Ethics approval

This study was approved by the Human Research Ethics Committee of the study institution (Approval number: SEHAPP 99-17).

Study participants

This study was designed as a cross-sectional study to capture the current views and self-reported practices of Australian practicing community pharmacists in commonly encountered pain and fever management, as well as their views on clinical guidelines. Data collection was conducted over an approximately eight-week period (March-May 2018). Participation involved completing an anonymous online survey that took approximately 10 minutes. This survey was open to all community pharmacists across Australia, although it is estimated that survey participants would be predominately pharmacists in Victoria, due to the recruitment. Implied consent was sought by completion of the survey. The investigators were responsible for the initial recruitment of pharmacists via local industry contacts and the Pharmaceutical Society of Australia newsletter, with further recruitment through snowball sampling.

Questionnaire

An anonymous, self-administered questionnaire was developed to collect a broad range of data from Australian community pharmacists. Qualtrics software was used to develop and deliver the online questionnaire.

Questions were developed under four sections. To ensure that a broad range of pharmacist responses were captured, demographic data such as age, gender, employment status, area of primary employment, tertiary qualifications and approximate years of experience as an Australian registered pharmacist were obtained.

The main body of the questionnaire consisted of questions relating to daily pharmacy practice observations, which included questions on the most common types of pain, and the frequency of over-the-counter (OTC) analgesic requests. In the next section, pharmacists were presented with a series of hypothetical case scenarios of patients presenting to the pharmacy with symptoms of either fever or pain with different severities. The case scenarios are patient-based presentations typically seen in an Australian community pharmacy setting. Examples of scenarios include: general mild to severe musculoskeletal pain, headaches, migraines, osteoarthritis and fever; as well as preference for treatment options relating to adults and paediatric assessments of fever. Pharmacists were provided with a number of different available treatment (no brand names were used) and referral options, and were asked to select their preferred treatment strategy in each case (given that there are no contraindications in the case scenarios).

The final section of the questionnaire consisted of a series of categorical questions (5-point Likert scale ranging from Strongly disagree to Strongly agree) investigating the pharmacist’s views and opinions on their knowledge, training, clinical guidelines and clinical experience in the context of pain and fever management.

The questionnaire underwent a series of pilot tests with a small group of pharmacists and pharmacy academics before final release. The survey was preliminarily pre-tested for ease of use and to identify any technical or interpretative issues, and a second round of pilot tests were conducted before the questionnaire was made available to Australian community pharmacists.

Data analysis

Statistical tests and descriptive statistics were conducted (using SPSS version 18) to assess responses to the questionnaire. A Chi-square goodness-of-fit analysis was also performed to specifically compare the demographic parameters of age and gender distributions of this study’s surveyed population with Pharmacy Board registrant data to assess sampling and external validity.

Paracetamol vs ibuprofen

Non-prescription medicines such as paracetamol and ibuprofen are important OTC medicines readily available and are important treatment components in primary healthcare for minor ailments such as pain and fevers. Patients frequently visit the pharmacists for pain treatment and patients frequently use OTCs to self-manage their pain.¹⁴,¹⁵

Although studies and meta-analyses comparing the effectiveness, safety and tolerability profiles of paracetamol and ibuprofen have led to variable conclusions, many studies identified that ibuprofen is as safe and effective as paracetamol in many basic analgesic and fever scenarios, in both adult and paediatric populations.¹⁶,¹⁷,¹⁸,¹⁹,²⁰ Despite this, globally paracetamol is still perceived as having a better safety and overall better tolerability profile than ibuprofen.¹⁷ It was also suggested several reasons why this perception exists, including lack of distinction between the different Non-steroidal anti-inflammatory drugs (NSAIDs) resulting in a “class effect bias”; ingrained negative perceptions of NSAIDs, as well as lack of overall understanding with regards to ibuprofen safety and tolerability, and the lack of confidence to put this knowledge into practice.¹⁷ However, it is important to also recognise the risk of hepatic toxicity associated with paracetamol, particularly in high doses.

Interestingly, despite the popularity of OTC paracetamol and ibuprofen use, studies examining perceptions and practices of healthcare professionals and their preference for recommending paracetamol or ibuprofen are quite limited. One study examining non-prescription medicines for pain and fever identified that paracetamol was clearly the recommendation of choice by pharmacy staff, compared to NSAIDs.²¹ Furthermore, that study also reported a small proportion of staff recommending NSAIDs when paracetamol was requested by the patient.²¹ This is supported in a large national cross-sectional study of NSAID use by GPs, paediatricians and pharmacists where NSAIDs were only recommended in a minority of cases.²² Furthermore, it was identified that NSAIDs use was generally associated with older children, higher temperatures, pain due to otitis and in the absence of a rash or gastroenteritis.²² In a study looking at analgesics recommended by dentists and pharmacists, it was reported that ibuprofen was the OTC analgesic preferred and recommended by majority of both dentists and pharmacists for toothache relief in adults, with paracetamol as the second-choice agent.²³

Choice of NSAID

Aspirin, ibuprofen, diclofenac and naproxen are the four OTC non-selective NSAIDs available in different formulations in Australia. The current Australian Therapeutic Guidelines suggests paracetamol remains the first-line treatment option for mild acute pain when non-pharmacological treatment strategies are inadequate.¹⁰ As the severity of pain increases, the use of a NSAID may be warranted and the choice of which NSAID is at the healthcare professional’s discretion. In moderate acute pain, clinical guidelines list ibuprofen as the drug of choice because of the widespread experience with its use.¹⁰ In migraine pain presentations, guidelines suggest the use of high dose (900-1000 mg) soluble aspirin as a suitable NSAID. Results of this study suggest that Australian pharmacists are aware of the fact that soluble aspirin is the drug of choice in migraine pain symptoms, since it was the most selected treatment option in the hypothetical migraine pain cases. The Australian Medicines Handbook (AMH) advises medical practitioners and pharmacists that approximately 60% of patients will respond to any NSAIDs, and those who do not respond to one may respond to another.²⁴

