HAR §16-95-130. Emergency contraception written collaborative agreement

(a) Each arrangement between a licensed pharmacist and a licensed physician relating to the distribution to a patient of emergency contraception drugs shall be documented in a signed collaborative agreement in accordance with the form attached hereto as Exhibit A entitled "Emergency Contraception Drug Therapy Collaborative Agreement" dated December 2004, located at the end of this chapter and made a part of this chapter. The agreement shall be delivered to the board by the licensed pharmacist within ten days of the execution of the agreement by the pharmacist and the physician. (b) Before a pharmacist may participate in the collaborative agreement, the pharmacist shall have completed an emergency contraception training course approved by the ACPE, curriculum-based programs from an ACPE-accredited college of pharmacy, applicable state or local health department §16-95-130 95-45 programs, or programs recognized by the board of pharmacy. Training shall include procedures listed in Exhibit A, entitled, “Emergency Contraception Drug Therapy Collaborative Agreement”, dated December 2004 and located at the end of this chapter, the management of the sensitive communications often encountered in emergency contraception, providing service to minors, quality assurance, referral for additional services, and documentation. (c) By executing the collaborative agreement, both the physician and pharmacist agree and acknowledge that: (1) They accept the responsibility for the distribution of the emergency contraception drugs and that the licensed pharmacist shall dispense only certain drugs approved for emergency contraception by the United States Food and Drug Administration. Some of the currently approved drugs are listed in the attached Exhibit B entitled "Brands and Doses", dated August 2004, located at the end of this chapter and made a part of this chapter however, drugs approved for emergency contraception are not limited to this list. Other drugs listed in Exhibit B entitled "Brands and Doses", dated August 2004 and located at the end of this chapter, may be dispensed instead of Plan B® in the following circumstances: (A) Plan B® is unavailable; (B) Plan B® is not covered under the patient's health insurance plan and another drug listed in Exhibit B is covered; or (C) The patient chooses another listed drug after the pharmacist advises the patient that side effects are usually less with Plan B®. The list of approved drugs in Exhibit B also shall include adjunctive drugs for treatment of nausea and vomiting that may be associated with emergency contraceptives; (2) The licensed pharmacist shall provide the patient with drug information concerning dosage, potential adverse side effects, and follow-up contraceptive care; (3) The collaborative agreement shall be effective for a period of at least two years from the date of its delivery to the board, unless rescinded in writing by either the physician or the pharmacist, with written notice to the other and the board, or unless the pharmacy board invalidates the agreement or changes the terms of the agreement. After the two year period, the agreement shall continue to be valid from month to month unless rescinded, invalidated, or changed as provided herein. The licensed pharmacist or the licensed physician, who rescinds the agreement, shall notify the §16-95-130 95-46 board within three business days of the rescission. At the time the collaborative agreement is rescinded, the licensed pharmacist shall not have prescriptive authority to dispense emergency contraceptives until another collaborative agreement with a physician is completed and received by the board; and (4) Each drug therapy prescription authorized by the physician and dispensed by the pharmacist shall be documented in a patient profile. (d) Additionally, the collaborative agreement between the licensed pharmacist and licensed physician shall include: (1) The name, address, and phone number of the licensed pharmacist and pharmacy and the signature of the licensed pharmacist; (2) The name, address, and phone number of the licensed physician and the signature of the licensed physician; (3) The purpose of the collaborative agreement, which is to permit emergency contraception drug therapy within one hundred twenty hours of the patient having unprotected sexual contact and to ensure that the patient receives appropriate information from the licensed pharmacist regarding the drug therapy; (4) The procedures, delineated in Exhibit A, to be followed by the licensed pharmacist when the patient requests drug therapy, including any applicable referrals; (5) Any limitation agreed upon by both the licensed pharmacist and the licensed physician including but not limited to approved drugs that may not be prescribed to the patient or whether the licensed pharmacist's or the licensed physician's decision shall control in the event of a disagreement on the prescription for a patient; (6) A provision that the licensed pharmacist shall refer the patient to a licensed physician; (7) A statement that the label placed on the drug therapy product shall contain the names of both the pharmacist