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1

Rosenau, Pauline Vaillancourt. "Rx-to-OTC Switch Movement." Medical Care Review 51, no. 4 (1994): 429–66. http://dx.doi.org/10.1177/107755879405100403.

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Bonner, Loren. "In Rx-to-OTC switch, FDA approves first OTC retinoid." Pharmacy Today 22, no. 9 (2016): 28. http://dx.doi.org/10.1016/j.ptdy.2016.08.017.

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Wion, Ann H. "RX-TO-OTC Switch—The Process and Procedures." Drug Information Journal 19, no. 2 (1985): 119–26. http://dx.doi.org/10.1177/009286158501900207.

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Halperin, Jerome A. "Strategic Issues in the Rx-to-OTC Switch." Drug Information Journal 24, no. 1 (1990): 13–18. http://dx.doi.org/10.1177/009286159002400104.

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Peck, Jonathan C. "Future Health Care Trends Affecting Rx-to-OTC Switch." Drug Information Journal 24, no. 1 (1990): 49–56. http://dx.doi.org/10.1177/009286159002400110.

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Marwick, Charles. "From Rx to OTC: More Drugs Make the Switch." JAMA: The Journal of the American Medical Association 278, no. 2 (1997): 103. http://dx.doi.org/10.1001/jama.1997.03550020033015.

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Marwick, C. "From Rx to OTC: more drugs make the switch." JAMA: The Journal of the American Medical Association 278, no. 2 (1997): 103. http://dx.doi.org/10.1001/jama.278.2.103.

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&NA;. "No adverse effect of Rx-to-OTC switch for H2RAs." Reactions Weekly &NA;, no. 1046 (2005): 5. http://dx.doi.org/10.2165/00128415-200510460-00016.

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Oster, Gerry, Daniel M. Huse, Thomas E. Delea, Graham A. Colditz, and James M. Richter. "The Risks and Benefits of an Rx-to-OTC Switch." Medical Care 28, no. 9 (1990): 834–52. http://dx.doi.org/10.1097/00005650-199009000-00012.

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Hewitt, Nancy M., Joan M. Lausier, and Sara Rosenbaum. "Labeling and Advertising of OTC Medicines Special Emphasis on RX-to-OTC Switch Products." Clinical Research and Regulatory Affairs 11, no. 3-4 (1994): 207–23. http://dx.doi.org/10.3109/10601339409035943.

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Halperin, Jerome A. "Introduction to Session IV: What Comes after Rx-to-OTC Switch?" Drug Information Journal 19, no. 2 (1985): 177–78. http://dx.doi.org/10.1177/009286158501900219.

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Chan, Clarissa. "FDA approves Rx-to-OTC switch of head lice removal product." Pharmacy Today 27, no. 1 (2021): 18–19. http://dx.doi.org/10.1016/j.ptdy.2020.12.008.

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Gumbie, M., B. Parkinson, and H. Cutler. "Is The Oral Contraceptive Pill Rx to Otc Switch Cost-Effective?" Value in Health 21 (September 2018): S59. http://dx.doi.org/10.1016/j.jval.2018.07.446.

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Chan, Clarissa. "FDA approves Rx-to-OTC switch of head lice removal product." Pharmacy Today 27, no. 1 (2021): 18–19. http://dx.doi.org/10.1016/j.ptdy.2020.12.008.

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Palumbo, Francis B. "The Impact of the Rx to OTC Switch on Practicing Pharmacists." American Pharmacy 31, no. 4 (1991): 41–43. http://dx.doi.org/10.1016/s0160-3450(16)33704-7.

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Bowden, Mark, and Shalom I. Benrimoj. "Pharmacists' Attitudes Toward the Switch from Rx to OTC: The Australian Situation." Journal of Pharmaceutical Marketing & Management 10, no. 1 (1995): 29–43. http://dx.doi.org/10.3109/j058v10n01_03.

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Pellise, L., and M. Serra. "The Economic Impact of an Hypothetical Rx-To-otc Switch in Spain." Value in Health 18, no. 7 (2015): A341. http://dx.doi.org/10.1016/j.jval.2015.09.146.

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Milonas, C., A. Milonas, D. Kouvelas, G. Dokios, and N. Maniadakis. "PHP84 The Economic Health Value from Rx to OTC Switch in Greece." Value in Health 15, no. 7 (2012): A303. http://dx.doi.org/10.1016/j.jval.2012.08.626.

