Can you provide references for the QuickStart approach to initiating Depo-Provera injections?

Q:        I attended the Contraceptive Technology conference in October 2009.  It was reported that the WHO now states you may initiate Depo-Provera even after day 7 of menstrual cycle and may give injections up to 4 weeks after the normal injection timing.

I have tried to find the WHO reference to initiate policy changes in our clinic and can not find it on line.  What is the reference that lists these changes?

Thanks for any help my may provide.

A:  Great question.  Thank you!  It gave me the opportunity to prepare a more complete reference to this practice.  Here are the places the QuickStart method is described:

Email from RAH on 1-14: Did you get my reply?  What are you doing with regard to initiating Depo injections?

Her reply on 1-14: “Yes, thank you it was helpful.  I work at the University of South Carolina student health center.  We usually will start Depo within the first 7 days of the cycle.  We are discussing our current policy and deciding if changes need to be made.  I was more interested in how late an injection may be given.  I had found in the Selected Practice Recommendations for Contraceptive Use, 2^nd edition of WHO recommendation #6 that you may give Depo Provera up to 2 weeks late (after the 13 week injection time frame) and do not need additional contraception.  I thought I had heard at the conference from two different lectures that you could give it up to 4 weeks late.  I didn’t know if the WHO had updated the 2004 Selected Practice Recommendations.” 

“Thanks for your input.”

Julie Cuy Castellanos, WHNP
Women’s Health Nurse Practitioner

Key words:  Contraceptive Technology conference, Depo-Provera injections, timing, menstrual cycle, WHO (World Health Organization), reference, change policy, QuickStart, Family Planning: A Global Handbook for Providers, Selected Practice Recommendations for Contraceptive Use, Managing Contraception, Injectable contraceptives, Dr. Alisa B. Goldberg, Dr. David A. Grimes

References:

Goldberg AB, Grimes DA. Injectable contraceptives IN Hatcher RA, Trussell J, Nelson AL. et al Contraceptive Technology 19^th edition, pages 168 and 169: Ardent Media Inc. 2008

Zieman N. In Hatcher RA, Cwiak C, Darney P, Creinin MD, Stosur HR. et al Managing Contraception, page 128: 2007-2009

1. Burke AE. Extended regimens and Quick Start: why prescribe it? Presented at the 2009 Contraceptive Technology Quest for Excellence conference. Atlanta; October 2009.

2. Nelson AL. Quick-Start/ Same-Day-Start contraception: breaking down barriers for women. Female Patient 2008; accessed at: http://www.femalepatient.com/html/arc/sig/prac/articles/033_03_025.asp

3. Zieman M, Hatcher RA, Cwiak C, et al. 2007-2009 Managing Contraception for Your Pocket. Tiger, GA: Bridging the Gap; 2007.

4. Berenson AB, Radecki CM, Grady JJ, et al. A prospective, controlled study of the effects of hormonal contraception on bone mineral density. Obstet Gynecol 2001; 98:576-582.

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After using withdrawal and taking Plan B ONE STEP, could I still be pregnant?

Q:        On December 14th, I had (unplanned) unprotected sex with my boyfriend.  He pulled out right before he ejaculated. About 17 hours later, I took Plan B ONE STEP. On December 23rd or 24th, I started having some brown (and occasionally red) discharge. And today, December 27th I started what I’m guessing is my period. My periods are very irregular (I hadn’t had a period since October), so I have no idea if I was in a fertile stage or not when we had sex.

Should I still consider taking a pregnancy test, and if so, when? Also, today I started Amoxicillin for strep throat. Would this cause an issue with Plan B even though it was taken over 10 days ago?

Thanks Dr. Hatcher!!

A:        You and your boyfriend used pulling out (withdrawal) followed by Plan B ONE STEP.  Eight or nine days later, you had brownish red discharge, followed in 4 days by a period (probably).

Did you have any other intercourse in December?  If so, what did you use as a contraceptive?  

Please keep me posted.

Her reply on 12-29: “Thanks for getting back to me so quickly!”

