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Switching of Prescription Drugs to Over-the-Counter Status

Is it a Good Thing for the Elderly?

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Abstract

Prescription medicines are increasingly being switched to over-the-counter (OTC, nonprescription) status in the developed world, with the support of government policy. These changes may provide greater choice for individuals and offer potential savings in government spending on health while expanding the market for pharmaceutical companies. However, there is concern regarding the safety of these reclassifications.

Elderly people are the largest consumers of prescription and OTC medicines and are more vulnerable to drug adverse effects and the risks of multiple or inappropriate medications. Commonly purchased agents such as NSAIDs have recognised adverse effects which have been shown to be more common in the elderly. Furthermore, all sedatives, including antihistamines, have a propensity to cause falls in older people. As many doctors do not ask patients about OTC medicine use, problems related to use of these drugs may go undetected. Furthermore, the increased availability of OTCs may result in a delay in patients consulting medical practitioners for potentially serious conditions, although this has not so far been investigated. In the UK, the recent switch of a low-dose HMG-CoA reductase inhibitor (statin) to OTC status has caused concern. Although there might theoretically be some benefits from improved access to medications used in primary and secondary prevention of heart disease, the actual outcomes of use of this reduced dose of the statin will be difficult or impossible for patients or practitioners to monitor.

OTC drug use implies a mutual responsibility for communication between patients and health professionals that in practice is not always achieved. Epidemiological research is needed to investigate patterns of OTC use and evaluate the potential risks of OTC medicines in elderly people. Governments, regulatory bodies, professionals and the drug industry have a responsibility to ensure that robust systems are in place if the increased use of OTC medicines by elderly people is to be safe and effective.

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References

  1. Lowell M. Consumer trends in self diagnosis, home testing and over the counter medication: implications for the registered nurse. Kans Nurse 1995; 70(5): 1–2

    PubMed  CAS  Google Scholar 

  2. Barber N. Drugs: from prescription to pharmacy only. BMJ 1993; 307: 640

    Article  PubMed  CAS  Google Scholar 

  3. Food and Drug Administration/Centre for Drug Evaluation and Research. Over-the counter drug products public hearing 2000 [online]. Available from URL: http://www.fda.gov/cder/meeting/otcga-6000.htm [Accessed 2004 Mar 10]

  4. Minghetti P, Casiraghi A, Cilurzo F, et al. The situation of OTC drugs in Italy compared to the other EU states. Pharmacol Res 2000; 42: 25–31

    Article  PubMed  CAS  Google Scholar 

  5. Parmley WW. OTC or not OTC — that is the question. J Am Coll Cardiol 2000; 36(4): 1426–7

    Article  PubMed  CAS  Google Scholar 

  6. Schulke DG. American Pharmaceutical Association review of literature on prescription to over-the-counter drug switches. Clin Ther 1998; 20Suppl. C: C124–33

    Article  PubMed  Google Scholar 

  7. Amoako EP, Richardson-Campbell L, Kennedy-Malone L. Self-medication with over-the-counter drugs among elderly adults. J Gerontol Nurs 2003; 29(8): 10–5

    PubMed  Google Scholar 

  8. Pharand C, Ackman ML, Jackevicius CA, et al. Use of OTC and herbal products in patients with cardiovascular disease. Ann Pharmacother 2003; 37(6): 899–904

    Article  PubMed  Google Scholar 

  9. Thomas J, Straus WL, Bloom BS. Over-the-counter nonsteroidal anti-inflammatory drugs and risk of gastrointestinal symptoms. Am J Gastroenterol 2002; 97(9): 2215–9

    Article  PubMed  CAS  Google Scholar 

  10. Sleath B, Rubin RH, Campbell W, et al. Physician-patient communication about over-the-counter medications. Soc Sci Med 2001; 53(3): 357–69

    Article  PubMed  CAS  Google Scholar 

  11. Ackman ML, Campbell JB, Buzak KA, et al. Use of nonprescription medications by patients with congestive heart failure. Ann Pharmacother 1999; 33(6): 674–9

    Article  PubMed  CAS  Google Scholar 

  12. Roumie CL, Griffin MR. Over-the-counter analgesics in older adults: a call for improved labelling and consumer education. Drugs Aging 2004; 21(8): 485–98

    Article  PubMed  Google Scholar 

  13. Stoehr GP, Ganguli M, Seaberg EC, et al. Over-the-counter medication use in an older rural community: the MoVIES Project. J Am Geriatr Soc 1997; 45(2): 158–65

