The community pharmacist as an independent prescriber: a scoping review

doi:10.21203/rs.3.rs-2500812/v1

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The community pharmacist as an independent prescriber: a scoping review

https://doi.org/10.21203/rs.3.rs-2500812/v1

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Background

Due to the shortage of professionals, the ever-increasing needs and demands for appointments, consultation of physicians is getting harder, and delays are getting longer. To limit this issue, several countries have experimented different models of independent prescribing through pharmacies.

Aim

This study aimed to analyze the contribution of independent prescribing by community pharmacists, in primary care, using the micro, meso, macro level framework.

Method

Three different databases were used: Medline, Scopus and Embase. The search was executed on March 23rd, 2022, for each of them. Some relevant articles were added manually to the search. To be selected for the review, articles needed to be published after 2000, written in English or French, focus on independent prescribing by community pharmacists, and concern a minor condition. Original research was accepted. Articles were imported into the Covidence systematic review software to perform the review.

Results

The search resulted in 1768 articles and 846 after removing duplicates. After title and abstract screening, 792 articles were qualified as irrelevant, and 54 full text studies were reviewed for eligibility. Finally, eight studies were included in the scoping review. The various studies included are recent (from 2013 to 2021) and mostly of Canadian origin (6/8). For five of them, a quantitative study design is observed. As an independent prescriber, the community pharmacist can improve patient access to primary care, reducing consultation delays for minor conditions. In addition, patient safety is maintained, and the patient’s quality of life is increased. The pharmacist independent prescriber model seems to be cost-effective for society.

Conclusion

This review highlights the potential value and relevance of the pharmacist independent prescriber. The benefits to society are felt at all levels: micro, meso, and macro. Effectiveness and efficacy seem established, but further studies are needed in other fields, as efficiency.

Pharmacist

community pharmacy

independent prescribing

primary healthcare

health policy

scoping review

PIP is one possible solution mainly found in Canada and in the United-Kingdom.
Accessibility to care is improved for the patient, with reduced delays.
The benefits of PIP to society are felt at all levels: micro, meso and macro.
The pharmacist independent prescriber model is cost-effective for society.
Further studies are needed to evaluate the implantation of PIP in other settings.

In many developed countries, patients’ access to primary care is becoming harder. Due to the shortage of professionals, the ever increasing needs and demands for appointments, consultation of physicians is getting harder, and delays are getting longer[1–3]. Prescription of drugs by non-medical health professionals, and particularly pharmacists is one newly implemented solution[4]. It appeared at the beginning of the 21st century, firstly in Canada and in the United Kingdom, and then in the United States, Australia, New-Zealand[5]. In most cases, this new pharmaceutical service started in hospitals or clinics, before reaching the community.

Several models of pharmacist prescribing are offered, depending on the country, the pharmacist’s level of training, or access to other healthcare providers. Some adjectives like “non-medical prescribing”, “additional prescribing”, “collaborative prescribing”, “supplementary prescribing”, “emergency prescribing”, or “independent prescribing” are used to clarify the pharmacist's capabilities and scope of practice[6–10]. These terms describe the range of authorized pharmacist prescribing practices and authorities, such as prescribing over the counter (OTC) medicines or prescription drugs, the necessity or not of a prior agreement from the physician to prescribe, or the possibility to continue a therapy. This study will focus only on the pharmacist independent prescribing (PIP) model, also named “autonomous prescribing” because it does not require any systematic agreements with prescribers[9]. PIP is generally proposed when a new diagnosis is not necessary, or for minor conditions like allergies, acne, contact dermatitis, sore throat, etc. Usually, only pharmacists specifically trained for this new service can prescribe independently. PIP is regulated and often based on national protocols[11].

