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

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

The role of self-care in health systems | 7 November 2008|

BENEFITS of SELF-CARE