    PubMed  CAS  Google Scholar 

  14. Conn VS. Self-management of over-the-counter medications by older adults. Public Health Nurs 1992; 9(1): 29–36

    Article  PubMed  CAS  Google Scholar 

  15. Salom IL, Davis K. Prescribing for older patients: how to avoid toxic drug-reactions. Geriatrics 1995; 50: 37–43

    PubMed  CAS  Google Scholar 

  16. Fillenbaum GG, Horner RD, Hanlon JT, et al. Factors predicting change in prescription and nonprescription drug use in a community-residing black and white elderly population. J Clin Epidemiol 1996; 49(5): 587–93

    Article  PubMed  CAS  Google Scholar 

  17. Johnson RE, Ried LD. OTC drug use in an HMO: comparing the elderly and younger adults. J Aging Health 1996; 8(1): 114–35

    Article  PubMed  CAS  Google Scholar 

  18. Chrischilles EA, Lemke JH, Wallace RB, et al. Prevalence and characteristics of multiple analgesic drug use in an elderly group study. J Am Geriatr Soc 1990; 38(9): 979–84

    PubMed  CAS  Google Scholar 

  19. Conn VS. Older adults: factors that predict the use of over-the-counter medication. J Adv Nurs 1991; 16(10): 1190–6

    Article  PubMed  CAS  Google Scholar 

  20. Hanlon JT, Fillenbaum GG, Studenski SA, et al. Factors associated with suboptimal analgesic use in community dwelling elderly. Ann Pharmacother 1996; 30(7–8): 739–44

    PubMed  CAS  Google Scholar 

  21. Walop W, Amos S, Dalziel W, et al. Prescription and nonprescription drug use among at-risk community-dwelling seniors in Ottawa-Carleton. Can J Clin Pharmacol 1999; 6(2): 93–100

    PubMed  CAS  Google Scholar 

  22. Hanlon JT, Fillenbaum GG, Ruby CM, et al. Epidemiology of over-the-counter drug use in community dwelling elderly: United States perspective. Drugs Aging 2001; 18(2): 123–31

    Article  PubMed  CAS  Google Scholar 

  23. Sihvo S, Klaukka T, Martikainen J, et al. Frequency of daily over-the-counter drug use and potential clinically significant over-the-counter-prescription drug interactions in the Finnish adult population. Eur J Clin Pharmacol 2000; 56(6–7): 495–9

    Article  PubMed  CAS  Google Scholar 

  24. Espino DV, Lichtenstein MJ, Hazuda HP, et al. Correlates of prescription and over-the-counter medication usage among older Mexican Americans: the Hispanic EPESE study. Established Population for the Epidemiologic Study of the Elderly. J Am Geriatr Soc 1998; 46(10): 1228–34

    PubMed  CAS  Google Scholar 

  25. Westerlund LOT, Marklund BRG, Handl WHA, et al. Nonprescription drug-related problems and pharmacy interventions. Ann Pharmacother 2001; 35: 1343–9

    Article  PubMed  CAS  Google Scholar 

  26. McElnay JC, McCallion R. Non-prescription drug use by elderly patients. Int J Pharm Pract 1996; 4: 12–8

    Article  Google Scholar 

  27. Mason P. Has reclassification of GI drugs changed the treatment of disease? Pharm J 1996; 257: 731–2

    Google Scholar 

  28. Erwin J, Britten N, Jones R. General practitioners’ views on the over-the-counter availability of H2-antagonists. Br J Gen Pract 1997; 47(415): 99–102

    PubMed  CAS  Google Scholar 

  29. Brass EP. Changing the status of drugs from prescription to over-the-counter availability. N Engl J Med 2001; 345: 810–5

    Article  PubMed  CAS  Google Scholar 

  30. Stuart B, Grana J. Are prescribed and over-the-counter medicines economic substitutes? A study of the effects of health insurance on medicine choices by the elderly. Med Care 1995; 33(5): 487–501

    Article  PubMed  CAS  Google Scholar 

  31. Byrns PJ. Prescription to over-the-counter switches: the physician perspective. Clin Ther 1998; 20Suppl. C: C118–23

    Article  PubMed  Google Scholar 

  32. Batty GM, Oborne CA, Swift CG, et al. The use of over-the-counter medication by elderly medical in-patients. Postgrad Med J 1997; 73(865): 720–2

