Description of the health care challenge
A range of health workforce strategies are needed to address issues of health service access and efficiency. In developed countries, the increasing demand for health services arises from an ageing population and the resultant increasing burden of chronic disease (Bhanbhro 2011; Duckett 2005; Phillips 2008; WHO 2012).
Increased health demands can be met in part by task substitution within the health workforce. One health workforce strategy for task substitution is to permit prescribing by healthcare providers other than medical staff (doctors or dentists). Non-medical prescribers may include nurses, pharmacists, allied health professionals and physician assistants. Extending a health provider's scope of practice, including the right to prescribe, has been supported in a number of countries as a means of benefiting patient care by the effective use of health professionals' skills, improving patient access to timely care, improving patient choice and enhancing teamwork and better use of resources (Department of Health 1999; Ellis 2006; Hooker 2006; Stewart 2010).
The devolution of prescribing rights in developed countries has continued from a historical base in the United States of America (USA) in the 1970s through to more recent government led reforms in the United Kingdom (UK), Canada, the Netherlands, New Zealand and Australia. While the definition of prescribing may vary between countries for the purpose of our review prescribing is defined as "an iterative process involving the steps of information gathering, clinical decision making, communication, and evaluation that results in the initiation, continuation or cessation of a medicine" (Australian National Health Workforce 2010). The term 'medical prescribing' is prescribing by medically qualified doctors. Prescribing by dentists is excluded from the definition of 'medical prescribing' and this review. The supply of non-prescription (over-the-counter) medicines by pharmacists or pharmacy assistants working in community pharmacies is excluded from our definition of prescribing. The term 'non-medical prescribing' originates from the UK, where it is defined as "prescribing by specially trained nurses, optometrists, pharmacists, physiotherapists, podiatrists and radiographers, working within their clinical competence as either independent or supplementary prescribers" (National Prescribing Centre 2012).
Supplementary prescribing which was introduced in 2003, is defined as "a voluntary partnership between an independent prescriber (a doctor or dentist) and a supplementary prescriber (e.g. nurse, optometrist, pharmacist, physiotherapist, chiropodist/podiatrist and radiographer) to implement an agreed patient-specific Clinical Management Plan with the patient's agreement" (Department of Health 2003). Non-medical prescribing rights were extended in 2006 with the introduction of independent prescribing. The UK Department of Health defines independent prescribing as "prescribing by a practitioner (e.g. doctor, dentist, nurse, pharmacist, and optometrist) responsible and accountable for the assessment of patients with undiagnosed or diagnosed conditions and for decisions about the clinical management required, including prescribing". Independent prescribing is one element of the clinical management of a patient and occurs in partnership with the patient. It requires an initial patient assessment, interpretation of that assessment, a decision on safe and appropriate therapy, and a process for ongoing monitoring. The independent prescriber is responsible and accountable for at least this element of a patient's care. (Department of Health 2006). Independent prescribing does not require a Clinical Management Plan. From 1 May 2006, nurse and pharmacist independent prescribers who completed the appropriate training could prescribe, with a few exceptions, any licensed medicine for any medical condition within their competence. In 2009, independent prescribing rights were extended to include unlicensed medicines. While prescribing of controlled drugs was restricted, this limitation was removed through legislative change in April 2012 (Home Office 2012).
In the USA, devolution of prescribing authority varies from State to State. Collaborative Practice Agreements in 46 States allow a pharmacist to partner with a physician to manage a number of health services, including drug therapy (Law 2013; Thomas 2006). Physician assistants and nurse practitioners were introduced in 1967 to support medical care. These practitioners undertake a range of clinical functions including prescribing (Hooker 2006). Within Canada, a pharmacist's scope of prescribing practice varies between the provinces from independently prescribing to adapting (modifying) or continuing prescriptions (Law 2012). A collaborative prescribing model has emerged as the preferred model of practice within New Zealand and Australia. Collaborative prescribing is undertaken within a multidisciplinary team and can include the continuum of prescribing from transcription of orders (with or without medical signature), prescribing specified drugs and doses by protocol, prescribing by clinical management plan (allowing choice of drugs and doses) to independent prescribing where a prescribing consultation with a medical practitioner is not required (Weeks 2008; Wheeler 2012). Health Workforce Australia has recently developed a pathway for non-medical prescribing. Prescribing models emphasise team communication and are divided into autonomous prescribing, prescribing under supervision and prescribing via a structured prescribing arrangement (Health Workforce Australia 2013). As part of the reform process health agencies in Australia, Canada, New Zealand and the UK have developed prescribing competency frameworks for non-medical health professionals (National Prescribing Centre 2012; National Prescribing Service 2012; Pharmacy Council of New Zealand 2013; Yuksel 2008).
