Series 2.1 Health system and HCP barriers - PowerPoint Presentation

Slide1

Series 2.1Health system and HCP barriers

What factors influence the prevalence of IUC use?

Slide2

INTRA group: Intrauterine co

N

traception: Translating Research into Action

A panel of independent physicians with expert interest in intrauterine contraception

Formation of the INTRA group and its ongoing work is supported by Bayer Pharma

Purpose:

To encourage more widespread use of IUC methods in a broad range of women through medical education

Slide3

Core Slide Kit: Terms of use

If any adjustments are made to the originals, neither Bayer Pharma nor the INTRA Group can accept responsibility whatsoever for their content.

If you make changes you should not use the INTRA slide template.When using any of these slides, even if you modify them in some way, please acknowledge to your audience that the original slides were provided by the INTRA Group:

“The global INTRA group is a panel of independent physicians with expert interest in intrauterine contraception. Formation of the INTRA group and its ongoing work is supported by Bayer Pharma”.

You may select any combination of slides to present on to others; however, the context of the slides should be maintained wherever possible.

Please be aware that recommendations and regulations around communications on contraception as well as product labels vary globally, and ensure that the content and recommendations included in the slides are aligned to the local regulations and product labels of the country where you are presenting.

Slide4

Overview:

Health system, HCP and user barriers are interlinked

Health system barriers

HCP barriers

User barriers

Available as separate

slide series

Funding models influence whether women can

access IUC

Availability of practical training influences HCPs’ confidence in performing insertions

HCPs’ misperceptions are passed on to women

Recommendations

on

overcoming these

barriers

Slide5

Health system level

Factors influencing IUC use

Slide6

Guidelines and product labels

G

uidelines and product labels in some countries recommend IUC for multiparous women

HCPs in many large organisations are obliged to practise within product labels

HCPs not allowed to place in nulliparous women

even if they believe they are suitable candidates

Slide7

Guidelines: variation in pre-insertion screening requirements may influence IUC uptake accordingly

STI screening

Cervical cancer screening

UK

Pre-placement Pap smears are not mandated

1

US

Can screen for STIs and place IUC on the same day and treat any positive result

in situ

4

UKHigh-risk women should be tested for STIs prior to placement, but if not possible, antibiotic prophylaxis should be given1Australia

Screening recommended in higher risk groups e.g sexually active women younger than 25 years old3

Germany

Pap smear within 6 months of placement is mandatory

2

NICE 2005

German guidelines 1985

Family Planning NSW 2011

ACOG 2011

Slide8

The US medico-legal environment may discourage provision of IUC services

Stanwood 2002

IUD use leads to litigation

Respondents

(%)

Mean

number of IUDs inserted last year

P

*

Agreed

164<0.001

Neutral236

Disagreed6110

*Overall significance from one-way analysis of variance

Fear of litigation may discourage providers

from performing IUC insertions

Survey of 400 obstetrician/gynaecologists in the US

1

Slide9

Cost-effectiveness of IUC is misunderstood by payers

Black 2012

Mavranezouli

2008

Trussell

2009

Chiou

2003

The upfront costs of the

LNG-IUS is high in some countries

1Incorrect perception that an LNG-IUS is an ‘expensive’ option

Once placed, copper IUDs and the LNG-IUS are effective for several years and over time become highly cost-effective2–4

MisperceptionReality

Slide10

IUC options are the most cost-effective at 5 years: US-based analysis1

Method

Method-related costs (US$)

Failure

cost

(US$)

Cost of

side-effects

(US$)

Total cost (US$)

Copper IUD

60542

0

647

Mirena

823

58

49

930

Implant

2,142

5

31

2,178

Female condom

1,043

1,633

0

2,676

Injectable

2,341

300

40

2,681

Sterilisation (tubal ligation)

2,866

59

53

2,978

Vaginal ring

2,467

683

8

3,158

Oral contraceptive

2,630

682

69

3,381

Transdermal patch

2,774

683

1

3,458

No method

0

4,739

0

4,739

Increasing

cost-effectiveness

Trussell

2009

Slide11

Individual payers may not benefit from averting costs of unplanned pregnancy1

Black 2012

A healthcare system as a whole will benefit from averting costs of unplanned pregnancy

However, where different budgets have no crossover, particular payers may not benefit

