13-067 Code Vt. R. 13-140-067-X
Prior to initiating emergency contraception drug therapy, a pharmacist must complete an emergency contraception therapy training and education program which is specifically approved by the Vermont Board of Pharmacy as a precondition to entering a Vermont Collaborative Practice Agreement. Only then may the pharmacist enter into a Collaborative Practice Agreement with a physician or other prescriber.
A pharmacist and physician or other prescriber may enter into a Collaborative Practice Agreement as set forth in Form A. The Agreement sets forth the purpose, limits, and intent of the collaboration.
For each client seeking emergency contraception, the pharmacist shall complete a Client Informed Consent and Referral (Form B). The Informed Consent and Referral shall be signed by both the client and the licensed pharmacist.
In addition to information required by law, the prescription label placed on the drug therapy product shall identify:
For each emergency contraception drug therapy initiated pursuant to this protocol, the pharmacist shall provide the client receiving the emergency contraceptive drug with the following original/photocopy:
In addition to the other requirements set forth in these rules, the collaborating pharmacist shall be sensitive to the privacy and emotional needs of those seeking emergency contraception. The collaborating pharmacist shall be aware of Vermont state law reporting requirements relating to vulnerable individuals.
Form A. Pharmacist/Prescriber Collaborative Practice Agreement and Protocol.
I, , as a licensed health care provider authorized to prescribe medications in the State of Vermont, authorize , R.Ph./Pharm D to initiate emergency contraception drug therapy according to the protocol that follows. The protocol provides written guidelines for initiating drug therapy in accordance with the statutes and regulations of the State of Vermont.
Purpose: Provide access to emergency contraception within the required time frame and to ensure the client receives adequate information to successfully complete therapy.
Procedure: When the client requests emergency contraception (EC) drug therapy, the pharmacist will assess the need for EC drug therapy and will dispense EC drug therapy, as agreed with the health care provider regarding the type, timing, and dosage, according to the protocol established in this agreement and according to the practices recommended in the pharmacist training as approved by the Vermont Board of Pharmacy.
Referrals: If EC drug therapy services are not available at the pharmacy, the client will be referred to another EC provider or to a family planning health center. The pharmacist should refer the client to a health care provider or family planning health center if established pregnancy cannot be ruled out.
If there is a concern that the client may have contracted a sexually transmitted infection through unprotected sex, and/or if the client indicates that she has been sexually assaulted, the pharmacist will provide appropriate referral information while providing ECP's. Referrals can be made to health care providers, community clinics, a sexual assault hot line, or a hospital emergency department with a Sexual Assault Nurse Examiner (SANE) program. See Form C.
Prophylactic Provision: The pharmacist may dispense a course of EC drug therapy to a client in advance of the need for emergency contraception. In addition, the pharmacist will counsel the client on available options for regular contraceptive methods or offer to refer the client to a health care provider or family planning health center for additional contraceptive services.
EC Product Selection: The pharmacist will only dispense medication from a list of products approved for emergency contraception and agreed upon as part of this agreement. The pharmacist should seek to provide the most effective EC product to the client. The list will contain EC drug therapies and adjunct medications for nausea and vomiting associated with EC drug therapy. The list will be maintained at the pharmacy and shared by all participants in the agreement. Along with the medications, the client will be provided with information concerning dosing, potential adverse effects, and follow-up contraceptive care.
Documentation and Quality Assurance: Each prescription initiated by the pharmacist will be documented in a client profile as required by law and maintained at the pharmacy. EC drug therapy prescriptions and other client information shall be provided the same confidentiality as all other client records maintained at/by the pharmacy.
Communication with PCP: The pharmacist may, at the request of the client, communicate information to either the client's primary care provider or OB/GYN for purposes of being referred to a practitioner as a new client regarding her care relevant to emergency contraception drug therapy.
On an annual basis (or more often as agreed upon by prescriber and pharmacist) the authorizing prescriber and the pharmacist will perform a quality assurance review of the decisions made according to mutually acceptable criteria.
Other provisions consistent with the intent of 26 V.S.A. § 2079(a):
The pharmacist named below has completed a training program approved by the Vermont Board of Pharmacy covering procedures listed above, the management of the sensitive communications often encountered in emergency contraception, and the appropriate use of referral sources.
Authorized Prescriber Signature: Date:
Authorized Prescriber Printed Name:
Type or Print Full Name
VT Medical License. #: Vt. Medicaid #
DEA # NPI #
Authorized Prescriber's Office Address: (Street Address)
(City) (State) (Zip Code)
Phone #: Fax #: Email:
Licensed Pharmacist Signature: Date:
Licensed Pharmacist Printed Name:
Type or Print Full Name
VT Pharmacist License #: Pharmacist NPI #
Pharmacy Address: (Street Address)
(City) (State) (Zip Code)
Phone #: Fax #: Email:
The name of this collaborating pharmacist will be provided to the Vermont Department of Health for posting on the Vermont Department of Health's website's EC Collaborative Practitioner listing.
If you do not wish to be included in this listing check here:
This agreement must be renewed every two years. The original copy shall be kept with Pharmacist's files along with EC training certification. One copy shall be maintained at the Prescriber's Office. One copy shall be sent to the Vermont Board of Pharmacy/Office of Professional Regulation. The pharmacist participating in a collaborative practice agreement must notify the prescriber and the Board of Pharmacy of any changes in his/her practice site.
Form B. Client Informed Consent and Referral.
