Questions and answers about Plan B®, other EC products, age restrictions, safety, cost, insurance coverage and resources.
Consumers: FAQ’s about Pharmacy Access to EC (PDF-148 KB)
Pharmacists: FAQs about Pharmacy Access to EC (PDF-196 KB)
Quick overview: Answers about billing, prescribing and coverage issues, EC timing and dosing, refills, liability, services to minors and/or men, phone consultation& OTC availability
(updated September 2009)
On April 22, 2009, the FDA decreased its previous age limitation from 18 to 17 and now allows consumers ages 17 and older to purchase Plan B over the counter (OTC). Teva Pharmaceuticals, Inc. issued a new EC product: Plan B® One-Step, replacing the previous Plan B® product delivering 1.5 mg levonorgestrel that came as two tablets with the same medication delivered in a single tablet. The Plan B® One Step product is available OTC for consumers 17 and older and with a prescription for women younger than 17. Watson Pharmaceuticals, Inc. released a generic version of EC –Next Choice™ – that comes as two tablets.
Even though Plan B is available OTC for some, EC pharmacy access services continue to be especially crucial for younger women, undocumented women, and women without proof of age who are trying to prevent pregnancy within the short window of time that EC is effective. For Fact Sheets (for pharmacists and consumers) regarding access to Plan B as an OTC product, as well as press release documents, go to www.pharmacyaccess.org.
Below are questions and answers relating to provision of EC pharmacy access services.
- EC Products
- Billing
- Prescribing and Coverage Issues
- Pharmacists’ Rights (NEW)
- EC Timing and Dosing
- Refills
- Liability
- Minors
- Services to Men
- Phone Consultation
- Other
Q: What EC products are available to consumers?
A: (1) Plan B® One Step, manufactured by Teva Pharmaceuticals, Inc., is a “dual-labeled” product for both prescription and OTC usage with the following restrictions: prescription for women 16 years and younger and OTC for consumers 17 and older. It contains 1.5 mg levonorgestrel delivered as one tablet.
(2) Next Choice™, manufactured by Watson Pharmaceuticals, Inc., is a generic EC containing 1.5 mg levonorgestrel delivered in two tablets. It is FDA approved as is a “dual-labeled” product for both prescription and OTC usage with the following restrictions: prescription for women 16 years and younger and OTC for consumers 17 years and older.
(3) Plan B® is a “dual-labeled” product for both prescription and OTC usage with the following restrictions: prescription for women 16 years and younger and OTC for consumers 17 years and older. This product containing 1.5 mg levonorgestrel delivered in two tablets will be phased out and replaced by Plan B® One Step; and
(4) The Yuzpe Regimen is when a designated number of specific, regular birth control pills are used as EC.
Q: Whose DEA number, phone number, and name should the pharmacist use on the prescription label?
A1: Using Collaborative Protocol: DEA — used only for insurance transactions. The physician’s number can be used. Phone number — the pharmacy’s number should be used. Name — the collaborating physician and pharmacist’s name.
A2: Using Statewide Protocol (in CA): DEA — used only for insurance transactions. The pharmacy number can be used. Phone number — the pharmacy’s number should be used. Name — the pharmacy and pharmacist’s name.
Q: Is the pharmacist allowed to prescribe anti-nausea medication or can they only recommend the OTC products listed on their protocol’s Exhibit B?
A: The pharmacist must follow his/her protocol. OTC medications are sufficient for most situations. If the protocol does not specifically indicate other agents then OTC agents are recommended.
Prescribing and Coverage Issues
Q: Is the pharmacist allowed to substitute the generic drug for the name brand if they have to break up a pill pack?
A: The same regulations apply to generic substitution for all prescriptions. Unless the prescriber has indicated “DO NOT SUBSTITUTE,” the pharmacist may select a generic provided she/he follows the pharmacy law.
Q: Does Medicaid cover Plan B?