    Article  PubMed  CAS  Google Scholar 

  33. Busto UE, Sproule BA, Knight K, et al. Use of prescription and nonprescription hypnotics in a Canadian elderly population. Can J Clin Pharmacol 2001; 8(4): 213–21

    PubMed  CAS  Google Scholar 

  34. Barnett NL, Denham MJ, Francis SA. Over-the-counter medicines and the elderly. J R Coll Physicians Lond 2000; 34(5): 445–6

    PubMed  CAS  Google Scholar 

  35. Honig PK, Gillespie BK. Clinical significance of pharmacokinetic drug interactions with over-the-counter (OTC) drugs. Clin Pharmacokinet 1988; 35(3): 167–71

    Article  Google Scholar 

  36. Royal College of Physicians. Medication for older people. 2nd ed. London: RCP, 1997

    Google Scholar 

  37. Department of Health. National service framework for older people. London: The Stationery Office, 2001

    Google Scholar 

  38. Bisseil P, Ward PR, Noyce PR. Mapping the contours of risk: consumer perceptions of non-prescription medicines. J Soc Adm Pharm 2000; 17: 136–42

    Google Scholar 

  39. Rumelt MB. Blindness from misuse of over-the-counter eye medications. Ann Ophthalmol 1988; 20(1): 26–7, 30

    PubMed  CAS  Google Scholar 

  40. Ferris DG, Nyirjesy P, Sobel JD, et al. Over-the-counter antifungal drug misuse associated with patient-diagnosed vulvovaginal candidiasis. Obstet Gynecol 2002; 99(3): 419–25

    Article  PubMed  Google Scholar 

  41. Benrimoj SI, Langford JH, Bowden MG, et al. Switching drug availability from prescription only to over-the-counter status: are elderly patients at increased risk? Drugs Aging 1995; 7(4): 255–65

    Article  PubMed  CAS  Google Scholar 

  42. Marklund B, Lemne C, Andersson I-L, et al. Short- and long-term behavioural and medical effects of the OTC introduction of the first H2-blocker in Sweden. J Soc Adm Pharm 2001; 18(1): 35–40

    Google Scholar 

  43. Shaw MJ, Fendrick AM, Kane RL, et al. Self-reported effectiveness and physician consultation rate in users of over-the-counter histamine-2 receptor antagonists. Am J Gastroenterol 2001; 96(3): 673–6

    Article  PubMed  CAS  Google Scholar 

  44. Cebollero-Santamaria F, Smith J, Gioe S, et al. Selective outpatient management of upper gastrointestinal bleeding in the elderly. Am J Gastroenterol 1999; 94(5): 1242–7

    Article  PubMed  CAS  Google Scholar 

  45. Lanza FL, Codispoti JR, Nelson EB. An endoscopic comparison of gastroduodenal injury with over-the-counter doses of ketoprofen and acetaminophen. Am J Gastroenterol 1998; 93(7): 1051–4

    Article  PubMed  CAS  Google Scholar 

  46. Doyle G, Furey S, Berlin R, et al. Gastrointestinal safety and tolerance of ibuprofen at maximum over-the-counter dose. Aliment Pharmacol Ther 1999; 13(7): 897–906

    Article  PubMed  CAS  Google Scholar 

  47. Blot WJ, McLaughlin JK. Over the counter non-steroidal anti-inflammatory drugs and risk of gastrointestinal bleeding. J Epidemiol Biostat 2000; 5(2): 137–42

    PubMed  CAS  Google Scholar 

  48. Motola G, Russo F, Mazzeo F, et al. Over-the-counter oral nonsteroidal anti-inflammatory drugs: a pharmacoepidemiologic study in southern Italy. Adv Ther 2001; 18(5): 216–22

    Article  PubMed  CAS  Google Scholar 

  49. Scheiman JM, Cryer B, Kimmey MB, et al. A randomized, controlled comparison of ibuprofen at the maximal over-the-counter dose compared with prescription-dose celecoxib on upper gastrointestinal mucosal injury. Clin Gastroenterol Hepatol 2004; 2(4): 290–5

    Article  PubMed  CAS  Google Scholar 

  50. Lasagna L. Over-the-counter hypnotics and chronic insomnia in the elderly. J Clin Psychopharmacol 1995; 15(6): 383–6

    Article  PubMed  CAS  Google Scholar 

  51. Johnson JE. Insomnia, alcohol, and over-the-counter drug use in old-old urban women. J Community Health Nurs 1997; 14(3): 181–8

