Over-the-counter Switch Research Articles

Survey of community pharmacists' opinions on drug scheduling in Ontario and Québec.

Over the past decade, Canada has witnessed a shift of several drugs from prescription-only to behind-the-counter (BTC) and over-the-counter (OTC) status. This work examined community pharmacists' agreement with the current scheduling of agents used in the management of allergic rhinitis, heartburn, and vulvovaginitis. From September to October 2022, an online survey was administered to pharmacists practicing in in Ontario and Québec. The survey aimed to gather insights into their preferred scheduling for 15 medicines commonly used to manage the three selected conditions. Pharmacists were asked whether they agreed with the current scheduling status of each and, if not, how they feel it should be scheduled. 715 pharmacists completed the survey, 462 from Ontario and 253 from Québec. Most were staff pharmacists working 30 or more hours per week, having been a pharmacist for 1-10 years. Ontario pharmacists expressed a preference for scheduling change for five drugs (four prescription [terconazole for intravaginal use, famotidine, rupatadine, mometasone nasal spray] and one unscheduled [ranitidine 75 mg]), while Québec pharmacists expressed preference for scheduling change for three prescription drugs (terconazole for intravaginal use, famotidine, rupatadine). As pharmacy practice continues to evolve, pharmacists' comfort with initiating previously prescription-only therapy independently or assisting patients with self-selection may similarly evolve. Of the five drugs identified as having a discrepancy between current status and pharmacist preference, four are prescription and may be candidates to consider for prescription to OTC switch. Pharmacists in Ontario and Québec have expressed preference for most products used in the treatment of allergic rhinitis, heartburn, and vulvovaginitis to be categorised as Schedule II (BTC) or Schedule III (OTC) available only in pharmacies.

Rx -to- OTC switch increased access and lowered cost of topical adapalene.

Topical adapalene gel is an effective and well tolerated acne treatment that transitioned from prescription to over-the-counter (OTC) availability in 2016. Historically, prescription to OTC transitions have lowered costs to patients and payers and increased access to medications. This study used sales and prescriber data to assess access to topical retinoid therapies and their costs in the pre- and post- Rx-to-OTC transition. We demonstrate that the prescription to OTC transition of adapalene gel increased access to this medication, while lowering costs to patients and payers, including Medicare patients. These results provide a necessary call to action for future OTC shifts with other high safety profile, well-tolerated medications in ultimate efforts and hopes of cost savings for patients, insurers, and Medicare within our healthcare industry.

Modeling the potential benefit of an over-the-counter progestin-only pill in preventing unintended pregnancies in the U.S.

To develop a model to estimate the possible impact of use of an over-the-counter (OTC) progestin-only pill (POP) on the number of unintended pregnancies in the United States. Using typical use failure rates (7% for POPs), we compared the expected number of unintended pregnancies for two theoretical cohorts of 100,000 women: one which purchased and used an OTC POP exclusively for contraception, the other using contraceptive methods at proportions obtained from an actual-use clinical trial simulating OTC use of norgestrel 0.075 mg (including 35% using no method and only 19% using hormonal contraception or long-acting contraceptives). Sensitivity analyses were conducted using alternative model inputs such as different failure rates for OTC POPs and varied alternative contraceptive method mix. An estimated 37,624 unintended pregnancies would occur annually if 100,000 women continued their usual contraceptive method as used at baseline in the actual use trial. This would be reduced by 81% to 7,000 pregnancies with the exclusive use of an OTC POP - a net reduction of 30,624 unintended pregnancies annually. While the number of unintended pregnancies prevented varied as the model parameters were modified (ranging from 1,461 to 34,124), a net benefit of OTC POP use was observed over a wide range of input values. Using data from a real-world contraception user profile, our model suggests that use of an OTC POP could reduce the overall number of unintended pregnancies in the United States. This conclusion remains true across a wide range of modeled scenarios. The estimates suggested by this model are supportive of an OTC switch for a POP.

