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1
Safe PrescribingSafe Prescribing
ofof
Second LineSecond Line
Combined OralCombined Oral
ContraceptiveContraceptive
A workbook for GPA workbook for GP
traineestrainees
Dr Catherine Hyde
2
3
Contents
Page
2. Using this Workbook : Who, What, How
3. What you need to know to do this workbook
4. Revision of Different pills
5. Pill Safety – the pill check
6. Reasons for changing the pill
7. Case 1 Progesterone side-effects
8. Case 2 Oestogen side-effects
9. Case 3 Break through bleeding
11. Practical tips
12. Summary
13. Evaluation
14. Sources
15. Appendix 1. Medicines Eligibility Criteria categories
16. Appendix 2. Medicines Eligibility Criteria for Combined Oral Contraceptive
17. Appendix 3. Advice for women missing Combined Oral Contraceptive Pills
18. Appendix 4. MIMS – Composition of Combined Oral Contraceptive Pills
Activities index
Page ACTIVITY
3. ACTIVITY 1: Medical Eligibility Criteria (MEC) For Contraceptive Use
4. ACTIVITY 2: Different COC Pills.
7. ACTIVITY 3: Side Effects of Progesterogens
8. ACTIVITY 4:Options for changing the Pill to reduce Progesterogenic side-effects
9. ACTIVITY 5: Options for Changing the pill to reduce oestrogenic side effects
10. ACTIVITY 6: Advice for missed low dose COC
10. ACTIVITY 7: Forming differential diagnosis for Breakthrough Bleeding
10. ACTIVITY 8: Forming management for Breakthrough Bleeding
4
Using this workbook
Who should use the book?
This book is designed for GP trainees to provide a solution to the problem of how to
safely prescribe a second line combined oral contraceptive (COC) pill.
It may be useful by anyone who has experience, and learning needs, in family planning
work.
I realised the need for producing this workbook came while I was watching a powerpoint
presentation on the topic. It was presented by a GP trainee and she was struggling with
a case, as I also had. I realised:
 It is a common scenario
 It is important
 there is evidence and good practice to guide us
The GP trainee’s name was Aisha, and she will provide a trainee
viewpoint to help guide you throughout this workbook.
GP curriculum objectives covered are:
 Contraception – effectiveness rates, risks, benefits and appropriate selection
of patients for all methods
 Contraception – the safe provision of all methods of oral contraception
Aims : by the end of this book you should be able to:
1) Demonstrate how perform a pill check
2) Demonstrate how to elicit common side-effects of the COC pill
3) Demonstrate how to start an alternative choice of COC pill
How should it be used?
Activity Time Reference
Most learning comes from
completing the activities in this
workbook
See the contents page for a list
of activities
you can do it all in one go
you can complete just one
section
Each section takes 5-10 mins
Contents of different pills and
WHO Medicine Eligibility
Criteria are in the Appendix
pages15-18
Yellow boxes in the workbook
have additional information
Hi there! I’m Aisha, a GP trainee – so
WHAT will I learn from the workbook?
5
What you need to know to do this workbook
Why is this topic important?
24% of women use the COC in the UK making is second favourite choice after
condoms1
Side-effects are common, can be life-threatening, can indicate misuse and can put
the patient at risk of pregnancy.
We expect you to know how to:
conduct a consultation
take a medical and sexual history
do appropriate examination
give information
check understanding
 use your basic sciences knowledge
prescribe the COC pill safely for the first time
ACTIVITY 1 - Medical Eligibility Criteria (MEC) For Contraceptive Use
What to do: draw a line between the MEC Category, and the correct definition of
risk
Ok. So I did this for my Diploma of
Family Planning, but after 18 months
stuck in hospital I’ve forgotten
everything. Where can I remind
myself?
The Faculty of Family planning
(FPRHC)& GP notebook provide great
guidance – look in the ‘Sources’, Page 14
MEC Definition of MEC risk
Category
1 A a condition which represents an unacceptable health risk if the
contraceptive method is used.
2 C a condition for which there is no restriction for the use of the contraceptive
method.
3 B a condition where the theoretical or proven risks usually outweigh the
advantages of using the method.
4 D a condition where the advantages of using the method generally outweigh
the theoretical or proven risks.
6
Revision of Different Pills
All combined oral contraceptive pills contain 2 different hormones ____________ and a
progesterogen.
Drug :Oestrogen may be either ______ estradiol or its prodrug __________ (which is converted
in vivo into estradiol).
Dose: Standard strength contains ethinylestradiol 30 or 35micrograms or (30– 40microgram   
biphasic or _________ preparations).
Low dose contains ethinylestradiol ___ micrograms
Progesterogens
2nd
Generation progesterogens are Norethisterone and ____________. They are associated
with a lower risk of venous thromboembolism . Therefore they should be the first choice when
prescribing the COC.
First choice of pill should:
• contain either of these progestrogens
• be monophasic
• contain 30 micrograms of ethinylestradiol
In practice this means prescribing __________,
Ovranette, Brevinor, Loestrin 30.
3rd
Generation
Use these words to fill in the blanks if you are finding this tough:
Levonorgestel, 20, oestrogen, mestranol, triphasic, Microgynon 30, Femodene,
Drospirenone, ethinyl, norgestimate.
For confirmation of answers, see Appendix 4, page18
Progestrogen Special Features of Drug Pill containing this drug
desogestrel Less counteractivity against oestrogen Marvelon
___________ Cilest
gestodene _____________
___________ Derived from spironolactone
Caution in renal failure/high potassium
Yasmin
Circumstance
not using COC
and not pregnant
using a 2nd
generation
COC
Using a 3rd
generation
COC
pregnant
VTE Risk per 100,000
woman -years
5
15
25
60
Table 1 Risk of venous thromboembolism (VTE)
associated with combined oral contraception (COC) use
and non-use
ACTIVITY 2 –Different COC Pills.
What to do: fill in the blanks with the correct word (answers at bottom of the page if
needed)
7
Pill Safety – the Pill check
What to do in the follow-up consultation
Check :
Has she found it easy to use?
Has she noticed any adverse effects?
Does she understand how to take it?
Does she know how to manage missed pills?
Has the pattern of withdrawal bleeds been
regular?
Has there been any breakthrough bleeding?