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Millier, Aurelie, Joshua Cohen, and Mondher Toumi. "Economic Impact of a triptan Rx-To-OTC Switch in Six EU Countries." PLoS ONE 8, no. 12 (2013): e84088. http://dx.doi.org/10.1371/journal.pone.0084088.

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Dr., Shivalika* Rohit Dhiman Sachin. "The Silent Pillars of Self-Care: A Deep Dive into Over-the-Counter Drug." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 3066–88. https://doi.org/10.5281/zenodo.15458796.

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This study examines the vital role that over-the-counter (OTC) medications play in contemporary healthcare, highlighting their affordability, accessibility, and role in self-medication. It explores the regulatory frameworks, approval procedures, and categorization criteria put in place by organizations like the FDA and WHO to guarantee consumer safety. The study emphasizes the advantages of over-the-counter medications as well as their possible drawbacks, such as drug abuse, incorrect self-diagnosis, and unfavorable drug combinations. The characteristics of the Indian OTC industry, the growing
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21

Madhavan, Suresh, and Stephen W. Schondelmeyer. "Attitudes of Pharmacists Toward Rx-to-OTC Switches and Their Effect on Pharmacists' Overall Judgment of Switch Appropriateness." Journal of Pharmaceutical Marketing & Management 4, no. 4 (1990): 3–25. http://dx.doi.org/10.3109/j058v04n04_02.

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Madhavan, Suresh. "Attitudes of Pharmacists Toward Rx-to-OTC Switches and Their Effect on Pharmacists' Overall Judgment of Switch Appropriateness." Journal of Pharmaceutical Marketing & Management 4, no. 4 (1990): 3–25. http://dx.doi.org/10.1300/j058v04n04_02.

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23

Schneider-Ziebe, Anissa, and Uwe May. "The treatment of migraine patients with triptans – is there a need for further Rx-to-OTC switches?" Gesundheitsökonomie & Qualitätsmanagement 25, no. 01 (2019): 15–23. http://dx.doi.org/10.1055/a-0836-2852.

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Abstract Objective The disease migraine affects a large share of the German population and is linked to a high economic potential in terms of direct and indirect sickness costs. Triptans are the recommended treatment in the case of an acute migraine attack. Both, the disease and its appropriate treatment are of interest in the context of self-medication and Rx-to-OTC switch efforts. Therefore, a survey was carried out with the intention to collect data among migraine patients regarding the use of analgesics in general and of triptans specifically. This data can be the basis for further health
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24

Wei, Jianxiang, Guanzhong Feng, Zhiqiang Lu, Pu Han, Yunxia Zhu, and Weidong Huang. "Evaluating Drug Risk Using GAN and SMOTE Based on CFDA’s Spontaneous Reporting Data." Journal of Healthcare Engineering 2021 (August 27, 2021): 1–14. http://dx.doi.org/10.1155/2021/6033860.

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Adverse drug reactions (ADRs) pose health threats to humans. Therefore, the risk re-evaluation of post-marketing drugs has become an important part of the pharmacovigilance work of various countries. In China, drugs are mainly divided into three categories, from high-risk to low-risk drugs, namely, prescription drugs (Rx), over-the-counter drugs A (OTC-A), and over-the-counter drugs B (OTC-B). Until now, there has been a lack of automated evaluation methods for the three status switch of drugs. Based on China Food and Drug Administration’s (CFDA) spontaneous reporting database (CSRD), we propo
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25

Madhavan, Suresh, and Prasanna R. Gore. "Influence of Physicians' Attitudes Toward Rx-to-OTC Switches on Their Prescribing Behavior and Overall Judgment of Switch Appropriateness." Journal of Pharmaceutical Marketing & Management 8, no. 1 (1994): 55–84. http://dx.doi.org/10.3109/j058v08n01_05.

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Madhavan, Suresh. "Influence of Physicians' Attitudes Toward Rx-to-OTC Switches on Their Prescribing Behavior and Overall Judgment of Switch Appropriateness." Journal of Pharmaceutical Marketing & Management 8, no. 1 (1994): 55–84. http://dx.doi.org/10.1300/j058v08n01_05.

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Andrade, Susan E., Jerry H. Gurwitz, and Leslie S. Fish. "The Effect of an Rx-to-OTC Switch on Medication Prescribing Patterns and Utilization of Physician Services." Medical Care 37, no. 4 (1999): 424–30. http://dx.doi.org/10.1097/00005650-199904000-00012.