Prescription to Over-the-Counter Switch of Metronidazole and Azelaic Acid for Treatment of Rosacea

In 1951, the Durham-Humphrey Amendment to the US Federal Food, Drug, and Cosmetic Act of 1938 was enacted to label medications into 2 specific categories: prescription vs over the counter (OTC). This amendment required that any habit-forming or potentially harmful medications be dispensed under the direct guidance of a health care professional. “Rx to OTC switch” is defined as the transfer of prescription drugs to OTC status; it is a data-driven process, rigorously regulated by the US Food and Drug Administration (FDA). For the switch to occur, the candidate drug must demonstrate proven efficacy and a wide safety margin and bear understandable labeling for proper use. In recent decades, the increased demand by consumers to take charge of their own medical care has impelled the prescription to OTC switch of more than 100 medications that were previously available only by prescription. In this Viewpoint, we consider the possibility that the topical treatments for rosacea, specifically metronidazole and azelaic acid, should undergo review for the prescription to OTC switch. We outline the potential advantages and disadvantages of such a switch.

Over-the-counter access to oral contraceptives as a reproductive healthcare strategy

The aim of this review is to summarize the current evidence on the safety and effectiveness of moving oral contraceptives from prescription-only to over-the-counter (OTC) status. The review also examines women's interest in OTC access to oral contraceptives, as well as potential barriers and facilitators to an OTC switch. Studies show that women can safely self-screen for contraindications to oral contraceptives - especially progestin-only pills - without the aid of a clinician. One study in Texas found that women using pills obtained OTC in Mexico were significantly less likely to discontinue compared to women obtaining pills at US clinics by prescription. A national representative survey of US women at risk of unintended pregnancy found widespread interest in using OTC pills, and many women worldwide already have access to pills without a prescription. On average, the most US women report being willing to pay for an OTC pill is $20. OTC access to oral contraceptives could help to reduce unintended pregnancy by increasing the number of pill users, improve continuation and reduce gaps in use. It is critical that a future OTC pill be made available at an accessible price, and it should be covered by insurance without a prescription. Research suggests that common concerns about the safety of oral contraceptives OTC and a potential negative effect on women's use of preventive services are largely unsupported.

Results of a National Survey on OTC Medicines, Part 2: Do Pharmacists Support Switching Prescription Agents to Over-the-Counter Status?

Switching prescribed medications to over- or behind-the-counter status is considered an option to improve accessibility to treatment while insuring appropriate and safe use. For example, in the UK, omeprazole and simvastatin have already been granted over-the-counter (OTC) status, while omeprazole has nonprescription status in the USA. KEY POINTS Pharmacists in Canada do not support the deregulation of simvastatin or omeprazole and only moderately support an OTC switch for fluticasone. The complexity of disease and drug management was listed as the main barrier to OTC switch. Additional training was perceived as a facilitator of OTC switch. Other issues included access to laboratory test results, liability issues and loss of drug plan coverage POINTS CLES Les pharmaciens ne sont pas en faveur de la dereglementation de la simvastatine ou de l'omeprazole et ne sont que moderement en faveur de la mise en vente libre du fluticasone. La complexite de la maladie et de la prise en charge pharmaceutique a ete citee comme principal motif d'opposition a la mise en vente libre. On estime qu'une formation supplementaire serait necessaire pour faciliter le reclassement du produit parmi les medicaments en vente libre. Parmi les autres questions soulevees, mentionnons l'acces aux resultats d'analyses de laboratoire, les questions de responsabilite et le retrait du regime d'assurance-medicaments. In Canada, switching prescribed medications to OTC status (Schedule II) can have major implications for pharmacists. The level of care required to ensure safe selection and use may be quite significant. To date, few reports in Canada have dealt with pharmacists' readiness to expand practice in this area. Indeed, some concern has been expressed over the ability of pharmacists to engage in more patient assessment.1 In this paper, we explore pharmacists' readiness for switching simvastatin, omeprazole and fluticasone to Schedule II status. We also identify the barriers and facilitators for such a switch.

