Improving the agenda for Advertising and Switching for Nonprescription products

Advancing Self-Care and Responsible Self-Medication for a Healthier Future5 – 6 October 2015, Mexico City

Dr. Gerald Dziekan, Director GeneralWorld Self-Medication Industry (WSMI)

Evolving landscape for self-care

Dailychoices

Self-managedailments

Minorailments

Chronic conditions

Acuteconditions

Major trauma

Medical Care

Lifestyle Compulsorypsychiatric

Care

Collaborative CareSelf Care

Limited engagement in healthcare

Passive recipient of care

Limited in influencing own health

Engages in improvement of own health

Proactive participation

Able to influence own health

Classic medical care system

Empowered and health-literate people-driven self-care system

• Demand for involvement• Patients / consumer organizations• Internet (NetDoctor, social media etc.)

• mHealth• Health literacy• Patient empowerment

10 minor ailment responsible for

over 75% of consultationsMA

Total consultations

(millions)Back Pain 8.4Dermatitis 6.8Heartburn and indigestion 6.8Nasal Congestion 5.3Constipation 4.3Migraine 2.7Cough 2.6Acne 2.4Sprains and Strains 2.2Headache 1.8Earache 1.7Psoriasis 1.7Conjunctivitis 1.3Sore Throat 1.2Diarrhoea 1.2Haemorrhoids 0.9Cystitis 0.7Hay Fever 0.7

Burden on HC systems & potential for cost savings

United States (Booz study, CHPA 2012)

Australia (MUCHE OTC Value study

2014)

Avoided doctors’ visits

77 billion USD 3.86 billion AUD

Drug costs 25 billion USD

Productivity 23 billion USD estimated savings in

productivity loss

6.55 billion AUD

Total 102 billion USD For every USD spent on OTC medicines, the US

healthcare system saves 6–7 USD in

avoided costs

10.4 billion AUD Over 4 AUD saved per

dollar spent

Healthcare system

4 billion USD estimated additional

annual savings in avoided emergency department visits

2.1 billion AUD additional savings if 11

categories of Rx were to be switched to OTC

> 16 billion Euro annual savings by shifting 5% of care to self-medication (EU, 2004)AESGP, Economic and public health value, 2004

0

2

4

6

8

10

12

14

16

Treated Diagnosed Suffering

Value of access to OTC

+80%

+50%

OTC medicines provide symptomatic relief for an estimated 60 million US citizens who would otherwise not seek treatment

Booz & Co study, 2012

Nicotine Replacement Therapy (NRT) up 150% in 1st year after RX to OTC switch• Appr. 114,000 to 300,000 new ex-smokers annually• Appr. 2 billion USD annual societal benefit from NRT switch

Shiffman (1997, 2000), Keeler (2002)

New paradigm• People driven self-care is the

foundation of health care

• Economic studies demonstrating huge cost savings to the HC system

• … but … in evaluating the regulation on advertising and switching, economic and public health benefits are not (always) taken into account

• Need for an appropriate regulation based on proportionality

Secondary /

tertiary Care

Primary Care

Self-Care

Hospital costs

Professional / medical

costsSelf–care

costs

Improving the benefit-risk (B/R) assessmentprocess for non-prescription medicines

Brass et al Clin Pharmacol Ther 90(6):791, 2011Brass et al J Clin Pharmacol 53(5):475, 2013

Benefit-Risk Considerations

Benefit Considerations

Risk Considerations

Improved clinical outcomes

Improved public health

Enhanced consumer involvement

Economic benefits

Improved access

Unintended misuse

Intentional misuse with therapeutic intent

Accidental ingestion

Intentional overdose

Worsened outcome due to self-management

Decision analysis toolValue tree

Common Domains for Nonprescription Drugs

Referenced in national guidelines(e.g. UK, Canada, New Zealand)

Improving the benefit-risk (B/R) assessmentprocess for non-prescription medicines

• Integrating value tree to decision making framework

• More structural dialogue and collaboration between regulators and the industry

• Emphasizing transparency, communication and rational evidence-based decision making

Adapted from International Risk Governance Council (IRGC) Framework: maximize communication and transparency

Thank you