World Pharmacist Day

Emergency Contraception

Today, September 25, 2015, is World Pharmacist Day; the theme is “Pharmacist: Your Partner in Health”. This partnership is essential to the responsible use of medicines. The issues involving women’s health are always evolving and it is the responsibility of health professionals to educate the public. The St Vincent and the Grenadines (SVG) Pharmaceutical Association and the SVG Pharmacy Council have chosen to focus on the “Morning after Pill”.{{more}}

The merits and demerits of the “Morning after Pill”

Despite the availability of highly effective methods of contraception, many pregnancies are unplanned and unwanted and even though abstinence before marriage is still the best solution, it is not practised generally. Unwanted pregnancies carry a higher risk of morbidity and mortality, mostly due to unsafe abortion.

Half of all pregnancies are unintended; emergency contraception offers women a last chance to prevent pregnancy after unprotected intercourse. Although emergency contraception does not prevent sexually transmitted infections, it is well documented that many of these unplanned pregnancies can be avoided using safe hormonal methods of contraception, the “Emergency Contraceptive Pills” (ECPs).

There are two methods of emergency contraception:-

1. Emergency contraceptive pills (ECPs)

2. Copper-bearing intrauterine devices (IUDs).

It is important to understand the mechanism of action of ECPs when one attempts to discuss the ethical issues surrounding emergency contraception, as contrary to popular belief, ECPs are not abortive, and should be distinguished from abortifacient substances.

1. Emergency contraceptive pills are commonly referred to as “The Morning after Pills” or “Post Coital Pills”. These terms have, however, been replaced, because they do not convey the important message that ECPs should not be used regularly. They are intended for emergency use only and secondly they do not accurately convey the best possible period for use. These pills can be used up to five days or 120 hours after unprotected sex, but the sooner the better.

There are three general types of emergency contraceptive pills:

o Combined ECPs containing both estrogen and progestin, also known as the yuzpe method

o Progestin-only

o Antiprogestin-ulipristal acetate aka Ella one

Progestin-only and antiprogestin pills are available as dedicated (specifically packaged for use as) emergency contraceptive pills. Combined estrogen and progestin pills are no longer available as dedicated emergency contraceptive pills, but certain regular combined oral contraceptive pills may be used as emergency contraceptive pills. However, this practice is hardly encouraged because the regimen increases your chances of side effects and is bothersome to take. For example, one dose is taken, followed by a second dose 12 hours later, where each dose consists of as many as six (6) pills, depending on the brand.

Studies have been done on the progestin levonorgestrel for independent use as an emergency contraceptive. WHO reports show levonorgestrel to be 52-94 per cent effective in preventing pregnancy. The original treatment schedule was a 0.75mg dose within 72 hours after unprotected intercourse, and a second 0.75mg dose 12 hours after the first dose. However, studies have shown that a single dose of 1.5mg is as effective as two 0.75 mg doses taken 12 hours apart.

Progestin only ECPs have now largely replaced the older combined ECPs because they are more effective and cause fewer side effects. In SVG, the progestin only pills are most prevalent in use; some brand names available are ‘postinor’, ‘one pill’, ‘norlevo’ or ‘emkit’.

In the United States, the FDA has approved the distribution of ECPs as an over-the-counter product to enhance accessibility and as such, reduce abortion rates. There are newer, effective, highly tolerated ECPs, for example, ulipristal acetate or ellaone. It is given as a single 30mg dose and has been marketed for use in Europe since October 2009; it was approved by the FDA in the USA August 2010 and is available for sale by prescription only, marketed under the brand name Ella. This pill is not yet available here in SVG.

Emergency contraception should not be used as regular birth control. Overall, ECPs are less effective than regular contraceptive methods. Failure rates following the use of ECPs cannot be directly compared to failure rates of regular contraceptives, which represent the risk of failure during a full year of use. In addition, frequent use of emergency contraception can result in side effects, such as menstrual irregularities, and ectopic pregnancies.

