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SWITCHING OF
MEDICINES
19 June 2009
SWITCH
• Reclassification of legal status of a medicine
• Typically one with many years of experience of
safe use
• From prescription to non-prescription status
SWITCH
Switches are motivated mainly by 3 factors:
•
Pharmaceutical firms’ desires to extend
the viability of a brand
•
Attempts by healthcare funders to contain
costs
•
The self-care movement
SWITCH
Generally a medicine becomes a candidate for OTC use if• Used for non-chronic condition
• Relatively easy to self-diagnose / self-treat
• Self limiting
• Has low potential for harm from abuse
WORLD HEALTH ORGANISATION
WHO
• Impact of chronic diseases growing
• Requires a new approach by leaders to
strengthen chronic diseases prevention
• 80 % chronic diseases deaths – low and middle
income countries
• Threat growing
• 60 % of all deaths due to chronic disease
WHO
NON-COMMUNICABLE
DISEASES
• Primary source of disease burden
• Both developed and developing countries
• Prevention is essential
WHO
Self-care is at the base of healthcare
Tertiary
care
Secondary care
Primary Care
Self-Care
| The role of self-care in health systems | 7 November 2008
Economic Benefits of Self-Care
Health benefits
•
Patient/ user wellness and
productivity
•
Better risk management approaches (disease
prevention)
Economic gain (Private sector)
•
Worker productivity
•
Encouragement of healthy health services industry
Cost savings (Public sector)
•
Reduced physician visits
•
Better managed public medicines budgets
Benefits and risks of
self-care and self-medication
•Incorrect self-diagnosis
•Delay in treatment
of serious conditions
•Drug misuse
RISK
| The role of self-care in health systems | 7 November 2008
BENEFIT
•Improved access
to effective medicines
•Lower costs
•Increased efficiencies in
healthcare system
•Greater consumer
autonomy
•Improved consumer
education
•Reduction in selfprescription
Not to forget:
•Medical errors in Rx
writing or dispensing
•Overtreatment/unnecessary procedures
•Helps address
undertreatment of the
‘invisible undiagnosed’
OTC MARKET DEVELOPMENT
Key points
• Use of indications in product names, and use of umbrella
branding to enable consumers to make an informed
choice of OTC medications
• Clear Switch processes for Prescription to Pharmacy to
General Sale based on experience and safety in use
• Appropriate self-regulatory or co-regulatory codes to
ensure responsible advertising
SWITCH
All stakeholders are linked
DofH/Regulators
Industry
H/c professionals
Consumers/patients
√
Department of
Health/Regulators
INDUSTRY
Consumers/patients
Healthcare
professionals
X
6
SWITCH
• Key stakeholders –
patients and
consumers
• Fundamental principle
of market economy –
identify / create
customer needs
• Satisfy the demand
• Switches a good
example
BENEFITS OF SWITCHING
•
•
•
•
•
•
Worldwide 100s of millions of consumers benefited
Wider and more convenient access to appropriate selftreatment options
200 ingredients are available for OTC use
Over 100 000 non-prescription medicines available
worldwide
In past most switched medicines – considered unsuitable
for OTC use
Survey National Consumers League in States 65 % of Americans wish that some Rx medicines would
be made available OTC
HOW TO REALISE BENEFITS
• Increase range of medicines available through switching
• A proactive approach by all the various stakeholders in
the UK, Germany and Australia has worked well
• Provided impetus to safe and appropriate switches
• Identify suitable products for switching
• Type of education and information campaigns necessary
to facilitate switches
FUTURE
• Number of drugs being switched from Rx to OTC likely to
rise
• Classes of drugs available OTC expanding to include
those for prevention of serious illnesses
• Possible molecules losing or lost patent protectioncetirizine, esomeprazole, lansoprazole, pravastatin,
simvastatin, zolpidem
• Manufacturers likely to apply for switching before patent
expires to gain a foothold in expanding market of OTC
medicines ahead of generic competition
• Healthcare funders will support switches to curb costs
EXAMPLES
•
•
•
•
•
•
•
In USA loratadine, cetirizine and fexofenadine – US health insurer
petitioned FDA
Cost main motive behind switching whilst under patent protections
In Sweden omeprazole switched prior to patent expiry – cost
underlying reason
Co-payments of Rx alternatives in same class invariably rise
Switching drugs to OTC reduces insurer’s drug costs and rises
patients
Benefit – avoid cost of visit to doctor and Rx costs
Lack of pharmacist intervention in sales and ‘behind the counter’
status makes FDA reluctant to switching
UNITED STATES
• January 2005 - US FDA
recognised need to be
proactive in switching
• Result - consumer
empowerment
• 2009 study showed
switching heartburn
therapies - $174 saving
per patient (office visits
and medication)
AUSTRALIA
• 15 % of all GP consultations –
treatment of minor ailments
• 7 % - minor ailments alone
• Projected annually – total of 25
million GP consultations
involve minor ailments
• 59 % of minor ailments
consultations result in a Rx
• 15 million Rxs written for minor
ailments
IRELAND
• Switch of 5 % of
prescribed items to
OTC – enhanced selfcare and selfmedication
• Projected € 75 million
in health savings (Irish
Pharmaceutical & Healthcare
Association 2009)
UNITED KINGDOM
• UK criticised for
switching statins
• Driven by drug
sponsor
• Supported by
Government
• Safety of switching
debated thoroughly
• Patient safety prime
consideration
UNITED KINGDOM
• Case made – convincingly that balance between
potential health risks and risk overwhelmingly
positive for low to moderate patients
• Coronary heart disease (CHD) – preventable by
cholesterol lowering
• Kills more than 110 000 people in UK annually
• CHD – estimated cost to UK economy – ₤9
billion
• Switch expedited by MHRA to save NHS
costs
UNITED KINGDOM
Advantages –
• Improved and broader access to treatment
• Patients ineligible for NHS prescriptions gained access
to drug
• Increased education about risk factor modification
• Greater patient autonomy in decision making
• Healthcare savings resulting from reduced coronary
events
• High risk patients still eligible for NHS prescriptions
CONCLUSION
• Worldwide OTC medicine sector emerging as a distinct
and separate part of self-care
• Being encouraged by country authorities wishing to take
advantages of the benefits – for their people’s health,
and for the healthcare system
• Countries encouraging the OTC sector in general
through switch in particular, through various policy and
regulatory approaches
• Working with all stakeholders is essential
BENEFITS of SELF-CARE
| The role of self-care in health systems | 7 November 2008