In every follow up consultation, we need to check
Blood pressure
Is it still the best choice of contraception?
any change in circumstances
Is it still safe?
Any relevant change in Medical/family history that may
alter MEC category (see Table 2)
Cervical smear status
Sexual health screening (Awareness and need of
services)& using condoms
So the blood pressure is fine, she doesn’t have
any problems and we’ve discussed the
important information. What now?
Excellent! Prescribe another 6-12
months of the same pill, and advise her to come
back if there are any problems.
Risk Factor Cut off – UKMEC>2
Smoking If Age>35yrs
Migraine With Aura
Or if Age>35yrs
BMI ≥35 kg/m2
Blood
pressure
Consistently 140-159/
90-94
>160/95 – stop
immediately
VTE Personal or FH<45yrs
CVD/Stoke Multiple risk factors of
personal history
Medication Long term liver enzyme
inducers
Surgery Major surgery with
immoblisation
Table 2: Risk factor for harm when using the COC
and instances when UKMEC category is 3/4
8
Reasons for changing pill
1.Breakthrough bleeding
 Is common1&2
 Up to 30% of women experience irregular bleeding during the first cycle2
 Usually resolves after 3 cycles2
 Does not indicate that the pill has reduced contraceptive effect (as long as it is being taken
properly) 3
 We need to consider
2. Side-effects
Progestrogen
 scanty menses
 leukorrhoea, dry vagina
 breast tenderness
 dull type of headache –
often of pill withdrawal
 appetite increase, weight gain
 premenstrual depression
 leg cramps, softening of ligaments
 acne, greasy hair
 vaginal dryness
So after 2 months on the pill, a woman comes back.
She’s not happy with the pill and wants to change.
What now?
Well, we still need to do a formal pill check (see page
5) to ensure that its safe and right to continue with a COC.
Then we need to explore her reasons.
Oestrogen
 menorrhagia
 cervical ectopy
 breast fullness
 migraine type headaches
 fluid retention
 weight gain (fluid)
 tiredness, irritability
 nausea
 bloating
Compliance - how/when is the pill being taken
Interference - has there been vomiting within 2 hrs of taking the pill, diarrhoea, or any drug
interactions (including St.John’s Wort/herbal remedies)
Pregnancy - interuterine or ectopic
Infection - Chlamydia and Sexually Transmitted Infections
Pathology - endometrial or cervical polyp
- cervical cancer/CIN
Endocrine - hypo/hyperthroidism
Blood - bleeding disorders
9
Progesterogen case
 Lisa is a 21 year old women
 She comes to see you after 3 months taking Microgynon 30
(Ethinylestradiol 30 microgram, levonorgestrel 150 microgram)
 She complains of
 increased appetite
 acne
 low mood before her withdrawal bleed
 She was previously on injection which she stopped due to weight gain and low mood,
and then she used condoms for 6 months
ACTIVITY 4: Options for Changing the pill
What to do: Fill in the blank with the correct pill name
1. Light withdrawal bleed
2. Increased white vaginal discharge
3. Leg cramps
4. Heavy withdrawal bleeds
5. Breast tenderness
6. Greasy hair
7. Vaginal dryness
8. Fluid retention
True / False
True / False
True / False
True / False
True / False
True / False
True / False
True / False
ACTIVITY 3:Side Effects of Progesterogens
What to do: circle True if the symptom is cause by progesterogens, False if not
(answers at bottom of page)
ACTIVITY3.Answers1.T2.T3.T4.F9associatedwithoestrogen)5.T6.T7.T8.F(Associatedwith
oestrogen)
Action to reduce side-
effects
New Pill content New Pill name
Reduce progesterogen
content
Not an option in this case
Increase oestrogen 35 micrograms of ethinyl oestradiol
500 micrograms norethisterone
Ovysmen and
i)__________
Change to less
androgenic progestrogen
30 micrograms of ethinyl oestradiol
150 micrograms desogestrel
ii)_________
Change to 3rd generation
progesterogen e,g.
35 microgram of ethinyl estradiol
norgestimate 0·25 mg
iii)________
10
Oestrogen case
Seema is a 19 yr old woman
She has just started a new relationship
She has taken 3 months of Brevinor, which her friend had recommended
(contains Ethinylestradiol 35 microgram/norethisterone 0·5 mg)
She complains of :
 increased appetite
 heavy period
 tiredness
 nausea and bloating
ACTIVITY 5: Options for Changing the pill to reduce oestrogenic side effects
What to do: Fill in the blank with the correct pill name
Action Pill content Pill name
Original pill 35 microgram ethinyl oestradiol
0·5 mg norethisterone
Brevinor
Dose
:
Reduce oestrogen
content
<35 micrograms ethinyl oestradiol
20 micrograms ethinyl oestradiol
1 mg norethisterone acetate
All pills except
a)_________ &
Norimin
Loestrin 20
Increase progesterogen
content
30 micrograms ethinyl estradiol
1.5 mg norethisterone acetate
Loestrin 30
Type Alternative oestrogen type 50 micrograms Mestranol
1 mg norethisterone
b)_________
Is it safe to prescribe a low strength oestrogen pill (eg 20 micrograms
ethinyl oestradiol )?
Efficacy of 20mcg and 30mcg pills are similar, but breakthrough bleeding
is more common with the lower dose3
.
Missed pill advice is also more cautious in lower dose pills. If 2 or more pills
are missed, extra protection needs to be used for 7 days, and you need to
consider if emergency contraception is required (see appendix page 17).
Low dose dose oestrogen is available with Northisterone, Gestodene,
Drospirenone and Desorgestrel.
ACTIVITY4:Answersi)Brevinorii)Marveloniii)Cilest
ACTIVITY5:Answersa)Ovysmenb)Norinyl-1
11
Breakthrough Bleeding Case
Helen is a 18 yr old woman
She has just started a new relationship
She has taken 6 weeks of Loestrin 20, which her friend had recommended
(contains ethinylestradiol 20 microgram/1mg norethisterone)
She complains of :
 A small amount of bleeding every day
You take a thorough history – which reveals she has missed 2 pills during the past week
(week 2 of the current pill packet). She has not had unprotected intercourse since her last
proper period.
ACTIVITY 6:You advise her to:
What to do: circle True if you would give the advice, False if not (answers overleaf)
You emphasise it is important to take the pill regularly ( though one pill may be missed in
the month without affecting contraception). You reassure that most bleeding settles after
3
months.
