Background

It is estimated that, in India, nearly 3/4th conceptions occurring annually are unplanned and almost 1/4th are unwanted or mis-timed. They result in nearly 11 million recorded abortions annually and many more unrecorded and unreported abortions. These unsafe abortions are associated with a high maternal mortality and morbidity. All this is due to poor awareness and accessibility of contraceptive services. It is, therefore, necessary to improve the access and awareness about different methods being offered in the ‘cafetaria-contraceptive basket’. One of the methods which needs to be added to this basket is ‘emergency contraception’ to take care of unplanned sexual exposure.

Several methods are available for use as Emergency Contraception. A brief on their merits and demerits was provided to the group as background material.

The choices included :

- a specially-packed EC Pill as per Yuzpe regimen

- 4 tablets cut from a pack of high dose combined oral contraceptive (COC)

- 8 tablets cut from a low dose COC pack

- specially-packed Levonorgestrel pill

- 20 tablets of progesterone only pill

- mifepristone as a single tablet

- copper containing intra-uterine contra-ceptive devices

Questions to be Answered

The Group needed to decide on :

a. Which is the best method for India?

b. How should it be packaged?

c. What should be the cost of this method?

Factors which may help in deciding about a specific method include :

- intrinsic character of method

- efficacy and failure rate

- the window period

- side-effects and safety profile

While deciding on a dedicated method of choice, the Group was requested to deliberate on the following issues :

• Should we have a method that is already available, though it may not be specified as EC?

• Do we need a new method to be introduced in India based on research evidence about safety and efficacy?

• Do we need a single method or a method-mix with two or more methods to take care of the diverse needs of women?

Views of the Group

A. Which is the best method for India?

The Group divided the recommendations in two sections, viz

I. For immediate implementation - drugs/ methods already available in India.

II. For future introduction – drugs/methods which are currently not available, but are better in terms of efficacy and safety profile, thus need to be introduced in India as soon as possible.

I. Immediate introduction

• Yuzpe regimen – 2 tablets containing Ethinyl Estradiol 50µg and Levonorgestrel 0.25mg – 2 tablets to be taken within 72 hours and 2 tablets 12 hours later. These tablets are already available as combined oral contraceptive pills (COC).

• Copper IUD – if delay is upto 5 days, after checking and ruling out PID, ideal for parous women who need subsequent regular contraception.

• Method-mix – both Yuzpe method and IUD to be made available initially.

II To be introduced in future

• Levonorgestrel only 0.75 mg tablet, 1 tablet within 72 hours and repeat 1 tablet after 12 hours

• Mifepristone – 10 mg single tablet

• Single dose Levonorgestrel (1.5 mg), if multicentre WHO trial results show efficacy equal to total dose being given in two doses, 12 hours apart. This will take care of the problem of getting up in the middle of the night to take the second dose.

B. How should it be packaged?

It was recommended that tablets for Yuzpe regimen should not be cut from a 21/28 tablet packet. The Group felt that it should be made available as a 4 tablet separate pack, or LNG as a two tablet pack, with the following qualities:

• Moisture-resistant blister pack

• Insert in the pack conveying instructions for use, side-effects, additional dose requirement, failure rate, instructions on what to do if period is missed, etc., in multilingual /local languages

• Brand name / shape of pack (e.g. bottle) to maintain secrecy

C. What should be the cost of this method ?

Since it is something for women’s health and well-being, the Group felt it should be available cheap or free as Government supply

Discussion

A. Method of choice

• Most experts in the Group felt that there should be a single dedicated method of choice. Repackaging the COC, though already available is not the ideal method as research has undisputedly shown that LNG alone has a higher efficacy and lesser side-effects compared to Yuzpe regimen. Yuzpe method has been given up in many countries. Though there may be some delay in introducing LNG in India, but since we are starting a new programme, it is more appropriate to start with a better method. The Expert Group felt that a small wait will do no harm, but we will be compromising the efficacy by using COC, which can put the whole programme into disrepute. Based on the emerging data that LNG only regimen is more effective and has fewer side-effects than the combined regimen, the expert Group unanimously felt that the product of choice should be LNG.

