James C. McElnay School of Pharmacy The Queen’s University of Belfast Pharmaceutical care in community pharmacy

Pharmaceutical care Three main components: ensure patient is receiving optimal drug therapy (minimise drug related problems) patient education (illness, medication, healthy lifestyle, treatment goals, need for compliance with medication regimens) monitoring patient outcomes –self-monitoring plan –monitoring of goal achievement

Outcomes of Pharmaceutical Care F cure of a disease (CAP) F elimination or reduction of a patient’s symptomatology (asthma; diabetes, PUD) F arresting or slowing of a disease process (rheumatoid arthritis; diabetes; CHF; COPD) F preventing a disease or symptomatology (smoking cessation)

H.Pylori eradication Brit. J. Clin. Pharmacol. (2002) 53,

Methods Methods Study design Prospective, randomised, controlled clinical trial Combination therapy used Lansoprazole, amoxicillin and clarithromycin Patients Endoscopy confirmed PUD with H. pylori Intervention group (n = 38 ) Control group (n = 38) Pharmaceutical care intervention Patient education (disease / need for compliance with treatment) F/U telephone call midway through therapy

Adherence rate

Eradication rate

Conclusions H pylori eradication rate and compliance rate were significantly increased Significant difference between the routine clinical practice and counselling enhanced treatment Involvement of pharmacist led to improved cost-effectiveness of treatment

Question What percentage of community pharmacists provide robust advice to, and follow-up adherence checking of, patients who are receiving H. pylori eradication therapy?

Pharmaceutical care of asthma patients J. Appl. Ther. (1997) 1, Pharmacotherapy (2001) 21,

Comparison of inhaler scores in controls and in patients receiving education/monitoring intervention * p<0.05 * ** Assessment period: 1-3 baseline, 4-6 intervention % Inhaler score (±95% CI) Inhaler scores in control Inhaler scores in patients receiving education J. Appl. Ther., 1, (1997)

Comparison of prophylactic asthma treatments used in the first 6 months and last 6 months of study period % Intal Inhaled Steroids Oral Steriods Theophyllines Medications FIRST SIX MONTHS LAST SIX MONTHS

Asthma International Perspective Northern Ireland Netherlands Belgium Iceland Denmark Malta

Conclusion Positive Impact on: Health Related Quality of Life Inhaler Technique Peak Expiratory Flow Self-Reported Symptoms Pharmacist-patient Relationship Hospitalisation?

Question What percentage of community pharmacists provide good pharmaceutical care / medicines management to their asthma patients?

Care of elderly patients Pharmacotherapy (1999) 19, Pharm. World Sci. (2003) 25, Pharmacoeconomics (2003) 21, Clin Drug Invest (2003) 23, Brit. J. Clin Pharmacol. (2005) 60,

Question What percentage of community pharmacists provide good pharmaceutical care / medicines management services to all their elderly patients?

Individualised smoking cessation programme (PAS) Pharmacoeconomics (1998) 14, Addiction (2001) 96,

Aim of smoking cessation study The aim of the study was to examine, in a randomised controlled clinical trial, the success of the PAS model as a method of smoking cessation in the community pharmacy setting.

The PAS Smoking Cessation Model STEP 1 STEP 4 STEP 3 STEP 2 To encourage and motivate clients using the pharmacy to stop smoking To identify what type of help and support your client’s need to stop smoking Gaining your client’s commitment to stop smoking To support and monitor smokers wishing to stop smoking

Intervention subjects (PAS) Verbal advice and leaflets Client’s NRT needs and position on the cycle of change assessed Details of intervention recorded on individual patient file Return visit at established intervals

Control subjects Normal practice as usually performed in pharmacy (including use of NRT) Patient profile sheet completed Contact 3, 6 months and 1 year for feedback on smoking status

Outcome Measures Self reported smoking cessation at 3, 6 and 12 months Cotinine confirmed smoking cessation at 12 months Pharmacist views on the service (focus groups)

Results Intervention (PAS) (n=265) – 14.34% smoking abstinence at 1 year (n=38) Control (ad hoc) (n=219) – 2.74% smoking abstinence at 1 year (n=6) PAS significantly increases cessation rates (P<0.01)

Sensitivity Analysis Sensitivity analysis cost per life year saved per successful intervention* Uptake rate (50% - 75%)£ £ Throughput rate ( patients/yr)£ £ Success rate (5 - 25%)£ £ Natural cessation rate (0 - 2%)£ £ Relapse Rate (0 - 15%)£ £ Fixed costs (£40,000 - £70,000)£ £ Variable costs (£15 - £45 /patient)£ £ Discount rate (3 - 5%)£ £ cost per life year saved per successful intervention based on a 45 year old male

Conclusions PAS model is much more cost-effective that a number of other disease prevention practices e.g. hyperlipidaemia treatment A clear case can be made for NHS remuneration of this pharmacy service

Question What percentage of community pharmacists provide robust smoking cessation programmes?

Integrated Medicines Management Journal of Evaluation in Clinical Practice (2007) 13,

Integrated Medicines Management (IMM) Healthcare organisations face major challenges including: Suboptimal prescribing Poor patient adherence to prescribed medication regimens Adverse drug reactions and interactions Medication administration errors Inadequate communication across the primary/secondary interface

IMM readmission statistics

Influence of medicines management on patient knowledge of medicines

Prescription queries

Medication storage seen during home visits

Drug reactions / interactions and OTC use

Adherence issues

Patient understanding / monitoring

Question What percentage of community pharmacists provide robust integrated medicines management services to patients?

Behavioural Pharmaceutical Care Scale (BPCS) N. Ireland 1996 vs 2006 AJHP (1998) 55,

BPCS Scores 1996 vs Respondents’ Scores Dimension and DomainNo.MaxMean+ SDMean+ SD Direct Patient Care Activities Documentation Patient Assessment Therapeutic Plans Record Screening Patient Consultation Verification of Patient Understanding

BPS Scores 1996 vs Respondents’ Scores Dimension and DomainNo.MaxMean+ SDMean+ SD Referral and Consultation Activities

BPS Scores 1996 vs Respondents’ Scores Dimension and DomainNo.MaxMean+ SDMean+ SD Instrumental Activities Counselling Location Filled prescription validation Informational Support Evaluation of patient satisfaction Competency Improvement Performance Evaluation Provision of Medical Information

BPCS Response Rate (n=230) % (n=213) Mean Scores [46.7% of achievable score] [46.3% of achievable score] (maximum possible score = 160)

Translation of Research Bench → Bedside Clinical Trials → Policy and Routine Practice Translation

Community Pharmacy - untapped healthcare resource Community pharmacists trusted by patients Highly trained healthcare professionals available without appointment in the High Street We have run a number of successful initiatives (in collaboration with GPs) via community pharmacies –Care of asthma patients –Repeat dispensing –Smoking cessation –OTC drug abuse –Care of elderly patients –Medicines management –Treatment of URTIs (minor ailment scheme)

Questions Does the responsibility of researchers end when trials are completed and published? Who is responsible for translating research results into policy and routine practice? Why is policy often not evidence based, e.g. emergency hormonal contraception and pharmacist prescribing in the UK introduced ahead of robust research? Do researchers keep pharmacy services negotiators fully informed of research outcomes and is this evidence used in negotiations with payers?