In the UK

Gynaecology/ contraception

Obstetrics/ maternity

NO CROSSOVER

Slide12

Lack of incentives to provide or seek practical insertion training

Lack of incentive for experts to provide insertion training

Lack of incentive for non-experts

to seek training

A survey in the US found that of the HCPs not providing IUC,

47%

cited lack of reimbursement as a reason for not performing insertions

1

Experts may be hesitant to train other for fear of losing a source of income

Referral systems may make it more beneficial for HCPs to send women elsewhere for IUC placement

Harper 2008

Slide13

HCP level

Factors influencing IUC use

Slide14

HCPs misperceptions of IUC: overview

These misperceptions lead to reluctance and lack of confidence in performing IUC insertions in nulliparous women

1

Black 2012

Slide15

Dalkon Shield: historical reason for concern regarding PID and infertility

The Dalkon Shield is no longer available, but it still tarnishes the reputation of IUC

Multifilament threads facilitated the ascension of infection into the uterus, leading to PID, infertility and cases of fatal sepsis

1,2

Modern devices use monofilament threads that do not cause PID

Nevertheless, younger women are still deterred from using IUC methods by older family members

Women’s misperceptions regarding the efficacy, safety and risk of expulsion may deter them from using IUC methods

3–5

Tatum 1975;

MacIssac

2007Rubin 2010Gutin 2011Asker 2006

Slide16

PID: myths versus reality

Myth

Reality

IUC causes

PID

1–6

PID is caused by STIs, NOT the on-going presence of IUC

in the uterine

cavity1–6

The reputation of modern IUC has been tarnished by the Dalkon Shield, an IUD responsible for several cases of severe and potentially fatal pelvic sepsis, which has now been off the market for more than 30 years1

MacIsaac

2007

Stanwood 2002

Lyus

2009

ARHP 2004

Allen 2009

Middleton 2011

Slide17

There is an increase in the risk of PID in the first 20 days after IUC insertion

Farley TM

et al

. 1992

This increase in risk of PID in the first 20 days after IUD placement is related to the potential transfer of a pre-existing STI from the vagina/cervix into the uterine cavity during placement

1

Risk is higher in the first 20 days after insertion than at all other times, during which risk is uniform and low for up to eight years of use

1

Slide18

Routine use of antibiotic prophylaxis is not evidence-based

US study

11,985 women were randomly assigned antibiotic or placebo

Kenyan study

2

1,813 women were randomly assigned antibiotic or placebo

Clinic visits for symptoms of PID within 90 days of IUD insertion

Placebo

(n=915 )

Antibiotic

(n=918)37Neither study showed a significant benefit of prophylactic antibiotic use in reducing the risk of PID after IUC insertion

Rates and relative risks of PID for the first month after IUC insertion

Placebo(n=828)Antibiotic(n=827)RR

95% CI1.9%1.3%0.690.32-1.5

Walsh T et al 1998

Sinei

SK et al 1990

Slide19

LNG-IUS may protect against PID

Hypothesis

Thickening of cervical mucus

Prevents

STIs ascending into the uterus

In a multicentre European study, 937 women were randomised to

Cu-IUD and

1821 women to LNG-IUS

1

After 36 months, the cumulative gross rate of PID was significantly lower in LNG-IUS users

Cumulative

36-month gross discontinuation rate due to PID1

Cu-IUDLNG-IUSP2.0

0.5<0.013

Toivonen

J et al 1991

Slide20

Infertility: myth versus reality

Myth

Reality

IUC may impair future fertility

1–6

Having

IUC

in situ

does NOT cause infertility

1–5

The principal mechanism by which IUC might, in theory, increase risk of infertility is through the development of PID, leading to pelvic adhesions and tubal disease

5However, having IUC

in situ does NOT cause PID6

MacIsaac

2007;

Lyus

2009;

ARHP 2004;

Allen 2009;

Middleton 2011

Stanwood 2002

Slide21

Risk of tubal occlusion is NOT associated with previous IUD use1

In a study of 1,895 women in Mexico, use of copper IUDs was not associated with subsequent infertility

Hubacher

2001

Previous use of a copper IUD

Infertile women with tubal occlusion

(N=358)

Infertile controls

(N=953)

Odds ratio*

(95% CI)

Pregnant controls(N=584) Odds ratio*(95% CI)No, n (%)

335 (93.6)896 (94.0)1.0544 (93.2)1.0

Yes, n (%)23 (6.4)57 (6.0)

1.0 40 (6.8)

0.9

*The odds ratios are for the comparison with the infertile women with tubal occlusion