Description of the intervention
For the purpose of our review the term 'non-medical prescribing' will be used to cover the prescribing of medicines by a broad range of healthcare providers other than doctors and dentists, prescribing in primary or secondary care. No limitation is set on the type of non-medical health care provider undertaking prescribing nor the scope of their prescribing practice. Our review looks at prescribing, which as per our definition is much broader than issuing a prescription. Frequently, non-medical prescribing is done in collaboration or partnership with doctors, and within this practice there are different models of prescribing. Our review may cover degrees of substitution and supplementation.
The role of non-medical prescribers in the secondary care settings may involve supporting acute or chronic care by prescribing in a timely way medication on admission, discharge or where there is a specialist need e.g. total parenteral nutrition. Specialist outpatient clinics managed by non-medical health professionals may exist in either the primary or secondary care setting e.g. for the management of hypertension, lipids, diabetes and pain. In primary care settings, prescribing may be undertaken by nurses or other healthcare providers caring for patients in their homes or through involvement with general practice teams, community health centres, mental health teams or community pharmacies.
How the intervention might work
Non-medical prescribing has developed as an accepted health care policy in a number of countries to improve access to health care, to better use the skills of doctors who can focus on more acute patient needs, to better use the skills of pharmacists, nurses and other health providers, to potentially reduce costs for achieving the same or better health outcomes for consumers, and to retain health workers by increasing job satisfaction (Department of Health 1999; Tonna 2007). While qualitative studies support non-medical prescribing from a patient and practitioner perspective, robust evidence is required of clinical, economic and humanistic outcomes. It is noted that where non-medical prescribers are practicing in collaborative teams it may be difficult to apportion the impact of the non-medical prescriber on the primary and secondary outcomes of this review. Wider adoption of non-medical prescribing practice in developed countries frequently faces local regulatory hurdles and opposition from the medical establishment which has raised concerns about professional autonomy, patient safety, the diagnostic competency of non-medical prescribers and costs (Cooper 2008). Evidence that patient outcomes arising from non-medical prescribing are equivalent or better than doctors will provide a basis for policy makers to support wider implementation of this practice outside of the UK.
Why it is important to do this review
It is important for health practitioners and policy makers to understand the evidence existing for non-medical prescribing to address access or health workforce needs. This information will also guide future decision making with regards to implementing or expanding non-medical prescribing.
Potential beneficiaries of the findings include:
policy makers seeking to use workforce resources more efficiently;
policy makers seeking to improve health systems in primary and secondary care;
policy makers seeking to meet a clinical need;
policy makers and consumers seeking evidence of safe and effective practice;
consumers seeking greater choice and easier access to medicines;
non-medical health professionals seeking to better utilise their skills and/or extend their scope of practice;
medical staff seeking to focus on patients with the greatest medical need; and
researchers interested in evaluating non-medical prescribing.
Despite gradual rolling out of reforms, the evidence for the potential benefits of non-medical prescribing from well controlled trials involving a wide range of health professionals requires identification, synthesis and evaluation. Several narrative reviews of the non-medical prescribing literature have been undertaken (Australian National Health Workforce 2010; Kay 2004; Tonna 2007), and the British government commissioned two evaluations covering supplementary and independent prescribing (Bissell 2008; Latter 2010).
A Cochrane systematic review on substitution of doctors by nurses in primary care cautiously found substitution of doctors in primary care with suitably trained nurses can produce as high a quality of care and as good health outcomes with no appreciable difference between doctors and nurses in resource utilisation outcomes associated with prescribing (Laurant 2004). The review was limited to nurses in the primary care setting as first contact or ongoing care for undifferentiated patients.
A further Cochrane review "found that the question of whether pharmacists can manage drug therapy as well as physicians remains unanswered due to a shortage of studies" (Benney 2000). The review found a single randomised controlled trial (RCT) of pharmacist managed drug therapy including prescribing drugs (Hawkins 1979), which demonstrated some improvement in process outcomes but there was no big difference in patient outcomes.
Against this background, we seek to systematically identify, review and update the evidence from controlled studies and uncontrolled studies (e.g. interrupted time series (ITS) studies) on the clinical, humanistic and economic outcomes of non-medical prescribing in primary and secondary care settings. This review will also consider any adverse effects of non-medical prescribing which may be clinical (e.g. deterioration in care or incidence of adverse drugs reactions), economic (e.g. increased treatment costs) or humanistic (e.g. decreased patient satisfaction).
The proposed review will cover a wider range of healthcare providers undertaking non-medical prescribing; span primary and secondary care settings and consider acute and chronic prescribing situations.