Prescription to Over-the-Counter Switch

Field: Medicine (Health Sciences)

Nearly 55 years after the FDA approved the pill,[i] as it is commonly known, controversies continue to accompany its journey to become an integral part of reproductive choice. Today, a large majority of the countries have access to oral contraceptives as a method of birth control. Birth control pills are the most common form of contraception in Africa, Europe, and Oceania, and are the most commonly used reversible contraception in the Americas.[ii] However, there still exists a disparity between countries in the ease of access to these contraceptives. While about 33 countries have oral contraceptive pills as prescription medication, a majority of the countries of the world have oral contraceptive pills with an over-the-counter (OTC) designation. It appears that most of the countries with OTC oral contraceptives are less developed countries. It thus seems that this OTC designation is due to the fact that these countries need to encourage family planning and to make birth control methods readily available. If this is an advantage of OTC contraceptive pills, then why do these oral contraceptive pills remain available only by prescription in many developed countries? To answer this question, it is necessary to explore the rationale behind maintaining a medication in prescription status, and the criteria that need to be fulfilled for a medication to become designated as OTC. Before the United States Food, Drug, and Cosmetic Act (FDCA), any drug had the potential to be marketed legally without a prescription. However, according to the FDCA, the Food and Drug Administration (FDA) has to make individual decisions regarding what drugs can be sold and purchased OTC. According to the FDCA, a drug ought to be designated a prescription medication if: • It is a habit forming drug; • It has potential harmful effects or toxicities that make it unsafe for use except under professional supervision; and • Its approved new drug application (NDA), specifically limits it to prescription status. Therefore, based on the above, for a drug to be considered for an Rx-to-OTC switch, it should: • Have benefits that outweigh the risks; • Have low potential for abuse or misuse; • Be able to be used by consumers for self-diagnosed conditions; and • Not rely on health practitioner supervision for its safe and effective use[iii]. According to the State Food and Drug Administration (SFDA) in China, a prescription drug qualifies for over the counter evaluation if: • “Its formulation or active pharmaceutical ingredient [is] approved by SFDA and [is] widely applied in patients over a long period of time; • There is sufficient research on its formulation or active pharmaceutical ingredient with precise results and satisfactory safety data; • There are statutory quality specifications for its formulation or active pharmaceutical ingredient and a proven quality profile thereof; • The method of use, dosage, and treatment course are precise and the efficacy can be ascertained; • The indication is listed in SFDA’s approved scope of OTC indications, typically common diseases or symptoms, recurring diseases or chronic diseases; • The instructions for clinical application are clear if intended for pediatric diseases or pregnant women; and • The route of administration, dosage form, dosage, specification, timing of administration, storage, packaging, label, and insert sheets are suitable for self-medication.”[iv] Although the guidelines provided by the Chinese SFDA are more detailed than those of the U.S. FDA, it is clear that both serve the function of ensuring that OTC medications are generally safe for self-administration. If this is the case, then it would appear that oral contraceptive pills have been deemed safe for this purpose by China’s SFDA. Hence, their sale as OTC drugs. However, the U.S. FDA has yet to approve these same oral contraceptive pills as OTC drugs. The issue raised here, in comparing these two systems with fairly comparable pharmaceutical regulatory authorities, raises questions about the variations in different global pharmaceutical regulatory bodies’ perception of safety However, this issue will not be addressed in-depth in this paper. As alluded to in the portions of Acts outlined above, other decisive factors comprise the general theme of drug safety, one of which is the ability of an OTC drug to be self-administered effectively without a health professional’s intervention. Therefore, even if a drug ticks all the boxes and there is no consensus as to whether such a drug can be trusted entirely in the hands of patients, then that drug is likely to face difficulties in transitioning from prescription to OTC. Before further addressing this point and how it applies to oral contraceptive pills, I would like to highlight the implications that an Rx-to-OTC switch has on the key players in the drug manufacturing, marketing, and utilization sector, and how these implications factor into an ethical