Proactive Planning of the Timing of a Partial Switch of a Prescription to Over‐the‐Counter Drug

This paper focuses on the proactive planning of a partial switch of a prescription (Rx) drug brand to over‐the‐counter (OTC) status within the former's patent‐protected life. The planning issues are whether and when to make this switch from the “single‐status” Rx drug phase to the “dual‐status” Rx+OTC phase with or without the grant of a 3‐year market exclusivity period for the OTC drug by the US Food and Drug Administration. We formulate an optimal control problem that leads to a two‐phase optimization problem with finite‐time horizon involving switching time‐dependent switching cost and terminal value. Applying a variational approach, we establish the conditions under which it can be optimal to make the partial switch. Counter to conventional thinking, the grant of market exclusivity is neither necessary nor sufficient for a partial switch before the Rx drug's patent expiry. Further, we show in a functionally specified model‐based illustration, involving varying combinations of plausible ratios of OTC and Rx version margins and potential market sizes, that denial of OTC market exclusivity can imply that the firm should advance rather than delay the partial switch, and yield greater savings for Rx drug consumers. Implications for pharmaceutical Rx–OTC switch planners and policymakers are discussed.

Corrigendum: Are Nonprescription Medications Needed for Weight Control?

ObesityVolume 16, Issue 7 p. 1723-1723 Corrigendum: Are Nonprescription Medications Needed for Weight Control? First published: 06 September 2012 https://doi.org/10.1038/oby.2008.241AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat George A. Bray Obesity 16, 566–571 (2008) Following the print publication of this article, the author noted that an acknowledgment of intellectual and financial support from GlaxoSmithKline (GSK) was inadvertently omitted (1). The basis for this omission is described below and the acknowledgment made. About 5 years ago, Roche asked me whether I wanted to consult on their proposal to switch orlistat from a prescription to an over-the-counter (OTC) product. Following the withdrawal of phenylpropanolamine by the Food and Drug Administration (FDA), there were no OTC compounds for weight loss available to the public, only “herbal medications” which had little or no testing. Being a firm believer in availability of safe medications for use by the public, I accepted the offer and duly met with the Company and the FDA. The FDA laid out the plan of what was needed for a prescription to OTC switch. Roche then either sold or licensed orlistat to GSK to market as the OTC pill now called “Alli.” GSK subsequently asked me whether I was interested in writing a paper about the place of OTC medications in the treatment of obesity. This seemed like a good idea, and we originally planned to do it jointly with one or more people from GSK as co-authors on the paper. Their focus was on the potential value of orlistat (Alli) to reduce the public health burden of obesity. Believing, as Oliver (2) said in his 2006 book, that “The greatest share of the market for diet products is not made up of people who are trying to lose 200 lb, but by people who are trying to lose only 20 (p. 52)” my concern was largely with the balance between the risks and benefits that OTC products for weight loss bring to improving the quality of life, or cosmetic value that might result from use of this product, and not the public health message that it could improve “risk factors” for disease. With this divergence of opinion, the potential GSK co-authors decided that they should not be authors, so it became a single-authored paper. In the process of this change, I forgot to publish an acknowledgment to their help in writing the paper or for a travel grant they provided for me to attend the 10th International Congress on Obesity in Sydney, Australia. My discussions with them were beneficial, particularly their pointing out the existence of the National Business Journal which reviewed the use of products for weight loss and which was cited in the paper. I thus acknowledge both the intellectual contributions to this paper and the financial support for travel to the International Congress on Obesity. REFERENCES 1 Bray GA. Are non-prescription medications needed for weight control? Obesity 2008; 16: 566– 571. 2 Oliver JE. Fat Politics. Oxford University Press: Oxford, UK, 2006. Volume16, Issue7July 2008Pages 1723-1723 ReferencesRelatedInformation

EXAMINATION OF PROPOSED OTC STATUS FOR NONSEDATING ANTIHISTAMINES*

ABSTRACTLoratadine, fexofenadine, and cetirizine are orally active H1-receptor antagonists that do not have the sedating side effects of earlier antihistamines like chlorpheniramine. In 1998, Wellpoint Health Networks filed a citizen petition with the FDA to request the reclassification of certain marketed products containing these second generation antihistamines to over-the-counter (OTC) status in the United States. Contrary to common practice, this switch request did not originate from the manufacturers of these drugs. This remarkable departure from conventional practice related to the switch process makes this citizen switch petition unprecedented in nature. The unparalleled nature of this case raises many significant regulatory, safety, and legal issues related to the OTC switch process in the United States. This article aims to present an objective and detailed examination of the regulatory and safety issues related to this OTC switch petition.

