Assessing the contribution of prescribing in primary care by nurses and professionals allied to medicine: a systematic review of literature

Safe and timely access to effective and appropriate medication through primary care settings is a major concern for all countries addressing both acute and chronic disease burdens [1]. From the nineteenth century onwards, governments have responded to concerns for public protection and concerns about drug misuse through medicine regulation legislation. By the twentieth century, legislation started to incorporate prescriptive authority restricted to a small number of occupational groups such as doctors, dentists and vets for certain classes of drugs [2]. Medicine regulation has developed at different rates in high and low income countries, as has the mechanisms to enforce them. The development in the later part of the twentieth century of a more effective range of medicines has seen a different set of public health preoccupations which range from the prevention of antibiotic resistance, to issues both of how to fund and contain medicine costs in health care systems and at the same time ensure equity of access for citizens to basic health care and essential medicines [1]. Each country places different emphasis on these issues but in many it has led to consideration of the use of other health professional groups in addition to doctors to prescribe regulated classes of medicines or medicines provided through a state sponsored or funded health care provision.

Some other countries, for example Spain, the Netherlands, Finland, Jamaica and Hong Kong have initiated efforts to introduce legalisation on NMP [4]. There is great variety in the prescribing legislation of different countries. Some countries legislate for the initial qualification and registration of the nurse as sufficient to undertake prescribing certain classes of medicines and in certain situations, for example Kenya, while others require further qualifications, for example Namibia. Within a country there can also be variations between the extent of classes of medicines nurses can prescribe either as a result of different state legislation, for example the United States of America (USA) or different levels of prescribing qualifications, for example in the United Kingdom (UK). In the UK 'independent prescribing' qualifications allows almost all medicines to be prescribed within the individual's clinical competence and 'community practitioner prescribing' qualification gives only authority over a small limited nurses formulary. In addition, many countries have mechanisms whereby individual nurses (or other professionals) have authority, agreed by their employer and/or doctor responsible for a service, to prescribe and dispense or administer a specified list of medicines to a pre-defined group of patients in specific circumstances and within specified parameters. Common international examples of this are within public health immunisation programmes [5]. These are known by a variety of names such as standing orders. In the UK these are known as patient group directions [6] and are used widely across the spectrum of health services [7].

In the last fifty years different models of primary care have developed in countries, influenced by health care funding, government policies and the aspirations of family medicine and general practice [8]. The extent to which groups of professionals such as nurses and pharmacists are present in the primary care system of each country is dependent on both history and these current policy imperatives. This varies between countries even neighbouring in the same continent, for example, the UK has seen significant numbers of nurses employed in general practice over the past thirty years [9], where as there are small numbers of nurses employed in primary care in France [10].

Extending prescribing authority in primary care is a health care innovation driven by various factors in each country. Addressing shortages of medical staff particularly in remote and rural areas has been one driving factor in North America, Africa and Australia [11, 12]. In African countries such as South Africa, Botswana, Uganda and Zimbabwe, the aim has been to meet community health care needs by improving access to medicines [13]. In Sweden, the UK and New Zealand; NMP was commenced in order to improve the efficiency of services for specific groups, such as elderly people or those who receive nursing care in the community [14, 15]. In some countries, the aspirations of professional groups have been significant in changes to the legislation [16] but only when they have coincided with other public health and health policy imperatives. In summary, the key policy goals to date have been to improve patient access in primary care settings to safe, timely and effective medicines and increasing the efficiency of health service delivery. However, NMP exists in a minority of countries and the extent of prescriptive authority is contentious in some [17]. A sociological narrative review has explored these dimensions further [18]. Other recent narrative reviews [19, 20] have considered nurse prescribing in any setting without acknowledging that prescribing in primary care is a very different context from a hospital setting. In primary care settings the prescriber may have little immediate access to other professionals and may be seeing patients with previously undiagnosed illnesses. Therefore the question remains as to the contribution NMP makes to the care of patients in primary care and what is the evidence on which clinicians, commissioners of services and policy makers can consider this innovation.