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28

Creyer, Elizabeth H., Illias Hrsistodoulakis, and Catherine A. Cole. "Changing a drug from Rx to OTC status: the consumer behavior and public policy implications of switch drugs." Journal of Product & Brand Management 10, no. 1 (2001): 52–64. http://dx.doi.org/10.1108/10610420110382821.

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Jaidka, Ridham, Parul Verma, Deepali Thakur, Kiran Bala, Amar Pal Singh, and Ajeet Pal Singh. "Review article on over the counter drugs: Growth, benefits and side effects, RX to OTC switch process, classification, pharmacist role." International Journal of Pharmaceutical Research and Development 7, no. 1 (2025): 305–11. https://doi.org/10.33545/26646862.2025.v7.i1d.124.

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Chang, Dong W., Jonathan Grotts, Chi-hong Tseng, and Eric P. Brass. "Time Trends in Physician Visits for Gastroesophageal Reflux Disease Before and After the Rx-to-OTC Switch of Proton Pump Inhibitors." Journal of Clinical Pharmacology 57, no. 4 (2016): 452–58. http://dx.doi.org/10.1002/jcph.825.

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Sullivan, P., KV Nair, and BV Patel. "PAL1 THE IMPACT OF THE RX-TO-OTC SWITCH OF LORATADINE AND CHANGES IN PRESCRIPTION DRUG BENEFITS ON UTILIZATION AND COST OF THERAPY." Value in Health 8, no. 3 (2005): 338–39. http://dx.doi.org/10.1016/s1098-3015(10)62892-6.

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Sullivan, P., KV Nair, and BV Patel. "PAL1 THE IMPACT OF THE RX-TO-OTC SWITCH OF LORATADINE AND CHANGES IN PRESCRIPTION DRUG BENEFITS ON UTILIZATION AND COST OF THERAPY." Value in Health 8, no. 3 (2005): 339. http://dx.doi.org/10.1016/s1098-3015(10)62893-8.

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Plich, A., S. M. Karray, S. Flostrand, and M. Toumi. "PRM25 Switch of Prescription Drugs to the Over-the-Counter Status (Rx-to-OTC): The Development of a Flexible and Generic European Budget Impact Model." Value in Health 14, no. 7 (2011): A425. http://dx.doi.org/10.1016/j.jval.2011.08.1056.

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Shiffman, Saul, and Christine T. Sweeney. "Ten years after the Rx-to-OTC switch of nicotine replacement therapy: What have we learned about the benefits and risks of non-prescription availability?" Health Policy 86, no. 1 (2008): 17–26. http://dx.doi.org/10.1016/j.healthpol.2007.08.006.

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Sullivan, Patrick W., and Michael B. Nichol. "The Economic Impact of Payer Policies after the Rx-to-OTC Switch of Second-Generation Antihistamines* *Preliminary results of this analysis were presented at the 9th annual HMO Research Network Conference April 1-2, 2003." Value in Health 7, no. 4 (2004): 402–12. http://dx.doi.org/10.1111/j.1524-4733.2004.74003.x.

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Newton, Gail, Nicholas G. Popovich, and W. Steven Pray. "Rx-to-OTC Switches: From Prescription to Self-Care." Journal of the American Pharmaceutical Association (1996) 36, no. 8 (1996): 488–95. http://dx.doi.org/10.1016/s1086-5802(16)30103-6.

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Cada, Dennis. "Rx-to-otc Switches for HMG-CoA Reductase Inhibitors." Hospital Pharmacy 35, no. 10 (2000): 1024. http://dx.doi.org/10.1177/001857870003501007.

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Mahecha, Laura A. "Rx-to-OTC switches: trends and factors underlying success." Nature Reviews Drug Discovery 5, no. 5 (2006): 380–86. http://dx.doi.org/10.1038/nrd2028.

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Narui, Koji, Mayumi Mochizuki, and Kinzo Watanabe. "A Survey of Consumer Views on Rx-to-OTC Switches." Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences) 39, no. 12 (2013): 726–32. http://dx.doi.org/10.5649/jjphcs.39.726.

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Kubota, Sachie, Kazuyuki Saito, Shunsuke Ono, and Yasuo Kodama. "Survey of Pharmacists' Views on Rx-to-OTC Switched Drugs." Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences) 43, no. 6 (2017): 287–96. http://dx.doi.org/10.5649/jjphcs.43.287.

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41

Hoy, Mariea Grubbs. "Switch Drugs Vis-à-Vis Rx and OTC: Policy, Marketing, and Research Considerations." Journal of Public Policy & Marketing 13, no. 1 (1994): 85–96. http://dx.doi.org/10.1177/074391569401300107.