Some studies show that patients have high expectations and satisfaction about PIP service[12–14]. Other studies and reviews have examined pharmacists’ capabilities or barriers and facilitators to implement this new model[15]. Although PIP seems to be a lever to improve access to care, the efficacy, effectiveness and efficiency of this service have not been well explored yet in terms of public health policy. This study aimed to analyze the contribution of independent prescribing by community pharmacists, for minor conditions in primary care, for patients (micro-level), organizations (meso-level) and society (macro-level), in terms of efficacy, effectiveness and efficiency. Efficacy can be defined as the ability to achieve the desired effect under controlled circumstances; effectiveness is about achieving the desired effect under ordinary circumstances (real-life); efficiency focuses on achieving objectives in the most economical way[16]. In other words, productive efficiency refers to maximizing the health outcome for a given cost, or minimizing the cost for a given outcome[17].

Due to the lack of evidence in literature for the benefits of PIP, a scoping review was conducted. This methodology is particularly appropriate for answering a specific question with relatively few studies, and of a heterogeneous nature, in contrast to systematic reviews[18]. Moreover, scoping reviews are preferred to clarify key concepts and identify research gaps for new topics[19, 20]. The PRISMA extension for scoping review (PRISMA-ScR) guidelines were followed to conduct this study[21].

Search strategy

To identify articles of interest, three bibliographic databases were chosen and explored: Medline, Scopus and Embase, as they are generally considered as major databases for biomedical research. To be selected for the review, articles needed to be published after 2000 (due to recent implementation of pharmacist independent prescribing), written in English or French, focus on independent prescribing by community pharmacists, and concern a minor condition. All types of studies were accepted (quantitative, qualitative, and mixed-method studies). Papers were excluded if:

They were not an original research;
They were not focused on the main topic (e.g., supplementary prescribing, collaborative prescribing, non-medical prescribing);
They took place on a non-community setting (hospital, emergency, primary care clinic);
They analyzed the implementation process (barriers and facilitators to PIP implementation);
They explored the patients’ experiences and views about PIP.

Papers mentioning specific measures regarding the COVID pandemic or vaccination, contraceptive, naloxone, chronic conditions were also rejected because this area was considered not related to a minor condition.

The search was executed on March 23rd, 2022, for each database. The bibliographies of included papers were reviewed for additional studies. The Medline search strategy is presented below and was adapted for Embase and Scopus.

(Pharmaci*[Title] AND prescri*[Title]) NOT ((vaccin*[Title] OR contrac*[Title] OR hospit*[Title] OR emergenc*[Title] OR error*[Title] OR inappropriat*[Title] OR attitude*[Title] OR train*[Title] OR educat*[Title] OR barrier*[Title] OR facilitator*[Title] OR view*[Title] OR physician*[Title] OR practitioner*[Title] OR review*[Title]))

Articles were imported into the Covidence systematic review software to perform the review[22].

Selection of studies and analysis

Studies were included in three steps. First, titles and abstracts were screened. Second, full text review was made. Third, extraction and analysis were achieved. These steps were performed independently by the two reviewers (AP and DB). A consensus was reached between the two reviewers at the end of each step. Criteria for screening and full text review were entered into the software.

An iterative process was used to create the data charting form. General information like lead author, year of publication, title, and country was collected. Some characteristics of studies like study objective, study design, level, scope, and key findings were also collected. The two reviewers independently completed the data charting form and discussed the results. The results were presented in a table to allow comparison between the studies and to get an overview. Key findings from each study were classified into categories to show the contribution of PIP.

The search initially resulted in 1768 articles, reducing to 846 after removing duplicates. In total, 792 articles were qualified as irrelevant after title and abstract screening, and 54 full text studies were reviewed for eligibility. Of these, 46 were considered irrelevant and were removed. Therefore, eight studies were included in the scoping review and their data were extracted. All the process is available in Fig. 1.

Characteristics of included studies

All the studies included are recent (from 2013 to 2021) and mostly from Canada (6/8). A quantitative study design is observed for five of the studies. Half of the studies rated the efficacy of the PIP (4/8); and only two studies measured the effectiveness of the PIP (Table 1). Studies are presented by level of intervention (micro, meso, macro-level).