At 3 months she comes to see you – she is still experiencing spotting every day.
History reveals she has been taking the pill regularly, she has had intercourse without
condoms since the last withdrawal bleed. She had post-coital bleeding yesterday.
ACTIVITY 7: What are you concerned about?
write a differential diagnosis below ACTIVITY 8: What will you do next
Form a management plan below
i) use extra protection for the next 7 days True/False
ii) use emergency contraception True/False
iii) run this pill packet into the next True/False
a) __________________
b) __________________
c) __________________
d) __________________
e) __________________
f) __________________
1. _____________________________
2. _____________________________
3. _____________________________
4. _____________________________
5. _____________________________
12
Breakthrough Bleeding Case
The Case continues:
Answers to ACTIVITY 6
You correctly advise that she use extra protection for the next 7 days as she was on a low dose
pill. She does not need to have emergency contraception, as there had been no intercourse &
as she has missed pills in week 2 – there was no need to run pill packets together ( see
appendix – page if you’re still not sure).
ACTIVITY 7&8
Your immediate concern is the possibility of ectopic pregnancy, then possible interuterine
pregnancy and pelvic inflammatory disease. The differential is fairly wide – you can discuss this
futher with your GP trainer & colleagues (& refer back to page 6).
You carefully examine:
Abdomen is soft, non-tender.
All obervations are normal.
pelvic exam is normal, cervix looks healthy & there was no cervicitis. There is a significant
amount of greenish discharge. You take a smear, high vaginal and endocervical swabs.
You are lucky to have pregnancy tests available in the practice – which is negative.
Are you happy this woman is not in immediate danger ?___________________________
You send her home, advising to her continue with this pill, but use extra protection until the
results of the swabs are back.
3 days later – the swab results show evidence of gonorrhoea infection. You treat this with a
single oral dose cefixime 400mg & urinary rescreen at day 16 is clear. However, the
breakthrough bleeding is still an issue.
What will you do next? Select one of option a) to e)_____
(all options are suitable, and a combination of changes can also be effective)
Action Pill content Pill name
a) Increase oestrogen content 35 micrograms of ethinyl
oestradiol 1 milligram
norethisterone
Norimin
b) Change dose of
progesterone
35 micrograms of ethinyl
oestradiol 500 micrograms
norethisterone
Brevinor
c) Alternative 2nd
generation
progesterogen
30 micrograms of ethinyl
oestradiol 150 micrograms
levonorgestrel
Micrgynon or
Ovranette
d) 3rd
generation
progesterogen
20 micrograms of ethinyl
oestradiol /gestodene
75 microgram
Femodette
e) Change to triphasic pill Ethinyl oestradiol &levonorgestrol logynon
13
Practical Tips
When I prescribe the Microgynon – it always gives me
an ‘Microgynon ED’ choice. Does Microgynon treat ED
too?!
ED stand for EveryDay – these pills contain 21 active
pills (beige in microgynon)& 7 inactive pills (white in
microgynon). So women take one tablet every day& start the
next packet without a break.
When do I prescribe Dianette?
Dianette is 2 mg cyproterone acetate, 35 micrograms ethinylestradiol. It has
greater anti-testosterone activity, but also increased risk of
thromboembolism. It is not licensed for contraception alone– though it does
work as a COC!
It is only licensed for severe acne not responding to prolonged oral
antibiotics, or moderately severe hirsutism.
It needs to be stopped 3-4 months after acne or hair-growth completely
resolve, but can be restarted subsequently.
So how, practically, does a women start that second choice of pill I
have prescribed?
1. Prescribe 3 months of the new pill
2. Advise that she starts the pill after taking 21 days of the first type of pill
– ie she does not have a withdrawal bleed.
(If she is taking an EveryDay pill – she shouldn’t take any of the last
7(inactive) pills but start the new pill after the active pills)
14
Summary
In this workbook you have worked though:
 Revision of different pills
 Pill Safety – how to do a pill check
 Reasons for changing the pill
 A case of Progesterone side-effects
 A case of Oestogen side-effects
 A case of Break through bleeding
 Practical tips on pill changing
GP curriculum objectives guiding learning were:
 Contraception – effectiveness rates, risks, benefits and appropriate
selection of patients for all methods
 Contraception – the safe provision of all methods of oral
contraception
Aims : you should now be able to:
1) Demonstrate how perform a pill check
2) Demonstrate how to elicit common side-effects of the COC pill
3) Demonstrate how to start an alternative choice of COC pill
Self summary:
In doing this workbook I learnt __________________________________________
____________________________________________________________________
____________________________________________________________________
15
Evaluation
We would be really grateful I you could fill in the following and send it to us, so that we can
continue to improve the workbook. Please keep a copy of your self-evaluation.
Self-Evaluation
What to do: Please rate how strongly you agree or disagree with each of the following
statements by circling the appropriate statement.
1) I know how to perform a pill check
Strongly Disagree Somewhat Disagree Somewhat Agree Strongly Agree
Comments ___________________________________________________________
____________________________________________________________________
2) I know how to elicit common side-effects of the COC pill
Strongly Disagree Somewhat Disagree Somewhat Agree Strongly Agree
Comments ___________________________________________________________
____________________________________________________________________
3) I know how to start an alternative choice of COC pill
Strongly Disagree Somewhat Disagree Somewhat Agree Strongly Agree
Comments ___________________________________________________________
____________________________________________________________________
Workbook evaluation
1.One thing that I found useful about this workbook was….
____________________________________________________________________
____________________________________________________________________
2.One thing I thought could be done better in this workbook was…
____________________________________________________________________
____________________________________________________________________
Any additional comments….
____________________________________________________________________
____________________________________________________________________
16
Sources
Sources & Further Reading
1.BNF: http://www.bnf.org/
2.Faculty of sexual and reproductive health www.ffprhc.org.uk/
3. www.gpnotebook.co.uk
4.www.patient.co.uk/
5. MIMS www.healthcarerepublic.com/
References
1. McMorran J, Crowther DC, McMorran S, Prince C, YoungMin S, Pleat J, et
al. Contraception – general overview. [cited 6th March 2009]; Available
from: http://www.gpnotebook.co.uk/simplepage.cfm?ID=-617283574
2. Willacy H. Contraception - General Overview. Patient.co.uk 2008 [cited 6th
March 2009]; Available from: http://www.patient.co.uk/showdoc/40000129/
3. FFPRHC guidance. First prescription of combined oral contraception. J Fam
Plann Reprod Health Care 2003;29(4):209-23
4. Faculty of Family Planning and Reproductive Health Care. UK MEDICAL
ELIGIBILITY CRITERIA FOR CONTRACEPTIVE USE (UKMEC 2005/2006).
