Eurordis patients and pharmacovigilance .pdf



Nom original: Eurordis_patients_and_pharmacovigilance.pdf
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What does the new PhV system
mean for patients in real life?
François Houÿez
Director of Treatment Information and Access
European Organisation for Rare Diseases

Information Day on Risk Management Planning and
Post-Authorisation Studies
7 November 2016 | London, UK

“Acting on the treatment information you have”:
a patient survey
EURORDIs DITA task force survey on Treatment information in rare
diseases 2016
Funded by an operating grant from the public health programme
Questionnaire in 13 languages
INSERM IRB approval July 2015
Field work 15 February- 31 May 2016
1,965 responses collected
– Of which 1,453 valid (more than 75% completion score)
• Of which 1,401 with agreement to participate
– Of which 1,350 reports on medicines
– Other on medical devices, food supplements….

Asking respondents to have their package leaflet by them
2

A multi-thematic survey

Off-label
use of
medicines

Pharmaco
vigilance
and the
impact of
the
legislation

Medication

errors

NATC
treatments
Natural,
Alternative,
Traditional,
Complementary

Medicines
used by
EURORDIS
members,
access
issues…

3

Demographics
Age groups
30,0%

26,6%

25,0%

22,1%

20,5%

20,0%
15,0%

13,0%

10,5%

10,0%
5,0%

4,9%

2,3%

0,0%
15-18

19-29

30-39

40-49

50-59

60-69

70 or
older

Sex/gender
Other
0,4%

Female
71,2%

Male
28,5%

Number of different rare diseases covered:
4

Estonia

1

Denmark

6

Finland

22

Latvia

1

Bulgaria

7

Hungary

28

Lithuania

1

Austria

7

Netherlands

29

Moldova

1

Poland

8

Belgium

67

Ukraine

2

Greece

8

Croatia

104

Sweden

2

Ireland

12

Portugal

121

Bosnia

3

Luxembourg

13

United Kingdom

84

Russia

4

Czech Rep.

14

Italy

162

Iceland

3

Romania

14

Spain

195

Norway

3

FYROM
(Makedonia)

15

France

204

Cyprus

4

Switzerland

18

Germany

213

Slovakia

6

Serbia

19

Calculation in progress  500-600

1,401

Results: all

Can you contact your health care team
between visits (incl. nights, weekends)?

I don't know
8%

yes
57%

Prescription medicine

113
8%
1225
92%

no
35%

Prescribed
non-prescribed

Can you contact your health care team between
visits (incl. nights, weekends)? If yes:
41,0%
35,6%

20,5%

1,5%
phone only phone and
email

5

e-mail only

phone,
email, IT
device

0,6%

0,4%

0,4%

phone,
an app only
An IT
email, app
connective
device only

Prescribed where? Where do you get it from?

If not (n=274), where do you
get it from?

Prescribed at usual care
centre

20%

Yes
No
80%

6

I go to a
different
town
20%

I go to a
different
region
14%

I go to a
different
country
15%

I go to a
different
hospital or
pharmacy
51%

Results: all
Nbr medicines used

4
medicines
15%
3
medicines
16%

2
medicines
22%

7

5
medicines
18%

only 1
29%

Average number of
medicines used

2.7

Proportion of
respondents using
NATC

4-8%
(in progress)

Results: “from your package leaflet”

Off-label use
detected

Different
indication

Different
Different
Total
dose administration

543

449

243

114

40.2%

55.7%

30.1%

14.1%

Off-label not
detected

Blank

Total

806

496

311

1,350

100%

36.7%

23%

100%

40 to 63% of respondents are using a medicine off-label for their rare disease

8

Comparing 812 from Croatia, France, Germany, Italy,
Portugal and United Kingdom

9

Off-label

Not off-label

All

440 (54.1%)

373 (45.9%)

Croatia

35 (49.3%)

36 (50.7%)

versus others

405

337

France

72 (47.7%)

79 (52.3%)

versus others

368

294

Germany

104 (59.4%)

71 (40.6%)

versus others

336

302

Italy

79 (62.7%)

47 (37.3%)

versus others

361

326

Spain

69 (50%)

69 (50%)

versus others

371

304

United Kingdom

39 (59.1%)

27 (40.9%)

versus others

401

346

NS

NS

NS

p<0.05

NS

NS

Information on treatment

10

Informed consent?

Off-label

Not off-label

Informed consent?