discussion regarding OTC designation for oral contraceptive pills. Effect of Rx-to-OTC Switch on Physicians and Pharmacists After vaginal antifungal products made the move from prescription to over-the-counter (Rx-to-OTC), a study showed that there was a large decline in patient visits for physician consultation[v]. It can be assumed, that an Rx-to-OTC switch for oral contraceptives may cause the same type of decline. The fear, then, that has been expressed by some physicians opposed to this switch, is that women will be less likely to comply with routine gynecologist visits[vi]. Conversely, pharmacists will become more involved in dealing with patient issues regarding oral contraceptive use. This is because pharmacists will serve as the only professional link between a patient and her contraceptive pills, and so any question she has will need to be handled by the pharmacist. In addition, in countries that require some form of screening before patients are able to purchase OTC oral contraceptives, pharmacists typically carry out this screening. Therefore, an Rx-to-OTC switch for oral contraceptives could occur simultaneously with a shift in professional advice and assistance from physicians to pharmacists. Effect of Rx-to-OTC Switch on Patient Consumers A national survey carried out in the United States found that a new patient, on average, waits two weeks before being able to secure an appointment with an obstetrics-gynecologist[vii]. Women are more likely to miss oral contraceptive pills because of this difficulty in setting up an appointment, and the time and money it takes to set up a gynecology visit[viii]. These are some of the barriers that women face in reaching prescription-only oral contraceptives. It has also been shown that more women would prefer that they did not need to see a physician before having access to these contraceptive pills. In addition, it would appear that women from low-income areas, who would have difficulties in raising children, face the most restriction to acquiring oral contraceptive pills[ix]. These pieces of evidence support the fact that an Rx-to-OTC switch for oral contraceptive pills will benefit patients by increasing ease of access, thereby preventing unwanted pregnancies. Effect of Rx-to-OTC Switch on Manufacturers An Rx-to-OTC switch can be lucrative to brand name drug manufacturers, especially after patent expiration[x]. If more patients gain convenient access to the medication under discussion, and if previous non-users become users as a result of this OTC switch, then brand name manufacturers benefit more in terms of sales. In a study done on an allergen, Zyrtec, it was found that post-OTC switch, 84% of sales were derived from the OTC products, even though only 27% of prescription patients moved to Zyrtec OTC. What this showed is that the majority of the sales were from new users that were new allergy patients or that had not purchased any product to treat their conditions in the past two years[xi]. Although the monetary benefit to drug manufacturers is worth discussing, it should not take center stage when considering the ethics of an Rx-to-OTC switch for any medication, especially oral contraceptives. Ethical Discussion Justice in Oral Contraceptive Prescription/Over-the-Counter Disparity On the face of this discuss lies a glaring justice issue that is worth taking into consideration. At the beginning of this paper, I gave a brief summary of the percentage of countries that have oral contraceptive pills as OTC, against those that still require patients to obtain physician prescriptions. As shown in the map (see Appendix), there are a number of neighboring countries across continents that differ vastly in the OTC/Rx status of oral contraceptives. For example, in Africa, while patients in Zimbabwe require a physician prescription to purchase oral contraceptives, patients that share a border in Zambia are able to purchase oral contraceptives over the counter. The same is true in the United States versus Mexico, where patients in Mexico have OTC access to oral contraceptives, and patients in the United States are not afforded this option. In a 2010 study[xii] following the choices that women make who live on the US-Mexico border, it was found that women that purchased prescription-only oral contraceptive pills were younger, more likely to be single, have fewer children, have higher levels of education, and speak English more fluently than Spanish. In addition, women that purchased prescription-only oral contraceptive pills cited inconvenience as a disadvantage to their preferred practice, while OTC pill purchasers cited the fear of getting stopped by the US customs on getting to the border, as disadvantageous to their own preferred practice. These results show that patients have a desire to be able to procure oral contraceptives without the inconvenience of frequenting health care providers prior to do so. These results also show that there is a population of women that is not being catered to adequa