A1: Yes, as of August 2005, Medi-Cal (California’s version of Medicaid) covers Plan B as well as the combined oral contraceptive, the Yuzpe regimen, as a prescription product. If a patient asks for Plan B and it is not available and the pharmacist cannot provide her with another EC product, the pharmacist should refer her to a local family planning clinic or a local pharmacy if possible. A listing of local family planning providers is available by calling 1-800-942-1054.
A2. Yes, starting in 2007, nine states (HI, IL, MD, NJ, NM, NY, OK, OR, WA) offer Medicaid coverage of Plan B OTC. Many of these states pay for this new coverage with their own state dollars, while several have established policies that allow them to still receive federal reimbursement. For more information visit www.nirhealth.org/sections/ourprograms/documents/ECMedicaidMemoFormatted.pdf
Q: Are EC providers able to collect a consultation fee (in CA)?
A: Upon the August 24, 2006 FDA decision to make Plan B EC available OTC for consumers ages 18 and over, the $10 limit for the consultation fee for Plan B sold as a prescription product is no longer applicable. As of January 1, 2004, in accordance with CA law SB 545, pharmacists were allowed to charge up to $10 for consultation/ administrative fees for EC services, in addition to the cost of the drug. Similarly, providers or clinics were only allowed to charge EC clients up to $10 for fees related to phone consultation or online communication that results in a prescription for EC. Now there is no cost limit for this consultation fee for in person, phone or online providers in CA.
Q: If a pharmacist relocates to another part of California is his or her EC collaborative protocol still valid?
A: When a pharmacist moves outside of his or her geographic area, he or she has three options for maintaining a valid protocol: 1) Download the Statewide Protocol available on the Board of Pharmacy website at www.pharmacy.ca.gov/licensing/ec_protocol.pdf; 2) Contact Pharmacy Access Partnership (510-272-0150) to set up a new Collaborative Protocol with a local physician in the new geographic area; or 3) Sign a protocol with a local physician with whom the pharmacist has an established relationship by filling out and faxing this form to Pharmacy Access Partnership. If a pharmacists moves out of the state, they ability to provide pharmacy access to EC under a California based protocol does not transfer.
Q: Are pharmacies required by law to stock or provide EC?
Laws about stocking EC and other products in the pharmacy vary by state. For more information on state legislation on pharmacists’ rights, please visit our State Profiles, Merger Watch or the National Conference of State Legislatures. Also read “Pharmacy Refusals 101” (PDF-60KB) from the National Women’s Law Center.
Q: Are pharmacists required by law to provide EC?
Laws about stocking EC and other products in the pharmacy vary by state. Please visit our State Profiles page to learn more about policies in a specific state.
Q: What is Pharmacy Access Partnership’s position on refusing to stock or provide contraception?
Pharmacy Access Partnership supports the right of individuals to access safe, legal health care supplies and medications, including EC. While we acknowledge that some pharmacists may refuse to dispense medication based on personal beliefs, we urge the pharmacist to notify his/her employer prior to the onset of employment so that the employer can institute a protocol that: 1) provides that another on-duty pharmacist can dispense, and/or 2) allows for referral to a nearby pharmacist who will fill the prescription. This protocol should be seamless to the patient. To learn more about our policies or pharmacists rights in other states and nationwide, please visit our Pharmacy Policy & Legislation page.
Q: Can a woman take Plan B in one dose?
A: Teva Pharmaceuticals, Inc. received FDA approval and is currently marketing Plan B One Step® EC. This product contains the same medication as the original Plan B; however it is delivered as one tablet, instead of two.
Q: Where can pharmacists and consumers get literature about EC timing and dosing, especially about taking 2 tablets at once and the effectiveness of using EC up to 5 days after unprotected sex?
A: While Plan B is marketed for use within 72 hours of unprotected sex or contraceptive failure, CA protocols reflect new data and allow for use up to 120 hours, as well as taking both tablets at once (for the EC products sold as two tablets). The following are a collection of published studies relating to information available on EC timing and dosing. More research articles are available on www.go2ec.org/ECLibrary.htm.