Slide22

Risk of tubal occlusion is associated with previous Chlamydia infection1

IUD use

and presence of antibodies to

Chlamydia

Infertile women with tubal occlusion

(N=358)

Infertile controls

(N=953)

Odds ratio

(95% CI)Pregnant controls(N=584) Odds ratio(95% CI)*

No use of a copper IUD, n (%)Negative203 (56.7)583 (61.2)1.0420 (71.9)

1.0Positive132 (36.9)313 (32.8)

1.2 (0.9–1.6)124 (21.2)2.4 (1.7–3.2)Use of a copper IUD, n (%)

Negative18 (5.0)

33 (3.5)1.5 (0.8–2.8)

32 (5.5)1.1 (0.6–2.1)

Positive5 (1.4)

24 (2.5)

0.6 (0.2–1.5)

8 (1.4)

1.3 (0.4–4.1)

*The odds ratios are for the comparison with the infertile women with tubal occlusion

Hubacher

2001

Slide23

Ectopic pregnancy: myth versus reality

Myth

Reality

IUC increases the risk of ectopic pregnancy

(the ectopic pregnancy risk is misunderstood

1–3

)

IUC is associated with an extremely low risk of ectopic pregnancy

IUC failure

rate is extremely low;

4 therefore, the absolute ectopic pregnancy rate is also extremely low, and much lower than in women not using contraception

A history of ectopic pregnancy is listed as category 1 (no restriction) for use of an IUC in the WHO MEC5HCPs overestimate the risk of ectopic

pregnancy and consider a past history of ectopic pregnancy to be a contraindication to future use of IUC6

MacIsaac

2007

Harper 2008

Allen 2009

Trussell

2011

WHO 2015

Rubin 2011

Slide24

Misperception that IUC is unacceptable to nulliparous women

This belief is not evidence-based:

The evidence shows us that, if continuation rates are taken as a surrogate for acceptability, IUC is highly acceptable to nulliparous women

1

MacIsaac L

et al.

2007

Suhonen

S et al. 2004

Wildemeersch D et al. 2005Brockmeyer A et al. 2008Bahamondes MV et al. 2011

Continuation rate at 1 year (%)

1-year continuation rates in nulliparous women

Continuation rate at 1 year (%)

LNG-IUS

OCs

Parous women

*

IUD/IUS

Suhonen

et al.

2004

2

(N=94, N=99)

Wildemeersch

et al.

2005

3

(N=92)

Brockmeyer

et al.

2008

4

(N=90)

Bahamondes

et al

. 2011

5

(N=159, N=477)

1-year continuation rates in nulliparous women

*

Slide25

The placement failure rate is extremely low in nulliparous women

4,5

In two Scandinavian studies4,5

in nulliparous women:

Total reported placement failure rates were 2.1% and 2.7% in 94 and 224 women respectively

4,5

Placement was rated as ‘easy’ in 85% and 72% of cases

respectively4,5

Lyus R et al. 2009 Allen RH et al. 2009

Middleton AJ 2011 Suhonen S et al. 2004 Marions L et al. 2011

Placement failure rate (%)Suhonen et al.

20044(N=94)Marions

et al.20115(N=224)

Study

Placement failure rates in nulliparous women

Ease of insertion: myth versus reality

Myth: There is a misperception that it is very difficult/impossible to insert IUC in nulliparous women

1-3

Reality: In the vast majority of women, IUC is inserted with ease regardless of parity

Slide26

Risk of perforation: myth versus reality

Myth: The risk of uterine perforation is much higher in nulliparous women

1Reality: Risk of perforation is low, regardless of parity (although data are likely to underestimate the true incidence)2–5

Study

Country

Sample size and composition

Intrauterine

contraceptive

Rate of uterine perforation

Caliskan, 20032

Europe8,343 nulliparous and parous womenCopper T-380A2.2 per 1,000 insertionsHarrison-Woolrych, 20033New Zealand16,159 nulliparous and parous

womenMultiload® Cu3751.6 per 1,000 insertions

Brockmeyer, 20084UK

117 nulliparous womenCu-IUD/LNG-IUS0

Marions, 20115

Sweden224 nulliparous women

Cu-IUD/LNG-IUS

0

Lyus

R et al 2010

Caliskan

E et al 2003

Harrison-

Woolrych

M et al 2003

Brockmeyer

A et al 2008

Marions

L et al 2011

Slide27

Misperception that IUC methods are abortifacients1,2

Schulman 2009

Black 2012

HCPs (and women) incorrectly assume that because IUC

is placed in the uterus it aborts early pregnancies

HCPs are dissuaded from recommending or inserting IUC

Morally/ethically unacceptable to certain groups

Slide28

IUC methods prevent conception and are NOT abortifacient

Sivin

1989

Rivera 1999

WHO 1987

Stanford 2002

Mechanism of action

Cu-IUD

LNG-IUS

Effects on sperm

Sterile foreign body reaction in uterine cavity results in changes that may be toxic to sperm