    Article  PubMed  CAS  Google Scholar 

  52. Weintraub M. Guidance for industry: over-the-counter treatment of hypercholesterolaemia. 1998 [online]. Available from URL: http://www.fda.gov/cder/guidance/index.htm [Accessed 2004 Mar 10]

  53. Dyer O. FDA rejects sale of over the counter statins. BMJ 2005; 330: 164

    Article  PubMed  Google Scholar 

  54. Bayliss E, Rutter P. General practitioners’ views on recent and proposed medicine switches from POM to P. Pharm J 2004; 273: 819–21

    Google Scholar 

  55. Dyer O. Consumers’ Association voices concern at over the counter statins. BMJ 2004; 329: 310

    Article  PubMed  Google Scholar 

  56. OTC statins: a bad decision for public health. Lancet 2004; 3563: 1659

    Google Scholar 

  57. Bradley C, Blenkinsopp A. Over the counter drugs: the future for self-medication. BMJ 1996; 312: 835–7

    Article  PubMed  CAS  Google Scholar 

  58. Stoller EP. Prescribed and over-the-counter medicine use by the ambulatory elderly. Med Care 1988; 26(12): 1149–57

    Article  PubMed  CAS  Google Scholar 

  59. Holden MD. Over-the-counter medications: do you know what your patients are taking? Postgrad Med 1992; 91(8): 191–4, 199–200

    PubMed  CAS  Google Scholar 

  60. Sansgiry SS, Cady PS. How the elderly and young adults differ in the decision making process of nonprescription medication purchases. Health Mark Q 1996; 14(1): 3–21

    Article  PubMed  CAS  Google Scholar 

  61. Isacson D, Bingefors C. On Rx switches and access to over-the-counter drugs in Sweden. J Soc Adm Pharm 1999; 16(1): 13–25

    Google Scholar 

  62. Sansgiry SS, Cady PS, Paul S. Readability of over-the-counter medication labels. J Am Pharm Assoc 1997; NS37: 522–8

    CAS  Google Scholar 

  63. Johnson MM, Drungle SC. Purchasing over-the-counter medications: the influence of age and familiarity. Exp Aging Res 2000; 26(3): 245–61

    Article  PubMed  CAS  Google Scholar 

  64. Watanabe RK, Gilbreath K, Sakamoto CC. The ability of the geriatric population to read labels on over-the-counter medication containers. J Am Optom Assoc 1994; 65(1): 32–7

    PubMed  CAS  Google Scholar 

  65. Wogalter MS, Magurno AB, Dietrich DA, et al. Enhancing information acquisition for over-the-counter medications by making better use of container surface space. Exp Aging Res 1999; 25(1): 27–48

    Article  PubMed  CAS  Google Scholar 

  66. Lundberg L, Isacson D. The impact of over-the-counter availability of nasal sprays on sales, prescribing, and physician visits. Scand J Prim Health Care 1999; 17(1): 41–5

    Article  PubMed  CAS  Google Scholar 

  67. Bodenheimer TS. Affordable prescriptions for the elderly. JAMA 2001; 286(14): 1762–3

    Article  PubMed  CAS  Google Scholar 

  68. Martin RM, Quill J. Willingness to purchase over-the-counter (OTC) simvastatin 10mg is not related to coronary heart disease risk. BMJ 2005 [online]. Available from URL: http://bmj.bmjjournals.com/cgi/eletters/329/7461/310-e#76202 [Accessed 2005 Jan 26]

  69. Bowden M, Benrimoj SI. Proposals for amending the criteria for transferring medicines from prescription to non-prescription. Aust Pharmacist 1994; 13: 519–25

    Google Scholar 

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Acknowledgements

No sources of funding were used to assist in the preparation of this review. The authors have no conflicts of interest that are directly relevant to the content of this review.

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Authors and Affiliations

  1. Department of Practice and Policy, School of Pharmacy, University of London, London, UK

    Sally-Anne Francis

  2. Pharmacy Department, London, Eastern and South East Specialist Pharmacy Services, Northwick Park Hospital, Watford Road, Harrow, HA1 3UJ, UK

    Nina Barnett

  3. Department of Geriatrics, Northwick Park Hospital, Harrow, UK

    Michael Denham

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  1. Sally-Anne Francis
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  2. Nina Barnett
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  3. Michael Denham
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Correspondence to Nina Barnett.

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Francis, SA., Barnett, N. & Denham, M. Switching of Prescription Drugs to Over-the-Counter Status. Drugs Aging 22, 361–370 (2005). https://doi.org/10.2165/00002512-200522050-00001

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