An exploration of the role of pharmacists within general practice clinics: the protocol for the pharmacists in practice study (PIPS)

Participants for the long patient consultations will be practice patients who may be at an increased risk of MRPs [14].

Patients meeting one or more of the eligibility criteria will be considered for referral to the study by their general practitioner or clinic staff. Those patients who are referred to the study will be provided with an introductory letter and plain language statement in person during their clinic visit. Patients will be asked by the GP/clinic staff if they are willing to be contacted by the research team. If patients agree, the GP/clinic staff will provide the research team with the patient’s contact details.

The research assistant will contact patients who agreed to provide their contact details. Suitable and willing participants will be recruited by obtaining initial verbal consent. Written consent will be obtained at the time of the appointment with the practice pharmacist.

Baseline data will be collected by the research assistant using a structured questionnaire, either in person (at the clinic or the person’s home) or by telephone, and will include demographic information (age, sex, ethnicity, education, socioeconomic status, living arrangements etc.), health information (general health, health service use, health literacy [15] etc.), and medicines information (medication risk [14] adherence [16, 17] etc.). The research assistant will then organize for the participant to meet the practice pharmacist for a long consultation.

All participants will receive a 30–60 minute consultation with the pharmacist in a private room at the clinic (or a home visit if they prefer or are housebound) to perform a comprehensive medication review and identify medication-related problems (MRPs). Prior to the consultation, the pharmacist will discuss any health or medication-related issues with the GP or clinic staff, if needed. The pharmacist will also review participants’ general practice medical record (including progress notes, medication lists and pathology results) and dispensing histories if needed. The pharmacist will obtain written informed consent from the participant. In addition to reviewing the participant’s medication regimen, the pharmacist will assess medication adherence and knowledge. The pharmacist will provide counseling and education as needed on medication management and the use of medication devices, and reinforce lifestyle advice related to their health problems and medications. The pharmacist may provide the participant with a complete medication list and refer them to their community pharmacy for adherence aids (e.g. pill boxes, administration aids), if needed. Additionally, referral may be made to the GP or other health professionals as required. After the consultation, the pharmacist will write a short report outlining MRPs and recommendations, and provide this to the participant’s GP either electronically (via secure email or directly into the practice’s electronic medical record) or as a paper-based report, depending on the GP’s preference. The pharmacist may update the medication history within the practice’s medical record as needed. Following this, the pharmacist will discuss any issues with the GP, other staff and community pharmacist, if needed. Case conferencing may be organized where appropriate.

Participants will be followed up by the research assistant at three and six months either in the clinic or by telephone to collect data about implementation of pharmacist recommendations, resolution of MRPs identified by the practice pharmacist, participant’s medication adherence and participant’s general health and wellbeing.

Based on an expected average number of 2.5 MRPs per participant at baseline, an expected average reduction of 1 MRP (i.e. 40%) per participant with a within-participant standard deviation of 2.1 MRPs (assuming a correlation coefficient of 0.5), [18, 19] a power of 80% and a two-tailed alpha of 0.05, the required sample size is 37 participants. Allowing for a dropout/loss to follow-up rate of 25%, at least 50 participants will be recruited. This was calculated using PS Power and Sample Size Calculations (Version 3.0, Dupont & Plummer, 2009).

Patients with potential medication issues (e.g. nonadherence, newly prescribed medicines) who do not require a comprehensive review of their complete medication regimen may receive a short consultation with the pharmacist. Data will be collected about these consultations, but the patients will not be consented for the study (no personal or identifying data will be collected). Referrals may be made by GPs or clinic staff, or patients may self-refer. The short patient consultation will last 15–30 minutes and provides an opportunity for the pharmacist to provide brief education and counseling on specific needs or answer questions. Short patient consultations will only be undertaken in the clinic. After the consultation, the pharmacist will write brief notes directly into the electronic medical record, and update records as needed. Examples of services to be provided in these consultations include: new medication counseling, adherence assessment, assessment of and education on device technique (e.g. using asthma inhalers), and provision of a medication list. Patient satisfaction will be assessed by an anonymous questionnaire to be given to each patient by the pharmacist along with a reply-paid envelope addressed to the researchers.

The practice pharmacist will provide a drug information service for practice staff. Queries can be made to the pharmacist in person, by telephone or via email. All queries (and responses) will be documented by the pharmacist. Practice staff will also be invited to attend pharmacist-led group education sessions targeting topics relevant to them (e.g. new therapy or treatment protocols), and a weekly drug information newsletter may also be produced by the pharmacist and provided to staff.

The practice pharmacists will undertake a Drug Use and Evaluation (DUE) program in the clinic. The pharmacists will review current prescribing patterns, evaluate these against current best practice guidelines, and implement an intervention to address deficiencies identified using established DUE methodology [20]. A pharmacotherapeutic area of concern or importance will be identified by the pharmacist in conjunction with the GPs and clinic staff. The practice team, with assistance from the research team, will decide upon audit criteria and measurement instruments will be derived from published clinical practice guidelines. The pharmacist will collect and evaluate data relevant to medication use in this area by retrospectively reviewing electronic medical records. Confidentiality of data will be ensured by de-identifying all information collected. Results and feedback will be provided to staff. Multifaceted strategies to improve the quality of prescribing in the selected area will be developed and implemented by the interdisciplinary team, and re-evaluated at the end of the study period. Patients will not be recruited or consented to this part of the study, and no identifying data will be collected.

Actions arising from the DUE program (e.g. development and implementation of clinical guidelines, criteria, treatment protocols, education programs) will be assessed for effectiveness after six months by repeating the prescribing audit to complete the DUE cycle [20].

Patient satisfaction with the practice pharmacist will be determined by a structured, satisfaction questionnaire adapted from a previously validated patient satisfaction survey by Baker regarding physician consultations [24, 25]. The questionnaire will be anonymous and provided at the end of any interaction with the pharmacist (including long patient consultations and short patient consultations). Participants will be requested to complete and return the questionnaire before they leave the practice or at their earliest convenience, using a reply-paid envelope.

The effectiveness of the DUE program will be assessed by re-evaluating medication use in the targeted population at the end of the study and comparing this to baseline data.

The number of drug information queries made and answered, the type of queries made and by whom, will be evaluated at six months.

General information regarding the nature of the short consultations will be recorded, including the reason for referral, type of service provided and average time spent.

The views of a sample of stakeholders on their experiences with this new service will be explored using interviews and/or focus groups at the study’s conclusion. Patients and staff will have the opportunity to share their thoughts on the perceived benefits and challenges of the service and how it could be improved and developed further.