1 Improving the agenda for SWITCH for nonprescription Medicines Sheila Kelly WSMI September 2015

2 World Health Organisation support “…It has become widely accepted that self-medication has an important place in the health care system... Improvements in people’s general knowledge, level of education and socioeconomic status in many countries form a reasonable basis for successful self-medication.”

3 Switch Regulation – The starting point Many regulatory regimes start with an assumption of non-prescription status for all medicines, –EU “medicines shall only be prescription if they are likely to present a danger if used without medical supervision", are frequently abused, contain novel substances (NCEs) or are parenteral products. All others are nonprescription –The United States “a drug must be made available without a prescription if, by following the labelling, consumers can use it safely and effectively without professional guidance.” Japan, Australia, Canada, New Zealand, China follow this model Brazil is proposing a similar approach

4 The regulatory classification system The Spanish example: Law on the Guarantees and Rational Use of Medicines (2006):  Brought a distinction between prescription and nonprescription medicines  The presentation of a prescription when supplying prescription medicines became essential & enforced.  There must be a clear differentiation between prescription-only medicine and nonprescription medicine

5 The regulatory classification system Examples of “reclassification” or “switch” within this scheme:  Australia: a number of athlete’s foot remedies have been switched from ‘S2’ to ‘General Sale’ status since 2006  Finland: NRT products switched from ‘pharmacy-only’ to ‘general sale’ in February 2006  Sweden: sale of NRT products allowed outside of pharmacy in March 2008  In some countries there is a graduation in the level of availability of nonprescription products “behind the counter” “pharmacy self-selection” (Australia: “S2”) “general sale”

6 Country OTC ingredients tables

7 Future switches - Expanding the parameters Symptomatic relief Initial doctor diagnosis Long term usage Prevention

8 Identifying new areas for switch Source: AESGP

9 WHO Guidelines for the Regulatory Assessment of Medicinal Products for use in Self-Medication “It cannot be assumed that prescription status necessarily provides a greater guarantee of safety than non-prescription status. Where for example prescription status has been considered preferable it is important to know whether in practice physicians can and do perform diagnostic testing or monitoring. If commonly they do not, the provision of the medicinal product in self-medication form with appropriate warning instructions may provide at least as great a measure of safety for the user. OTC Safety

10 Identifying new areas for switch Collaborative care indications

11 Identifying new areas for switch Collaborative care indications

Why are new nonprescription medicines approved? We know what questions to ask We did not know how to priorities the data or evaluate the answers Needed a tool to enable industry and regulators to have a dialogue and come to a common position. 12

The Benefit risk model for evaluating a drug for nonprescription status 13 E P Brass, R Lofstedt and O Renn. Improving the Decision- Making Process for Nonprescription Drugs: A Framework for Benefit – Risk Assessment Clin. Pharmacol. Ther. 2011: doi: /clpt

Value tree for triptan for migraine

risk difference forest plot Favours comparatorFavours study drug Source: Bennett Levitan and Filip Mussen: Regulatory Rapporteur Vol 9 no 6 June 2012

Communication and stakeholder involvement is key from the beginning of a switch and afterwards International Risk Governance Council (IRGC) Framework: maximize communication and transparency Brass, Loftstedt and Renn: Clin Pharmacol Ther 90:791, 2011

17 Data protection  Data protection encourages innovation: For a defined and limited period, a regulatory authority does not refer to the data of one party to grant registration or approvals for another party, without the agreement of the owner.  Data exclusivity: a generic applicant can use the registration files of the original application only after a defined period of time (e.g USA and Japan: 3 years).

Essentials for a switch framework The default position is nonprescription, define the criteria to be met if a drug is to be restricted to prescription supply based on safety, all other drugs are nonprescription Publish lists of prescription and nonprescription medicines Guidelines for an application for change of legal classification with timelines and clear processes Scientific advice meetings between agency and manufacturer A benefit: risk approach to evaluate applications for switches involving new indications and major new ingredients Build data protection into the framework of legislation in sup An effective pharmacovigilance system