[india-drug] Are emergency contraceptive pills a necessary evil?

["Sampada Patvardhan" <dicmspc@yahoo.co.in>]

Are emergency contraceptive pills a necessary evil?
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Dear India-Drug Members,
   
Please find below the published article on: Emergency Contraceptive Pills.
I look forward to a very useful and proactive discussion by members on this issue.
   
Regards,
  Dr. Sampada Patvardhan (Ph.D.Tech.)  
  Director, Maharashtra State Pharmacy Council?s Drug Information Centre, 
  E.S.I.S. Hospital Compound, L.B.S. Marg, Mulund (W), Mumbai-400 080  
  Tel: 91-22-25930607   Telefax: 91-22-25684291
  email:  dicmspc@yahoo.co.in   or    dicmspc@gmail.com   
   
   
  Are emergency contraceptive pills a necessary evil?

SOURCE: WEB LINK - http://www.expresspharmaonline.com/20080430/management02.shtml
suja.nair@expressindia.com

  Increased use of emergency contraceptive pills has become the talk of the town. But is it really safe to pop in one like a routine pill? Suja Nair explores

  The concept of an emergency contraception pill is known since long, and has been practised from time immemorial. In ancient times, women used to douche themselves with potion, liquid and eat different types of food so as to abort a potential pregnancy. Present day women have modern ways of preventing pregnancy such as birth pills, emergency pills etc. What is currently known as an emergency contraceptive has been labelled as a morning after pill, postcoital pill, or contraceptive. 

  Of late, there has been debate on the safety issues concerning 'morning after' pills, arising due to the unsupervised overuse of these pills. Dr Chandra M Gulhati, Editor, MIMS, feels that since some of these pills contain high-dose levonorgestral they should be used only in emergency situations (such as sex under force) and certainly not as a substitute for conventional, much safer methods like condoms, low-dose oral contraceptives etc This is due to the relatively high failure rate and high incidences of irregular bleeding. The main aim of emergency contraception is to put the decision of contraception in the hands of women. In a patriarchal society like India, most women are not given the right to ask their partners to exercise contraception as the onus is on the woman to prevent pregnancies. 'morning after' pills, thus put another choice within the woman's reach in case the contraception routine is accidentally broken. They are not like normal contraceptives, according to Shalini Kaushik, Senior Product Executive-Product Management Team, Mankind Pharma. "What distinguishes the morning after pills from conventional contraceptive pills is the timing of use. Morning after pills are used after unprotected intercourse within 72 hours, whereas other conventional contraceptives such as birth control pills are taken regularly to prevent pregnancy," explains Kaushik. 
  
Timing matters
  The simple concept behind 'morning after' pills is that it is very effective at reducing the risk of pregnancy when taken within 72 hours of unprotected intercourse. Studies have shown that intake of emergency contraceptive tablets reduce the risk of pregnancy upto 120 hours after unprotected intercourse, but the sooner the dosing begins, the more effective the treatment will be. Dr Narendra Malhotra, President Federation of Obstetrics and Gynaecological Societies of India (FOGSI) 2008, says, "How these pills are different from the conventional regime is that they have only one pill which has to be taken after an unprotected intercourse within 72 hours, while conventional pills are a combination of oestrogen's and progesterone's and are taken from day two of menses for 21 days cyclically. The conventional pills stop ovulation, whereas emergency contraceptives or morning after pills stop implantation." 

  Emergency contraception gives the choice to women with respect to contraception, and thus, avoids pregnancy. But are they efficacious? Gulati points out that these pills have little role after 72 hours, therefore when used mid-cycle, one in every 20 women who use the pill is likely to conceive. Hence these pills are not 100 percent effective. Therefore, the importance of 'follow-up' for three-weeks must be clearly explained to users. "During this period, barrier method (condoms) must be used and if the menstrual period does not start, then the possibility of ectopic pregnancy (i.e. foetus outside the uterus, in the tubes which can be serious) or toxicity to the foetus needs to be assessed. None of this essential, safety and efficacy information is included in the high-pitched advertising blitz to promote sale of these pills,? says Gulati.

  The main reason for the spurt in the use of emergency contraceptive pills is that they are the most convenient method to end an unwanted pregnancy. Kaushik explains, "The only other option left for a female with undesirable pregnancy is medical termination of pregnancy (MTP), which is very traumatic and even associated with complications. So given a choice they opt for taking an emergency pill." 