“We have not had any other intercourse this month.  This experience freaked me out entirely too much, which is sad since it was our first time together.  And since it seems like my period has already stopped (if that indeed was what it was), I will be doing a pregnancy test as soon as I can get one.”

Here is more information on periods after emergency contraceptive pills:

Emergency Contraception

In the 19th edition of Contraceptive Technology

Felicia Stewart, MD 

James Trussell, PhD

Paul F.A. Van Look, MD, PhD, FRCOG

Menstrual changes. Two studies have been specifically designed to assess the effects of ECPs consisting of 1.5 mg levonorgestrel in a single dose on bleeding patterns. The first study found that when taken in the first three weeks of the menstrual cycle, ECPs significantly shortened that cycle as compared both to the usual cycle length and to the cycle duration in a comparison group of similar women who had not taken ECPs. The magnitude of this effect was greater the earlier the pills were taken. This regimen taken later in the cycle had no effect on cycle length, but it did cause prolongation of the next menstrual period. The ECPs had no effect on the duration of the post-treatment menstrual cycle, but the second period was prolonged. Intermenstrual bleeding was uncommon after ECP use, although more common than among women who had not taken ECPs.[i][i] The second study compared the baseline cycle with the treatment and post-treatment cycles. Cycle length was significantly shortened by one day when ECPs were taken in the preovulatory phase of the cycle and was significantly lengthened by two days when ECPs were taken in the postovulatory phase. No difference in cycle length was observed for women who took ECPs during the periovulatory phase of the cycle (from two days before to two days after the expected day of ovulation). Menstrual period duration increased significantly when ECPs were taken in the periovulatory or postovulatory phase in both the treatment and post-treatment cycles. The duration of the post-treatment menstrual cycle remained significantly longer when ECPs were taken in the postovulatory phase. During the treatment cycle, 15% of women experienced intermenstrual bleeding; this was significantly more common when ECPs were taken in the preovulatory phase.[ii][ii]

[iii][i]. Raymond EG, Goldberg A, Trussell J, Hays M, Roach E, Taylor D. Bleeding patterns after use of levonorgestrel emergency contraceptive pills. Contraception 2006;73:376-381. Erratum. Contraception 2006;74, in press.

[iv][ii].    Gainer E, Kenfack B, Mboudou E,  Doh AS, Bouyer J. Menstrual bleeding patterns following levonorgestrel emergency contraception. Contraception 2006;74:118-124.

Her reply on 1-5: “I was finally able to take a pregnancy test today, 22 days after the “act” and it is reading negative!  Do you think I’m in the clear or should I take another test in a week or two?”

I think you do not need a second test.  It is up to you, but it seems that you protected yourself well!

Her reply on 1-7: “I sure hope I did, but I still may do the second test.  I’m a little paranoid about this whole situation…ha ha.”

Thanks for your nice words.  Let me know the results of the second test.  What contraceptive will you use now, going forward?

Her reply on 1-11: “Well, I haven’t been able to do the second test yet due to having no privacy.  But I’ll get it done by the weekend for sure.  As for birth control…condoms combined with the pill have always been my birth control of choice.  But the practitioner at Planned Parenthood wouldn’t renew my prescription for my pills because she said my blood pressure was too high (140/90).  Sometimes it is lower and sometimes it is a tad higher, but it was only high because of being on the pills and she just didn’t understand that.  I told her I’d sign a waiver and everything just so I could stay on them, but she still said no.  So now that I’m in a relationship again (I’d stopped dating once I went off the pill…very extreme I know).  I guess I’ll just have to make do with condoms, which I should have used in the first place but the sex was highly unplanned and therefore condoms were unavailable.  I’d prefer to have tubal sterilization, but since I have never had kids (I have never had children and I don’t have insurance or a job anymore), that will not happen.”

“I will definitely give you the results of the second test when I’m able to take it.” 