Table 1

Characteristic and results of included studies
Author	Year	Country	Aim of study	Study design	Level	Scope	Key findings
Mansell[23]	2015	Canada	To determine whether patients prescribed medications for minor ailments by a pharmacist symptomatically improve within a set time frame.	Quantitative Interventional	Micro	Efficacy	Cold sores, insect bites and seasonal allergies were the most common minor ailment. The condition improved significantly/completely in over 80% of cases. Patients were satisfied with the outcome, both in clinical terms and in terms of pharmacist attributes.
Beahm[24]	2018	Canada	To evaluate the effectiveness, safety and patient satisfaction with pharmacist prescribing and care in patients with uncomplicated urinary tract infection.	Quantitative Interventional (prospective registry trial)	Micro Meso	Efficacy	Clinical cure was achieved in 88.9%, and no significant difference in clinical cure or in term of adverse events was observed between two arms. The management of uncomplicated urinary tract infection by pharmacists is effective and safe and that patients express a high level of satisfaction with this care.
Booth[25]	2013	UK	To compare the care pathway of patients with urinary tract infection symptoms attending GP services with those receiving management, including trimethoprim supply under patient group direction, via community pharmacies.	Mixed method Interventional	Micro Meso	Efficacy	There was no significant difference in the time to resolution of symptoms between patients receiving a prescription from the physician (n = 97) and those receiving pharmaceutical management (n = 56), but the duration of symptoms before treatment was shorter for patients presenting for pharmaceutical management.
Stewart[26]	2018	UK	To evaluate the initiative from the perspective of patients, GP practices and pharmacists, to determine whether the referral system was used appropriately and to review the clinical areas covered.	Mixed method Interventional	Micro Meso	Efficacy	1189 cases were managed by pharmacists, of which 78% resulted in a prescription for treatment by the pharmacist, 9% received advice only, and 13% were referred to the general physician. Two thirds of GPs (67%) and 59% of reception staff found the service useful, mainly because it reduced pressure on GP appointments.
Lathia[27]	2018	Canada	To conduct an economic evaluation of treating severe sore throat when a program for evaluating this condition was offered in community pharmacies.	Quantitative Observational (modelling)	Meso Macro	Efficiency	In a scenario where 60% of patients with severe sore throat seek care in a community pharmacy, the health care system saves a mean of $12.47 to $24.36 per patient.
Pojskic[28]	2014	Canada	To understand the factors influencing the genesis and formulation of the pharmacist prescribing policy in Ontario.	Qualitative	Meso Macro	Effectiveness	Pharmacy professional organizations and the Ontario government representatives see PIP as a way to improve patient access to primary care.
Kim[29]	2021	Canada	To estimate the potential economic impact of establishing a remunerated program for pharmacists prescribing for minor ailments from a public payer perspective in Ontario.	Quantitative Observational (modelling)	Macro	Efficiency	At a service uptake rate of 38% for the prescription-detached scenario, the PPMA model led to savings of $7.51, $4.08 and $5.15 per patient for upper respiratory tract infections, contact dermatitis and conjunctivitis, respectively.
Rafferty[30]	2017	Canada	To perform an economic impact analysis of the pharmacists prescribing for minor ailments program in Saskatchewan, including the current costs and savings of the program from both the public payer and societal perspective and the costs and savings of the program for a time horizon of five years after implementation.	Quantitative Observational (modelling)	Macro	Efficiency	Pharmacists prescribing for minor ailment program was cost-saving from a public payer perspective and much more so from a societal perspective. After 5 years of implementation, from a societal perspective, cumulative cost savings were projected to be $3,482,660.

Results of individual studies

Easy access

Access to a community pharmacist is the most important benefits of the PIP. Pharmacists are considered as an easy access to primary care. This is the main argument put forward by the patients who use it[24, 28]. For example, the quick management of a urinary tract infection is required. Beahm et al. observed a significant difference between the time to access to a pharmacist versus a general practitioner (GP) (1.7 day vs 2.8 days respectively; p = 0.0153)[24]. Pharmacist prescribing for minor ailments made it possible to avoid medical consultations (35.2%) and even emergency room visits (3.4%) according to Mansell et al.[23] Patients justified their choice to consult a pharmacist by the trust they gave them to treat minor ailments (26.0%), a health condition which did not require a medical visit (20.3%) or easy access to the pharmacist (17.2%).