1–4✓

✓Release of copper ions is spermicidal or cytotoxic1,2,4

✓

Thickening of cervical mucus may impede sperm transport through the cervix (preventing sperm reaching the egg)4

✓

Effects on fertilisation

Decrease in the number of fertilised ova in Fallopian tubes compared with women not using contraception

1-4

✓

✓

Effects on the endometrium

Increases leukocytes in the endometrium

4

✓

Altered cytokine and integrin profile in the endometrium

4

✓

✓

Endometrial suppression, decreased thickness and secretions

4

✓

Slide29

HCPs lack confidence in performing IUC placements

1

Black et al 2012

Lack of availability of practical training for HCPs

Lack of experience in performing placements, particularly in nulliparous women

Misperceptions regarding ease and pain associated with placement and risk of perforation

HCPs lack confidence in performing IUC placements,

particularly in nulliparous women

HCPs less likely to recommend IUC as an option to women

Slide30

Overcoming the obstacles

Slide31

Addressing health system barriers

Provide incentives for experts to offer practical

training

Rem

ove cost as a limiting factor for women

More HCPs with necessary skills for IUC placement

Provide incentives for non-experts to seek

training

IUC becomes more accessible leading to more widespread use

Promote adherence to evidence-based guidelines

Uncouple contraceptive

care and

cancer screening

Black et al 2012

Slide32

Addressing HCP misperceptions

Contraception must be an integral part of medical education, before the point of specialisation

Didactic and hands-on insertion training must be accessible to all women’s health practitioners, including those who qualified without acquiring insertion skills

More widespread use of IUC

HCPs across all medical specialities able to provide

accurate

 information to women

Wider range of providers

confident

in performing placements

Black et al 2012

Slide33

Educating women on the benefits of IUC is the key to increasing uptake

US Survey

1

Global Survey

2

In an ACOG survey, OB/GYNs were ~20-fold more likely to personally use IUC

In a global survey of 540 HCPs using contraception, LNG-IUS was the most frequently used method

ARHP 2004;

Gemzell-Danielsson

et al 2012

Women who have the best knowledge are

more likely to use IUC personally

Women using IUC (%)HCPs (%)

Slide34

Counselling women who have shown an interest in IUC

Method

Advantages

Disadvantages

Hormonal IUS

Duration

of

3 to 5 years

> 99% effectiveForgettableRapid

return to fertilityPossibility of lighter bleedingPossibility of irregular bleeding (most likely at the start)Must be inserted by HCPNon-hormonal IUDDuration of 10 years> 99% effective

ForgettableRapid return to fertilityPossibility of lighter bleedingPossibility of heavier periodsand/or more cramping Continued side effects with periodsMust be inserted by HCP

Slide35

Counselling women who have made the decision to have IUC

Studies have shown that psychological

preparation may1,2:Reduce the perception of pain by reducing uncertainty

Provide information/reassurance on what to expect

Increase motivation leading to higher tolerance of discomfort

Newton JR, Reading AE.1977

Backmann

T.

Drug Safety, 2004

Pre-placement Counselling Checklist

Mode of action (not abortifacient)What to expect during and after placementBenefits and risks

Effect on bleeding profile after placementReassurance on the size of device despite size of packet

Slide36

Adolescents and young women are more likely to think positively about IUC after a brief educational intervention1

Adolescents and young women reporting a positive attitude towards IUC before and after a 3-minute educational intervention (n = 144)

37.5%

53.5%

Women (%)

Whitaker et al 2008

Slide37

Areas for future research

Short- and long-term use of IUC among nulliparous women

Young women’s knowledge of and attitudes towards IUCGreater understanding of the health system and HCP barriers that prevent more widespread use of IUCImpact of training Impact of time constraintsImpact of remuneration

Impact of up-front cost of IUC methods on user uptake