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Pharmacy Act, 1974 (Act No. 53 of 1974)

Board Notices

Rules Relating to Good Pharmacy Practice

Chapter 2 : Professional Standard for Services

2.26 Minimum Standards for Emergency Postcoital Contraception (EPC) (SAPC GPP 2010)

 

2.26.1 Introduction

 

Emergency post-coital contraception (EPC) 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 EPC will not be effective if the woman is pregnant already, although it is not considered to be harmful to the foetus. EPC can alter the timing and type of bleeding of the next menstrual period. Bleeding may start a little early or a little late, but if it is more than five days late then pregnancy is a possibility and further referral is necessary. EPC is not as effective as conventional methods of contraception and is not recommended for regular use.

 

Emergency contraception should not be used in patients with a history of blood clots. Women with diabetes, liver disease, heart disease, kidney disease, or high blood pressure require special consideration.

 

2.26.2 Before testing (pharmacist must consider the following before supplying EPC)

 

(a) The following information must be obtained from the patient prior to the supply of EPC to the patient (in addition to that required in the course of dispensing a prescription):
(i) certainty that the patient does not want to become pregnant;
(ii) date of patient's last menstrual period to rule out established pregnancy;
(iii) the time that has elapsed since unprotected intercourse occurred (less than 72 hours is more likely to prevent pregnancy); and
(iv) whether the patient has been a victim of sexual assault.
(b) To assess how likely it is that the woman might be pregnant, the following questions could be asked:
(i) Is your period late? How late?
(ii) Was your last period lighter or shorter than normal?
(iii) Was your last period unusual in any other way? and
(iv) At any time before this occasion and since your last period, have you had unprotected sexual intercourse?

 

If the woman answers 'yes' to any of these questions, then a referral, or a pregnancy test, should be recommended. Supply of EPC could, however, be considered for a woman who, in addition to this current incident of unprotected sexual intercourse, has had within her current cycle previous incidents of unprotected intercourse since pregnancy may not have resulted from these, but could now.

 

2.26.3        Emergency contraception regimes

 

(a) Emergency contraception regimens consist of two doses of oral contraceptive tablets.
(b) The first dose is administered within 72 hours of unprotected intercourse. The second dose is taken 12 hours later. Studies support the administration of the first dose within 72 hours after unprotected intercourse.
(c) Dose: The number of tablets taken depends on the product used.
(d) The timing of the first dose of medication is critical. The regimen becomes completely ineffective by day 6 or 7 when implantation usually occurs.
(e) The sooner after unprotected intercourse the tablets are taken, the more effective they will be.
(f) Generally a total of 0.10 or 0.12mg ethinylestradiol and 0.5 or 0.6mg levonorgestrel are taken with each dose. Examples of regimens include:
(i) 2 tablets of Ovral®: each tablet contains 250ug d-norgestrel/500 ug ethinylestradiol;
(ii) 2 tablets E-gen-c® each tablet contains levonorgestrel 0.25mg ethinylestradiol 0.05mg; and
(iii) Norlevo® which contains 2 X levonorgestrel 0,75mg per tablet.

 

2.26.4        Use of EPC when breastfeeding

 

Small amounts of levonorgestrel may appear in breast milk. While not considered harmful, to reduce the amount that the baby might ingest, the woman can be advised either to express milk immediately before taking the EPC or to delay taking the medicine until immediately after feeding the baby.

 

This approach must be weighed against the need to minimise delays in treatment.

 

2.26.5 Professional and ethical responsibility of pharmacists in the provision of EPC

 

Pharmacists must ensure that the following standards are observed in the supply of EPC as an over-counter-medicine in a pharmacy:

(a) as with all medicines, the pharmacist who supplies EPC must have sufficient knowledge of the product to enable him/her to make an informed decision when requests for EPC are made;
(b) a pharmacist must deal with the request personally and decide whether to supply the product or refer the patient to another appropriate healthcare professional;
(c) pharmacists must ensure that all necessary advice and information is provided to enable the patient to assess whether to use the product suggested/supplied;
(d) requests for EPC should be handled sensitively with due regard being given to the customer's right to privacy;
(e) only in exceptional circumstances should pharmacists supply the product to a person other than the patient;
(f) pharmacists should, whenever possible, take reasonable measures to inform patients of regular methods of contraception, disease prevention and sources of help;
(g) to help reduce patient stress and anxiety, it is crucial that pharmacists remain supportive and refrain from making judgemental comments or indicating disapproval by means of body language or facial expressions while discussing EPC;
(h) supportive pharmacist attitudes, including respect for population diversity and patient beliefs, will also improve compliance and promote effective patient-pharmacist communication if follow-up is needed;
(i) pharmacists must bear in mind that patients seeking EPC may be under stress after unprotected intercourse for many reasons which may include:
(i) fear of becoming pregnant;
(ii) embarrassment at failing to use contraceptives effectively;
(iii) general embarrassment about sexual issues;
(iv) lack of knowledge about EPC;
(v) rape and/or sexual abuse trauma;
(vi) concern about auto-immune deficiency syndrome (AIDS) and sexually transmitted infections (STIs);
(vii) worry about missing the narrow window of opportunity for EPC; and
(viii) a combination of these factors.
(j) pharmacists who do not wish to provide EPC treatment for personal reasons should maintain objectivity and remain professional when dealing with patients. In this case, patients must be referred to an alternate source of EPC;
(k) if the patient questions the pharmacist as to why he or she will not be providing the product or service personally, the pharmacist should answer in a manner that does not make the patient feel uncomfortable; and
(l) alternate sources for EPC might include referral to one or more pre-arranged options such as:
(i) another pharmacist in the same pharmacy;
(ii) another pharmacy in the vicinity;
(iii) a medical practitioner; and
(vi) a nearby hospital, community health centre, primary health care clinic or reproductive health clinic.