Faculty of Family Planning and Reproductive Health Care. 2006. Available
from: http://www.ffprhc.org.uk/admin/uploads/298_UKMEC_200506.pdf
17
Appendicies
Page
16. Appendix 1. Medicines Eligibility Criteria categories3
17. Appendix 2. Medicines Eligibility Criteria for Combined Oral Contraceptive4
18. Appendix 3. Advice for women missing Combined Oral Contraceptive Pills3
19. Appendix 4. MIMS – Composition of Combined Oral Contraceptive Pills5
Appendix 1: Medicines Eligibility Criteria Catagories 3
UKMEC 1 A condition for which there is no restriction for the use of
the contraceptive method
UKMEC 2 A condition for which the advantages of using the method
generally outweigh the theoretical or proven risks
UKMEC 3 A condition where the theoretical or proven risks usually
outweigh the advantages of using the methoda
UKMEC 4 A condition which represents an unacceptable health risk if
the contraceptive method is used
18
Appendix 2. Medicines Eligibility Criteria
for Combined Oral contraceptive 4
19
Appendix 3. Advice for women missing
Combined Oral Contraceptive Pills 3
20
Appendix 4. MIMS – Composition of Combined
Oral Contraceptive Pills5
Norinyl-1 50
Mestranol
1.0
norethisterone
Monophasic
Pills
Ethinyl
Estradiol
(mcg)
Progestogen
(milligrams)
Monophasic
Pills
Ethinyl
Estradiol
(mcg)
Progestogen
(milligrams)
Desogestrel
Marvelon 30 0.15 Desogestrel
Mercilon 20 0.15 Desogestrel
Drospirenone
Yasmin 30 3.0 Drospirenone
Gestodene  
Femodene (
also ED)
30 0.075 Gestodene
Femodette 20 0.075 Gestodene
Katya 30 0.075 Gestodene
Sunya 20 0.075 Gestodene
Levonorgestrel
Microgynon 30 (
also ED)
30 0.15
Levonorgestrel
Ovranette 30 0.15
Levonorgestrel
Norethisterone
Brevinor 35 0.5 norethisterone
Loestrin 20 20 1.0 norethisterone
acetate
Loestrin 30 30 1.5 norethisterone
acetate
Norimin 35 1.0 norethisterone
Ovysmen 35 0.5 norethisterone
Norgestimate
Cilest 35 0.25
norgestimate
Mestranol /Norethisterone
Gestodene
Triadene 30
40
30
0.05 (6 tabs)
0.07 (5 tabs)
0.1 (10 tabs)
Levonorgestrel
Logynon
(also ED)
30
40
30
0.05 (6 tabs)
0.075 (5 tabs)
0.125 (10 tabs)
Norethisterone  
BiNovum 35
35
0.5 (7 tabs)
1.0 (14 tabs)
Synphase 35
35
35
0.5 (7 tabs)
1.0 (9 tabs)
0.5 (5 tabs)
TriNovum 35
35
35
0.5 (7 tabs)
0.75 (7 tabs)
1.0 (7 tabs)
Biphasic and
Triphasic Pills
Ethinyl
Estradiol (mcg)
Progestogen
(milligrams)

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Safe Prescribing of Second Line Combined Oral Contraceptive

  • 1. 1 Safe PrescribingSafe Prescribing ofof Second LineSecond Line Combined OralCombined Oral ContraceptiveContraceptive A workbook for GPA workbook for GP traineestrainees Dr Catherine Hyde
  • 2. 2
  • 3. 3 Contents Page 2. Using this Workbook : Who, What, How 3. What you need to know to do this workbook 4. Revision of Different pills 5. Pill Safety – the pill check 6. Reasons for changing the pill 7. Case 1 Progesterone side-effects 8. Case 2 Oestogen side-effects 9. Case 3 Break through bleeding 11. Practical tips 12. Summary 13. Evaluation 14. Sources 15. Appendix 1. Medicines Eligibility Criteria categories 16. Appendix 2. Medicines Eligibility Criteria for Combined Oral Contraceptive 17. Appendix 3. Advice for women missing Combined Oral Contraceptive Pills 18. Appendix 4. MIMS – Composition of Combined Oral Contraceptive Pills Activities index Page ACTIVITY 3. ACTIVITY 1: Medical Eligibility Criteria (MEC) For Contraceptive Use 4. ACTIVITY 2: Different COC Pills. 7. ACTIVITY 3: Side Effects of Progesterogens 8. ACTIVITY 4:Options for changing the Pill to reduce Progesterogenic side-effects 9. ACTIVITY 5: Options for Changing the pill to reduce oestrogenic side effects 10. ACTIVITY 6: Advice for missed low dose COC 10. ACTIVITY 7: Forming differential diagnosis for Breakthrough Bleeding 10. ACTIVITY 8: Forming management for Breakthrough Bleeding
  • 4. 4 Using this workbook Who should use the book? This book is designed for GP trainees to provide a solution to the problem of how to safely prescribe a second line combined oral contraceptive (COC) pill. It may be useful by anyone who has experience, and learning needs, in family planning work. I realised the need for producing this workbook came while I was watching a powerpoint presentation on the topic. It was presented by a GP trainee and she was struggling with a case, as I also had. I realised:  It is a common scenario  It is important  there is evidence and good practice to guide us The GP trainee’s name was Aisha, and she will provide a trainee viewpoint to help guide you throughout this workbook. GP curriculum objectives covered are:  Contraception – effectiveness rates, risks, benefits and appropriate selection of patients for all methods  Contraception – the safe provision of all methods of oral contraception Aims : by the end of this book you should be able to: 1) Demonstrate how perform a pill check 2) Demonstrate how to elicit common side-effects of the COC pill 3) Demonstrate how to start an alternative choice of COC pill How should it be used? Activity Time Reference Most learning comes from completing the activities in this workbook See the contents page for a list of activities you can do it all in one go you can complete just one section Each section takes 5-10 mins Contents of different pills and WHO Medicine Eligibility Criteria are in the Appendix pages15-18 Yellow boxes in the workbook have additional information Hi there! I’m Aisha, a GP trainee – so WHAT will I learn from the workbook?