Q: Is it possible for a pharmacist who is not EC trained to provide EC refills to a patient who has been previously counseled? Example: The EC pharmacist is not working, but an established patient is returning to the pharmacy for EC a second time.
A: Yes, if refills were permitted on the original order. If that is not the case, then the original pharmacist or another EC pharmacist should be contacted, OR
If the pharmacist feels the situation meets the pharmacy regulations for “emergency refill” the pharmacist may act accordingly.
Q: Is there a limit on how many times a pharmacist can furnish EC to a patient?
A: No legal limit — the pharmacist should use professional judgment. If a limit is part of the protocol then the pharmacist should follow those guidelines. Some state and private insurance programs also place limits on the number of EC packs they cover.
Q: Is there any limit to the number of EC prescriptions a pharmacist can give a woman for advance need?
A: No legal limit — the pharmacist should use professional judgment. If a limit is part of the protocol then the pharmacist should follow those guidelines. Some state and private insurance programs also place limits on the number of EC packs they cover.
Q: What should a pharmacist charge a patient for EC refills?
A: The pharmacist should have and follow a fee schedule. Some pharmacies do not charge any additional (administrative) fees for “refill”. A repeat patient is not the same as a refill. A pharmacist should not charge an administrative fee when the “service” is not performed.
If no refills were indicated on the original order and a repeat patient visit (counseling, encounter form) occurs, the pharmacist may (or may not) charge a fee — the pharmacist should use professional judgment.
Q: What should a pharmacist do if he or she has concerns about repeat visits to the pharmacy for EC?
A: Although pharmacists may have personal/moral concerns that a patient is getting EC too frequently, it is ultimately a woman’s choice as to how often she takes EC. There is no medically indicated limit as to the number of times a woman can take EC. Because EC is not as effective as other ongoing methods of birth control (it may have side effects including nausea and vomiting, and it is less cost effective than other methods), many women would not choose to use EC on a routine basis or as their preferred method of birth control. One suggestion is to provide a repeat visitor with some information about other more effective ongoing contraceptive options or offer a referral to a local family planning provider or clinic.
Q: Does a pharmacist have to conduct an assessment when providing EC refills to a patient who has been previously counseled?
A: Refills should be indicated on the original order (or the prescribing pharmacist would need to be consulted to approve them). Given current regulation, no encounter form is required for refill visits up to one year. A refill is not the same as a repeat patient visit (which involves counseling and the encounter form). If it has been more than one year since the patient’s visit for EC services, another intake form should be completed because a prescription order is only valid for up to one year. Although counseling for refills is not required by pharmacy law, good practice suggests offering the woman the option.
Q: If the patient ends up pregnant after the pharmacist provided her with EC, would the pharmacist be liable?
A: If the pharmacist had provided the standard of care and the state mandated EC “Fact Sheet,” (provided on the website and available for free by mail by filling in the Order Form on the website and faxing to 1-213-385-0705), then the pharmacist should not be liable. Liability or lack thereof, is a legal issue, open to interpretation. No “immunity” to liability exists. For more information, please consult a legal advisor.
Q: If a woman has a positive over-the-counter pregnancy test but she wants EC anyway, should the pharmacist give it to her?
A: No, the woman should be referred to another healthcare provider or clinic. EC is contraindicated in pregnancy because it will not work. This woman would be best helped with a referral.
Q: Does a pharmacist need to report patient records to Pharmacy Access Partnership or any other organization at any time?
A: No, it is not necessary to report patient records. Patient records are considered a confidential medical record under HIPAA.
Q: At what age can a woman get EC OTC?
A: On April 22, 2009, the FDA decreased its previous age limitation from 18 to 17 and now allows consumers ages 17 and older to purchase Plan B OTC. The Plan B® One Step product and the generic Next Choice product are available OTC for consumers 17 and older and with a prescription for women younger than 17. Women under 17 can still get EC (with a prescription) directly from participating pharmacy access pharmacists without getting an advance prescription from a doctor or clinic.
