Setting and patients
The study took place between September 2013 and December 2013 in an acute internal medicine unit of a 1099 beds teaching hospital in Italy. The unit has 39 beds and patients admitted are mostly elderly presenting typically with acute geriatric problems and multiple diseases. The healthcare team looking after patients is made of 5 physicians specialized in internal medicine, nurses, healthcare assistants, 1 physiotherapist, 1 dietician, and 1 social worker.
Patients aged 70 or over admitted to the unit were included in the study. Patients were excluded from the study if they suffered terminal illness (life expectancy < 3 months); if expected length of stay was ≤48 h; if they had been enrolled in the study during a previous admission; and if they had been transferred from another acute unit where they had been cared for by internal medicine physician(s).
Communication strategy
All key stakeholders (eg. hospital management, pharmacists, doctors, and nurses) were informed on the Strengths, Weaknesses, Opportunities and Threats (SWOT) of the new clinical pharmacy service using a SWOT analysis (Table 1). A SWOT analysis is a technique used in strategic planning to enhance understanding and decision-making in organizations and it can be applied to healthcare organizations when introducing a new service [18].
To prove effectiveness of the new clinical pharmacy service implemented to stakeholders type of interventions made was described, their acceptance rate was measured and their clinical significance was assessed. These goals were Specific, Measurable, Achievable, Realistic and Timely (SMART) in order to guide and facilitate reception of the message by stakeholders [19].
A marketing strategy targeting key stakeholders according to their degree of influence and importance was developed. Stakeholders’ analysis is reported in Fig. 1.
Hospital managers, chief pharmacist and senior medical staff were targeted with high priority as they would allocate resources and ultimately decide whether to introduce and expand the clinical pharmacy service as part of standard care. Junior doctors, nurses, patients and pharmacists had high importance as they would provide feedback to senior staff and hospital management. However, their influence was low as they were not decision makers. Local PCT had high influence as they were decision makers and were involved in allocating resources.
A marketing plan was developed according to characteristics of the new service implemented and stakeholders (Fig. 2) with particular emphasis on Awareness, Interest, Desire, Action (AIDA model). The AIDA model is used in marketing to help communicate effectively with stakeholders in a way that better responds to their needs and desires [20].
Intervention
An intervention was defined as any recommendation made by the clinical pharmacist to a healthcare professional, pertaining to drug therapy, which aims to improve the quality of medication use [14]. Recommendations were either made after a prescription was written in order to amend it or before a prescription was written in order to advise on most appropriate prescribing (e.g. statin post stroke in a patient with deranged liver function tests, beta-blocker post myocardial infarction in a patient with severe asthma). The pharmacist covered the internal medicine unit from Monday to Friday spending on average 7 h/day on the unit and providing pharmaceutical care from admission to discharge [21]. The pharmacist had knowledge in geriatric pharmacotherapy and was a trained clinical pharmacist. The pharmacist did ward rounds with the medical team in the morning and follow ups in the afternoon. The main tasks performed were: medicine reconciliation on admission; monitoring and optimization of medicine prescribed during hospital stay; and medicine reconciliation on discharge [22, 23]. Priority was given to new patients and patients going home on the day. The pharmacist contributed to choice of drug regimen, provided evaluated information on pharmaceutical, therapeutic and toxicological aspects of drug therapy, contributed to choice of dosage, form and route of medicine, and helped with dosage calculations [24]. A pharmaceutical care plan was made for each new patient [23, 25]. The pharmacist had access to patient’s medical records and blood tests. Interpretation of drug assays continued to be performed by the clinical pharmacology department as per standard care. When there was an opportunity for optimizing therapy, the pharmacist discussed it with the prescriber who could accept/ partially accept or reject the intervention. The pharmacist answered questions about medications asked by the healthcare team on the ward. Interventions could be triggered either by the pharmacist or by a member of the healthcare team asking a question to the pharmacist. Interventions made were usually communicated orally and recorded afterward in an intervention form. In the event the doctor looking after the patient was not present on the ward interventions made were communicated in writing on a pharmacist intervention note. The note reporting the intervention advised by the pharmacist was attached to the drug chart for the doctor to be reviewed.
Data collection
Information recorded on the intervention form were: underlying drug-related problem (DRP) category; drug involved (Anatomical Therapeutic Chemical [ATC] code) [26]; description of intervention; outcome; type of intervention and acceptance. Description of the outcome recorded for each intervention reported the changes that had occurred as a direct consequence of the intervention on the day it was made. A DRP was defined as an event or circumstance involving drug therapy that actually or potentially interferes with desired health outcomes [27]. DRPs and types of interventions were classified using a classification system previously described in the literature [14]. In brief, DRPs were divided in 17 categories and drug allergy was considered a DRP. Types of interventions were divided in 6 categories. Prior to the start of the study a pilot was conducted on a sample of 30 patients over a 2-week period to assess viability and reliability of the intervention form.
Clinical significance
Clinical significance of interventions was defined using a scale, developed by Spinewine and colleagues, with 5 categories: 1) minor: no benefit or minor benefit, depending on professional interpretation; 2) moderate: recommendation that brings care to a more acceptable and appropriate level of practice or that might prevent an adverse drug event (ADE) of moderate importance; 3) major: intervention might prevent serious morbidity, including readmission, serious organ dysfunction, serious ADE; 4) extreme: lifesaving; and 5) deleterious: might lead to adverse outcome [14]. Clinical significance of interventions was assessed by an independent panel consisting of one clinical pharmacist and one senior physician. They were from the UK and Australia, with expertise in geriatrics and knowledge of US guidelines (adopted locally). The scale was piloted on a sample of 25 interventions. Written instructions from the pilot were provided to the panel to easy the use of the scale. Panellists had no involvement in the care of patients included in the study. The panel reviewed only interventions accepted by the healthcare team and with direct clinical impact. Significance of each intervention was assessed independently by each panellist. If there was no agreement the panel met to reach consensus on the rating.
Data analysis
Data were analysed using SPSS software (Statistical Package for the Social Sciences, version 17.0). Characteristics of interventions were assessed using descriptive statistics. Level of agreement for classifying DRPs and types of interventions was assessed during the pilot study. The principal investigator and a clinical pharmacist external to the study coded 33 interventions finding a Cohen’s kappa of 0.80 for underlying DRPs and 0.85 for types of interventions. Agreement was considered substantial and almost perfect respectively [28].