Importance of QUM in the development of medicines and the role of Industry to implement QUM through out the process.

1. A M E E N A K A D A R K A
S E C O N D S E M M P H A R M
D E P T. O F P H A R M A C Y P R A C T I C E
S A N J O C O L L E G E O F P H A R M A C E U T I C A L S T U D I E S
ROLE OF INDUSTRY IN qum in
MEDICINE DEVELOPMENT

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QUALITY USE OF MEDICINE (QUM)
 QUM considers that all medicines should be used safely and effectively, by
selecting management options wisely and choosing a suitable medicine if
the medicine is considered necessary
 QUM activities are actively promoted by the Australian Government in
RACFs through the guiding principles for medication management in
Residential Aged Care Facilities.

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 The principles of QUM were developed to improve health outcomes for
patients, thus all industry activities should incorporate these principles to
ensure that their outcomes translate to positive patient benefits.
 The medicines industry has a key role to play in QUM with the main
responsibilities being:
 The development of safe and effective products
 Marketing products in a way that facilitates QUM
 Providing high quality, evidence-based information relevant to all
stakeholders
 Discouraging any activities that are not conducive to QUM.

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 Industry has a history of implementing activities that promote QUM and this
includes playing a role in
 Early patient access to innovative medicines
 Partnering with government and other stakeholders to shape healthcare
policy which supports QUM
 Pursuing new opportunities that add value and address unmet needs of
healthcare professionals and patients.

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ROLE OF INDUSTRY IN QUM IN MEDICINE
DEVELOPMENT
 The pharmaceutical industry plays an important role in the quality use of
medicines (QUM) in medicine development.
 The industry can contribute to QUM by:
1. Providing accurate and up-to-date information about
medicines. The industry can provide healthcare professionals and
patients with accurate and up-to-date information about medicines,
including their benefits, risks, and how to use them safely and
effectively. This information can help to ensure that medicines are used
in the best way possible to improve health outcomes.

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 Supporting education and training about medicines. The industry can
support education and training about medicines for healthcare professionals
and patients. This can help to ensure that healthcare professionals are able
to make informed decisions about prescribing medicines, and that patients
are able to understand and follow their medication regimens.
 Promoting the rational use of medicines. The industry can promote the
rational use of medicines by working with healthcare professionals and
patients to ensure that medicines are used in the most appropriate way. This
includes ensuring that medicines are only prescribed when they are
necessary, and that they are used at the correct dose and for the correct
duration.

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 Supporting research into the use of medicines. The industry can support
research into the use of medicines, including studies that look at the
effectiveness and safety of medicines in different populations. This
research can help to improve understanding of how medicines work and
how they can be used to improve health outcomes.
 Developing new medicines. The industry can develop new medicines that
are safe and effective. These new medicines can provide new treatment
options for patients and improve health outcomes.

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ROLE OF PHARMACIST IN INDUSTRY IN QUM IN MEDICINE
DEVELOPMENT
 Developing medicines that improve the health of patients by either targeting
specific diseases or by acting in a preventative capacity so that patients do
not develop illnesses.
 Contributing to the development & submission to provide access to
innovative medicines.
 Ensuring manufacturing processes result in high quality production.
 Providing balanced and evidence-based information to consumers and
healthcare professionals.
 Raise awareness about a specific therapeutic area and the various treatment
options available, including options other than medicines.

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 Partnering with Government and other stakeholders to shape healthcare
policy that is QUM focused .
 Ensuring packaging is easy to use for consumers, especially the elderly and
that labeling is clear and unambiguous.

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APPLICATIONS OF QUM PRINCIPLES IN INDUSTRY
 QUM principles supporting judicious, safe, appropriate and efficacious use of
medicines are embedded in the industry codes of conduct.
 Development of educational and promotional activities.
 Embracing QUM principles through internal staff training and the inclusion
of QUM goals in the performance to improve quality & safety of
manufactured products.
 An important example of industry contribution to QUM is the production of
consumer medicine information. This is based on the approved product
information for prescription medicines.

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Example For Industry-healthcare Collaboration For
Improving QUM
Twelve pharmaceutical companies in partnership with the National Heart Foundation
(2003)
conducted an extensive evaluation of the strengths and weaknesses of QUM in
cardiovascular health
selected a research project around an area of QUM which has strong potential to
enhance cardiovascular health in both indigenous and non-indigenous Australians

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CHALLENGES FOR INDUSTRY IN CONTRIBUTING TO
QUM
 The challenge for industry is to increase its contribution to QUM.
 Increase cost rather than profit.
 Effective contribution to QUM needs the strong support and endorsement
of company leadership to manage the tension between commercial
objectives and QUM.
 They have to provide evidence based informations. Because importance is
given to quality and safety of medicines.
 Need of more research works.

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REFERENCES
1 .Australian Government Department of Health and Ageing
(2002). The National Strategy for Quality use of Medicines.
Commonwealth of Australia: Canberra, AUS
2 .Consumer Health Forum website www.chf.org.au/history
3.Australian Government Department of Health and Ageing
(2002). Quality Use of Medicines: Statement of Priorities and
Strategic Action Plan 2001–2003. Commonwealth of Australia:
Canberra, AUS
4. TGA website www.tga.gov.au