Changing a drug from Rx to OTC status: the consumer behavior and public policy implications of switch drugs

The rapid proliferation of drugs being switched from prescription (Rx) to over‐the‐counter (OTC) status within the USA has raised a number of important consumer behavior and public policy concerns. The following issue served as the focus of our research. Given the increasing assortment and widespread availability of Rx to OTC switch drugs, how might consumers’ health care preferences change? That is, what factors influence whether a consumer is more likely to visit their physician rather than self‐medicate symptoms of heartburn and indigestion with a new switch drug?

Impact of the Switch of Nicotine Replacement Therapy to Over-The-Counter Status

PURPOSE: Nicotine replacement therapy (NRT) sales switched from prescription to over-the-counter (OTC) status in April 1996. The change was expected to benefit public health by increasing smokers' access to NRT, and industry data show a doubling of NRT sales since the switch. We used a population-based sample to assess whether OTC availability increased smokers' rates of 1) NRT use, 2) quit attempts, and 3) cessation. METHODS: We analyzed data from the Massachusetts Tobacco Surveys, telephone surveys of a probability sample of Massachusetts (MA) residents (response rates 68%–78%). We compared responses from past-year smokers in 1993 (pre-OTC; N = 1784) to those from 1997–99 (post-OTC; N = 1240), using multiple logistic regression. We also compared the demographic characteristics of NRT users before and after the OTC switch among smokers who had made a quit attempt in the past year. RESULTS: There was no significant change over time in the proportion of respondents using NRT at a quit attempt in the past year (20.1% pre-OTC vs. 19.9% post-OTC) and no significant change in the proportion of smokers who made a quit attempt or who quit smoking. Half of smokers who used NRT post-OTC used it to delay or cut down their smoking but not to make a quit attempt. Fewer non-whites used NRT post-OTC (3.3%) compared to pre-OTC (20.7%) (adjusted p = .002), but the proportion of whites using NRT did not change (20.6% pre-OTC to 21.9% post-OTC). A higher proportion of 18–30 year-olds and a lower proportion openface> 45 year-olds used NRT post-OTC compared to pre-OTC (adjusted p = .0004). CONCLUSION: We find no evidence that the OTC switch was associated with increased NRT use, quit attempts, or cessation rates among MA smokers, and one explanation may be that smokers purchase OTC NRT for reasons other than cessation. Since the switch, access to NRT appears to have increased for young adults but decreased for older and minority smokers. Even though NRT is now sold OTC, it remains important for physicians to encourage and monitor its use.

Rx to OTC Conversions: The Role of Epidemiology

This paper briefly reviews the history of prescription (Rx) to over-the-counter (OTC) switches and discusses perspectives of consumers, manufacturers, physicians, pharmacists, and the Food and Drug Administration (FDA) towards these switches. We then discuss the role of epidemiology in supporting Rx to OTC switches and present an example of an epidemiological study used to support the Rx to OTC switch of an anti-fungal medication to treat candidiasis infection in women.

Freedom Not to See a Doctor: The Path Toward Over-The-Counter Abortion Pills

American courts and lawmakers are engaged in an epic struggle over the fate of abortion pills. While some anti-abortion activists are attempting to drive the pills off the market entirely, supporters of reproductive rights are striving to make them more easily accessible. This Article advances the latter mission with a bold proposal: FDA should consider allowing abortion pills to be sold over the counter (OTC). Abortion rights supporters argue that FDA should repeal the special distribution and use restrictions it unnecessarily imposes on mifepristone, one of two drugs in the medication abortion regimen. Even if FDA removed these restrictions, however, abortion pills would still be prescription medicines—a status that, in and of itself, hinders people’s access to drugs. This Article thus advocates going further by repealing the prescription requirement for abortion pills. To support this proposal, the Article analyzes the prescription-to-OTC switch process for drugs generally, explores how prescription status impedes access, and argues that FDA should give greater weight to the benefits of improved access when considering any OTC switch. The Article discusses recent promising instances of successful switches—including naloxone and birth control pills— in which FDA emphasized the access factor more than it traditionally has. Finally, the Article considers various intermediate approaches between prescription and OTC status and explains how federal and state regulators might use these approaches to improve access to abortion pills in the absence of a complete switch.