Plan B [Emergency Abortion Pill] FAQs

January 08, 2005

Oral [so-called] "Contraceptives" FAQs: a Pill you may not want to swallow

Q: Is Plan B an abortifacient drug or a contraceptive?

A: Numerous studies support the notion that the high dose, high powered steroid(s) found in Emergency Abortion drugs like Plan B are abortifacient 75 to 89% of the time. Rarely will a drug like Plan B work to suppress ovulation and truly prevent the meeting of the male and female gametes PRIOR to the moment of conception.

Q: Who is able to purchase Plan B OTC?

A: Men and women age 18 and older may purchase Plan B OTC . It is very possible a sexual predator could buy Plan B to cover up and hide one or numerous instances of underage statutory rape or incest.

Q: Where can patients obtain Plan B OTC in the pharmacy?

A: Patients must obtain Plan B OTC at the pharmacy counter; it will only be available when there is a licensed pharmacist on duty. Plan B OTC will not be available in places that do not have a licensed pharmacist or prescriber at the facility (i.e. gas stations, convenience stores, food marts, etc.).

Q: Can patients obtain Plan B OTC at other healthcare facilities such as clinics?

A: Yes. Plan B OTC may be available at other healthcare facilities such as clinics provided they have a method of confirming the age of persons receiving the medication.

Q: Who can sell Plan B OTC?

A: The Food and Drug Administration (FDA) mandates that a healthcare professional (e.g. pharmacist or prescriber) be available to answer questions or address any concerns that the patient may have about Plan B OTC. Individual pharmacy practice will determine which staff members (e.g. pharmacists, pharmacy technicians, student pharmacists) will be allowed to sell the medication. It is possible an unqualified non-licensed staff member may end up dispensing this potent abortifacient steroid without any knowledge of medical or drug history and conditions of the end user.

Q: What kind of proof of age will be required for consumers 18 and older to purchase Plan B OTC?

A: The FDA has not issued specific guidelines regarding proof of age. However, the Drug Enforcement Administration (DEA) recently published a list of acceptable forms of ID for another drug product. Pharmacies may decide to follow these same guidelines, which include driver’s licenses, passports, and school ID’s. The complete DEA list is provided at the end of this document.

Q: How will the age restriction be monitored and enforced?

A: The manufacturer of Plan B OTC, Barr Pharmaceuticals, Inc., will conduct point of purchase monitoring at individual pharmacies; clinics and physician offices will not be subject to this monitoring. If a pharmacist sells Plan B OTC to someone under 18, Barr will increase its educational efforts regarding the age restriction. A second infraction will result in Barr reporting the pharmacist to the appropriate State Board of Pharmacy. Pharmacists of conscience are encouraged to monitor area pharmacies and to report instances of non-compliance to their respective board of pharmacy and/or the FDA.

Q: Can states place additional restrictions on access to Plan B OTC?

A: It is possible and very liekly. Many states have enacted statutes to prohibit the sale of medications that have an abuse potential or that are harmful to the health of the patient. As well some states, based on the recent scandal of Planned Parenthood centers not reporting cases of statutory rape and incest in KS, IN and OH, may lead to more restriction to protect underage girls from sexual predators. It is too early to know whether the states will use this authority.

Q: Will the switch impact pharmacist’s prescribing authority that currently exists in certain states?

A: The product’s dual-status will not impact collaborative agreements in the states that provide pharmacists prescriptive authority for emergency contraception. Patients under 18 in these states will continue to be able to access Plan B from pharmacists who have this authority to prescribe and dispense Plan B. Patients 18 or older will be able to purchase Plan B OTC. Check with your state laws and regulations through your state board of pharmacy for any additional requirements.

Q: When will the OTC version of Plan B become available?

A: Reports indicate that the first shipments of Plan B OTC were sent to distributors the first of November and are currently in circulation.

Q: Will the labeling on the new version differ from the Rx version?

A: The current prescription (Rx) version will be replaced by a dual label (Rx/OTC) version. It will include a drug facts section and a patient brochure; it will also have the statement “Rx for age 17 and younger” imprinted on the packaging.

Q: Are there quantity limits or registration procedures required for purchase?

A: No. The FDA has not specified any quantity limits or registration procedures. Systems to document that the pharmacy has checked the patient’s age may be established by each individual pharmacy.

Q: Can I invoke my rights of conscience when Plan B OTC is requested?

A: PFLI fully supports an individual pharmacist’s ability to choose not to dispense or counsel with respect to a medication for personal, religious and moral reasons PFLI also encourages pharmacists with objections to dispensing any medications, including Plan B OTC, should work with their management to protect their rights of conscience in advance, preferably in writing. A simple way to deal with this product is simply not to ever stock it, if possible. For employee pharmacists with a conscience, this may prove difficult, as corporate policy may allow or even mandate stocking Plan B.

Q: Where can I get more information?

A: PFLI has several resources on line at: http://www.pfli.org/main.php?pfli=kemikalkill