Diclofenac has the least potential of causing gastrointestinal side effects but has the highest risk of causing adverse cardiovascular effects.¹⁰,²⁴,²⁵ Results from this study identified that diclofenac was the NSAID of choice as the severity of musculoskeletal pain increases in the hypothetical case scenarios. Motives behind the popularity of diclofenac in these instances remain unclear, although its availability in a specialised oral formulation with a more rapid absorption rate, and the fact that diclofenac has the shortest half-life, could be contributing reasons.¹⁰,²⁶ The results in this particular section are not attuned to the recommendations of the clinical guidelines as diclofenac is listed as a second-line therapy (after ibuprofen) for moderate symptoms of pain.²⁷ However, it is important to note that clinical guidelines do not provide conclusive information on the comparative efficacy of the varying NSAID options, and hence guidelines advise health professionals to select a suitable NSAID based on patient comorbidities.¹⁰ Although studies comparing the effectiveness and safety profiles of diclofenac to other NSAIDs have led to variable conclusions, studies have identified that diclofenac is no more effective than other NSAIDs such as ibuprofen.²⁷,²⁸,²⁹,³⁰,³¹ The difference between the results in the moderate pain scenarios and clinical guideline recommendations for moderate pain management highlights that there may be additional factors influencing a pharmacist’s decision when recommending a suitable NSAID option.

Clinical guidelines vs clinical experience

Both clinical guidelines and clinical experience are critical to the application of evidence-based practice and are essential to patient care. The growth of research evidence impacts its translation into clinical guidelines, which impacts clinical practice.⁵ Many chronic conditions such as pain is currently under-diagnosed and under-treated and is likely to worsen unless there is a wider adoption of best pain management practice.³² Primary care management should be holistic and evidence-based, incorporating both pharmacological and non-pharmacological approaches, including complementary therapies and comprehensive management programs.³³

Although there is evidence to support the role of the community pharmacist in chronic disease management, it has been identified that a pharmacist’s skills, for example pain management, is often not fully utilised.³⁴,³⁵ Evidence suggests that chronic non-cancer pain (CNCP) management in primary care is suboptimal and barriers to optimal management are numerous.³⁶ These includes clinician’s knowledge and experience, particularly their perceptions on following and trusting in clinical guidelines. It is recognised that whilst guideline recommendations should be acknowledged, their implementation in practice may differ due to the complexity of perceptions and expectations, and due to the importance of focussing on the patient holistically.⁵

Interestingly, despite the importance of clinical guidelines to clinical practice, evidence supporting that clinical guidelines are being followed by healthcare professionals (particularly pharmacists) are more limited and variable. Despite significant efforts to promote and support guideline use, evidence indicates that adherence to guidelines for both pain and fever is often suboptimal despite its availability.¹¹,¹²,²²,³⁷,³⁸ It has been suggested that some pharmacists may even lack adequate knowledge of evidence-based practice for OTC medicines and make recommendations that lacks evidence.³⁹ Further, it has also been identified that barriers to adherence vary not only across guidelines but also across recommendations within guidelines.¹¹

Understanding and identifying barriers to evidence-based guidelines’ uptake is critical to closing the “evidence-practice” gap.¹² It has been suggested that the use of guidelines is influenced by the believability of the underlying evidence, the health practitioner’s consultation style, and uncertainties surrounding diagnosis and treatment.⁵ Other barriers include perceptions of the condition’s seriousness, clinicians’ preparedness, clinicians’ personal beliefs, and dissonant patient expectations.⁴⁰ A systematic review also identified that many clinicians viewed guidelines were categorical, prescriptive, and constrained professional practice.¹² Other studies among GPs have also demonstrated that barriers across guideline adherence are patient related, suggesting that guidelines do not always adequately incorporate patient preferences, needs and abilities.¹¹

Additionally, it was also noted that popular clinical practices superseded the guidelines, with adherence to following protocols decreasing with increasing physician experience.⁴¹ Interestingly, clinicians’ perceptions of guidelines often also demonstrates a lack of content knowledge, as well as a lack of appreciation of and trust in how guidelines are developed.¹² This indicates that targeted education on these aspects could be important in this context.

Limitations and future directions

Although a broad range of demographics were captured, it is likely that the pharmacists in this study do not fully represent all pharmacists. A larger sample size will increase generalizability of the results. To assess this, demographics data was compared with the Pharmacy Board registrant data. Furthermore, potential selection bias may also exist that can also influence sample representativeness. Another limitation of this study was that it was only designed to assess self-reported practice; the use of the simulated patient technique may be a more appropriate way to assess actual practice. Indeed, the use of simulated patients to assess analgesic recommendations have previously been reported in other contexts.⁴²,⁴³ Additionally, as this was a self-reported survey, response bias is possible. To minimise this, pharmacists were not explicitly told that their views were being compared to guidelines and were simply asked to suggest their recommendation of choice for the scenarios. To extend this work, it would be useful to further identify specific areas where practices may not align with guidelines, as well as further understanding how best practice guidelines can be optimally utilised to guide practice and decision making, including key drivers and barriers for specific views and practices, with the ultimate goal of improving patient care and health outcomes.