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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