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

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

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

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 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 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 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