Mode of Action:

Medical eligibility criteria and contraindications: Emergency contraceptive pills prevent pregnancy. If you are already pregnant, emergency contraception will not work. They should not be given to a woman who already has a confirmed pregnancy. IT IS NOT THE ABORTION PILL.

Based on results from studies of high-dose oral contraceptives (which are similar to ECPs), experts believe there is no harm or no known teratogenic effects (birth defects) to the pregnant woman or fetus if ECPs are inadvertently used during early pregnancy.

2. Copper-bearing intrauterine devices (IUDs)

WHO recommends that a copper-bearing IUD, as an emergency contraceptive, be inserted within five days of unprotected intercourse. This may be an ideal emergency contraceptive for a woman who is hoping for an ongoing, highly effective contraceptive method and requires consultation with your gynecologists.

Mode of action: As emergency contraception, the copper-bearing IUD primarily prevents fertilization by causing a chemical change that damages sperm and egg before they can meet.

Effectiveness: When inserted within five days of unprotected intercourse, a copper-bearing IUD is over 99 per cent effective in preventing pregnancy. This is the most effective form of emergency contraception available. Once inserted, the woman can continue to use the IUD as an ongoing method of contraception, and she may choose to change to another contraceptive method in the future.

Safety: A copper-bearing IUD is a very safe form of emergency contraception. The risks of infection, expulsion or perforation are low.

Medical eligibility criteria and contraindications: The only situation in which a copper-bearing IUD should never be used as emergency contraception is if a woman is already pregnant.

When should you use emergency contraception?

-You didn’t use birth control

-You were forced to have sex

-The condom broke or came off during sex

-Your diaphragm or cervical cap tears or slips out of place

-You have missed at least two or three active birth control pills in a row

-You were more than two weeks late getting your birth control shot

-Your patch or vaginal ring is placed too late, or removed too soon

-Your spermicidal tablet doesn’t melt before sex

-Your IUD comes out

-You are using the natural family planning method and didn’t abstain from sex on the fertile days of your cycle

-You have reason to think your regular birth control might have failed, through use of medications such as oral antibiotics or antifungals.

Who can provide ECPs? ECPs can be distributed safely by a variety of trained personnel and through clinical and non-clinical service delivery systems. Physicians, pharmacists, nurse, midwives, and other clinically trained personnel may be able to provide ECPs, depending on local regulations and practice. All ECP providers should receive training and be qualified as competent before distributing ECPs.

Appropriate distribution mechanisms can include family planning and reproductive health care clinics, general practitioners and family physicians, pharmacies, community-based services, and health service programmes for youth, among others.

When ECPs are provided through non-clinic outlets, the providers must have access to referral services for those cases where it may be required (for instance, if more than five days (120 hours) have elapsed since the act of unprotected sexual intercourse) and ECPs are no longer effective, and should not be given.

There are no other known medical contraindications to the use of ECPs. The dose of hormones used in emergency contraception is relatively small and the pills are used for a short time, so the contraindications associated with continuous use of Combined Oral Contraceptives (COCs) and Progestin only pills do not apply.

In the event that the client has had unprotected intercourse more than once within the last 120 hours, only one treatment of ECPs is necessary.

Although ECPs could be used as frequently as possible with no potential side effects, it is highly recommended to inform and counsel women on regular contraceptive methods and their correct use. You have to be certain that you do not want to become pregnant.

Requests for ECPs must be received sensitively with due regard for the woman’s right to privacy and confidentiality. The provider must attend to the request personally, giving all necessary advice and information in an appropriate manner to enhance the woman’s understanding and to enable her to make an informed choice. It is encouraged that the medicine be supplied directly to the woman herself, unless exceptional circumstances apply. Supportive attitudes will help improve compliance and set the stage for effective follow-up counselling about regular contraceptive use and STI prevention. To protect confidentiality, ECPs should not be dispensed in situations or premises where it is difficult to maintain privacy; counselling corners or rooms are recommended for all pharmacies. If you are concerned about possible infection, especially in cases of rape please use STI diagnostic services (or referrals given) and listen to the information about STI/HIV preventive measures.