and the physician signers of this agreement; (8) An informed consent, included in Exhibit A, to be used by the licensed pharmacist to inform the patient about the emergency contraception drug therapy. The informed consent shall be signed by both the licensed pharmacist and the patient; and (9) A screening checklist for emergency contraception pills, included in Exhibit A, to be filled in by the patient and signed by both the licensed pharmacist and the patient. §16-95-130 95-47 (e) Any modification to an existing collaborative agreement previously delivered to the board shall be submitted to the board by the licensed pharmacist at least ten working days prior to the intended implementation of the changed collaborative agreement. (f) The board shall have the authority to reject a collaborative agreement if the board determines that the collaborative agreement is not in compliance with this section or is not in the best interests of the patient. (g) The form of the collaborative agreement, the informed consent form, and the screening checklist for emergency contraception drugs attached as Exhibit A hereto, shall be made available by the board to licensed pharmacists and licensed physicians. [Eff and comp 12/25/04; am and comp 06/22/15; am and comp 8/15/16] (Auth: HRS §461-4.5) (Imp: HRS §461-1) 95-49 Amendments to and compilation of chapter 16-95, Hawaii Administrative Rules, on the Summary page dated March 31, 2016, were adopted on March 31, 2016, following a public hearing held on March 31, 2016 after public notice was given in the Honolulu Star-Advertiser, The Garden Island, Hawaii Tribune-Herald, West Hawaii Today, and The Maui News on February 28, 2016. They shall take effect ten days after filing with the Office of the Lieutenant Governor. /s/ Kerri Okamura KERRI OKAMURA, Chairperson Board of Pharmacy APPROVED AS TO FORM: Date /s/ Shari Wong Deputy Attorney General APPROVED: Date /s/ Catherine P. Awakuni Colón CATHERINE P. AWAKUNI COLÓN, Director Commerce and Consumer Affairs APPROVED: Date 7/18/16 /s/ David Y. Ige DAVID Y. IGE Governor State of Hawaii 8/5/16 Filed Chapter 16-95 December 2004 Page 1 of 6 EXHIBIT [“A”] A Emergency Contraception Drug Therapy Collaborative Agreement As a licensed physician authorized to prescribe medications in the State of Hawaii, I authorize the licensed pharmacist to initiate emergency contraception drug therapy according to the terms and conditions that follows and according to Hawaii Administrative Rule §16-95-130. This Agreement provides written terms and conditions for initiating emergency contraception drug therapy in accordance with the laws and rules of the State of Hawaii. This agreement shall be delivered to the Department of Commerce and Consumer Affairs within seven (7) days of the execution of the agreement by the licensed pharmacist and the licensed physician. Any modification to an existing collaborative agreement previously delivered to the Department shall be delivered also to the Department by the licensed pharmacist at least ten working days prior to the intended implementation of the changed collaborative agreement. Purpose: Permit the use of drug therapy within 120 hours of the patient having unprotected sexual contact and to ensure the patient receives adequate information to successfully complete drug therapy. Procedures: When the patient's pharmacist requests drug therapy, the pharmacist shall assess the need for drug therapy and/or referral for contraceptive care and reproductive health care. The pharmacist shall determine the following: 1. The date of the patient’s last menstrual period to rule out established pregnancy; 2. Whether the elapsed time since unprotected intercourse is less than 120 hours; 3. Whether the patient has been a victim of sexual assault; and 4. That the patient is at least 14 years of age. Referrals: The licensed pharmacist shall refer the patient to the licensed physician for follow-up. If drug therapy services are not available at the pharmacy, the pharmacist shall refer the patient to another licensed pharmacist. Also, the pharmacist shall refer the patient to see either a medical doctor or family planning clinic provider if: A. The pharmacist cannot rule out that the patient is pregnant or if the elapsed time since the patient having unprotected intercourse is greater than 120 hours; B. The pharmacist is concerned that the patient may have been exposed to a sexually transmitted disease; C. The patient does not have a regular contraceptive method; and D. The patient does not have a health care provider and needs free or low cost family planning services. This Emergency Contraception Drug Therapy collaborative Agreement was developed using the collaborative agreements of Washington and California, who developed their guidelines from the American College of Obstetricians and Gynecologists and the World Health Organization and physicians, pharmacists and nurses. This Agreement has been approved by the Board of Pharmacy, State of Hawaii. Page 2 of 6 If the pharmacist is concerned that the patient may have contracted a sexually transmitted disease through unprotected sexual activity and/or if the patient indicates that she has been sexually assaulted, the