Final, May 1, 2007
Client's Name: Phone #:
Address: City: State: Zip:
Date of Birth (Month/Day/Year): / /
I have been given the Emergency Contraception Key Facts and Instructions for Use and have had access to information about EC:
Client's signature Date
Pharmacist's signature Date
I understand that it may be useful to share this treatment information with my regular health care provider and I make the following decision:
No (Do not share)
Yes I request and authorize the release of this information to the following designated provider:
Name of Designated Provider
Provider's Address
For ASAP Referrals: Provider's Phone Number:
Provider's Fax Number:
Client's signature Date
FOR PHARMACIST USE ONLY:
Client provided with: Referral Made for? Additional pharmacist notes/comments:
Key Facts Sheet (Form C) Contraception
Informed Consent
(Form B - this sheet) STI/HIV
EC Product Pregnancy
Plan B TM Primary Care
Other Sexual Assault Child Abuse (Call DCF 1-800-649-5285)
Date: / / Tim
Pharmacist's Signature: R.Ph./Pharm D
Pharmacist:
Emergency Contraception: Key Facts and Instructions for Use in Vermont
Note: A copy of this form must be given to the client. This fact sheet may not be altered.
Emergency Contraception (EC) is a safe and effective way to prevent pregnancy after sex.
Consider using Emergency Contraception if you didn't use a contraceptive during sex, you think your contraceptive didn't work, or you were sexually assaulted or forced to have intercourse. EC in theory works by stopping the release of an egg from the ovary (ovulation), or it may prevent the union of a sperm and an egg (fertilization), or it may prevent a fertilized egg from attaching to the womb (implantation). EC will not disrupt an established pregnancy.
What are Emergency Contraception pills?
Emergency Contraception pills (ECP's) contain the same medication as regular birth control pills and help to prevent pregnancy. There are two basic types of Emergency Contraception pills:
. Plan B TM progestin-only pills.
. High doses of regular oral contraceptive pills (containing estrogen and progestin).
Don't wait! Take ECP's as soon as possible.
. While it is best to take ECP's within 3 days of unprotected sex, ECP's can be effective for up to 5 days after unprotected sex.
. You should use a birth control method for the remainder of your menstrual cycle and for preventing pregnancy in the future.
. For more information, talk to your pharmacist or health care provider.
ECP's are safe and effective.
. Progestin-only pills reduce the risk of pregnancy by 89 percent.*
. Combined estrogen/progestin pills reduce the risk of pregnancy by 75 percent.*
. For regular, long-term birth control, other contraceptive methods are more effective than EC.
. Emergency Contraception pills do not protect against sexually transmitted infections, including HIV/AIDS.
* EC has been associated with a slight risk of ectopic pregnancy in women who use birth control pills regularly. Call your doctor if you experience severe lower abdominal pain after taking EC.
ECP's won't cause an abortion.
. Emergency Contraception pills are not the same as RU-486 (the abortion pill).
. Emergency Contraception pills are not effective after pregnancy has occurred and cannot interrupt it.
ECP's won't harm a developing fetus.
. If Emergency Contraception pills are taken mistakenly during pregnancy, they will not harm the developing fetus.
. Using Emergency Contraception pills will not affect a woman's ability to become pregnant in the future.
Women can keep pills at home in case of an emergency.
. Many women find it convenient to have Emergency Contraception pills on hand in case of an emergency.
. Medical providers or a participating pharmacist can provide Emergency Contraception pills before they are needed.
Medical follow-up after taking Emergency Contraception pills.
. If you don't experience a normal period within four weeks, you may be pregnant and should see your health care provider or take a pregnancy test.
. It is important to visit your doctor or health care provider if you need a regular birth control method or information about preventing sexually transmitted infections, such as Chlamydia or HIV/AIDS.
Referral Sources
. Call 1-800-489-7273 for help if you have been raped or sexually assaulted.
. Call 1-800-228-7395 for help with domestic violence.
. For medical follow up call your health care provider or community clinic. To find the nearest Planned Parenthood Health Center, call....1-800-230-PLAN (7526)
Form C. Emergency Contraception -- Instructions for Use.
. Swallow the EC pills as soon as possible after receiving the medication from a pharmacist or health care practitioner. EC works better the sooner you use it.
. Some women may feel tired, dizzy, have headaches, or tender breasts. These side effects should go away within a day or two. Non-prescription pain relievers (such as ibuprofen or acetaminophen) can be used for headache or breast tenderness. You may also have some menstrual spotting (small amounts of bleeding -- less than a period) after taking EC. This should go away in a day or two.
You have been given: You have been given:
Oral Contraceptive Pills
Take: Take:
1 pill now and 1 pill in 12 hours
Take pill(s) ASAP and take pill(s) in 12 hours
2 pills as soon as possible
You have been given/advised to take: to prevent nausea. Take this medication 30-60 minutes before your first EC dose (as advised).
. With some types of EC, nausea and vomiting are possible, but not likely. If you vomit after 30 minutes of taking your dose, do not worry. The medication is already in your system. If you vomit before this time period, call your pharmacist -- you may need to take a repeat dose.
. If you are prescribed or advised to use a medication for possible nausea, take that medication as described in the following directions:
| Non-prescriptionDrugs: | Timing of Administration |
> Meclizine Hydrochloride (Dramamine II, Bonine) | One or two 25 mg tablets 1 hour before first EC dose; repeat if needed in 24 hours |
> Diphenhydramine Hydrochloride (Benadryl) | One or two 25 mg tablets or capsules 1 hour before first EC dose; repeat as needed every 4-6 hours |
> Dimenhydrinate (Dramamine) | One or two 50 mg tablets or 4--8 teaspoons liquid 30 minutes to one hour before first ECP dose; repeat as needed every 4-6 hours |
26 V.S.A. § 2079
13-067 Code Vt. R. 13-140-067-X