Introduction
This chapter is intended to assist pharmacists in providing effective care and support to patients seeking emergency contraception (EC).
While pharmacists are professionally prepared to provide care and support for patients seeking emergency contraception, the challenges inherent in increased distribution of emergency contraception (such as physician and public awareness) require a standardized approach. Currently, emergency contraception requires a prescription in all Canadian provinces, but several provinces are developing collaborative drug therapy agreements to allow patients to obtain EC directly at pharmacies.
Pharmacists' Professional Responsibility
To help reduce patient stress and anxiety, it is crucial that pharmacists remain supportive and refrain from making judgmental comments or indicating disapproval through body language or facial expressions while discussing EC. Supportive pharmacist attitudes, including respect for population diversity and patient beliefs, also will help compliance and set the stage for effective patient-pharmacist communication if follow-up is needed.
Patients seeking EC may be under stress after unprotected intercourse for many reasons:
- fear of becoming pregnant
- embarrassment at failing to use contraceptives effectively
- general embarrassment about sexual issues
- lack of knowledge about EC
- rape and /or sexual abuse trauma
- concern about auto-immune deficiency syndrome (AIDS) and sexually transmitted diseases (STDs)
- worry about missing the narrow window of opportunity for EC, or
- a combination of these factors.
Pharmacists who do not wish to provide EC treatment for personal reasons should maintain objectivity and remain professional in manner when dealing with patients. In this case, patients should be referred to an alternate source, as listed below. More information is found in the "Model Statement Regarding Pharmacists' Refusal to Provide Products or Services for Moral or Religious Reasons", approved by NAPRA Council in November 1999.
The Model Statement suggests that pharmacists not convey their personal objections to the patient. If the patient questions the pharmacist as to why he or she will not personally be providing the product or service, the pharmacist should answer in a manner that does not make the patient feel uncomfortable. Alternate sources for EC noted might include referral to one or more pre-arranged source options such as:
- another pharmacist in the same pharmacy
- another pharmacy in the vicinity
- the prescribing physician
- nearby hospital
- family planning clinic
Available Emergency Contraception Regimens
Emergency contraception regimens are two doses of oral contraceptive tablets. The first dose is administered within 72 hours of unprotected intercourse; the second dose is taken 12 hours later. The number of tablets taken depends on the product used. Generally a total of 0.10 or 0.12 mg ethinyl estradiol and 0.5 or 0.6 mg levonorgestrel are taken with each dose. Examples of regimens include:
- 2 tablets of Ovral®: each tablet contains 250ug d-norgestrel/50 ug ethinyl estradiol ·
- 4 tablets of Triphasil®: each yellow tablet contains125ug levonorgestrel/30ug ethinyl estradiol ·
- 5 tablets of Alesse®: each pink tablet contains 100ug levonorgestrel/20ug ethinyl estradiol
- 2 tablets of Preven®: each tablet contains 250 mcg levonorgestrel/50 mcg ethinyl estradiol
- 1 tablet of Plan B®: each tablet contains 750 mcg levonorgestrel
Progestin-only mini pills may also be used, although this regimen is less convenient because of the number of tablets that must be taken.
The timing of the first dose of medication is critical. The regimen becomes completely ineffective by day 6 or 7 when implantation usually occurs. The sooner after unprotected intercourse the tablets are taken, the more effective they will be. Studies support the administration of the first dose within 72 hours after unprotected intercourse.
Effectiveness
EC regimens can reduce the risk of pregnancy by 75%. This is best explained as follows: If 100 women have unprotected intercourse in the middle two weeks of their cycle, approximately 8 will become pregnant. Use of EC would reduce this number to 2 women. Even though this method of contraception reduces the risk of pregnancy substantially, it is still less effective than consistent use of other contraceptive methods. Therefore this treatment should only be used in emergency situations.
Adverse Effects
Nausea occurs in approximately 46% or patients who receive combination EC, and in 15% of women receiving progestin only products. Emesis occurs in 22% and 3% or patients respectively. Nausea and vomiting may occur after either dose of medication and tends to last for 2 days or longer. There is evidence that anti-emetics taken 1 hour before EC can reduce nausea and vomiting. Other adverse effects associated with both regimens include dizziness, fatigue, breast tenderness and headaches. These adverse effects generally do not last more than 24 hours.
Mechanism of Action
The precise mechanism of contraceptive activity of EC after intercourse is not known, although many of the mechanisms are the same as when the tablets are taken regularly as oral contraceptives. The mechanism may depend on when the drugs are administered relative to ovulation and the time since intercourse. The EC may prevent conception by delaying or inhibiting ovulation. It may also act by altering endometrial development and creating an environment that is hostile to uterine implantation of the fertilized ovum. Timing is critical to efficacy. Once implantation occurs (usually within 6-7 days after ovulation) emergency contraception is ineffective in terminating a pregnancy.
