Effect of an educational intervention to improve adverse drug reaction reporting in physicians: a cluster randomized controlled trial.

(1)

1. Department of Preventive Medicine and Public Health, University of Santiago de

Compostela, Spain.

2. CESPU, Instituto de Investigação e Formação Avançada em Ciências e Tecnologias da

Saúde, Rua Central de Gandra, 1317, 4585-116 Gandra PRD, Portugal.

3. Northern Pharmacovigilance Unit, Faculty of Medicine, University of Porto, Porto,

Portugal.

4. Consortium for Biomedical Research in Epidemiology & Public Health (CIBER en

Epidemiología y Salud Pública- CIBERESP), Santiago de Compostela, Spain.

GREPHEPI Group consists of Adolfo Figueiras, Francisco Caamaño, Juan J. Gestal-Otero,

Teresa Herdeiro, Margarita Taracido, Elena Lopez-Gonzalez, Montserrat Domínguez, Sandra

Comendador; Carlos Díaz, Ana Clavería, Isabel Sastre, María Piñeiro-Lamas, Ana Estany,

Paula López-Vázquez, Maruxa Zapata-Cachafeiro, Cristian González-González, Juan M.

Váquez-Lago, Angel Salgado, Ana López-Durán.

(2)

Internal medicine

Pneumology

Rehabilitation

Nephrology

Neurology

Surgery

Gastroenterology

Rheumatology

Radiodiagnosis

Paediatrics

Intensive care

Ophthalmology

Oncology

Anaesthetics

Ear, nose and throat

Dermatology

Psychiatry

Traumatology

Haematology

Allergology

Urology

Cardiology

Endocrinology

Clinical analysis

Geriatrics

Neurophysiology

* Hospital departments not intervened.

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12/09/14 II Jornadas de Farmacovigilância do Centro2

Maria Teresa Herdeiro UFN – CESPU

Adverse drug reaction

Harmful or undesirable response

to the drug

Occurring at standard doses used

for prophylaxis, diagnosis and

treatment

Causal link between drug and

ensuing adverse event

Public health activity focused on the

identification, cuantification,

evaluation and prevention of risks

associated to marketed drugs.

Spanish Regulation 1344/2007

Pharmavigilance

Morbidity and mortality associated

with drug consumption

(4)

ADR constitute the 4

th

_-6

th

_leading

causes of death in the USA

15%-20% of hospital budgets are

spent on solving drug-related

complications

Methods

Epidemiologic (cohort, case-control)

studies

Voluntary reporting

Prescription-event monitoring

Patient database studies

(5)

Voluntary reporting

•Whole population

•All drugs on the market

•Throughout drug’s life cycle

•No interference with prescribing

habits

•Enables very rare ADR to be

identified

Underreporting

☺

Voluntary report

•Whole population

•All drugs on the market

•Throughout drug’s life cycle

•No interference with

prescribing habits

•Enables very rare ADR to be

identified

Underreporting

☺

BUT...

why don’t we

report?

Are all serious adverse

drug reactions known

?

Yes, pharmaceutical

companies conduct pre-clinical

and clinical trials before drugs

are launched onto the market.

(6)

But...some drugs register a

small incidence of adverse drug

reactions that are not

detectable during such

pre-marketing clinical trials.

For example…

Chloranphenicol

, (aplastic

anemia: incidence 1/6,000) or

Halothane

(jaundice: incidence

1/10,000).

Selected

populations!

!

Short-term trials!

(7)

Healthy people!

!

Limited

size of

sample!

_!

When do I report?

I report, when I ascertain that a given drug is responsible for a

particular adverse reaction

(8)

I would only report an adverse drug reaction if I were sure that it was related to the use of a particular drug

.

!

I think that one should

always report when there

is a suspicion.

But...does the risk of a false

alarm exist?

No, because a committee

of experts evaluates all

(9)

Is my report important?

Maria Teresa Herdeiro UFN – CESPU Is my report important? Is my report important? Is my report important? Is my report important? Is my report important?Is my report important? Is my report important? A minha notificação será importante? Is my report important?

Is my report

important?

Is my report important? Is my report

important? A minha notificação _{será importante?} Is my report important? ? Is my report important?Is my report important? Is my report important? A minha notificação será importante? A minha notificação será importante?

Is my report

important?

Yes !!

Maria Teresa Herdeiro UFN – CESPU Unexpected Unexpected Unexpected Unexpected and expected and expected and expected and expected ADR ADR ADR ADR Serious and not

Serious and not Serious and not Serious and not serious ADR serious ADR serious ADR serious ADR

All suspected ADR

What ADR should I

report?

(10)

Unexpected and expected ADR Serious and not

serious ADR

All suspected ADR

All !!

How does it work

How does it work?

?

Receipt of data

Check to test validity of data Request for more data

Coding and entry onto database

Validation (attribution of causality)

Forwarding to Pharmacovigilance Department Analysis and assessment

(11)

Well...sometimes I don’t

have time to fill out the

yellow card...

But, it only takes

5 minutes.

But, it only takes 5

minutes.

Minimum information

Patients (initials, age, sex)

Report (name, address,

specialty)

Adverse reaction

(12)

Maria Teresa Herdeiro UFN – CESPU x x 31 Farmaprod 3 cp/día; VO18/09/0721/09/07 x Vómitos Diarrea intensa Recuperado Aun no recuperado 20/09/07 21/09/07 20/09/07 M. Pérez X Centro de Salud do Val Miñor

x 26/09/07 La Ramallosa 555-3421 Infección ORL X

Summary....

• ADR are a major public health problem

• Voluntary yellow-card reporting of ADR is

an easy method

• There is one disadvantage, i.e.,

UNDERREPORTING

• But with your help, it is possible to remedy

this, namely, by

REPORTING

.

Pharmacovigilance Centre in

Galicia

• Tel.:

981.54.36.77 / 981.54.36.92

• Fax:

981.55.87.59 • E-mail:

farmacovixilancia@sergas.es

• Dirección:

Subdirección Xeral de Farmacia e Productos Sanitarios Servicio Galego de Saúde

Edificio Administrativo-San Lázaro 15703- SANTIAGO DE COMPOSTELA

Thank you for your

attention

(13)

Period

0.95 (0.71 – 1.28)

0.7471

Group

0.83 (0.48 – 1.41)

0.4883

Intervention

1.87 (1.25 – 2.79)

0.0022

Effect of intervention on reports of serious ADRs

Period

1.02 (0.65 – 1.60)

0.9452

Group

0.64 (0.29 – 1.47)

0.2996

Intervention

2.59 (1.38 – 4.86)

0.0032

Effect of intervention on reports of unexpected ADRs

Period

0.94 (0.68 – 1.31)

0.7303

Group

0.76 (0.42 – 1.40)

0.3897

Intervention

1.68 (1.07 – 2.65)

0.0252

Effect of intervention on reports of high-causality (defined and probable) ADRs

Period

0.81 (0.56 – 1.19)

0.2829

Group

0.73 (0.36 – 1.47)

0.3928

Intervention

1.85 (1.09 – 3.12)

0.0215

Abbreviations: ADR, adverse drug reaction; CI, confidence interval.

*OR for period is the adjusted OR of ADR reporting between the pre and

post-intervention period in the control group. It assesses secular trends and possible

contamination of the control group by the intervention group. OR for the group

category is the adjusted OR of baseline ADR reporting between the intervention

group and the control group. OR for intervention measures the adjusted OR of ADR

reporting for the intervention itself, as an interaction between the group variable and

the period variable.