Transcript How to report ADRs - Medicines Authority

…… . How You, your Healthcare professionals and the
Medicines Authority can make medicines safer
“Our mission is to protect
and enhance public health
in Malta”
Reporting side-effects and medication
errors;
What you need to know.
Medicines Authority
203,Level 3,
Rue D’Argens,
Gzira,GZR 1368
Tel: (+356) 2343 9000
Fax: (+356) 2343 9161
postlicensing.medicinesauthority@g
ov.mt
This presentation will teach you important facts on
reporting events related to your medicine(s).
Side effects = adverse drug reactions
Side-effects can be unexpected and troublesome
If a medicine is used incorrectly, it may also cause
troublesome and unexpected side-effects
Medicine used incorrectly = medication error
Medication errors happen when people in contact with
medicines such as consumers or healthcare
professionals, do not follow directions for taking or
giving medications
Ways in which medications can be used incorrectly are:
OVERUSE when too much or the wrong strength of a
medication is taken, or taking a medication for longer
than recommended.
UNDERUSE when a medication is not taken when it
should be.
The Medicines Authority would like to know about
problems with the use of medicines so we can learn
from them and stop them from happening again to
other people.
Medication errors can
occur because of
several reasons;
-mixing up medicine
names or packaging
- forgetfulness
- lack of knowledge
To report side-effects and medication errors you need to
know the following:
• Which medicines should you report on?
• What are the types of side effects and errors you should
be reporting?
• Who should you inform about side effects?
• How do you report about a side effect and/or a
medication error to the Medicines Authority?
• How does the Medicines Authority use reports about side
effects and medication errors to help minimise risks?
Medicines to report on
Prescription medicines…..need a prescription
e.g. antibiotics, contraceptives, blood pressure and cholesterol
medicines, insulin etc.
Other examples: medicines to diagnose or treat diseases like cancer and
vaccines
Medicines to report on
Non-prescription medicines…over the counter
e.g. antacids, laxatives, nicotine replacement products,
some pain relievers, and cough and cold medicines, etc.
Other examples are herbal products and vitamin supplements
Side effects vary
• Some side effects start soon
• Others take time to develop
Side effects may occur
• Because of interaction with other medicines, foods or
medical conditions
• Because the medicine is used incorrectly
May not actually be a side effect at all
Which side-effects should you report?
Serious side effects that result in
• Hospitalisation
• Malformation
• Disability
• Further treatment
• Life-threatening
• Death
Some side effects are known
• Talk to your doctor or pharmacist
• Read the patient information leaflet that comes with your
medicine
• Contact the manufacturer
• Visit the Malta Medicines List www.maltamedicineslist.com
Keeping track of side effects
• Note your observations
- when a side effect started
- how long the side effect lasted
• Note your medicines
• Use a notebook or computer file or a medicines card
Keeping track of side effects
How your notes help
• May alert health care professionals to a problem
• Can be a useful record for the future
• Can help you complete an adverse reaction report
A team effort
• You
• Your health care professionals
• The Medicines Authority
Concerned about a possible side effect?
• Inform your health care professional(s)
• Report to the Medicines Authority
• Report to the manufacturer of the medicine
Reporting suspected side effects and medication errors due to medicines
marketed in Malta
•
•
•
•
Identifiable patient
Suspected medicine or health product
Description of the side effect/reaction
The reporter’s name and address
SECTION 1.1 Patient Details
• Identifier
• Age, gender, height, weight, ethnicity, area
SECTION 1.2 Suspected drug(s)/vaccines/blood
products
• Name of the medicine and active ingredient (INN)
• List only the one(s) you suspect most
• Ingredients
• Dose and frequency
Why it was prescribed (or why you took it)
Date when medicine was started
Date when medicine was stopped
SECTION 1.3 Suspected reactions
• Describe what happened
• Check off how serious each side-effect was in section 1.5
• Check off the results of the side effect (ADR) in section 1.6
SECTION 3.0 Reporter Information
• Give your name, address and phone number
• You can report for someone else
• Health professional, patient?
• Reported to manufacturer?
More information about your side effect
•Other medicines you were taking
•For this event
•Additional relevant information
•Allergies, pregnancy, other illnesses
•Tests/Lab results
•Was the manufacturer notified?
•Is this a first report, or a follow-up report of a case
Medication Errors
The Medicines Authority would like to know about mistakes with medicines so
we can work to stop them from happening again to you and others.
The information you can provide will help us do this.
The Medicines Authority will not keep:
information that will identify you as a reporter of an error,
or
information that identifies healthcare staff involved in the error
The form will only be used in order to see how medicines can be improved to be
used in a safer way.
What should be reported?
We're interested in learning about medication errors and near misses such as
those involving;
•Medicine labels and packaging
•Names of medications
•The preparation and/or mixing of medicines
•Inadequate medication instructions
SECTION 2.1 Product(s) involved in medication error
• Medicine name ®
• Medicine ingredient
• Pharmaceutical Form
e.g. tablet, suppository, injection
• Pharmaceutical strength
e.g. 1ug, 500mg, 1g or 2000 i.u.
• Dose frequency, duration, route of administration
e.g. 500mg three times daily, for 1 week by mouth
• Type of container
e.g. blister pack, sachets, no container-loose strip
SECTION 2.2
• Date medication error occurred
• Date medication error was discovered
SECTION 2.3
Describe the event, problem or medication error
SECTION 2.4
Where did the event occur?
• Nursing home
• Home
• Hospital inpatient
• Hospital outpatient
• Community pharmacy/ clinic
• Other ____________________
SECTIONS 2.5 and 2.6
• Suspected cause of medication error
• Suspected contributing factors to the medication errors
“ it could happen that your usual brand of blood-pressure medicines was changed to another
brand medicine. The pharmacist verbally told you that you must take only ½ tablet of the new
brand. You forget what the pharmacist said and take 1 tablet a day of this new brand for a few
days which then makes you feel tired, dizzy and unwell. When you go to your doctor to find out
what's wrong, he tells you that you’re blood pressure is low and realizes that a mistake has been
done with the blood-pressure tablets”
SECTION 2.7
Was the medication error preventable?
SECTION 2.8, 2.9
•Was any remedial action taken?
•Do you propose any remedial action?
SECTION 2.10
Did the medication error lead to an Adverse Drug Reaction
(side-effect)?
SECTION 3.0
• name
• e-mail address
-----------------------------------------------------------------------------
Contact us
www.medicinesauthority.gov.mt/pub/adr
• Online reporting
• Paper-copy report form
• Contact details
Post: 203, Level 3, Rue D’Argens, Gżira GŻR 1368
Phone: 23439178
Fax: 23439161
Email: [email protected] or [email protected]
Thank You