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The over-the-counter drug market is expected to nearly double in sales from 1990 to 2000, attributed primarily to a growing product class: prescription drugs that are “switched” to over-the-counter status. The author presents a framework in which to compare and contrast switch drugs with prescription and over-the-counter drugs by evaluating them in light of health and safety, economic, consumer behavior, and marketing considerations. She also addresses the general policy implications and marketing communications considerations for switch drugs in light of their relationship to consumer choice
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Madhavan, Suresh, and Prasanna Gore. "A Multidimensional Analysis of Physicians' Perceptions of Rx-to-OTC Switched Drug Products." Journal of Pharmaceutical Marketing & Management 8, no. 3 (1994): 3–28. http://dx.doi.org/10.3109/j058v08n03_02.

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Madhavan, Suresh. "A Multidimensional Analysis of Physicians' Perceptions of Rx-to-OTC Switched Drug Products." Journal of Pharmaceutical Marketing & Management 8, no. 3 (1994): 3–28. http://dx.doi.org/10.1300/j058v08n03_02.

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Morris, Louis A., Karen Lechter, Michael Weintraub, and Debra Bowen. "Comprehension Testing for OTC Drug Labels: Goals, Methods, Target Population, and Testing Environment." Journal of Public Policy & Marketing 17, no. 1 (1998): 86–96. http://dx.doi.org/10.1177/074391569801700109.

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Drug products may be switched from precription (Rx) to over-the-counter (OTC) status if labeling can be written that ensures that the label information is comprehensible to ordinary consumers, including persons with low literacy ability, under normal conditions of purchase and use. The Food and Drug Administration has been working with sponsors to develop methods to test consumer comprehension of proposed OTC product labels. The authors discuss several conceptual and operational elements of comprehension testing, focusing on the goals, methods, appropriate target audience, and testing environm
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Madhavan, S. "Factors influencing pharmacists' preference for the legal classification of Rx–to–OTC switched drug products." Journal of Clinical Pharmacy and Therapeutics 18, no. 4 (1993): 281–90. http://dx.doi.org/10.1111/j.1365-2710.1993.tb00589.x.

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Cohen, J., A. Millier, S. Karray, and M. Toumi. "Assessing the economic impact of Rx-to-OTC switches: systematic review and guidelines for future development." Journal of Medical Economics 16, no. 6 (2013): 835–44. http://dx.doi.org/10.3111/13696998.2013.793693.

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Noguchi, Yoshihiro, Aki Yoshida, Ikuto Sugita, et al. "Signal Detection Analysis of Serious Adverse Events Associated with the Digestive Disorder Treatment Agents Rx-To-OTC Switched." Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences) 42, no. 7 (2016): 529–35. http://dx.doi.org/10.5649/jjphcs.42.529.

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Karray, S. M., A. Plich, S. Flostrand, and M. Toumi. "PHP31 The Economic Impact of Switches of Prescription Drugs to the Over-the-Counter Status (Rx-to-OTC): A Systematic Literature Review." Value in Health 14, no. 7 (2011): A338—A339. http://dx.doi.org/10.1016/j.jval.2011.08.582.

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Noguchi, Yoshihiro, Hiroki Esaki, Shoko Asano, et al. "Analysis of Adverse Events Associated with the Anti-Allergic Agents Rx-to-OTC-Switched Using Data Mining of the Japanese Adverse Drug Event Report (JADER) Database." Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences) 41, no. 9 (2015): 667–75. http://dx.doi.org/10.5649/jjphcs.41.667.

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Waring, Mark, and Amritdeep Gill. "Impact of Switch to Non-Prescription Status on the Safety Profile of Sildenafil and Tadalafil: Assessment of Pharmacovigilance Databases." Indian Journal of Pharmaceutical Sciences, 2024, 01–16. https://doi.org/10.36468/pharmaceutical-sciences.24.12.497.

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Introduction: Sildenafil and tadalafil are phosphodiesterase type 5 inhibitors used to treat erectile dysfunction. In recent years, both medicines have increasingly been made available as Non-Prescription (non-Rx) or Over-TheCounter (OTC) medications in several countries. This analysis aimed to assess if these switches from prescription to non-Rx status had any impact on the safety profile of these medicines. Method: Individual Case Safety Reports (ICSRs) for sildenafil and tadalafil were retrieved from EudraVigilance, FAERS and SMARS databases for countries where these drugs switched to non-p
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