Booth et al. reported two relevant findings. First, patients visiting a pharmacy for care were treated more quickly than those with a physician's prescription. Second, one-third of patients cared for by a pharmacist were treated on weekends, when the medical offices were closed[25]. Patients themselves reported the ease of accessing a pharmacist, especially for those with a busy job. It allows easier access to a healthcare provider, without an appointment. In some territories, notably Ontario, Canada, PIP has reduced the workload of physicians and improved the ability of pharmacists to provide services[28].

The ‘Pharmacy First’ model which is available in UK was evaluated by Stewart et al. in respect of three conditions: urinary tract infections, impetigo and exacerbation of chronic obstructive pulmonary disease[26]. It was qualified as quick, efficient, and convenient. Physicians themselves found the service useful. One of the benefits was the release of medical time, thus reducing the pressure on appointments, and subsequently the physician's workload.

Health benefits and safety for patients

The PIP can improve the medication management of patients and avoid negative health outcomes. Beahm et al. conducted a prospective clinical study and found no significant difference in clinical cure or in term of adverse events between the pharmacist and physician arms[24]. These results are confirmed by Booth et al., where no significant difference was found between GP or pharmacy management in time to resolution of symptoms[25]. The study assessing pharmacists' prescribing for minor ailments supports these observations. Indeed, the patients' condition improved in almost all cases (99.2%)[23].

The PIP can also reduce the inappropriate use of antibiotics. According to Lathia et al., a rapid antigen detection test for group A Streptococcus is performed on average in one quarter of consultations by physicians[27]. In the two Canadian provinces that allow IPP (Alberta and Ontario), the test completion rates are 92% and 75% respectively. The management of sore throats by pharmacists could improve the detection of ‘strep throat’, and therefore the appropriate use of antibiotics.

Cost-effectiveness of the pharmacist independent prescriber model

For most of the studies, modelling showed pharmacist intervention as a cost-effective strategy. The study conducted by Kim et al. accurately quantified the savings in the pharmacists prescribing model for minor ailments. Based on 30,000 patients, this model would save 99 emergency department visits, 3,677 family physician visits, and 5,090 walk-in clinic visits[29]. From the public payer’s perspective, pharmacist management of simple urinary tract infection in women, contact dermatitis, and conjunctivitis would result in cost savings of $12.26, $4.89, and $9.27 per patient respectively.

An economic evaluation of the treatment of severe sore throat by community pharmacists was conducted by Lathia et al. in five Canadian provinces[27]. Depending on the province, cost savings of $12.47 to $24.36 per patient are expected if the pharmacist manages the sore throat. Savings of $1.3 to $2.6 million per year are projected for the five provinces. Rafferty's study focused on the province of Saskatchewan, Canada, and supports these results[30]. The pharmacists prescribing for minor ailments program saved approximately $800,000 in 2014 from the societal perspective. These cost savings were estimated to be about $3.5 million after 5 years.

Pojskic and colleagues investigated key stakeholders' perceptions of PIP. For many of them, redirecting patients to pharmacists for minor conditions is a way to reduce health care costs[28]. This reduction would be made possible by reimbursing the costs of minor care to less expensive health care providers, such as pharmacists.

Synthesis of results

The main findings from this scoping review, about independent community pharmacist prescribing, are available in Fig. 2.

This study was conducted focusing on patients (micro-level), healthcare providers (meso-level) and policymakers (macro-level) perspective[31]. It, therefore, allows us to look at the larger picture and provide a more comprehensive answer to our research question. As an independent prescriber, the community pharmacist can intervene at different levels of patient care, from the beginning to the end of the care process. The three types of benefits identified were improved access to care, a clinical benefit for patients, and cost savings for the health system.

