The Implications of the Shift from Prescribing to OTC use of Chronic Medications

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1 The Implications of the Shift from Prescribing to OTC use of Chronic Medications Dr John Blenkinsopp Senior Research Fellow Department of Medicines Management Keele University

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6 Traditional model of access to health service in UK All registered with General Practitioner who is gatekeeper to secondary care; Only GP can prescribe in primary care Prescription Only Medicines only from a Pharmacist against a prescription Other medicines over the counter from Pharmacist and/or general sale (P/GSL)

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8 Emerging model of access Policies driving wider access more convenient location, times and speed Wider access to range of professionals, medicines and information Wider use of technology to deliver access to information and advice

9 UK Government policy is to encourage self-care More medicines to move OTC People to manage chronic conditions with help from health professionals investment in processes and IT to make it happen

10 Switching to OTC The government has committed to: Doubling switch rate to 10 per year: Chronic migraine Cardiovascular disease prevention Gastro-intestinal conditions Skin conditions Asthma Pain management Eye infections

11 UK GP s approving of a switch Chloramphenicol eye drops (80%) Co-dydramol tablets (87%) Topical antibiotics (94%) Trimethoprim tablets (66%) Bayliss and Rutter 2004

12 UK GP s approving of a switch Chloramphenicol eye drops (80%) (34%) Co-dydramol tablets (87%) Topical antibiotics (94%) Trimethoprim tablets (66%) Bayliss and Rutter 2004, Morley et al 1983

13 UK GP s approving of a switch Chloramphenicol eye drops (80%) (34%) Co-dydramol tablets (87%) (41%) Topical antibiotics (94%) Trimethoprim tablets (66%) Bayliss and Rutter 2004, Morley et al 1983

14 UK GP s approving of a switch Chloramphenicol eye drops (80%) (34%) Co-dydramol tablets (87%) (41%) Topical antibiotics (94%) (18%) Trimethoprim tablets (66%) Bayliss and Rutter 2004, Morley et al 1983

15 UK GP s approving of a switch Chloramphenicol eye drops (80%) (34%) Co-dydramol tablets (87%) (41%) Topical antibiotics (94%) (18%) Trimethoprim tablets (66%) (35%) Bayliss and Rutter 2004, Morley et al 1983, Spencer 1992

16 UK GP s approving of a switch Chloramphenicol eye drops (80%) (34%) Co-dydramol tablets (87%) (41%) Topical antibiotics (94%) (18%) Trimethoprim tablets (66%) (35%) Triptans for migraine (61%) Thiazides for HBP (13%) Bayliss and Rutter 2004

17 Royal Pharmaceutical Society s List Over 90 products/classes of medicines: Acute and chronic condition management Minor ailments/injuries Health promotion A New View of switching: Is the medicine currently only POM? Can the condition currently be self-treated?

18 POM to P Switches for Pharmacy RPSGB view (Sue Kilby) Product New (drug/class) B Chloramphenicol D Simvastatin Existing A Canestan C EHC Existing New Therapy area

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20 Pharmacists perceptions of which groups of people would benefit from further products switching People that rarely/never visit their GP People who are able to self- care People who pay for prescriptions People who want to save time People who are well and wanted to stay well

21 What Is User Testing of Patient Information Leaflets? Evaluates 2 aspects of the document under test: Whether potential users can find and understand a number of key pieces of information Also known as performance based testing Contrasts with content-based testing

22 Why is User Testing important now? European Council Directive 2004/27/EC (Medicines review 2001) The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use Directive makes it mandatory for Such consultations to be conducted and documented Results submitted with other mandatory regulatory information necessary for the licensing of a drug July 2005 for UK, Oct 2005 for rest of EU

23 Quotes It It could be argued that, for many pharmacists, the most significant clinical developments in 2004 were not related to new drugs but the reclassification of old ones. Adcock, PJ 2005

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25 Quotes "The FDA's goal is to increase Rx- to-otc switches by 50% on average," the Food and Drug Administration said in a budget request for the recently completed fiscal year.

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27 Quotes The person who says it cannot be done should not interrupt the person doing it! Chinese Proverb