• As there is need for pre-introduction IEC, training of providers and counselling of clients, it was felt that having one dedicated method will give clear-cut focussed messages, rather than confusing now with one method and later on introducing another method. The advantages of having a single method rather than a method-mix will be :

- focussed campaigns

- IEC tailored to one product

- training accordingly

• The only concern expressed was delay in making a dedicated product available, which the Secretary, Family Welfare promised to look into, so that the waiting period can be made as short as possible. The Expert Group thus decided to have Emergency Contraceptive pill (ECP) with LNG (0.75mg per tablet), to be introduced in India as a pack containing two tablets.

• To evaluate the efficacy of single versus two doses of LNG, a double blind multicentre randomized WHO study (trial no. 97902) has already been completed. The interim analysis reveals equal efficacy of 10 mg Mifepristone, 0.75mg LNG in two doses 12 hours apart and 1.5mg LNG as a single dose. After the final analysis based on the results, it may be possible to give the total dose of LNG (2 tablets) as a single dose, if the trial does not reveal any increase in side-effects by doing so. The LNG formulation need not be changed in these circumstances; just the instructions need to be modified to say that the two tablets provided in the pack can be taken simultaneously instead of 12 hours apart. A probable name suggested was ‘Tatkal’ in Hindi meaning instant use. Once a dedicated product is made available, all IEC awareness campaigns and training can be more focussed and specific.

• Expert Group also supported having availability of IUD for EC, but main focus of efforts is to be directed to having an EC pill. There are no contra-indications to the use of pill and its distribution is not dependent on a network of trained doctors. Besides, so far, IUD training has been focussing on insertion in the post-menstrual phase to avoid unsuspected pregnancy; changing this may confuse the peripheral healthcare providers. Thus, it was decided that CuT should be available as an Emergency Contraception, but should not be specifically popularized since it has a number of contra-indications and is not suitable for a field- based programme.

• Mention of IUD as an effective EC with its potential advantages and disadvantages should be included in the IUD training manuals. A longer efficacy time-frame (coitus-intervention interval) of up to one week is to be highlighted as well as the possibility of continued contraception. Potential contra-indications and risks need to be explained. All providers should be informed about the potential benefits of IUD as EC, and they should be able to counsel the potential clients about it.

• No other specific steps are recommended for promoting IUD as an EC, especially since, in some emergency situations e.g. rape, coercion etc., IUD may not be a suitable choice due to potential risk of STI/RTI.

• A few in the Expert Group expressed the need for having Mifepristone (MFP) as EC. As and when MFP is marketed and is available in India, it can also be included in the armamentarium, as it has minimal side-effects. Dr von Hertzen from WHO informed the Group that MFP may not be a better choice. In terms of efficacy, it is the same as LNG. The only problem with Mifepristone is higher incidence of delayed periods, which not all women may find very convenient as the anxiety continues as long as periods do not come. Mifepristone if used early in the cycle may result in break-through ovulation, resulting in failure if subsequent unprotected intercourse takes place. Besides, it may be confused with an abortifacient tablet. Advantages of MFP include a single dose and fewer side-effects. If single dose LNG study reveals similar efficacy with no increase in side-effects, LNG can be regarded as the near ideal Emergency Contraceptive. Thus without confusing the issue further, it was decided to have a 2 year pilot introduction with LNG only.

• Availability of an approved dedicated product will extend legitimacy to make the project commercially viable.

B. Packaging

• Besides the points presented by the Group, the forum also felt that package insert should include a clear message that it is not a substitute for regular contraception.

• There was some discussion about including anti-emetic in the packet, but consensus was that it was not required. It is enough to inform that nausea and vomiting may occur. Most other side-effects are self-limiting.

• It was felt that a too attractive a packing might not be very suitable as it may discourage use by shy women, who may find it embarrassing to ask for one.

• Quality of product and batch to batch variation need to be controlled by scrupulous quality control at the production level.

C. Cost

• It may be difficult to decide the cost at this stage, as LNG has not yet been introduced in India. A composite view on logistics and other issues like type of community-setting (urban / rural / semi-urban) will need to be kept in view before deciding on the cost. In fact, women’s health is the primary concern, and cost cannot be linked with it. It may be useful to have both, free supply as well as moderately-priced, EC Pills.

Unresolved issue

The time-frame by when ECP is going to be available and its cost.

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