Progestin-only(LNG) Emergency Contraceptive Pills Training for Pharmacists

1. Progestin-only(LNG)Emergency ContraceptivePills Training for Pharmacists

2. Objectives 1. Describe the characteristics of progestin-only, levonorgestrel (LNG) emergency contraceptive pills (ECP) in a manner that customers can understand: • What LNG ECPs are and how they work (mechanism of action) • Effectiveness • Side effects • Safety • Possible precautions or complications • ECP regimens At the end of this session, participants will be able to:

3. Objectives (continued) 2. Discuss legal framework for ECPs in your country 3. Describe the indications for use of ECPs 4. Demonstrate how to screen customers for LNG ECP use 5. Demonstrate how to inform LNG ECP customers including: • Characteristics of LNG ECPs • How to use LNG ECPs • Possible side effects of LNG ECPs and how to manage them • The importance of using a barrier method if needed and/or starting regular contraceptives after ECP use

4. What are ECPs? • Emergency contraceptive pills (ECPs) are hormonal methods of contraception that can be used to prevent pregnancy following an unprotected act of sexual intercourse. • There are different types of ECPs. In this training, we will be focusing on the levonorgestrel-only LNG ECPs.

5. LNG ECPs: Mechanism of Action LNG ECPs interfere with the process of ovulation • ECPs do not inhibit implantation of a fertilized egg. • ECPs do not inhibit implantation of a fertilized egg. • ECPs do not cause abortion of an existing pregnancy • do not of an existing pregnancy • an existing pregnancy

6. Effectiveness of ECPs • The LNG regimen reduces a woman’s chance of pregnancy after a single sex act by at least half and possibly by as much as 80-90%. • Effectiveness for an individual woman depends on where she is in her menstrual cycle, when she had unprotected sex and when she used ECPs.. • Some types of ECP, ulipristal acetate (UPA) or mifepristone, are more effective than LNG ECPs and some (regular contraceptives- the Yuzpe regimen) are less effective. • Effectiveness may be affected by use of certain medications.

7. Fertilization EC pills have no effect after fertilization, do not cause abortion EC pills work before fertilization Last Day of Menstruation Ovulation Starts Implantation Positive Pregnancy Test First Day of Cycle Day 1

8. Side effects of ECPs LNG ECPs are well tolerated and leave the body within a few days. Some women experience mild and short-term side effects. These may include: • Altered bleeding patterns • Nausea (in up to 20% of women) • Vomiting (rare) • Headache • Abdominal pain • Breast tenderness • Dizziness • Fatigue Side effects

9. Safety of ECPs • ECPs have no known serious complications. • ECPs do not cause abortion • ECPs are safe for use by all women including adolescents. • ECPs are not harmful if taken by a woman who is already pregnant. • ECPs have been widely used in various formulations for over 30 years.

10. No contraindications to the use of ECPs • Women are able to decide for themselves if they can take ECPs; they have no medical precautions or contraindications ECPs • No pregnancy test or physical examination is needed • ECPs should not be taken if a woman is pregnant because they will not work.However they will not harm an existing pregnancy • ECP effectiveness may be affected by the use of certain medications.

11. ECP regimens Two LNG regimens are packaged and labeled specifically for emergency contraception • 1 tablet levonorgestrel (LNG), 1.5 mg or • 2 tablets of 0.75 mg LNG to be taken 12 hours apart (as labeled by the FDA) yet evidence shows that it is best if both pills are taken at the same time.

12. Other emergency contraceptive options Other types of emergency contraceptives include: • Ulipristal acetate, 30 mg in a single dose • Mifepristone, 10-25 mg in a single dose (not widely available) • Combined hormonal contraceptive pills (estrogen and progestin- Yuzperegimen) • Insertion of copper IUD

13. Indications for Use of ECPs • No contraceptive was used (including cases of rape) • A contraceptive was used incorrectly • A contraceptive was used correctly, but was immediately observed to have failed.