1. You have considered so many issues as you have sought to make wise decisions. 
2. You have reflected on the side-effects of combined pills and progestin only pills, the cost of contraceptives, privacy, avoiding intercourse until you have resolved the question of contraception, insurance, and your specific wish to use combined pills in spite of a slightly elevated blood pressure.
3. Your last note did not ask a question but gave me lots more information.
4. All I can say is that it would seem that you definitely do not want to become pregnant and you seem to be willing to wait until you are on a long term highly effective method such as pills or using a condom consistently. 
5. I wish all women and men were as intentional about these issues as you are. I respect the way you are proceeding so much.
6. I think you are a wise, thoughtful woman and I hope that the finances of birth control don’t stop you from continuing to protect yourself well.

    7. I have been asking myself, what could I do to further help you. Can I help you?

Her reply on 1-14: “I had thought about it, but after talking to some women about their experiences on the POPs, I decided against it…lots of spotting, vaginal dryness, etc. I’d rather be back on my old pill. The only bad side effect was it made my blood pressure go a little higher than normal, but I was okay with that. The nurse at the clinic told me a regular ObGyn would probably prescribe it, but that takes insurance, which I no longer have. So going that route is out of the equation.”

Her reply on 1-18: “I wanted to let you know that I did the second pregnancy test today and it was negative.  Talk about relief…ha ha.”

“Well honestly, you have helped me more than you may realize.  You’ve listened and understood when others wouldn’t.  Can’t really ask for much more than that.  So, thank you wholeheartedly for that and thank you for your kind words.  I do try to stay informed.  Thanks again, you really are fantastic!”

Thanks so much for your kind words.  It makes all of this work worth the effort.

Good luck! 

Reference:

Stewart F, Trussell J, Van Look PFA. Emergency contraception IN Hatcher RA, Nelson AL, Cates Jr. W. et al Contraceptive Technology 19^th edition, page 100: Ardent Media Inc. 2008

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I have a horrible discharge after sex with a new guy. What is going on?

Q:        I started having sex with a new guy. After sex I bleed. At first it was red, but now it’s a dark color that I sometimes get after my period.  I’ve bled before after getting too rough in the past. But, now it’s like, different. It’s dark and gross.

I am on birth control. It is the kind that gives me one period every 4 months. I’ve been taking it for about 2 years though.

I’m really scared because one site said it could be cancer. I don’t want to go to a gynecologist until I go home (I’m in college) next month. I’m really scared. Is this normal? It doesn’t itch, hurt, or anything. It’s just normal discharge, but brownish in color.

A:        Sex is complex, especially if a woman’s contraceptive completely changes her periods.

How old are you and have you been pregnant in the recent past? Are you using Depo-Provera injections as your contraceptive?  If you are having no pain my final suggestion is most likely going to be that you probably have nothing serious going on.

Her reply back on 12-5: “I’m 18 years old and I haven’t been pregnant before.  I just got off my period a week ago.  We had sex last night with a condom and I didn’t bleed today.  I looked further online and a lot of people said that Seasonique (the birth control pill I’m on) gives them problems like this.  Does this seem likely?  I am not using Depo-Provera.  I have no pain either.”

“Thank you so much for your time, by the way.”

My second reply (12-7):

Her second reply on 12-7: “Oh wow, thank you sooo much!  This makes me feel much better.”

12-21: You should be home now.  Are you planning on going to see your doctor?

1-11-2010: If you are still having sex with the same guy, are you still having any discharge?

Robert A. Hatcher MD, MPH

Professor of Gynecology and Obstetrics

Emory University School of Medicine

Atlanta, GA

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Stress is everywhere

 Robert A. Hatcher MD, MPH     

Stress is all about us.  It creeps into our lives like fog the day after a rainstorm.  Stress seems to taunt us with the refrain: “Stop me if you can.”  But sometimes it seems almost impossible to stop.  Sometimes it enters our lives from unexpected quarters. Sometimes we can see it a-coming and run from it! Sometimes we bring it on ourselves. Sometimes it happens in response to something completely beyond our control.

So where does all this leave us? Sometimes it leads to paralyzing uncertainty. Stress is undoubtedly a major cause of disease – a formidable foe for a person trying to be healthy! 

No one has written my destiny for me or your destiny for you. Perhaps each person’s response to the stress in her or his life is going to affect his or her health as much as any other factor.

