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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
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
NON-COMMUNICABLE DISEASES
• Primary source of disease burden
• Both developed and developing countries
• Prevention is essential
WHO
The role of self-care in health systems | 7 November 2008|
Self-Care
Primary Care
Secondary care
Tertiary care
Self-care is at the base of healthcare
Economic Benefits of Self-CareHealth benefits• Patient/ user wellness and productivity• Better risk management approaches (disease
prevention) Economic gain (Private sector)• Worker productivity• Encouragement of healthy health services industryCost savings (Public sector)• Reduced physician visits• Better managed public medicines budgets
The role of self-care in health systems | 7 November 2008|
Benefits and risks of self-care and self-medication
RISK BENEFIT
•Incorrect self-diagnosis•Delay in treatment of serious conditions•Drug misuse
•Improved accessto effective medicines
•Lower costs•Increased efficiencies in healthcare system•Greater consumerautonomy
•Improved consumer education
•Reduction in self-prescription
Not to forget:•Medical errors in Rx writing or dispensing•Overtreatment/un-necessary 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
6
All stakeholders are linked
INDUSTRY
Healthcare professionals
Department of Health/Regulators
Consumers/patients
DofH/Regulators
Industry
H/c professionals
Consumers/patients
√
X
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 self-
treatment 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 protection-
cetirizine, 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 self-care and self-medication
• 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