  In the pill
  Currently, two types of morning after pills are available: they are I-pill from Cipla and Unwanted-72 from Mankind. In India, only levonorgestrel (LNG) is available as a 'morning after' pill for example, Unwanted-72. Oestrogen alone is no longer used because of its side effects and is now almost abandoned in favour of the LNG regime.
 
  Gulati says that the equivalent tablet being sold in Western countries contains 750mcg of the medicine while I-Pill contains double the dose ie 1500mcg. In other countries, such as Britain, Australia etc, there are two dosage regimens: two tablets of 750mcg, 12 hours apart or two tablets of 750mcg - i.e. 1500mcg in one go. However he cautions by saying that it is not advisable to have two tablets in the case of I-Pill because of it is a higher dose.

  The other problem is that in the case of vomiting, the I-Pill will need to be taken again. Vomiting with 1500mcg tablet is also more common than with 750mcg tablet when taken twice. He further opines that the other brands available in India like Norlevo (Win Medicare) and Ecee-2 (German Remedies) are better as they contain only 750mcg of levonorgestrel. 

  How safe is it?
  The debate on the safety of emergency contraceptive pills has been going on for some time now. Listing the side effects of I-Pill and Unwanted-72, Gulati says they include ectopic pregnancy, vomiting, nausea, fatigue, abdominal pain, gastrointestinal upsets, diarrhoea, dizziness, headache, breast tenderness, early/late onset of next period, increased menstrual bleeding, vaginal haemorrhage etc. Severe side effects are relatively rare in women who are healthy and those who do not smoke while on LNG emergency contraceptives. The effects of the pills defer from person to person, thus making it nearly impossible to predict which users will have nausea or vomiting or which women will benefit from antiemetic pre-treatment. 
  Malhotra however downplays these side effects saying, "Morning after pills are safe apart from minor side effects of nausea, vomiting etc. Apart from these, there are no known side effects if the pills are administered properly. These side effects are sometimes found with normal birth control pills as well." He adds that though these pills are used to stop pregnancy they are definitely not abortion pills.

  Is OTC the right move?
  There is a strong move all across the world to make emergency contraception an over the counter (OTC) drug. It is believed that greater availability will improve proper use without compromising regular birth control or sexual health. Thus, stressing on the importance of birth control and unwanted pregnancies, Kaushik feels that there should not be any issues in positioning emergency pills as an OTC product, since even the US Food and Drug Administration (FDA) has approved LNG as an OTC product for females above the age of 18 years. Malhotra too believes that any form of contraception should be available OTC and should be promoted among the masses. 

  However Gulati disputes this reasoning, saying that rather than preventing unwanted pregnancies this move will only give the wrong message to teenagers. In countries like Britain where emergency contraceptive pills are prescription medicines, there has been increasing use of these pills by teenagers which has posed a serious challenge. 

  Apart from that, making these pills OTC will also indirectly discourage the use of condoms, which is very dangerous because emergency pills do not prevent sexually transmitted diseases likes AIDS etc. 

  Some experts estimate that widespread use of emergency contraception could prevent as many as half of the unintended pregnancies that occur each year, including as many pregnancies that now result in abortion. However Gulati points out that there are other more fundamental, ethical, clinical and legal issues involved in the approval and mass media promotion of products such as I-Pill. 

  Gulati adds, "It is most surprising that the Drugs Controller General, India (DCGI) has allowed its sale through OTC and permitted its publicity in mass media despite absence of mandatory clinical trails in India." He also points out that I-Pill advertisements are also misleading as they do not give information on precautions and side effects and do not stress the importance of timing. Gulati believes that a copper-bearing Intra-Uterine Device (IUD) offers a much safer and more effective method of contraception. 
  However it is believed that high abortion statistics of any country represent the true extent of the unmet need for contraception. Thus, pregnancies following unprotected sex are vastly damaging and should be prevented by emergency contraceptive measures. Unfortunately, in our country, awareness and knowledge levels on these medications is very low. "A rise in use of emergency contraception is good, as it will prevent a lot of unwanted births and unsafe abortions. It also increases awareness and need for safe sexual practice and contraceptive methods, but there should be lot of awareness campaigns so that they are not misused on a regular basis," concludes Malhotra.