  • 5. 5 What you need to know to do this workbook Why is this topic important? 24% of women use the COC in the UK making is second favourite choice after condoms1 Side-effects are common, can be life-threatening, can indicate misuse and can put the patient at risk of pregnancy. We expect you to know how to: conduct a consultation take a medical and sexual history do appropriate examination give information check understanding  use your basic sciences knowledge prescribe the COC pill safely for the first time ACTIVITY 1 - Medical Eligibility Criteria (MEC) For Contraceptive Use What to do: draw a line between the MEC Category, and the correct definition of risk Ok. So I did this for my Diploma of Family Planning, but after 18 months stuck in hospital I’ve forgotten everything. Where can I remind myself? The Faculty of Family planning (FPRHC)& GP notebook provide great guidance – look in the ‘Sources’, Page 14 MEC Definition of MEC risk Category 1 A a condition which represents an unacceptable health risk if the contraceptive method is used. 2 C a condition for which there is no restriction for the use of the contraceptive method. 3 B a condition where the theoretical or proven risks usually outweigh the advantages of using the method. 4 D a condition where the advantages of using the method generally outweigh the theoretical or proven risks.
  • 6. 6 Revision of Different Pills All combined oral contraceptive pills contain 2 different hormones ____________ and a progesterogen. Drug :Oestrogen may be either ______ estradiol or its prodrug __________ (which is converted in vivo into estradiol). Dose: Standard strength contains ethinylestradiol 30 or 35micrograms or (30– 40microgram    biphasic or _________ preparations). Low dose contains ethinylestradiol ___ micrograms Progesterogens 2nd Generation progesterogens are Norethisterone and ____________. They are associated with a lower risk of venous thromboembolism . Therefore they should be the first choice when prescribing the COC. First choice of pill should: • contain either of these progestrogens • be monophasic • contain 30 micrograms of ethinylestradiol In practice this means prescribing __________, Ovranette, Brevinor, Loestrin 30. 3rd Generation Use these words to fill in the blanks if you are finding this tough: Levonorgestel, 20, oestrogen, mestranol, triphasic, Microgynon 30, Femodene, Drospirenone, ethinyl, norgestimate. For confirmation of answers, see Appendix 4, page18 Progestrogen Special Features of Drug Pill containing this drug desogestrel Less counteractivity against oestrogen Marvelon ___________ Cilest gestodene _____________ ___________ Derived from spironolactone Caution in renal failure/high potassium Yasmin Circumstance not using COC and not pregnant using a 2nd generation COC Using a 3rd generation COC pregnant VTE Risk per 100,000 woman -years 5 15 25 60 Table 1 Risk of venous thromboembolism (VTE) associated with combined oral contraception (COC) use and non-use ACTIVITY 2 –Different COC Pills. What to do: fill in the blanks with the correct word (answers at bottom of the page if needed)
  • 7. 7 Pill Safety – the Pill check What to do in the follow-up consultation Check : Has she found it easy to use? Has she noticed any adverse effects? Does she understand how to take it? Does she know how to manage missed pills? Has the pattern of withdrawal bleeds been regular? Has there been any breakthrough bleeding? In every follow up consultation, we need to check Blood pressure Is it still the best choice of contraception? any change in circumstances Is it still safe? Any relevant change in Medical/family history that may alter MEC category (see Table 2) Cervical smear status Sexual health screening (Awareness and need of services)& using condoms So the blood pressure is fine, she doesn’t have any problems and we’ve discussed the important information. What now? Excellent! Prescribe another 6-12 months of the same pill, and advise her to come back if there are any problems. Risk Factor Cut off – UKMEC>2 Smoking If Age>35yrs Migraine With Aura Or if Age>35yrs BMI ≥35 kg/m2 Blood pressure Consistently 140-159/ 90-94 >160/95 – stop immediately VTE Personal or FH<45yrs CVD/Stoke Multiple risk factors of personal history Medication Long term liver enzyme inducers Surgery Major surgery with immoblisation Table 2: Risk factor for harm when using the COC and instances when UKMEC category is 3/4
  • 8. 8 Reasons for changing pill 1.Breakthrough bleeding  Is common1&2  Up to 30% of women experience irregular bleeding during the first cycle2  Usually resolves after 3 cycles2  Does not indicate that the pill has reduced contraceptive effect (as long as it is being taken properly) 3  We need to consider 2. Side-effects Progestrogen  scanty menses  leukorrhoea, dry vagina  breast tenderness  dull type of headache – often of pill withdrawal  appetite increase, weight gain  premenstrual depression  leg cramps, softening of ligaments  acne, greasy hair  vaginal dryness So after 2 months on the pill, a woman comes back. She’s not happy with the pill and wants to change. What now? Well, we still need to do a formal pill check (see page 5) to ensure that its safe and right to continue with a COC. Then we need to explore her reasons. Oestrogen  menorrhagia  cervical ectopy  breast fullness  migraine type headaches  fluid retention  weight gain (fluid)  tiredness, irritability  nausea  bloating Compliance - how/when is the pill being taken Interference - has there been vomiting within 2 hrs of taking the pill, diarrhoea, or any drug interactions (including St.John’s Wort/herbal remedies) Pregnancy - interuterine or ectopic Infection - Chlamydia and Sexually Transmitted Infections Pathology - endometrial or cervical polyp - cervical cancer/CIN Endocrine - hypo/hyperthroidism Blood - bleeding disorders
  • 9. 9 Progesterogen case  Lisa is a 21 year old women  She comes to see you after 3 months taking Microgynon 30 (Ethinylestradiol 30 microgram, levonorgestrel 150 microgram)  She complains of  increased appetite  acne  low mood before her withdrawal bleed  She was previously on injection which she stopped due to weight gain and low mood, and then she used condoms for 6 months ACTIVITY 4: Options for Changing the pill What to do: Fill in the blank with the correct pill name 1. Light withdrawal bleed 2. Increased white vaginal discharge 3. Leg cramps 4. Heavy withdrawal bleeds 5. Breast tenderness 6. Greasy hair 7. Vaginal dryness 8. Fluid retention True / False True / False True / False True / False True / False True / False True / False True / False ACTIVITY 3:Side Effects of Progesterogens What to do: circle True if the symptom is cause by progesterogens, False if not (answers at bottom of page) ACTIVITY3.Answers1.T2.T3.T4.F9associatedwithoestrogen)5.T6.T7.T8.F(Associatedwith oestrogen) Action to reduce side- effects New Pill content New Pill name Reduce progesterogen content Not an option in this case Increase oestrogen 35 micrograms of ethinyl oestradiol 500 micrograms norethisterone Ovysmen and i)__________ Change to less androgenic progestrogen 30 micrograms of ethinyl oestradiol 150 micrograms desogestrel ii)_________ Change to 3rd generation progesterogen e,g. 35 microgram of ethinyl estradiol norgestimate 0·25 mg iii)________
