherence to treatment and doctor-patient interactions. Med Care. 1985;23:556–563.

  10. 10.

    Slovic P. The Perception of Risk. London; Earthscan: 2000.

  11. 11.

    Alhakami AS, Slovic P. A psychological study of the inverse relationship between perceived risk and perceived benefit. Risk Anal. 1994;14:1085–1096.

  12. 12.

    Gibbs S, Waters WE, George CF. Prescription information leaflets: a national survey. J Roy Soc Med. 1990;83:292–297.

  13. 13.

    Rupf RE. Evaluation of Patient-oriented Drug Information: Package Leaflets as Viewed by the Patient and their Impact on Outpatients’ Behavior During Treatment. Doctoral thesis. University of Basel: Basel, Switzerland; 1991.

  14. 14.

    Peveler R, George C, Kinmonth AL, Campbell M, Thompson C. Effect of antidepressant drug counselling and information leaflets on adherence to drug treatment in primary care: randomised controlled trial. Br Med J. 1999;319:612–615.

  15. 15.

    Perkins DO. Adherence to antipsychotic medications. J Clin Psychiatry. 1999;60(Suppl. 21):25–30.

  16. 16.

    “Current Status of Useful Written Prescription Drug Information for Patients. Summary of FDA Public Workshop, held February 29-March 1, 2000, Rockville, MD, USA.”

  17. 17.

    Viscusi WK. Efficacy of labeling of foods and pharmaceuticals. Annu Rev Public Health. 1994;15:325–343.

  18. 18.

    Shenfield GM, Tasker JL. History in the making: the evolution of consumer product information (CPI). Med J Aust. 1997;166:425–428.

  19. 19.

    Amery WK. Coming full circle in pharmacovigilance: Communicating safety information to patients through patient package inserts. Pharmacoepidemiology and Drug Safety. 1999;8:121–129.

Download references

Author information

Correspondence to R. H. Vander Stichele MD.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Vander Stichele, R.H., Vandierendonck, A., De Vooght, G. et al. Impact of Benefit Messages in Patient Package Inserts on Subjective Drug Perception. Ther Innov Regul Sci 36, 201–208 (2002).

Download citation

Key Words

  • Drug labeling
  • Attitude toward health
  • Risk
  • Cognition
  • Pharmaceutical preparations