Q: What should a pharmacist do if a parent or guardian comes into the pharmacy and wants to know why the pharmacist prescribed EC or anti-nausea medication to his or her minor child?
A: The pharmacist is not permitted by law to discuss the matter with the parent or guardian. In California, HIPPA privacy laws prevent the pharmacist from discussing a patient’s contraceptive prescription with a third party – even if it is a parent or guardian. The parent can be informed of this and/or referred to discuss their concerns with the minor. In other states, pharmacists must refer to state law.
Q: A parent calls stating “I just found a filled prescription for Plan B in my daughter’s sock drawer – what is it for?” What does the pharmacist tell her?
A: In California, HIPAA privacy laws prevent the pharmacist from discussing a patient’s contraceptive prescription with a third party – even if it is a parent or guardian. The parent can be informed of these HIPAA laws and/or referred to discuss their concerns with the minor. In other states, pharmacists must refer to state law.
Q: Are there special consent forms the pharmacist should use when dispensing EC to a minor?
A: No.
Q: Are there any training/educational opportunities for pharmacists regarding minors’ rights and access to pharmacy services?
A: Yes; the Youth-Friendly Pharmacy Initiative (YFPI) promotes services in pharmacies that meet the needs of youth clients, and addresses minors’ rights to confidential reproductive and sexual health services. For information about the YFPI including pharmacist CE training opportunities, visit www.pharmacyaccess.org/YouthFriendlyPharmacy.htm.
Q: Can a pharmacist provide EC to a man if it is for his girlfriend/wife/partner?
A: Yes, if the man shows proof of age that he is 17 or older. Men under 17 do NOT have the option to obtain a prescription for Plan B®, nor to get EC through pharmacy access.
Q: Can anyone (i.e. a sister or a boyfriend) come in to the pharmacy and pick up an EC refill for the patient?
A: Anyone is allowed to pick up a refill. However, only the patient can request a refill for a prescription product.
Q: Can a pharmacist do an EC consultation over the phone with a patient and then call in the prescription to another pharmacy? Scenarios: (1) There are no trained pharmacists working at an EC pharmacy and a patient shows up, (2) The patient is located some distance from the closest EC pharmacy and cannot travel to it.
A: In California, yes; however there are some important considerations (see below). Consultation laws vary by state.
Scenario (1) The pharmacist “on call” will need to be able to document the encounter, take needed information, speak directly with the woman, transmit the order to the dispensing pharmacist and make sure the dispensing pharmacist provides the client with the state mandated EC “Fact Sheet” (provided on the website and available for free by mail by filling in the Order Form on the website and faxing to 510-272-0285 ).
Scenario (2) All of the concerns in scenario one apply, PLUS the pharmacist “furnishing” EC must have a mechanism to provide the dispensing pharmacist with the state mandated EC “Fact Sheet” (provided on the website and available for free by mail by filling in the Order Form on the website and faxing to 510-272-0285 ) and may experience difficulty with the dispensing pharmacy being unsure if the order is legal (it is). The protocol may need to be faxed to them (in addition to the “Fact Sheet”).
Q: If a trained EC pharmacist does a phone consult who does the record documentation?
A: The trained EC pharmacist is responsible for making sure their documentation (patient history) is done. The dispensing pharmacist is responsible for making sure the prescription filling aspects are done.
Q: When the pharmacist does an EC consult over the phone for another pharmacist, whose name goes on the label?
A: The pharmacist initiating the order over the phone would be the pharmacist on the label. If using a collaborative protocol, the physician on the EC protocol also must be on the label.
Q: Does Pharmacy Access Partnership offer any other programs (i.e. Diabetes, flu shots)?
A: Visit www.PharmacyAccess.org for more information about Pharmacy Access Partnership’s activities and training opportunities.