There is increasing interest in many health care systems to evaluate interventions and innovations in terms of the outcomes for patients, rather than just examine structural and process elements. Donabedian defines the outcome of care as "the effects of care on the health status of patients and populations. Improvements in the patient's knowledge and salutary changes in the patient's behaviour are included under a broad definition of health status, and so is the degree of the patient's satisfaction with care" [21], p. 1745. Donabedian differentiates this from the structural elements i.e. the attributes of the setting in which care occurs and the process elements i.e. what is actually done in giving and receiving care [21]. This paper reports on an integrative review of the empirical literature [22] which addressed the question what is the effect of NMP in primary care and community settings on patient outcomes?

A search strategy was devised to include published and grey literature. The electronic data bases CINAHL, MEDLINE, BNI, AMED, ISI Web of Knowledge and Index to theses were searched. A search to retrieve grey literature was also conducted of relevant websites: Google scholar, the Royal College of Nursing, Royal Pharmaceutical Society, NHS Modernisation Agency, King's Fund, National Institute of Clinical Excellence, Department of Health, and National Prescribing Centre. Searches also included follow up of reference lists and key authors. Searching was conducted by SB according to the inclusion and exclusion criteria, using terms of NMP.

The search terms employed were nurse prescribing, non-medical prescribing, supplementary prescribing, independent prescribing, pharmacist prescribing, allied health professional prescribing, prescribing rights and prescribing impact and outcomes. A combination of these search terms was used. All items within each terms section were combined with OR and then each section was combined with AND for different combinations of sections that produced the highest result. The inclusion criteria and the exclusion criteria were as follows:

The initial searches produced 1734 abstracts, of which 961 duplicate articles were removed. Titles and abstracts were screened by SB and VMD. After reading titles and abstracts 375 of the 773 papers were excluded. The remaining 398 papers were classified into three categories: empirical papers (n = 184), opinion papers (n = 209) and literature reviews (n = 5). The opinion papers and reviews were excluded.

One hundred and three of the 184 empirical papers were excluded as they did not relate to primary care settings and 17 were excluded as they reported combined primary and acute care data and it was not possible to separate the data relating to primary care (see table 2[26–41]). The full text of the remaining 64 papers were read (SB, RG, RH and VMD) and categorised as to whether they addressed questions of structure, process, or outcomes of NMP in primary care. Those presenting evidence only on the structure or process were excluded (n = 41). In six of the twenty-three remaining papers the research question and/or method were unclear or omitted important information to enable the quality of the paper to be assessed and were therefore excluded. A total of 19 articles of 17 studies reporting on the outcomes of NMP were included in the review (Figure 1). Two studies used the same data for two publications. Details of the papers are given in Additional File 1. Most studies were conducted in the UK. The majority investigated the contribution of nurses as a non-medical prescriber with a small number investigating the more recent development of pharmacists as non-medical prescriber (Table 3). Of the 17 studies, seven used qualitative methods only, eight quantitative methods and two employed mixed methods designs. We now turn to consider the evidence within the studies as grouped by questions of effectiveness, efficiency, acceptability and access. Issues of equity are considered within the section on access.