You must understand that ECPs offer no protection against STIs, including HIV/AIDS. If the survivor is a child who has reached menarche, discuss the use of ECPs with her and her parent or guardian, who can help her to understand and take the regimen as required.

Survivors seen at a health facility immediately after being raped are likely to be extremely distressed and may not remember advice given at this time. Ask that the information be repeated. It is important; better yet, let the provider give you advice and information in writing. (Even if the survivor is illiterate, she can ask someone she trusts to read it to her later.) Ask the provider any questions and voice your concerns.

Listen attentively to description of possible side effects, for this can help you know what to expect, may lead to greater tolerance, and improves your satisfaction.

ECPs will not protect you from pregnancy if you engage in unprotected sexual intercourse in the days or weeks following treatment. This is a common misperception among some clients. A barrier method, such as the condom, should be used for the remainder of your cycle. A different contraceptive method can be initiated at the beginning of your next cycle.

ECPs typically do not cause the client’s menses to resume immediately. This is another common misperception. The client should understand that her period might come a few days earlier or later than normal. If your menses is more than a week late, you may be pregnant.

The client should come back or visit a referral clinic (as appropriate) if there is a delay in her menses of more than one week, if she has any reason for concern, or as soon as possible after the onset of the menstrual period for contraceptive counselling, if desired.

Management of common side effects

Nausea

It rarely lasts more than one day. The best way to minimize nausea is to use the levonogestrel (progestin-only) regimen when possible. If the combined regimen is used, nausea can be minimized by taking the pills with food or milk.

Vomiting

1. Repeat the dose if vomiting occurs within two hours of taking ECPs.

2. In cases of severe vomiting, vaginal administration of the pills can be used.

Irregular bleeding or spotting

It should not last long and if there is a delay in menstruation of more than one week, a pregnancy test should be performed. Other potential side effects include breast tenderness, headache, dizziness, and fatigue.

To reduce discomfort due to headaches or breast tenderness, use a pain reliever e.g. aspirin, ibuprofen or paracetamol.

Common side effects like breast tenderness, headaches, or dizziness would not last long.

SVG Pharmaceutical Association & the SVG Pharmacy Council in collaboration with the Ministry of Health, Wellness and the Environment

• A pharmacist should never condone the dispensing, promoting, or distributing of drugs or medical devices, or assist therein, which are not of good quality, which do not meet standards required by law or which lack therapeutic value for the patient.

• A pharmacist should always strive to perfect and enlarge his professional knowledge. He should utilize and make available this knowledge as may be required in accordance with his best professional judgment.

• A pharmacist has the duty to observe the law, to uphold the dignity and honour of the profession, and to accept its ethical principles. He should not engage in any activity that will bring discredit to the profession and should expose, without fear or favour, illegal or unethical conduct in the profession.

• A pharmacist should seek at all times only fair and reasonable remuneration for his services. He should never agree to or participate in transactions with practitioners of other health professions or any other person under which fees are divided or which may cause financial or other exploitation in connection with the rendering of his professional services.

• A pharmacist should respect the confidential and personal nature of his professional records; except where the best interest of the patient requires or the law demands, he should not disclose such information to anyone without proper patient authorization.

• A pharmacist should not agree to practise under terms or conditions which tend to interfere with or impair the proper exercise of his professional judgment and skill, which tend to cause a deterioration of the quality of his service or which require him to consent to unethical conduct.

• A pharmacist should strive to provide information to patients regarding professional services truthfully, accurately, and fully, and should avoid misleading patients regarding the nature, cost, or value of the pharmacist’s professional services.

• A pharmacist should associate with organizations having for their objective the betterment of the profession of pharmacy; he should contribute of his time and funds to carry on the work of these organizations.