Informed consent?

I signed something, but do
not know what it was 2%

I signed something, but do
not know what it was 2%

I don't
remember
13%

I don't
remember 9%

No
62%

No
76%
Yes
13%

11

Yes
23%

p<0.001

No surprise, dissatisfaction regarding information on benefits

Off-label

Not off-label

Can you find information
on the benefits?

Can you find information
on the benefits?
No
P<0.001

39%
16%

Yes
No

Yes
No
84%

61%

12

Disconnect between written information and what doctor said

Off-label

Not off-label

Does it correspond to
what doctor said?

20%

20%

Does it correspond to
what doctor said?

Yes

12%

No

60%

13

Yes

8%

I don't
remember

No
80%

I don't
remember

No
P<0.001

Also on safety

Off-label

Not off-label

Comfortable with the
information, Possible
side effects
yes

33%
8%

59%

14

Comfortable with the
information, Possible
side effects

6%

no
I don't
remember

yes

21%

73%

no
I don't
remember

No
P<0.001

And about the dose

Off-label

Not off-label

Comfortable with the
information, Dose

Comfortable with the
information, Dose

yes
9%
3%
88%

15

3%

no

2%

yes
no

95%

I don't
remember

I don't
remember

No
P<0.001

And about the administration

Off-label

Not off-label

Comfortable with the
information, How to take

Comfortable with the
information, How to take

yes
9%
2%
89%

16

yes
3%

no

2%

no

95%

I don't
remember

I don't
remember

No
P<0.001

Trustworthy source of information
No off-label

17

Off-label

52%
47%

22%

24%

NS

NS

p<0.01
9%
1%

1%

3%

3%

2%

3%

9%

5%
2%

1%

0%

0%

1%

1%

3%

2%

9%

Potential for medication errors?

18

271 respondents reported confusing presentation / info

Off-label

Not off-label

Is the presentation
(packaging, name,
documents) confusing?
No
68%

No
78%
Yes
32%

19

Is the presentation
(packaging, name,
documents) confusing?

Yes
22%

Examples
Country

FYROM (Macedonia)

Country

Ireland

methotrexate

Package leaflet is
reduced to 5-6
sentences, there is no
information

Gylenia® (fingolimod)

Package leaflet too
long. Would like to see
updates marked

Country

United Kingdom

Levothyroxin

The pharmacist's label
often covers the dose
strength

ursodeoxycholic acid

The information is
about a completely
different disease

Country

Belgium

Esbriet® (perfenidone) Packaging and aspect
of the drug has
changed
Country

Croatia

Florinef®
(flucrocortisone
acetate)

The instructions are
only in German

Motilium®
(domperidone)

The instructions are
only in German

Lodotra® (prednisone) I am not sure what
some of the side
effects mean

20

Side effects and pharmacovigilance

21

Any side effect? Very reassuring

Off-label

Not off-label

Any side effect?

Any side effect?

No
39%

Yes,
severe
11%

Yes,
moderate
29%

22

No
35%
I don't
remember
3%

Yes,
severe
10%

Yes, mild
18%

I don't
remember
4%

Yes, mild
23%
Yes,
moderate
28%

If any, did you report?
if yes, did you report it?
15%
1%

No

if severe, did you report it?
8%
92%

23

0%

15%
1%

Yes
I don't remember

84%

if moderate, did you report?

84%

No
I don't remember

if mild, did you report?
20%
2%

Yes

No
I don't remember

Yes

78%

Yes
No
I don't remember

If not reported (90), why?
I did not see the connection
between the drug and the
event 15%
It went away before I
could report it 7%

I assumed that the effect
would not last long 11%

I preferred to wait
and see 16%
I did not want to annoy
my doctor 2%
Reporting was too complex
or hard to fill in 3%

I didn’t know I could
report it 16%

I had been told that the
effect would not last long
or be too severe 18%

24

I did not know who to
report it to 12%

Future communication campaigns on patient reporting
should insist on:
You have a side effect, please report! And explain how

Do not wait and see
Even if the ADR doesn’t last for long
Even if the ADR is not too severe
Even if you reported it to your doctor/pharmacist already
And report even if you don’t see a connection between the drug and the ADR
25

Reporting behaviours

To whom did you report it?

How did you report it?