Complete reference	Country
Latter S, Blenkinsopp, A., Smith, A., Chapman, S., Tinelli, M., Gerard, K., Little, P., Celino, N., Granby, T., Nicholls, P., Dorer, G.: Evaluation of nurse and pharmacist independent prescribing. London: University of Southampton & Keele University; 2010 [26].	UK
Hoti K, Sunderland B, Hughes J, Parsons R: An evaluation of Australian pharmacist's attitudes on expanding their prescribing role. Pharmacy World & Science: PWS 2010, 32(5):610-621 [27].	Australia
Hacking S, and Taylor, J: An evaluation of the scope and practice of non-medical prescribing in the North West for NHS North West. Lancashire: School of Nursing & Caring Sciences, University of Central Lancashire 2010 [28].	UK
Hobson RJ, Scott J, Sutton J: Pharmacists and nurses as independent prescribers: exploring the patient's perspective. Family Practice 2009, 27(1):110-120 [29].	UK
Drennan J. NC, Allen D., Hyde A., Felle P., O'Boyle K., Treacy P., Butler M.: Independent Evaluation of the Nurse and Midwife Prescribing Initiative. Dublin: University College Dublin; 2009 [3].	Republic of Ireland
Courtenay M, Stenner K, Carey N: An exploration of the practices of nurse prescribers who care for people with diabetes: a case study. J Nursing & Healthcare of Chronic Illness 2009, 1(4):311-320 [30].	UK
Dunn SV, Cashin A, Buckley T, Newman C: Nurse practitioner prescribing practice in Australia. Journal of the American Academy of Nurse Practitioners 2008, 22(3):150-155 [31].	Australia
Courtenay M, Carey N: Nurse independent prescribing and nurse supplementary prescribing practice: national survey. Journal of Advanced Nursing 2008, 61(3):291-299 [32].	UK
Courtenay M, Carey N: Preparing nurses to prescribe medicines for patients with diabetes: a national questionnaire survey. Journal of Advanced Nursing 2008, 61(4):403-412 [33].	UK
Cooper R, Anderson C, Avery T, Bissell P, Guillaume L, Hutchinson A, Lymn J, Murphy E, Ratcliffe J, Ward P: Stakeholders' views of UK nurse and pharmacist supplementary prescribing. Journal of Health Services Research & Policy 2008, 13(4):215-221 [34].	UK
Bissell P, Cooper, R., Guillaume, L., Anderson, C., Avery, A., Hutchinson, A., James, V., Lymn, J., Marsden, E., Murphy, E., Ratcliffe, J., Ward, P., and Woolsey, I: An Evaluation of Supplementary Prescribing in Nursing and Pharmacy. London: Department of Health 2008 [35].	UK
Latter S, Maben J, Myall M, Young A, Baileff A: Focus. Evaluating prescribing competencies and standards used in nurse independent prescribers' prescribing consultations: an observation study of practice in England. Journal of Research in Nursing 2007, 12(1):7-28 [36].	UK
Latter S, Maben J, Myall M, Young A: Evaluating the clinical appropriateness of nurses' prescribing practice: method development and findings from an expert panel analysis. Quality & Safety in Health Care 2007, 16(6):415-421 [37].	UK
Courtenay M, Carey N, Burke J: Independent extended and supplementary nurse prescribing practice in the UK: a national questionnaire survey. International Journal Of Nursing Studies 2007, 44(7):1093-1101 [38].	UK
George J, McCaig DJ, Bond CM, Cunningham ITS, Diack HL, Watson AM, Stewart DC: Supplementary prescribing: early experiences of pharmacists in Great Britain. The Annals Of Pharmacotherapy 2006, 40(10):1843-1850 [39].	UK
Flenniken MC: Psychotropic prescriptive patterns among nurse practitioners in nonpsychiatric settings. Journal of the American Academy of Nurse Practitioners 1997, 9(3):117-121 [40].	USA
Batey MV, Holland JM: Prescribing practices among nurse practitioners in adult and family health. American Journal of Public Health 1985, 75(3):258-262 [41].	USA

While there have been previous published reviews of non-medical prescribing, none have considered the evidence from one setting, in this case primary care, or have focused on outcomes.

In this review, 19 papers of 17 empirical studies (two studies published two articles each) were identified which provided evidence of patient outcome of NMP in primary care settings. The majority were undertaken in the UK with only one each from the USA, Canada, Botswana and Zimbabwe. Seven papers report on UK studies of nurse prescribing from a limited nurses' formulary. Seven papers reported on qualitative designs and four of these had fewer than ten participants. Two reported on surveys of opinion and experience. Eight papers reported on record reviews of prescriptions or clinical consultation by NMPs. Those studies that provide objective measures are mainly descriptive. Only one provided some comparative evidence of another type of prescriber, GPs, by which to judge the impact on patient outcomes or outcomes on the efficiency for the health system [52]. While there may be a publication bias in reporting positive outcomes present in those identified, many of the studies included in the review had design weaknesses and limitations, both as indicated by the authors and evident through critical appraisal of the papers. The strength of evidence they provide on the whole is limited.

The review findings from stakeholders' perspectives suggest that NMP in primary care effectively improves patients' understanding of treatment, condition and self-care and provides a better level of care. As the literature suggests that concordance is a major issue in the effective use of medicines in primary care settings [62] the impact of additional information and advice may be significant in considering which type of prescriber is effective for which particular patient groups. This proposition requires further testing and investigation.