  • 10. 10 Oestrogen case Seema is a 19 yr old woman She has just started a new relationship She has taken 3 months of Brevinor, which her friend had recommended (contains Ethinylestradiol 35 microgram/norethisterone 0·5 mg) She complains of :  increased appetite  heavy period  tiredness  nausea and bloating ACTIVITY 5: Options for Changing the pill to reduce oestrogenic side effects What to do: Fill in the blank with the correct pill name Action Pill content Pill name Original pill 35 microgram ethinyl oestradiol 0·5 mg norethisterone Brevinor Dose : Reduce oestrogen content <35 micrograms ethinyl oestradiol 20 micrograms ethinyl oestradiol 1 mg norethisterone acetate All pills except a)_________ & Norimin Loestrin 20 Increase progesterogen content 30 micrograms ethinyl estradiol 1.5 mg norethisterone acetate Loestrin 30 Type Alternative oestrogen type 50 micrograms Mestranol 1 mg norethisterone b)_________ Is it safe to prescribe a low strength oestrogen pill (eg 20 micrograms ethinyl oestradiol )? Efficacy of 20mcg and 30mcg pills are similar, but breakthrough bleeding is more common with the lower dose3 . Missed pill advice is also more cautious in lower dose pills. If 2 or more pills are missed, extra protection needs to be used for 7 days, and you need to consider if emergency contraception is required (see appendix page 17). Low dose dose oestrogen is available with Northisterone, Gestodene, Drospirenone and Desorgestrel. ACTIVITY4:Answersi)Brevinorii)Marveloniii)Cilest ACTIVITY5:Answersa)Ovysmenb)Norinyl-1
  • 11. 11 Breakthrough Bleeding Case Helen is a 18 yr old woman She has just started a new relationship She has taken 6 weeks of Loestrin 20, which her friend had recommended (contains ethinylestradiol 20 microgram/1mg norethisterone) She complains of :  A small amount of bleeding every day You take a thorough history – which reveals she has missed 2 pills during the past week (week 2 of the current pill packet). She has not had unprotected intercourse since her last proper period. ACTIVITY 6:You advise her to: What to do: circle True if you would give the advice, False if not (answers overleaf) You emphasise it is important to take the pill regularly ( though one pill may be missed in the month without affecting contraception). You reassure that most bleeding settles after 3 months. At 3 months she comes to see you – she is still experiencing spotting every day. History reveals she has been taking the pill regularly, she has had intercourse without condoms since the last withdrawal bleed. She had post-coital bleeding yesterday. ACTIVITY 7: What are you concerned about? write a differential diagnosis below ACTIVITY 8: What will you do next Form a management plan below i) use extra protection for the next 7 days True/False ii) use emergency contraception True/False iii) run this pill packet into the next True/False a) __________________ b) __________________ c) __________________ d) __________________ e) __________________ f) __________________ 1. _____________________________ 2. _____________________________ 3. _____________________________ 4. _____________________________ 5. _____________________________
  • 12. 12 Breakthrough Bleeding Case The Case continues: Answers to ACTIVITY 6 You correctly advise that she use extra protection for the next 7 days as she was on a low dose pill. She does not need to have emergency contraception, as there had been no intercourse & as she has missed pills in week 2 – there was no need to run pill packets together ( see appendix – page if you’re still not sure). ACTIVITY 7&8 Your immediate concern is the possibility of ectopic pregnancy, then possible interuterine pregnancy and pelvic inflammatory disease. The differential is fairly wide – you can discuss this futher with your GP trainer & colleagues (& refer back to page 6). You carefully examine: Abdomen is soft, non-tender. All obervations are normal. pelvic exam is normal, cervix looks healthy & there was no cervicitis. There is a significant amount of greenish discharge. You take a smear, high vaginal and endocervical swabs. You are lucky to have pregnancy tests available in the practice – which is negative. Are you happy this woman is not in immediate danger ?___________________________ You send her home, advising to her continue with this pill, but use extra protection until the results of the swabs are back. 3 days later – the swab results show evidence of gonorrhoea infection. You treat this with a single oral dose cefixime 400mg & urinary rescreen at day 16 is clear. However, the breakthrough bleeding is still an issue. What will you do next? Select one of option a) to e)_____ (all options are suitable, and a combination of changes can also be effective) Action Pill content Pill name a) Increase oestrogen content 35 micrograms of ethinyl oestradiol 1 milligram norethisterone Norimin b) Change dose of progesterone 35 micrograms of ethinyl oestradiol 500 micrograms norethisterone Brevinor c) Alternative 2nd generation progesterogen 30 micrograms of ethinyl oestradiol 150 micrograms levonorgestrel Micrgynon or Ovranette d) 3rd generation progesterogen 20 micrograms of ethinyl oestradiol /gestodene 75 microgram Femodette e) Change to triphasic pill Ethinyl oestradiol &levonorgestrol logynon