What are the diseases linked to stress?

             Heart disease

• Hypertension
• Cancer
• Accidents
• Depression
• Anxiety attacks
• Some kinds of headaches
• Failure of women to ovulate (and therefore infertility – more on this in an upcoming column)
• Eating disorders
• Poor school and job performance

What are some ways to lower the stress level?

• Deep breathing is a part of virtually every stress reduction program for the past several thousand years.
• Exercise is important for health and one of the healthiest aspects of regular exercise are the benefits in terms of stress reduction.
• Carrying a book at all times so that frustration from delays while driving, waiting rooms, lines, broken appointments, and waiting for the completion of car repairs becomes a treat rather than an event that raises your blood pressure.
• Carrying a charged up cell phone may also let you make a call you have been wanting to make diminishing your frustration from a delay.
• Daily meditation
• Counting to ten when beginning to become angry.

The serenity prayer outlines the two things you and I can do in the face of each stressful event, experience or relationship we face in the course of a day. This short prayer helps many millions of people every day is this:    “God, grant me the serenity to accept the things I cannot change, the courage to change the things I can, and the wisdom to know the difference.”

Lest stress be given a 100% negative rating, it is certainly true that stress may have some beneficial motivating effects.  Stress can heighten our awareness in some situations where awareness is essential. Stress may cause us to eliminate procrastination. And stress may help us to visualize the best course of action for a given situation. But for the most part stress is something I hope to minimize today.

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I had a patient today looking for hormonal contraception. She is currently being treated for latent tuberculosis with Rifampin and INH for 9 months.  She and her partner are using condoms sporadically and wanted something more reliable.

Are all hormonal contraceptives at risk for reduced effectiveness if a woman is using Rifampin?  I have recommended better condom use, a ParaGard or a diaphragm, but was wondering if Mirena would also be acceptable in her case.
I’d love more information on contraception for women using Rifampin.

Thanks so much for your guidance on this topic.

A:         

The question of Depo Provera effectiveness in women using anti-seizure meds or anti- tuberculosis meds was raised last week.  One of the advantages of Depo is that its effectiveness is NOT compromised by either Rifampicin or anti-seizure meds. Many anti-seizure meds are also used to treat depression, anxiety and even insomnia. Below is information from the chapter in Contraceptive Technology on injectable contraception relating to this issue:

 Injectable Contraceptives by Alisa B. Goldberg, MD, MPH and David A. Grimes, MD

8.   Minimal drug interactions. There has been no demonstrated interaction between DMPA and antibiotics or enzyme-inducing drugs. The only drug that decreases the effectiveness of DMPA is aminoglutethimide, which is usu­ally used to suppress adrenal function in selected cases of Cushing’s disease.

9.   Fewer seizures. DMPA has been found to decrease the frequency of grand mal seizures. Improvement in seizure control is probably due to the sedative properties of progestins and this effect may be mediated through gamma-aminobutyric acid (GABA) receptors in the hippocampus. Taking anti-seizure medicine has no impact on the efficacy of DMPA.

The drugs that lower and do not lower pill effectiveness are listed below:
The drugs that do and do not decrease the effectiveness of hormonal contraceptives are listed below:
Drugs that decrease pill effectiveness by increasing liver hormone breakdown:
Carbamazepine (Tegretol), Nevirapine, Oxcarbazepine (Trileptal), Phenobarbital, Phenytoin (Dilantin), Primidone (Mysoline), Rimidone (Mysoline), Rifabutin, Rifampicin, St. John’s Wort, Topiramate (Topamax), Lamotrigine (Lamictal)*
*Lamictal is, itself affected by pills and pills affect Lamictal

Drugs that do not cause induction of liver enzymes:
Sodium Valproate (Depakote, Depakene), Clonazepire,
Ampicillin, Clarithromycin, Metronidazole,    Ciproflaxacin, Ofloxacin, Doxycycline, Fluconazole, Ethosuximide (Zarontin), Levetiracetam (Keppra), Vigabatrin (Sabril), Zonigamite (Zonegram), Pregabalin (Lyrica), Clonazepam (Klonopin), Tigabine (Gabitril), Possibly ethosuximide, griseofulvin, troglitazone, Vigabatrin and Provigil (modafinal)