Easy access

Pharmacies are known to be accessible and available without appointment[32]. These criteria are the reason why they are often the first step in the chain of care, and sometimes the main link to the health care system[33]. This is one of the arguments that leads public authorities to extend community pharmacists' competencies, especially when medical time is limited or insufficient[28, 34, 35].

The lack of physician availability for a minor and acute ailment (e.g., acute cystitis) can slow down patient care and lead to inappropriate referrals to emergency services. Hospitals are required to respond to this unscheduled demand, which does not require a technical platform or specialized expertise. It should be noted that patients themselves see PIP as a way to avoid visits to a GP or even to the emergency room[36]. For example, 17.7% of patients who received pharmacist services in Canada for a minor infection (n = 34) would have visited a physician or emergency department if this service did not exist[23].

Health benefits and safety for patients

Even though there are various reasons why health authorities authorize PIP, the main benefit is for patients. A few studies have already assessed patient satisfaction with the PIP. The results show that patients trust the pharmacist and recognize his or her competence[14, 23, 37, 38]. They were satisfied with the service, both the ease and speed of access, and the quality of advice. These aspects are essential for patient acceptance of this new pharmacist role. A study reports that patients were convinced that their pharmacist prescribed medications as safely as their GP. Another indication of patient confidence was the strong recommendation to see a prescribing pharmacist[37].

Patient safety can also be improved with PIP. When the pharmacist is a prescriber, he needs to follow some guidelines. One of the most famous examples is Canada, with Bill 41 and Bill 31 in 2015 and 2020 respectively[39–41]. In order to prescribe some drugs within specific conditions, pharmacists must complete appropriate training. In addition, they are required to follow the algorithms, which are validated beforehand by the health authorities and the medical community[11]. This process makes it possible to secure patient care and ensure compliance with recommendations. Some drugs, such as antibiotics, require specific precautions. Their misuse can be the source of non-cure and, more widely, of antimicrobial resistance[42]. The use of protocols or algorithms helps to limit this risk. A Canadian study shows that the treatments prescribed by pharmacists for urinary tract infections were compliant with the recommendations in 95% of cases, this rate was 35% for physicians (p < 0.001)[43]. A protocol for the management of uncomplicated cystitis in women, similar to the one that exists in Canada, was recently authorized in France[44, 45].

Cost-effectiveness of the pharmacist independent prescriber model

The effectiveness of PIP seems to be the least explored aspect of this new pharmaceutical service. However, the cost-effectiveness of PIP is probably the most important criterion from a societal point of view. Because medical time is more expensive than pharmaceutical time, it may be more cost-effective to refer patients to pharmacists than GPs for minor ailments[28]. In practice, pharmacists are often already managing these patients with minor conditions with OTC medications. In the UK, specially trained clinical pharmacists and prescribing support teams work with general practices to support GPs and primary care services. Maskrey et al. have observed that clinical pharmacists are effective in supporting physicians and help them to free medical time[46]. The time spent on prescribing activities was reduced by half. This saved medical time was accompanied by increased patient safety and caregiver well-being. It should be noted that the right to prescribe for pharmacists in the UK depends on where, how and what services are provided.

Beyond PIP, pharmaceutical care has already been suggested to be cost-effective for a specific pathology (e.g. hypertension[47, 48]), a category of patient (e.g. elderly patients[49]) or in specific places (e.g. emergency department[50]). The incremental cost-effectiveness ratio per quality-adjusted life-year of pharmaceutical care in the management of diabetes and hypertension in elderly patients was evaluated in a prospective clinical trial in Brazil[51]. Clinical improvements were observed in several areas (blood pressure, fasting blood glucose, haemoglobin A1c, cholesterol, 10-year coronary heart disease risk). Nevertheless, the cost-effectiveness ratio remains positive, with an insignificant increase in overall health care costs with the addition of the pharmaceutical care program. Patients' health outcomes and quality of life were improved. In the R_XEACH study, conducted by Tsuyuki et al., the effectiveness of the pharmacists’ interventions on cardiovascular risk was measured[52]. In the intervention group, pharmacists prescribed medications or laboratory tests after conducting Medication Therapy Management Review. Patients showed better results than the control group (lower LDL-cholesterol, lower systolic blood pressure, and lower glycosylated hemoglobin). Moreover, smoking cessation was higher for the intervention group. The same study also provided information on benefits in terms of patient’s quality of life. Indeed, Al Hamarneh et al. reported that pharmacist care would be associated with a gain of 576,689 quality-adjusted life years and avoid more than 8.9 million cardiovascular events[53]. They also show that this service could save more than $4.4 billion over 30 years.