The online service
provided in the
patient leaflet 1%
Doctor / nurse /
another professional
at the medical centre
93%

National
Authorities 1%
Manufacturer
1%
I don't
remember 4%

26

By phone
13%
online 4%

Directly to
the medical
centre 81%

Shared on social
media/facebook 2%

Measuring the impact of the pharmacovigilance legislation (1)

Off-label

Not off-label

Do you see a black
triangle?

Do you see a black
triangle?

P<0.001

80%
89%
11%

Yes

Yes

No

No

20%

27

Measuring the impact of the pharmacovigilance legislation (2)

Off-label

Not off-label

If yes (n=47), do you
know what it means?

If yes (n=83), do you
know what it means?

58%

P<0.01

81%
Yes

Yes

No

No

19%
42%

28

Measuring the impact of the pharmacovigilance legislation (3)

The 1 Million € question
– For how many leaflets didn’t the MAH implement the black triangle? 

Number of presentations with no  seen
Of which presentations on the  list
%

29

366
19
5,2%

Which are they?
Medicine
Revlimid
Corlentor
Flixabi
Glivec
Ilaris
Depakin
Cinryze
Esbriet
Depakine
Xarelto
Raxone? Mnesis?
Revlimid
Ergenyl Chrono
Cinryze
Relvar Ellipta
Orphacol
Opsumit
Tysabri
Vedrop
30

Active substance
lenalidomid
ivabradine
infliximab
imatinib
vanakinumab
valproate
c1 inhibitor, human
pirfenidone
valproate
Rivaroxaban
idebenone
lenalidomid
valproate
c1 inhibitor, human
Fluticasone furoate /
vilanterol trifenatate
cholic acid
valproate
macitentan
natalizumab
Tocofersolan d-alpha ….

MAH

Member State

Celgene
Servier
Samsung Bioepis UK Ltd
Novartis Europharm Limited
Novartis Europharm Limited
Sanofi Aventis
ViroPharma SPRL
Roche Registration Limited
Sanofi Belgium
Bayer Pharma AG
Santhera
Celgene
Sanofi Aventis
ViroPharma SPRL

United Kingdom
United Kingdom
Italy
Italy
Italy
Italy
Belgium
Belgium
Luxembourg
Luxembourg
Portugal
Germany
Germany
Germany

Glaxo Group ltd

Spain

Laboratoires CTRS
NA
Actelion Registration Ltd
Elan Pharma International Ltd.
Orphan Europe S.A.R.L.

Spain
Spain
Hungary
Romania
Croatia

And which MS applied the  policy?
MS using the EMA list

MS using their own list

23

3

Belgium
Lithuania

Belgium
Lithuania
France

Austria
Bulgaria
Croatia
Denmark
Estonia
Finland
Germany
Hungary
Ireland
Italy
Latvia

31

Malta
Netherlands
Norway
Poland
Romania
Slovak Republic
Slovenia
Spain
Sweden
United Kingdom

MS with no mention of the
black triangle policy/list
(that we could find…)
6

Cyprus
Czech Republic
Greece
Iceland
Luxembourg
Portugal

How effective?

32

Is the off-label use of any use?

Off-label

Not off-label

Would you say your
health improved?
Less than
expected
46%

More than
expected
16%

Less than
expected
31%

More than
expected
19%

P<0.001

As expected
38%

33

Would you say your
health improved?

As expected
50%

Thank you to EURORDIS Drug Information Transparency
and Access ‘DITA’ task force members 2013-2016
FRA

Lise Murphy, Marfan syndrome, SWE
Oliver Timmis, Alkaptonuria Society,

Juan Fuertes, Primary Pulmonary

GBR

Hypertension, SPA

Sigurður Jóhannesson, Alternating

Ellen van Veldhuizen, Addison

Haemiplegia, Ice

Disease Org., NLD

Thomas Sannié, Association Française

Rainald von Gizycki, Pro Retina,

des Hémophiles, FRA

GER

Dragomir Slavev, Thalassemia org. ,

Danijela Szili, Rett synd., HUN
Luc Matthyssen, Htap Belgium
Inge Schwersenz, SMA Ger
Vesna Stojmirova, Life with

BLG

Claudie Baleydier, Friedreich Ataxia,

Challenges, FYROM

Isabel Fernandez Aldeguer,
FEDER, Spa
34

Tatiana Foltanova, Nl alliance, Slk
Richard West, Behcet Society, GBR
François Houÿez, Anne-Mary
Bodin, EURORDIS, Paris
Rob Camp, EURORDIS, SPA

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