Pharmacists in Smoking Cessation

CLINICAL TIPS Tara Kelly, IPU Product File Pharmacist
Education Materials
Educational materials
associated with
specific medicinal
products are now
available online on
the HPRA website and should
prove a useful resource for
pharmacists. The HPRA has
advised that pharmacists
should be aware of these
educational materials where
they exist for a particular
medicinal product and use
them to enhance the safe and
effective use of these products
in practice.
Educational materials
form part of what are called
‘additional risk minimisation
measures’. Routine risk
minimisation measures apply
to all medicinal products and
include the information that
we routinely refer to in order
to learn about how to use the
product safely and effectively.
These include the SmPC, the
product labelling, the package
leaflet and the prescription
status of the product.
Sometimes, additional riskminimisation
measures are
required to manage risks
identified with the use of
the product; educational
materials can form part of
these additional risk-reducing
measures.
The aim of these measures
is to prevent or reduce
the occurrence of adverse
reactions associated with
exposure to a medicine,
or to reduce their severity
or impact on the patient
should such adverse
reactions occur. These
materials may be directed
at pharmacists (and other
healthcare professionals)
or may be directed towards
the patient. The company
responsible for placing the
product on the market is
required to distribute these
educational materials in
hard copy to either the
healthcare professional or
the patient. Now that these
materials are published on
the HPRA website, this gives
pharmacists greater access
to them should they be
required. They can either be
downloaded for use in the
pharmacy or alternatively,
hard copies can be requested
from the marketing
authorisation holder.
Some examples of
Educational materials that
may prove useful include:
n Combined oral
contraceptives:
Information Cards and
Q&A Leaflets for Patients
(Risk of Blood Clots);
n Epilim: Healthcare
professional booklet,
Patient booklet, Patient
Cards (Risks of Valproate
in Pregnancy);
n Fastum Gel: Leaflet
for Patients (Risk of
Photosensitivity);
n Eliquis, Pradaxa,
Xarelto, Lixiana:
Patient Alert Card
(Risk of Bleeding);
n Exelon Transdermal
Patch: Patient Diary
(Instructions for use and
Record Sheet); and
n Humira: (Patient
Information Cards).
These documents are
located on the HPRA website
alongside the SmPC and
PIL when you ‘Search for
a Medicine’. A full listing
of products that have
educational materials
associated with them can be
found by using the ‘Advanced
search’ function and selecting
‘Only Medicines with
Educational Materials’.
IPU PRODUCT FILE
The IPU Product File has been in existence
for more than 30 years and is an indispensable
resource for community pharmacists.
It was designed for pharmacists by pharmacists
and is also used by doctors and hospital
personnel. It is a vital support tool for
prescribing, dispensing, claiming with PCRS,
stock ordering, stock taking, price checking
and product sourcing.
What is in the File?
The File contains information on over 63,000 products,
including:
Licensed medicinal products
Unlicensed medicinal products
Medical devices and sundries (bandages, dressings,
ostomy equipment etc.)
Nutritional products, including foods for special diets
Veterinary products
Photographic products
Cosmetic products
Front of Shop products (shampoos, vitamins etc.)
In addition to pricing information, barcodes etc.,
the IPU Product File provides valuable professional
information on health products. The professional
information provided includes the Medicinal Product
Name, PA/EU number, Generic Name, Pharmaceutical
Form, Strength and Legal Status.
ISO Certified
In 2016, the IPU Product File achieved
ISO Certification for 9001 (Quality)
ISO 9001
Registered
and 27001 (Information Security).
Quality
The audit and certification process for
Management
ISO Certification emphasises the robustness of the
IPU Product File and underpins its position as the
definitive medicinal product catalogue in Ireland.
ISO 27001
Registered
Information Security
Management
Easy to Use
The IPU Product File is an open system, so no matter what
vendor you choose, the file can be adapted for your needs.
The IPU Product File is available by electronic download,
where you can log-in and download your monthly update.
Contact Us
The IPU Product File team are available to answer your
queries, whether it’s on sourcing a product, pricing queries
etc., the team will be able to assist you.
For any queries relating to the IPU Product File, please
contact a staff member on 01 406 1550 or datainfo@ipu.ie
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IPUREVIEW FEBRUARY 2017