  • 13. 13 Practical Tips When I prescribe the Microgynon – it always gives me an ‘Microgynon ED’ choice. Does Microgynon treat ED too?! ED stand for EveryDay – these pills contain 21 active pills (beige in microgynon)& 7 inactive pills (white in microgynon). So women take one tablet every day& start the next packet without a break. When do I prescribe Dianette? Dianette is 2 mg cyproterone acetate, 35 micrograms ethinylestradiol. It has greater anti-testosterone activity, but also increased risk of thromboembolism. It is not licensed for contraception alone– though it does work as a COC! It is only licensed for severe acne not responding to prolonged oral antibiotics, or moderately severe hirsutism. It needs to be stopped 3-4 months after acne or hair-growth completely resolve, but can be restarted subsequently. So how, practically, does a women start that second choice of pill I have prescribed? 1. Prescribe 3 months of the new pill 2. Advise that she starts the pill after taking 21 days of the first type of pill – ie she does not have a withdrawal bleed. (If she is taking an EveryDay pill – she shouldn’t take any of the last 7(inactive) pills but start the new pill after the active pills)
  • 14. 14 Summary In this workbook you have worked though:  Revision of different pills  Pill Safety – how to do a pill check  Reasons for changing the pill  A case of Progesterone side-effects  A case of Oestogen side-effects  A case of Break through bleeding  Practical tips on pill changing GP curriculum objectives guiding learning were:  Contraception – effectiveness rates, risks, benefits and appropriate selection of patients for all methods  Contraception – the safe provision of all methods of oral contraception Aims : you should now be able to: 1) Demonstrate how perform a pill check 2) Demonstrate how to elicit common side-effects of the COC pill 3) Demonstrate how to start an alternative choice of COC pill Self summary: In doing this workbook I learnt __________________________________________ ____________________________________________________________________ ____________________________________________________________________
  • 15. 15 Evaluation We would be really grateful I you could fill in the following and send it to us, so that we can continue to improve the workbook. Please keep a copy of your self-evaluation. Self-Evaluation What to do: Please rate how strongly you agree or disagree with each of the following statements by circling the appropriate statement. 1) I know how to perform a pill check Strongly Disagree Somewhat Disagree Somewhat Agree Strongly Agree Comments ___________________________________________________________ ____________________________________________________________________ 2) I know how to elicit common side-effects of the COC pill Strongly Disagree Somewhat Disagree Somewhat Agree Strongly Agree Comments ___________________________________________________________ ____________________________________________________________________ 3) I know how to start an alternative choice of COC pill Strongly Disagree Somewhat Disagree Somewhat Agree Strongly Agree Comments ___________________________________________________________ ____________________________________________________________________ Workbook evaluation 1.One thing that I found useful about this workbook was…. ____________________________________________________________________ ____________________________________________________________________ 2.One thing I thought could be done better in this workbook was… ____________________________________________________________________ ____________________________________________________________________ Any additional comments…. ____________________________________________________________________ ____________________________________________________________________
  • 16. 16 Sources Sources & Further Reading 1.BNF: http://www.bnf.org/ 2.Faculty of sexual and reproductive health www.ffprhc.org.uk/ 3. www.gpnotebook.co.uk 4.www.patient.co.uk/ 5. MIMS www.healthcarerepublic.com/ References 1. McMorran J, Crowther DC, McMorran S, Prince C, YoungMin S, Pleat J, et al. Contraception – general overview. [cited 6th March 2009]; Available from: http://www.gpnotebook.co.uk/simplepage.cfm?ID=-617283574 2. Willacy H. Contraception - General Overview. Patient.co.uk 2008 [cited 6th March 2009]; Available from: http://www.patient.co.uk/showdoc/40000129/ 3. FFPRHC guidance. First prescription of combined oral contraception. J Fam Plann Reprod Health Care 2003;29(4):209-23 4. Faculty of Family Planning and Reproductive Health Care. UK MEDICAL ELIGIBILITY CRITERIA FOR CONTRACEPTIVE USE (UKMEC 2005/2006). Faculty of Family Planning and Reproductive Health Care. 2006. Available from: http://www.ffprhc.org.uk/admin/uploads/298_UKMEC_200506.pdf
  • 17. 17 Appendicies Page 16. Appendix 1. Medicines Eligibility Criteria categories3 17. Appendix 2. Medicines Eligibility Criteria for Combined Oral Contraceptive4 18. Appendix 3. Advice for women missing Combined Oral Contraceptive Pills3 19. Appendix 4. MIMS – Composition of Combined Oral Contraceptive Pills5 Appendix 1: Medicines Eligibility Criteria Catagories 3 UKMEC 1 A condition for which there is no restriction for the use of the contraceptive method UKMEC 2 A condition for which the advantages of using the method generally outweigh the theoretical or proven risks UKMEC 3 A condition where the theoretical or proven risks usually outweigh the advantages of using the methoda UKMEC 4 A condition which represents an unacceptable health risk if the contraceptive method is used
  • 18. 18 Appendix 2. Medicines Eligibility Criteria for Combined Oral contraceptive 4
  • 19. 19 Appendix 3. Advice for women missing Combined Oral Contraceptive Pills 3
  • 20. 20 Appendix 4. MIMS – Composition of Combined Oral Contraceptive Pills5 Norinyl-1 50 Mestranol 1.0 norethisterone Monophasic Pills Ethinyl Estradiol (mcg) Progestogen (milligrams) Monophasic Pills Ethinyl Estradiol (mcg) Progestogen (milligrams) Desogestrel Marvelon 30 0.15 Desogestrel Mercilon 20 0.15 Desogestrel Drospirenone Yasmin 30 3.0 Drospirenone Gestodene   Femodene ( also ED) 30 0.075 Gestodene Femodette 20 0.075 Gestodene Katya 30 0.075 Gestodene Sunya 20 0.075 Gestodene Levonorgestrel Microgynon 30 ( also ED) 30 0.15 Levonorgestrel Ovranette 30 0.15 Levonorgestrel Norethisterone Brevinor 35 0.5 norethisterone Loestrin 20 20 1.0 norethisterone acetate Loestrin 30 30 1.5 norethisterone acetate Norimin 35 1.0 norethisterone Ovysmen 35 0.5 norethisterone Norgestimate Cilest 35 0.25 norgestimate Mestranol /Norethisterone Gestodene Triadene 30 40 30 0.05 (6 tabs) 0.07 (5 tabs) 0.1 (10 tabs) Levonorgestrel Logynon (also ED) 30 40 30 0.05 (6 tabs) 0.075 (5 tabs) 0.125 (10 tabs) Norethisterone   BiNovum 35 35 0.5 (7 tabs) 1.0 (14 tabs) Synphase 35 35 35 0.5 (7 tabs) 1.0 (9 tabs) 0.5 (5 tabs) TriNovum 35 35 35 0.5 (7 tabs) 0.75 (7 tabs) 1.0 (7 tabs) Biphasic and Triphasic Pills Ethinyl Estradiol (mcg) Progestogen (milligrams)

Editor's Notes

  1. Clear structure – cognitivism