pharmacist may recommend referral to a medical doctor, a family planning clinic, a sexual assault treatment center, the police, or multiple referrals to these entities as the pharmacist may deem appropriate, while providing drug therapy. While drug therapy can be used repeatedly without serious health risks, patients who request drug therapy shall be referred to a medical doctor or family planning clinic provider for consideration of the use of a regular contraceptive method. Drug Therapy product selection: The pharmacist shall provide medication from a list of drugs approved for emergency contraception by the United States Food and Drug Administration ("FDA") listed in Exhibit "B" and agreed upon as part of this collaborative Agreement. Plan B® shall be the preferred drug therapy. The list shall include emergency contraceptives and adjunctive medications for treatment of nausea and vomiting associated with emergency contraceptives. The list shall be maintained at the pharmacy and shared by all participants in the agreement. Along with the medication, the pharmacist shall provide drug information concerning dosage, potential adverse effects, and follow-up contraceptive care. Prescription labeling: The label placed on the drug therapy product shall contain the names of both the pharmacist and the physician signers of this Agreement. Documentation: Each drug therapy prescription authorized by the physician and initiated by the pharmacist shall be documented in a patient profile. Training: The pharmacist who participates in the drug therapy shall have received appropriate training that includes programs approved by the American Council of Pharmaceutical Education (ACPE), curriculum-based programs from an ACPE-accredited college of pharmacy, state or local health department programs, or programs recognized by the board of pharmacy. Training must include procedures listed above, the management of the sensitive communications often encountered in emergency contraception, service to minors, quality assurance, referral for additional services, documentation and a crisis plan if the pharmacy operations are disrupted by individuals opposing the emergency contraception. Further, the pharmacist agrees to participate in the Emergency Contraception Hotline. Term of the Agreement: This agreement shall be effective for a period of at least two years from the date of its delivery to the Department unless rescinded in writing earlier by either the physician or the pharmacist, with written notice to the other and to the Department, or unless the Pharmacy Board invalidates such Agreement or changes the terms of the agreement. After the two year period, the agreement shall continue to be valid month to month unless rescinded, invalidated, or changed as provided herein. The licensed pharmacist or the licensed physician, who rescinds the agreement, shall notify the Department within three business days of the rescission. At the time the collaborative agreement is rescinded, the licensed pharmacist shall not have prescriptive authority to dispense emergency contraceptives until another collaborative agreement with a physician is completed and delivered to the Department. Page 3 of 6 (Name of Pharmacy) Informed Consent for Emergency Contraception Drug Therapy Name of Patient: Age: Address: Phone No.: First day of last menstrual period: ___/___/_____ Mo/Day/Year Date of unprotected sexual intercourse: ___/___/____ Mo/Day/Year If more than one exposure, give date and time of initial exposure: Was this sexual intercourse the result of sexual assault? Yes ___ No ___ Before giving your consent, be sure that you understand both the pros and cons of Emergency Contraceptive Pills (ECPs). If you have any questions, we will be happy to discuss them with you. Do not sign your name at the end of this form until you have read and understood each statement and the pharmacist has answered your questions and can witness your signature. This information is confidential. I understand that: 1. ECPs contain hormones that act to prevent pregnancy. These pills are taken after having unprotected sex (sex without birth control or birth control failure). They are to be used as an emergency treatment only and not as a routine method of contraception. 2. ECPs work by preventing or delaying the release of an egg from the ovary, preventing fertilization, or causing changes in the lining of the uterus that may prevent implantation of a fertilized egg. I understand that if I am already pregnant, ECPs will not stop or interfere with the pregnancy. 3. ECP treatment should be started within 5 days (120 hours) of unprotected sex. 4. ECPs are not 100 percent effective. 5. Reactions to the pills may include: nausea and vomiting, fatigue, dizziness, breast tenderness, early or late menstrual period. 6. I should see a physician if my period has not started within 3 weeks after treatment. 7. I should use condoms, spermicides, or a diaphragm, or continue taking birth control pills to prevent pregnancy if I have sex before my next period. After that, I should continue to use a method of contraception. 