In the same way that pharmacists can initiate prescriptions, they can deprescribe through a physician. This includes medication reviews for older people with polypharmacy. The cost-effectiveness of this service with follow-up was demonstrated in community pharmacies in Spain, with the conSIGUE study[54]. It is considered as an effective intervention to optimize prescribed medications and improve patients' quality of life.

A strong signal was observed in this scoping review regarding the cost-effectiveness of the PIP model[27, 29, 30].

Study limitations

This study was conducted rigorously, following the baseline methodology in accordance with the PRISMA-ScR statement[21]. Some selection and classification bias could be suspected but were reduced by the consensus methodology. In case of doubt, the study was accepted for the next step and discussed between the two reviewers. In addition, the inclusion of each study was monitored by two independent raters. Although no geographic restrictions were made, most of the selected studies (6/8) were from Canada. This reflects the history of the PIP model in that country. This may also limit the external validity of the study, especially to countries where access to primary care is difficult like in Canada.

As explained in the introduction, PIP is the model which provides the most autonomy to pharmacists. However, this practice can’t be implemented everywhere, and that is why stakeholders prefer to start with moderate things, such as supplementary prescribing or dispensing under protocol[7]. Indeed, these methods allow for greater acceptance by society, particularly the medical community[4, 12]. There are many steps to take, and acceptance by the medical community is one of the major hurdles to overcome[55, 56]. The patient safety argument is often the first to emerge when physicians and pharmacists disagree about PIP[57]. It is considered a step forward. A sociological study suggests that prescribing can be considered as an indicator of autonomy[58].

Edwards et al. conducted a review of the literature and identified several levers for the implementation of PIP; their work can be seen as a toolkit for stakeholders[59]. An interprofessional environment is naturally conducive to this kind of initiative, and allows the different actors to get to know each other[60]. Transitional measures are needed to accompany and support these new prescribers[61]. Moreover, beyond the possibility offered by the authorities, this practice must be accepted by the pharmacists themselves and appropriate training must be defined[12, 62, 63]. Pharmaceutical prescribing can then be seen as a major expansion of pharmacists' skills, granting them medical autonomy.

Further research is needed to strongly assess the efficiency of PIP, using more robust data. The extension of pharmaceutical prescribing around the world will also be a way to assess it in several countries, with different health systems.

This study demonstrates the potential value and relevance of the pharmacist independent prescriber. The benefits to society are observed at all levels: micro, meso, and macro. The beneficiary of this service remains the patient, for whom accessibility is improved and delays before consultations are reduced. In addition, its safety is maintained and even improved[24, 29, 53]. Finally, this service is proving to be cost-effective for society. It reduces the cost of care for patients and increases their quality of life. Effectiveness and efficacy seem established in some contexts, but further studies are needed in the field of efficiency.

Ethics approval and consent to participate

Not applicable

Consent for publication

Not applicable

Availability of data and materials

The datasets used and/or analyzed during the current study available from the corresponding author on reasonable request.

Competing interests

The authors declare that they have no competing interests.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Author contributions

AP conceived the idea for the study, AP and DB developed the study protocol. AP conducted the literature searches and wrote the first draft of the manuscript. DB reviewed the manuscript for critical content. DB provided the visualization. ARR and SF supervised and reviewed the document.

Acknowledgments

This article (English correction and formatting of the manuscript) was supported by the French network of University Hospitals HUGO (‘Hôpitaux Universitaires du Grand Ouest’). We thank Laval University for free access to Covidence software.

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No competing interests reported.

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The community pharmacist as an independent prescriber: a scoping review

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