[Speroff, Darney; A Clinical Guide for Contraception.  Fourth edition 2005, page 101]

[Guillebaud, Contraception: Your Questions Answered; Fourth edition, Pages 123-130] [Physicians Desk Reference 2007: p.990] Broad-spectrum antibiotics:

“Broad-spectrum antibiotics such as amoxicillin and tetracycline, which alter the intestinal flora thought to be instrumental in promoting absorption of the sex steroids, do not reduce the efficacy of oral contraceptives. 

Women using the antibiotics do have statistically significant but not clinically lower serum levels of estrogen and progestins.  However, virtually every woman taking these antibiotics has remained well within the therapeutic range for the sex steroids.  168-170[Murphy 1991] [Neely 1991] [Friedman 1980]. 

As a result, back-up methods should not be necessary unless the patient has problems taking her pills, e.g., if her underlying medical condition interferes with pill taking or absorption.  Long-term use of broad-spectrum antibiotics (such as erythromycin or tetracycline for acne) is compatible with OC use; back-up methods are not routinely needed for pregnancy prevention. 171[Helms 1997].

Here are the words of advice from the Planned Parenthood Federation of America: “There is no pharmacologic evidence that the acute or chronic use of systemic antibiotics (e.g. tetracycline, ampicillin) decreases the efficiency of low-dose COCs in women who take them correctly.”

Her reply 12-23: “Dear Dr. Hatcher, thank you for your clear and helpful information about TB meds and hormonal contraception.  I appreciate the information and will share it with my colleagues at PPLM in Boston.”

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Happy Birthday, Pills!

Birth control pills are 50 years old now. From the very start birth control pills have been popular, effective when used correctly, safe for most, but not all, women, and often embroiled in controversy. 

YAZ is one of the most recent pills – there are now more than 80 pills being hawked to American women.  There are all too many different pills. YAZ has 20 micrograms of the estrogen, ethinyl estradiol, and 3 mg of the progestin, drospirenone. YAZ is the most commonly prescribed pill in the United States as of January, 2010, the month of the 50^th birthday of oral contraceptives. YAZ finds itself surrounded by some of the same issues pills encountered in their first 10 to 15 years. Why are lawyers reaching out to women using YAZ birth control pills? You have seen their ads. The complications that have come to the attention of lawyers are in the same family as the earliest serious pill complications: blood clots and pulmonary emboli. But it remains unclear if serious complications are more frequent in women on YAZ than in women on other pills.

You have seen other ads about YAZ because YAZ is still under patent and sells for upwards of about $85 per cycle. A woman takes thirteen (13) 28 day cycles of pills per year so 13 x $85 = $1,105 per year.  As Yogi Berra says: “That’s real money.”

Now I have been critical of Wal-Mart for a number of things, but a woman can go to her local Wal-Mart and buy Tri-Sprintec or Sprintec for about $10 per cycle or 13 x $10 = $130 per year. The advantages of YAZ are minimal and I suggest that clinicians prescribe and women buy and use Sprintec or Tri-Sprintec.

But back to the question of safety. Below is one prominent Emory physician’s overview of the issue of the safety of YAZ and Yasmin pills. Dr. Mimi Zieman has added the following paragraph to the soon-to-be- published 2010-2012 edition of Managing Contraception:

Dr. Jeffrey T. Jenson, professor of obstetrics and gynecology at the Oregon Health Sciences University in Portland, Oregon, recently reviewed the issue of venous thromboembolism in the November, 2009 issue of OB/GYN Alert.  He is clearly impressed by the European study of 58,674 women followed for 142,475 woman-years of observation [Dinger JC. Contraception 2007]. Only 2.44% of women were lost to follow-up. The investigators found no difference in the overall incidence of serious adverse events between users of pills containing drospirenone like YAZ and Yasmin and any other oral contraceptive groups. 

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