 

2.26.6 Confidentiality

 

It is important that all pharmacy staff, including pharmacists, pharmacist interns, pharmacist's assistants and any staff who may be the first contact for the patient be informed of the EPC service available at the pharmacy. Adequate training of personnel in the pharmacy is advocated in the handling of patients seeking these services.

(a) All staff must show sensitivity and ensure confidentiality.
(b) The test should be conducted in a private counselling area.
(c) In the testing and counselling:
(i) use non-specific language to refer to sensitive terms (e.g. use 'the incident' or the 'situation' rather than saying 'unprotected intercourse' or 'sex'); and
(ii) use a written form to collect key information about the patient's situation.

 

2.26.7 Patient counselling

 

2.26.7.1 General principles

 

(a) Through the course of counselling, it may become evident that a referral is needed to a medical practitioner, reproductive health clinic, etc.
(b) If the EPC product comes with a pregnancy test, it is meant to be used to rule out a pregnancy that may have occurred since her last menstrual period.
(c) The pharmacist should refer to the patient information leaflet and ensure that she understands how to use the pregnancy test correctly.
(d) Women must be counselled to take the first dose of EPC as soon as it is convenient, keeping in mind the timing of the second dose. For example, rather than encouraging the patient to take the first dose at 16h00 (with the second dose at 04h00), it might be better to suggest that she takes the first dose at 19h00.
(e) The pharmacist must explain that emergency contraception does not protect against or treat sexually transmitted infections (STIs). If the patient thinks she may have contracted a STI, she will need to see a medical practitioner immediately.
(f) The pharmacist must remind the patient that EPC is not 100% effective and will not terminate an established pregnancy. If her period does not commence within three weeks, she should consider having a pregnancy test.
(g) The patient should be advised that her period will probably begin on time but may be a few days earlier or later than normal.
(h) The pharmacist must emphasise that emergency contraception is for emergency use only and that it is less effective than other means of birth control if used repeatedly.
(i) The patient must be reminded to begin using ongoing contraception as soon as she resumes intercourse. She may be at high risk of pregnancy following EPC use if ovulation is delayed. If her regular method of contraception failed, the patient must be counselled on an effective method to use if necessary.
(j) The patient must be supplied with a patient information leaflet containing instructions, as well as the pharmacy phone number. She must be encouraged to call if she has any further questions.

 

2.26.7.2 Continued contraception

 

(a) Emergency contraceptives are meant solely for emergency use and are not as effective as other birth control methods for ongoing contraception. Pharmacists should encourage patients to talk to a medical practitioner or nurse about using an ongoing contraceptive method to prevent pregnancy in the future.
(b) If the patient does not have a regular health care provider, the pharmacist can offer referrals to local providers.
(c) Women should be told that EPC will not provide continued protection against pregnancy for the remainder of the menstrual cycle, and be advised about other contraceptive measures — including recommending referral where appropriate.
(d) A woman seeking EPC because she has missed one or more oral contraceptive pills should be advised to continue taking her pills as normal. In addition she should be advised to use a barrier method of contraception for the next seven days.

 

2.26.7.3 Referral

 

The woman should be advised to see her doctor or reproductive health clinic for a pregnancy test if her next period is more than five days late or is unusual in any way or — for those taking an oral contraceptive — if there is no bleed in the pill-free interval

 

2.26.7.4 Repeated use of emergency contraception

 

(a) Although experience has shown that very few women request emergency contraception repeatedly, mainly because of the unpleasant side effects some women experience while using them. Patients should nonetheless be asked if they have used emergency contraception before, and should be counselled accordingly.
(b) EPC is less effective at preventing pregnancy than typical use of regular contraceptive methods. Therefore a patient presenting repeatedly for emergency contraception should be provided with treatment but informed of the high cumulative failure rate with repeated use, and provided with referrals for ongoing care.

 

2.26.7.5 HIV and sexually transmitted infections (STIs)

 

(a) Patients must understand that EPC do es not protect against STIs, including HIV/AIDS, and that use of a condom is necessary to protect against these infections.
(b) Patients may be very concerned about possible infection, especially in cases of rape. Counselling on this topic is essential, with referral for diagnosis and treatment provided when needed.
(c) Medical referral may be necessary to screen for infections. For this purpose, patients should be advised to schedule a follow-up appointment with a medical practitioner or reproductive health or sexual health clinic after taking the EPC.
(d) If appropriate, the pharmacist should provide information (e.g. leaflets) on sexual health and STIs.

 

2.26.7.6 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.

 

2.26.7.7 Dealing with children and parents

 

Parents often have inaccurate information about their child's contraceptive use. Parents may react with anger if they find oral contraceptives, condoms, or a product for emergency contraception in the child's personal belongings because these indicate a level of sexual activity of which they were not aware.

 

They may also feel displeased because the child did not first discuss the matter with them. Sometimes the provider (e.g. pharmacist, nurse) becomes the primary target of the parent's feelings.

(a) 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:
(i) be direct, honest and professional;
(ii) tell parents that you understand their concern; and
(iii) inform parents that minors can consent to contraceptive and reproductive health services and it is the pharmacist's obligation to provide them.
(b) If the pharmacist becomes aware that a child (any one under the age of 16) has been physically harmed, sexually abused or sexually exploited by a parent or other person, the pharmacist must report these circumstances to the appropriate local/provincial authority.