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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