14. Client Interaction • Privacy and confidentiality are very important when speaking with clients about ECPs. • Asking other customers to stand back from the counter can help create privacy. Additionally, you can step into another room or even outside to have a private conversation. • Because ECPs are so safe, women are usually able to determine for themselves whether they should take them.

15. Screening customers for ECP use The most important screening question for ECP use is: Did you have unprotected sex within the last 5 days (120 hours)? If “yes” then the client is eligible for ECPs. Effectiveness will be lower the longer a woman waits to take ECPs.

16. Screening questions for ECP use (continued) You can also ask questions to determine if the woman is pregnant. ECPs will not work if she is pregnant. • Was your last menstrual period less than 4 weeks ago? If “No,” the client may be pregnant. • Was this period normal for you in both its length and timing? If “No,” the client may be pregnant. • Is there reason to believe you may be pregnant? If “Yes,” the client may be pregnant. If the client is not pregnant, ECPs may be given. If the client’s pregnancy status is unclear, ECPs may still be given, with the explanation that the method will not work if she is already pregnant. You can also ask about other drugs the woman is taking: Are you taking the any of these drugs: rifampicin, griseofulvin, Saint John’s Wort, anticonvulsant drugs or ritonavir? ECPs may be less effective if you are taking any of these medications. But ECPs should still be given, as there are no contraindications to ECPs.

17. Providing information to ECP customers When providing information about ECP: • Reassure the customer that all information she gives you is kept confidential • Provide a private and supportive environment • Do not make judgmental comments or indicate disapproval through body language • Be responsive to the customer’s needs • Be supportive of the customers choices • Be respectful

18. Addressing rumors about ECPs Correct common concerns, rumors or misconceptions by emphasizing: • The availability of ECPs does not increase risky sexual behavior. • ECPs do not prevent implantation • ECPs do not cause abortions • ECPs do not cause deformed babies • ECPs are not dangerous

19. When do rumors occur? • Information given is important to people, but it has not been clearly explained. • There is nobody available who can clarify or correct the incorrect information. • The original source is perceived to be credible. • People are motivated to spread them for moral, religious or political reasons.

20. How to counteract rumors • Listen politely and don’t laugh • Find out where the rumor came from • Explain the facts • Answer questions • Always tell the truth • Clarify information • Use examples • Reassure the customer

21. How to use ECPs ECP information for the customer should include: • How and when to take the pills. • What to expect once the pills are taken, including possible side effects and what the woman should do. • Effectiveness/failure rates. • Importance of using regular contraception.

22. Possible side effects of ECPs Some women experience: Changes in bleeding patterns (not serious and will resolve without treatment) • Slight irregular bleeding for 1-2 days or • Monthly bleeding that starts earlier or later than expected Within the week after taking ECPs (these side effects are not serious, require no treatment and usually resolve within 24 hours) • Nausea • Vomiting (rare with LNG-only ECPs) • Abdominal pain • Fatigue • Headaches or dizziness

23. Starting regular contraceptives after ECP use Contraceptive use should never be made a condition for ECP use. Customers should use condoms or abstain from sex until initiating regular contraception during or after the next menstrual period. Whenever possible, customers receiving ECPs should be given a contraceptive method or referred to a place where they are offered: • Condoms and injectablescan be given immediately. • Combined oral contraceptive pills can be given the next day • IUDs and implants can be given within the first 7 days of the next menstruation.

24. Action items for pharmacists • Maintain a stock of ECPs. • Make sure all of your pharmacy’s employees know that you provide ECPs. • Provide women with instructions for using ECPs • Provide ECPs in advance to customers when possible • Prescribe ECPs for adolescents if allowed in your country • Advertise the availability of ECPs in your pharmacy. • Notify near-by clinics and emergency rooms that you offer ECPs. • Discuss ECPs with customers privately and confidentially • Refer customers to other health care providers for continuing family planning and STI/HIV management