Patient Counseling Summary
Many women who seek EC may be embarrassed about not using a method or having a contraceptive "accident". It is important that pharmacists listen respectfully and openly to patient concerns, and avoid appearing judgmental while discussing EC. Through the course of counseling, it may become evident that a referral is needed to a family physician, family planning clinic or other resource centre ( see # 3, 5 and 8 below).
1. Obtain the following information from the patient (in addition to that required in the course of dispensing a prescription:
- certainty that the patient does not want to become pregnant
- date of patient's last menstrual period to rule out established pregnancy
- the time that has elapsed since unprotected intercourse occurred (less than 72 hours is more likely to prevent pregnancy)
- whether the patient has been a victim of sexual assault
2. Explain how to take the EC correctly and conveniently. Recent research has shown that the earlier the regimen is initiated, the more effective it is. Women should be counseled to take the first dose as soon as it is convenient, keeping in mind the timing of the second dose. For example, rather than encouraging her to take the first dose at 4:00 p.m. (with the second dose at 4 am), it might be better to begin at 7pm.
3. Explain that emergency contraception does not protect against or treat sexually transmitted diseases. If she thinks she may have contracted a sexually transmitted disease, she will need to see a physician immediately.
4. If the EC product comes with a pregnancy test, it is meant to rule out a pregnancy that may have occurred since her last menstrual period. The pharmacist should refer to the patient information insert and ensure that she understands how to use the pregnancy test correctly.
5. Remind the patient that EC is not 100% effective and will not terminate an established pregnancy. If she does not get her period within 3 weeks, she may want to take a home pregnancy test or call for a referral or follow up with a nurse or physician.
6. Remind the patient that her period most likely will come on time but may be a few days earlier or later than normal.
7. Emphasize that emergency contraception is for emergency use only and it is less effective than other means of birth control if used repeatedly.
8. Remind the patient to begin using ongoing contraception as soon as she resumes intercourse. She may be at high risk of pregnancy following EC use if ovulation is delayed. If her regular contraception failed, counsel her on an effective method to use if necessary
9. Explain to the patient that her prescription includes a patient information sheet that has instructions on it as well as the pharmacy phone number. Encourage her to call if she has any further questions.
10. Refer the patient to a physician or family planning clinic provider if established pregnancy cannot be ruled out or if the elapsed time is greater than 72 hours.
Counseling Issues
Follow up with the physician
After taking EC, the woman's next menstrual period should occur within a few days of her regular cycle. Follow up with a physician is required if the patient has a delay in her next regular cycle or wishes to initiate use of a regular contraceptive method.
Responsibility to minors
If the pharmacist becomes aware that a child (any one under the age of 19) has been physically harmed, sexually abused or sexually exploited by a parent or other person, the pharmacist must report these circumstances to the appropriate provincial authority. See "Reporting Child Abuse and Neglect".
Dealing with parents
Parents often have inaccurate information about their child's contraceptive use. Parents may react with anger if they find oral contraceptives, condoms, or an emergency contraceptive prescription in the child's personal belongings because these indicate a level of sexual activity of which they were not aware. They may also feel displaced because the child was not talking with them first.
Often, the provider (e.g. pharmacist, nurse, physician) becomes the primary target of the parent's feelings. In such cases pharmacists must first be able to address the parent's immediate concerns and provide accurate information about contraceptives, and then address their questions. In talking with parents, pharmacists should keep the following objectives in mind:
- Be direct, honest and professional
- Tell parents that you understand their concern
- Inform parents that minors can consent to contraceptive and family planning services and it is the pharmacist's obligation to provide them.
Confidentiality in the pharmacy setting
It is important that all pharmacy staff on duty be informed of the Emergency Contraception service available at their pharmacy. This includes pharmacists, technicians and any staff who may be the first contact for the patient (telephone or walk-in). All staff must be prepared to show sensitivity and ensure confidentiality.
The optimal scenario for any patient counseling is one in which pharmacists counsel patients in private counseling areas. In the Emergency Contraception scenario, the need for sensitivity, privacy and confidentiality is magnified. Minimally, pharmacists must be aware of and sensitive to the need for confidentiality and privacy, and conduct the consultation in the appropriate professional manner.
Suggestions for improving the level of patient privacy include:
- using a separate counseling room or private area of the pharmacy
- using non-specific language to refer to sensitive terms (e.g. use "the incident" or the "situation" rather than saying "unprotected intercourse" or "sex")
- using a written form to collect key information about the patient's situation (see form #1)
- it may be helpful to use the telephone to counsel
Referral for ongoing contraceptive care
Emergency Contraceptives are meant for emergency use and are not as effective as other birth control methods for ongoing contraception. Pharmacists should encourage patients to talk to a physician or nurse about using an ongoing contraceptive method to prevent pregnancy in the future. If the patient does not have a regular health care provider, the pharmacist can offer referrals to local providers.