  2. Who is this for – ASSURE analysis Aims – GP curriculum allign with learners objectives/motivation - 􀁺 Contraception – effectiveness rates, risks, benefits and appropriate selection of patients for all methods, including methods of emergency contraception 􀁺 Contraception – the safe provision of all methods of oral contraception (including emergency hormonal Relate to own experience. Dialogue style ( Lockwood) How should it be used Active learning – knowles Activites – lockwood Dip in/out, all at once/reference – reflected in clarity of titles/ different page types, contents page
  3. Background knowledge - expected Refresh - advance organiser (cognitivism) Theories – instructional design theory ( systematic development of instructional specifications – ie storyboard) Cognitivism - chunking into meaningful parts &amp; memonics well organised clearly structured prior knowledge important perceptual aspects of design important
  4. Oral contraception is used by 25 - 30% of couples in the UK. It is highly effective and in addition to preventing pregnancy, it may be used to manage irregular menstrual cycles and to ameliorate dysmenorrhoea. Preparations with low doses of oestrogen and relatively more progestogen may be used to manage endometriosis. Factors to consider when choosing a preparation include: patient&amp;apos;s age smoking habit pre-existing acne / hirsutism cost . FOLLOW-UP (Women should be encouraged to use a COC for at least 3 months before considering an alternative) A follow-up at 3 months allows an assessment of blood pressure and problems and re-instruction if required. In the absence of special problems, a 12-month supply of COC can be given at follow-up. Women should be encouraged to return if any problems arise. INSTRUCTIONS FOR USE A monophasic COC containing 30 μg (micrograms) of ethinylestradiol with norethisterone or levonorgestrel is a suitable first pill. One pill should be taken daily for 21 days followed by 7 pill-free days. Women may choose to take more than one packet of pills continuously followed by a 7-day pill-free interval. COC may be started up to and including Day 5 of the menstrual cycle without the need for additional barrier contraception. COC can be started at other times if it is reasonably certain a woman is not pregnant but additional barrier contraception is required for the first 7 days of pill taking. If vomiting occurs within 2 hours of pill taking another pill should be taken as soon as possible. With persistent vomiting or severe diarrhoea for &amp;gt;24 hours instructions for missed pills (see Figure) should be followed. If taking antibiotics women should be advised to use condoms during antibiotic use and for 7 days after the antibiotic is stopped. If there are fewer than 7 pills remaining in the packet the pill-free interval should be omitted. If a non-liver enzyme-inducing antibiotic has been used for ≥3 weeks additional barrier contraception is no longer required. When used consistently and correctly, COC is &amp;gt;99% effective at preventing pregnancy. Missing pills is not encouraged but one pill can be missed any time without loss of contraceptive protection. Instructions for missed pills are outlined in the Figure. starting COC post-higher or same dose COC    The new combined oral contraceptive pill is started immediately. This is because of reports of rebound ovulation occurring at the time of tansfer. No extra contraceptive precautions are required for the first 7 days after transfer. starting COC post-lower dose COC    The new preparation is started after the usual 7 day break, e.g. after completion of an every day packet of a combined oral contraceptive pill. No extra contraceptive precautions are required for the first 7 days of use of the new preparation sudden severe chest pain (even if not radiating to left arm); sudden breathlessness (or cough with blood-stained sputum); unexplained swelling or severe pain in calf of one leg; severe stomach pain; serious neurological effects including unusual severe, prolonged headache especially if first time or getting progressively worse or sudden partial or complete loss of vision or sudden disturbance of hearing or other perceptual disorders or dysphasia or bad fainting attack or collapse or first unexplained epileptic seizure or weakness, motor disturbances, very marked numbness suddenly affecting one side or one part of body; hepatitis, jaundice, liver enlargement; blood pressure above systolic 160 mmHg or diastolic 95 mmHg; prolonged immobility after surgery or leg injury; detection of a risk factor which contra-indicates treatment (see Cautions and Contra-indications under Combined Hormonal Contraceptives below or under Oestrogens for HRT (section 6.4.1.1)).
  5. This is a checklist in cases of possible breakthrough bleeding (BTB) occurring in COC takers. BTB bleeding may occur during the first few months after prescribing a new COC. If it persists then a cause must be sought. History:taking of COC - ? missed pills ? taken at same time medication - ? antibiotics ? enzyme inducers history of gastroenteritis ? is there a possibility of pregnancy or disorder associated with pregnancy e.g. trophoblastic tumour ? factors affecting absorption of pill e.g. ileostomy ? history of post-coital bleeding ? CIN ? Examination: pelvic and speculum examination - swabs and cervical smear if indicated If all possible causes have been excluded then the COC may be changed. Options include: a user taking a monophasic pill may try a phasic pill an increased level of progestogen a different type of progestogen e.g. consider a 3rd generation COC in some cases a high dose (50 mcg pill) may be considered
  6. Case 1 – constructivism, authentic task, case-based learning
  7. Case 2
  8. Case 3
  9. Practical tips timing of changing pill
  10. Summary - theory constuctivism repetition (Lockwood) Ouctomes
  11. Evaluation – learner – record what have learnt Reflection – schon Separate paper / internet link One thing like, one thing improve – appropriate space provided (Lockwood)
  12. References/ sources/ further information FFPRHC guidance (October 2003): First prescription of combined oral contraception. J Fam Plann Reprod Health Care 2003: 29(4): 209-223 http://www.gpnotebook.co.uk/simplepage.cfm?ID=x20040427100241089560&amp;linkID=67538&amp;cook=yes Patient leafter http://www.patient.co.uk/showdoc/23068708/ Breakthrough bleeding for professionals http://www.patient.co.uk/showdoc/40025247/ Follow up consultation http://www.patient.co.uk/showdoc/40025029/
  13. http://www.who.int/reproductive-health/publications/mec/mec_update_2008.pdf Reproduction of above – different paper – to easily select.