Haw. Code R. § tit. 16, ch. 95, subch. 16, exh. A

Current through November, 2024

Exhibit 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.

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.

(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:__________

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:______________

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:_________

Informed Consent for Emergency Contraception Drug Therapy Continued

Pharmacist's Signature:__________________________________Date:__________

Pharmacist only: Referral made to:__________________________________________

Rx No.:____________________________

Haw. Code R. tit. 16, ch. 95, subch. 16, exh. A

Effective 12/25/04