8. ECPs will not protect me from or treat sexually transmitted diseases and I should seek diagnosis and treatment if I am concerned because I have had sex with a new partner in the past month or my partner has had sex with someone else in the past month or my partner has a sexually transmitted disease. 9. I understand that it may be useful to share this treatment information with my regular health care provider. Therefore, I request and authorize the release of this information to the following designated provider: Yes ___ No ___ 10. Designated Provider’s Name: Patient’s Signature: Date: Page 4 of 6 Additional Terms or Limitations: Physician's Name: Street Address/City/State; Zip Code: Phone Number: MD License No.: Physician's Signature: Date: Pharmacist's Name: Street Address/City/State/Zip Code where Drug Therapy will occur (include name of pharmacy, pharmacy license number, pharmacist-in-charge and pharmacist-in-charge license number): Pharmacist License No.: Phone Number: Pharmacist's Signature: Date: Pharmacist-in-charge's Signature: Date: Page 5 of 6 Screening Checklist for Emergency Contraceptive Pills Patient Name: Today’s Date: Address: Age: These questions are to help us understand what you need right now. 1. Have you had unprotected sex during the last 5 days? Yes ___ No ___ 2. On what day(s) did you have unprotected sex in the past 5 days? Monday ___ Tuesday ___ Wednesday ___ Thursday ___ Friday ___ Saturday ___ Sunday ___ 3. What time of day was the first unprotected sex in the past 5 days? ______ A.M. _____ P.M. 4. Have you had unprotected sex prior to the last five days? Yes ___ No ___ 5. When was the first day of your last menstrual period? Date: __________________________ 6. Are you currently using a method of birth control? No method ___ Birth Control Pills ___ Condoms ____ Diaphragm ________ IUD ________ Other Method ______ Contraceptive Shot (Depo Provera®) ___ 7. Did you have unprotected sex as a result of sexual assault (or, did anyone pressure you into having sex when you didn’t want to?) Yes ___ No ___ 8. Would you like a pharmacist to call you in the next couple of weeks to see how you’re doing? Yes ___ No ___ If yes, what time of the day is best to call? ______ A.M. ______ P.M. Patient’s Signature: ____________________________Date: _________ For Pharmacist Use Only Date and time of interview: ___________________ EC Provided: Yes ___ No ___ Referral made for (check all that apply): Contraception follow-up ___ Evaluation for STD ___ Other medical evaluation ___ Pregnancy counseling _____ Assault Counseling ___ No referrals made ________ Date and time of callback: ___________________ Referrals made then? ___________ Pharmacist’s Signature: ____________________________Date: _________ Page 6 of 6 Informed Consent for Emergency Contraception Drug Therapy Continued Pharmacist’s Signature: Date: Pharmacist only: Referral made to: Rx No.: Chapter 16-95 August 2004 Page 1 of 2 EXHIBIT [“B”] B Brands and Doses Of Oral Contraceptive Pills Used For Emergency Contraception There are now two prepackaged emergency contraceptive pill products (dedicated emergency contraceptive pills) as well as 14 brands of birth control pills that can be used for emergency contraception. Brand Manufacturer Pills per Dose (Treatment schedule is one dose ASAP after unprotected intercourse, and a second dose 12 hours later) Ethinyl Estradiol per Dose (mcg) Levonorgestrel per Dose (mg)* Dedicated Emergency Contraceptive Pills Plan B Women’s Capital Corporation 1 white pill 0 0.75 Preven Gynetics 2 blue pills 100 0.50 Oral Contraceptive Pills Levora Watson 4 white pills 120 0.60 Levlen Berlex 4 light-orange pills 120 0.60 Lo/Ovral Wyeth-Ayerst 4 white pills 120 0.60* Low-Ogestrel Watson 4 white pills 120 0.60* Nordette Wyeth-Ayerst 4 light-orange pills 120 0.60 Alesse Wyeth-Ayerst 5 pink pills 100 0.50 Aviane Duramed 5 orange pills 100 0.50 Levlite Berlex 5 pink pills 100 0.50 Ogestrel Watson 2 white pills 100 0.50* Ovral Wyeth-Ayerst 2 white pills 100 0.50* Tri-Levlen Berlex 4 yellow pills 120 0.50 Triphasil Wyeth-Ayerst 4 yellow pills 120 0.50 Trivora Watson 4 pink pills 120 0.50 Adapted from RA Hatcher, et al, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Ardent Media, 1998. Updated by Felicia Steward, MD 2001. * This progestin in Ovral, Lo/Ovral, Low-Ogestrel, Ogestrel and Ovrette is norgestrel, which contains two isomers only one of which (levonorgestrel) is bioactive; the amount of norgestrel in each dose is twice the amount of levonorgestrel. Page 2 of 2 Anti-nausea Treatment Options for use with Emergency Contraception Drug Dose Timing of Administration Non-prescription Drugs Meclizine hydrochloride (Dramamine, Bonine) One or two 25mg tablets 1 hour before first EC dose; repeat if needed in 24 hours Diphenhydramine hydrochloride (Benadryl) One or two 25mg tablets or capsules. 1 hour before first EC dose; repeat as needed every 4-6 hours. Dimenhydrinate (Dramamine) One or two 50mg tablets or 4-8 teaspoons liquid 30 minutes to l hour before first ECP dose; repeat as needed every 4-6 hours. Cyclizine hydrochloride (Marezine) One 50mg tablet 30 minutes before first EC dose; repeat as needed every 4-6 hours. Adapted from RA Hatcher, et al, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Ardent Media, 1998. Updated by Felicia Steward, MD 2001.