Repeated use of emergency contraception
Experience has shown that very few women request emergency contraception repeatedly, mainly because of the unpleasant side effects some women experience while using them. Because ECs are less effective at preventing pregnancy than typical use of regular contraceptive methods, a patient presenting repeatedly for emergency contraception should be provided treatment, but informed of the high cumulative failure rate with repeated use, and provided with referrals for ongoing care.
HIV and STDs
Patients must understand that Emergency Contraceptives do not protect against STDs, including HIV/AIDS. Patients may be very concerned about possible infection, especially in cases of rape. Counseling on this topic is essential, with referral for diagnosis and treatment provided when needed.
Alcohol/drugs
In some cases the patient may not remember whether penetrative sex took place or not. In such cases, it is best to assume that intercourse occurred and provide emergency contraceptives.
Presenting after 72 hours/multiple acts of unprotected intercourse
Some women may have unprotected intercourse more than once, with some acts of intercourse occurring more than 72 hours before seeking emergency contraception and some occurring within the 72 hour period. The pharmacist and patient should evaluate the decision to use emergency contraception in light of the following information, and the patient should be referred as needed:
- The effectiveness of emergency contraception taken 72 or more hours after intercourse has not been well documented. It is not likely that efficacy drops suddenly to zero, so treatment after 72 hours may be reasonable
- Unprotected sex that occurred more than 72 hours before emergency contraception treatment may have already resulted in pregnancy. If the woman is pregnant, emergency contraception will not disrupt or harm the pregnancy
- With multiple acts of unprotected sex, emergency contraception treatment can reduce the risk of pregnancy resulting from unprotected sex that occurred within the 72 hour period.
Patient Information
What are emergency oral contraceptives?
You have been prescribed a form of emergency contraception that is often referred to as the morning after pill. Emergency contraceptive pills are birth control pills used in high doses, taken within 72 hours of unprotected sex. The two most commonly prescribed oral contraceptives are Ovral® and Min- Ovral®
How effective is emergency contraception?
Although emergency contraception may not be as effective as a regular contraceptive, it is useful in preventing pregnancy at least 75 per cent of the time. In order to obtain maximum effectiveness, it is important that you follow the pharmacists and physicians directions regarding the appropriate use of this product.
What is the dose?
The dose of emergency contraception depends on the oral contraceptive prescribed. EC regimens are two doses of oral contraceptive tablets: the first dose administered within 72 hours of unprotected intercourse and the second dose taken 12 hours later. The number of tablets taken depends on the product used. Generally a total of 0.10 or 0.12 mg ethinyl estradiol and 0.5 or 0.6 mg levonorgestrel are taken with each dose:
Examples:
- 2 tablets of Ovral®: each tablet contains 250ug d-norgestrel/50 ug ethinyl estradiol
- 4 tablets of Triphasil®: each tablet contains125ug levonorgestrel/30ug ethinyl estradiol
- 5 tablets of Alesse®: each tablet contains 100ug levonorgestrel/20ug ethinyl estradio
- 2 tablets of Preven®: each tablet contains 250 mcg levonorgestrel/50 mcg ethinyl estradiol
- 1 tablet of Plan B®: each tablet contains 750 mcg levonorgestrel
Progestin-only mini pills may also be used, although this regimen is less convenient because of the number of tablets that must be taken.
The timing of the first dose of medication is critical. The regimen becomes completely ineffective by day 6 or 7 when implantation usually occurs. The sooner after unprotected intercourse the tablets are taken, the more effective they will be. Studies support the administration of the first dose within 72 hours after unprotected intercourse.
What unwanted effects should I expect?
Nausea and vomiting are common side effects because of the high estrogen dose. This problem can be minimized by taking the contraceptive with food. Dimehydrinate (for example, Gravol®) may also have been prescribed to help prevent nausea and vomiting. Dimenhydrinate should be taken one half hour to one hour before each dose of contraceptive. Your physician may have prescribed an extra dose of emergency contraception in case one is lost from vomiting. Some physicians recommend repeating the dose if you vomit within one hour after taking the tablets.
Other unwanted effects include breast tenderness, headaches and cramps. Your menstrual cycle should resume around the regular time. If not, please call your physician.
Who should not use emergency contraceptives?
Emergency contraceptives should not be used if you have a history of blood clots. People with diabetes, liver disease, heart disease, kidney disease, or high blood pressure require special consideration while receiving this drug. Ensure your physician knows if you have one of these conditions. Important: Emergency contraceptives are for emergency use only and should not be used on a regular basis. If you encounter problems or have any questions about this product, please do not hesitate to contact your physician or pharmacist.
References:
1. "Emergency Contraception in British Columbia - The Role of the Pharmacist", College of Pharmacists of British Columbia
2. "Morning After Pill - Patient Information", DIAL Access Drug Service Information, Saskatchewan (Developed for the Saskatchewan Pharmaceutical Association)
3. "Oral Contraceptives for Emergency Contraception Purposes". NAPRA 1999
4. "Reporting Child Abuse and Neglect", Pharmacy Connection, July/August 2000.