Why A New Medicines Service?

1. Why A New Medicines Service? Nick Barber The School of Pharmacy University of London

2. New Medicines Service • What the service does – the quick version • Why we need a new medicines service • Harm from medicines • Nonadherence and why it is a priority • What happens as a result of the GP consultation • Why the experience of medicine taking is unpredictable • What happened after people started new medicines • What a new medicines service delivered.....

3. Avoidable harm caused by medicines • Around 5% of hospital admissions (=rate for cancer) are caused by medicines and are avoidable

4. Nonadherence primer • 30-50% of those prescribed medicines for a chronic condition • Around half intentional and half unintentional • Different causes and hence solutions • Intentional: eg Beliefs of necessity and concern; being taken seriously; understanding the rationale of prescribing • Unintentional: Same beliefs as adheres. Find what problems stop the person adhering: eg forgetfulness, interference with lifestyle, problems with the formulation etc

5. Map of medication errors in primary care Garfield et al BMC Medicine 2009 N Barber www.pharmacy.ac.uk

6. 100 80 e g a t s 60 h c a e t a e e r f r o r r 40 e % Q u a l i t y f i l t e r 20 N N T = 2 N N T = 1 0 0 Prescribing Cashing Dispensing Taking Clinical outcome N Barber www.pharmacy.ac.uk

7. Studying the GP consultation • Interviewed patients before/after consultation; recorded the consultation • Patients often not raise important issues about disease, side effects, not wanting a Rx; also found misunderstandings and concerns about not being listened to/understood as a person (biomedical vs ‘social lifeworld’ views) • Nonadherence, worries, misunderstandings and problems ensued from these problems

8. Studying the GP consultation • References: • Barry et al Patients' unvoiced agendas in general practice consultations. BMJ 2000; 320:1246-1250 • Britten et al Misunderstandings in general practice prescribing decisions: a qualitative study, BMJ, 2000; 320: 484-488. • Barry et al Giving voice to the lifeworld. More humane, more effective medical care? A qualitative study of doctor-patient communication in general practice. Social Science and Medicine, 2001; 53: 487-505.

9. Can prescribing be ‘right first time’? • We do not know if the drug will work – virtually all NNT>2 .... So less than 50% chance of producing the health outcome desired.. • We cannot tell the patient the probability they will be side effect free. We cannot predict their side effects, if they have them • Prescribing is always an experiment of n=1. We need a feedback loop to capture what is happening and intervene if necessary

10. Do patients have problems with medicines? • 272 patients treated for a new chronic medical condition. 10 days after receiving the prescription: • 66% said they had problems • 32% were non-adherent Barber et al Quality and Safety in Health Care 2004

11. Our original intervention • Theoretical: Technology adoption and Necessity-Concerns framework • Practical: delivered by community pharmacists • Accessible: conducted via telephone • Grounded: in patients’ perspective • Timely: start of new medicine • Focused: on priority groups for the NHS in the UK

12. Method: Design • Randomised controlled trial: • Self-reported adherence • Medicine-related problems • Beliefs about the medicine • Experts’ assessment of safety and utility • Patients’ perspectives of the service • Preliminary economic evaluation • Main evaluation by phone at 4/52 + q’iare at 6/12 • Clifford et al Pharmacy World & Science, 2006; 28:165-170 • Clifford et al J. Psychosom Res, 2008; 64: 41-6 • Elliott et al Pharmacy World & Science, 2008; 30:17–23

13. Method: Recruitment criteria • Convenience sample of 40 community pharmacies from the Moss Pharmacy chain in the UK: • Patient recruitment: opportunistic, informed consent taken • Randomisation: pharmacist blind to treatment allocation • Inclusion criteria: • Prescription for a new medicine • And • Stroke, cardiovascular disease, diabetes, asthma, rheumatoid arthritis OR aged 75 and over

14. Delivering the intervention • Intervention delivered by two pharmacists at Moss pharmacy head office two weeks after recruitment • “How are you getting on with your medicines” • Information, advice or reassurance given in response to patients’ expressed needs • Control group: usual care

15. Method: Outcome Measures at 4 Weeks • Telephone interview and postal questionnaire at 4 week follow-up with researcher: • Self-reported adherence: non-adherence defined if at least one dose missed in previous 7 days (Haynes et al, 2002) • Self-reported medicine-related problem or concern • Beliefs about Medicines Questionnaire (Horne et al, 1999) N Barber www.pharmacy.ac.uk

16. Method: Experts’ & Patients’ Views • Experts: two academic general practitioners, two academic pharmacists, clinical pharmacologist. • 100 interventions were sampled and sent to experts. • Harm: scale from 0 (no harm)- 10 (death) (Dean & Barber, 2001) • Helpfulness: 5-point Likert scale • Patients: open-ended question in the 4-week follow-up interview with the researcher.

17. Method: Economic Evaluation • Cost-effectiveness analysis from the NHS perspective: • Costs: NHS resource use data (NHS contact, pharmacist training and time) • Effectiveness: number of adherent patients • Incremental cost effectiveness ratios (ICERS) were calculated: cost per extra adherent patient • Non-parametric bootstrapping was conducted as a sensitivity analysis

18. Results: Flow of Participants Consented = 500 Randomised to intervention group = 261 Randomised to control group = 239 Received intervention = 229 (Excluded = 32) * Follow-up interview =185 (Excluded = 44) * Follow-up interview = 194 (Excluded = 45) * * Not eligible, taken off med by GP

19. Results: Demographics

20. Results: Non-adherence and Medicine-related Problems

21. Examples of non-adherence that the pharmacist dealt with “I often fall asleep and forget to take my evening medicines” “I work shifts and find it difficult to remember all the different tablets and times I need to take them” “I don’t like taking tablets much so I’ve stopped taking them to give my system a good clear out” “I got terrible side effects so I stopped taking it”

22. Results: • Experts’ views (on sample of 100 interventions): Helpful and safe • Patients’ beliefs were significantly shifted to greater feeling of necessity and concerns were lessened (we did not target this specifically) • Patients’ views on usefulness: • 138 (77%) rated it as useful • 42 (23%) expressed neutral views • The pharmacists loved it!

23. Cost-effectiveness of the intervention

24. Overview of findings • Intervention: Improved outcome measures • Experts’ view: Safe and helpful • Patients’ view: Useful • Economic evaluation: Cost-effective

25. Why did it work? • Is entirely patient centred – does not preach • It is underpinned by knowledge of why nonadherence occurs • It works for both intentional and unintentional nonadherence • It does what we should be doing – we care for patients and they respond to this