We found very limited evidence in relation to other indicators of effectiveness of NMP outcomes such as of patient safety and clinical outcomes. The overall number of research-based studies to evaluate impact and outcome of NMP was low given that NMP was introduced in many countries over 30 years ago. In part this reflected the number of papers excluded as it was not possible to separate primary care related data from secondary care related data but it may also be that NMP is seen as producing positive outcomes in situations where there are no alternative prescribers. This may explain the absence of empirical outcome evidence from low income countries in particular, although this may also reflect the review search strategy, which did not search country specific journals not indexed on the major electronic databases. Given that it is a minority of countries that have given prescribing authority to professionals other than doctors and dentists, it may be that it is this type of evidence that would be of value to policy makers and requires further investigation and publication.

In relation to efficiency of NMP in primary care, the review suggests that patients received services that were timely, seamless and of high quality from nurse and pharmacist prescribers. One study reported opinions that NMP was cost effective in primary care. We were unable to find any papers from a health economics perspective or that modelled the efficiency impact from either patient or the health services perspective. We suggest that this is an aspect that warrants further investigation.

All the studies investigating acceptability of NMP indicated that NMP was well accepted and favoured by patients, nurses, pharmacists and other health care professionals. The gradual growth over time of legislative authority to NMP and also of the numbers of non-medical prescribers, particularly nurses, in countries such as the USA and the UK, suggests that the acceptability is based not just on immediate levels of satisfaction with the clinical encounter but perceived value to the health care system as a whole.

The review findings also report that patients considered it was easier, quicker and convenient to get an appointment with NMP and their access to medicine and health care professionals was improved. For all countries the issue of timely access to appropriate medicines has health service and public health ramifications. For countries with well developed primary care services such as the UK, the ability of primary care professionals other than doctors to provide consultations that include prescribing may improve waiting times to consult and help manage demand and potential dissatisfaction. The issue of equitable access to safe and affordable medicine is critical for lower-income countries where the access to medicines is compromised by insufficient health facilities and staff, low investment in health and the high cost of medicines [63]. In these settings if legislative authority to prescribe is not extended to groups other than doctors and dentists, using mechanisms such as patient group directions or standing orders for community health workers for a specified essential drug list and immunisation list may have significant and critical public health impact. The contribution of these types of mechanisms with a broader group of community health staff is not within the scope of this review but warrants further investigation.

This review has limitations in that it included only English language studies and those accessed through electronic sources and therefore may have excluded evidence from many Scandinavian, African, South East Asian and South American countries. However, our review of countries that have legislated for prescribing authority for professionals other than doctors and dentists would suggest that researchers from many of these countries are likely to publish evidence in English language journals, although not necessarily ones that are indexed through the databases we searched.

Our focus on patient and health service outcomes has been both a strength and a weakness: while outcomes are important, the small number of studies finally included demonstrate how limited the evidence is. We argue that it is these aspects that most urgently need investigation. Our focus on solely primary care has also meant that we have had to exclude some more recent studies providing evidence from mixed primary and secondary care settings, aspects such as clinical appropriateness of NMP, e.g. Drennan et al, 2009, Latter et al, 2010, and Bissell et al, 2008 [3, 26, 35]. In many of these studies there were substantial numbers of NMP in primary care settings. We suggest that secondary data analysis of some of these studies by health care setting may be invaluable to providing evidence for service planners, commissioners and managers.

NMP has been implemented and evolved differently in different countries. Around twenty countries out of 193 member states of the World Health Organisation (WHO) provide legal authority to nurses and other professionals allied to medicine to prescribe medicines at a certain level and others are considering introducing legislation. This suggests that internationally twenty first century policy makers are beginning to look as to how to move beyond twentieth century established professional boundaries for the benefit of both public health and their health care economy. Primary health care is the setting where timely, and equitable, access to safe and appropriate medicines is most critical for the well-being of any population. Our review suggests that there are substantial gaps in the knowledge base to help evidence based policy making in this arena. We suggest that this review indicates there is a need for secondary data analysis of existing studies and commissioning of new studies that address questions of non-medical prescribing in primary care across a broad range of patient and health service outcomes, including economic dimensions.