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Prescribing as an intervention became open to suitably qualified mental health nurses (MHNs) across England in April 2003. Initially, MHNs were only able to act as supplementary prescribers (SPs) – prescribing through a patient-specific clinical management plan, formulated collaboratively with a doctor and patient, and based on a diagnosis established by a doctor. In 2006, the British National Formulary (BNF) was opened up to appropriately qualified MHNs. Within their area of competence, independent prescribers (IPs) can therefore diagnose and prescribe any licensed medicines and some controlled drugs without supervision from a doctor.
Original policy objectives for non-medical prescribing (NMP) came from the NHS plan (Department of Health 2000) to improve care, choice and access to medicines. Independent prescribing (IP) has the potential to further streamline the care provided in acute and community mental health services and improve service users' access to prescribed medicines (Jones 2006, 2008); nurse prescribing could also potentially help improve concordance (Wilhelmsson & Foldevi 2003, Nolan & Bradley 2007) and generally enhance information and education (Smith & Hemingway 2005).
The same training programme qualifies nurses for both supplementary prescribing (SP) and IP, with a generic preparation common to all nursing specialities. Nurses are required to ensure that their prescribing practice remains within their area of competence and the limits of their knowledge (Department of Health 2007). The majority of trusts across England have implemented governance strategies and policies for NMP (Latter et al. 2011). With respect to MHN prescribing, the majority of trusts have developed local processes specifying that nurses should prescribe as SPs before gaining IP status (Dobel-Ober et al. 2010). Transition between SP and IP typically lasts between 6 and 12 months and often includes additional training or mentorship (Dobel-Ober et al. 2010).
Mental health nurses have experienced a number of difficulties utilizing the SP role. Barriers to implementation include a lack of remuneration for taking up the role, unsupportive medical colleagues, limited administrative support (Kaas et al 1998, Bradley et al. 2008), limited organizational readiness, misunderstanding among colleagues, lack of confidence in ability to prescribe (Latter & Courtenay 2004, Smith & Hemingway 2005, Skingsley et al. 2006, Bradley et al. 2008, Elsom et al. 2008) and difficulties in defining MHN's remit for prescribing practice in order to assure continued competence to prescribe (Bradley, Hynam & Nolan 2007). Level of interest taken by different trusts has also varied significantly (Dobel-Ober et al. 2010). Consequently, a relatively low number of MHNs than hoped have undertaken prescribing training and a large proportion of those who have trained have not implemented their roles in practice (Gray et al. 2005, Norman et al. 2007, Dobel-Ober et al. 2010).
The project reported here was carried out by a trust in the West Midlands with funding from the Strategic Health Authority.
Shortly before this project started, a number of activities and governance structures had been implemented to support NMP within the trust. A register of active nurse prescribers was developed, supported by an annual approval to practice form and a defined return to practice process. A competency framework was designed to promote continued professional development for trained prescribers and several peer support groups were developed. Meetings also took place with managers and doctors in order to raise their awareness and understanding of the NMP role. Clear criteria were set out for nurses aspiring to undertake NMP training and for their managers.
The main aims of the project were to increase the number of active independent MHN prescribers and ensure good practice among new and existing IPs. Lack of self-confidence and structured support have been identified as barriers to becoming active prescriber (Hemingway 2005, Skingsley et al. 2006) and discussions with local IPs seemed to confirm this perception. By setting out a clear framework and guidance, specific formularies were expected to increase prescribers' confidence and promote transition to IP for those who had remained inactive or had only prescribed supplementary. Formularies were also expected to provide renewed support for existing IPs.
The project developed formularies reflecting the clinical speciality and area of competence of each prescriber. Formularies were either designed for individuals or for teams if appropriate. Each formulary was designed through a process of consultation with nurses, a consultant psychiatrist working in the specific clinical area and a pharmacist. Formularies were drafted by the pharmacist, and then approved by the local medicines management committee. For each medication, formularies include: drug group, condition to be treated, general cautions, contraindications, administrative route, dose and administration schedule, use in pregnancy, use in breast feeding, monitoring, quick reference guide to common side effects and important drug to drug interactions, condition where dose adjustment are required.
This paper describes an evaluation of this project, assessing its impact on the numbers of IPs, their utilization of the formularies, barriers to the full implementation of independent MHN prescribing locally and the views and experiences of existing IPs utilizing formularies.
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The project design was reviewed against guidance issued by a local research ethics committee. The project fell clearly within the remit of service evaluation, with the main aim of evaluating the success of the service development and to improve the quality of patient care in the local setting. The study was registered with the local audit committee.
A project lead recruited 20 trained nurse prescribers (NPs) and worked collaboratively to design specific formularies; selection was based on discussion with nurses and their managers to ensure that there was a definite need for the role within their team or service and that this role would receive full managerial support. Trained prescribers who had remained or become non-active because their current role did not lend itself to prescribing were not asked to take part in the project; this included essentially nurses working in management positions.
Participants were interviewed 1 month after having received the formulary. Interviews were semi-structured and focused on current prescribing practice, expectations of the potential use of the formularies and how the formularies were created. Ten interviews were carried out before data saturation was reached. The selection of interviewees was done in order to represent a wide range of situations among project participants. Variables taken into account included the use of a team or individual formulary, and the fact that nurses were non-active SPs or IPs when formularies were issued. A second phase of semi-structured interviews took place 6 months after the introduction of the formularies and focused on their utilization, whether they were perceived to have been useful or had an impact on practice. All 10 initial interviewees were seen again and a further four participants were interviewed; this led to data saturation for the second phase of interviews. This increase in the number of interviewees reflected the need to further explore issues that had been raised by some interviewees but had not been discussed with all of them.
Interviews were recorded, transcribed verbatim and entered into NVivo 8, a software package designed to support qualitative data analysis. Thematic analysis was carried out on all transcripts (Miles & Huberman 1994, Denzin & Lincoln 1998).
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The 20 nurses recruited to the project worked in six different clinical areas: assertive outreach, crisis resolution and home treatment, early intervention, perinatal, substance misuse and services for older people. The majority worked in the community (n= 16) and four worked either solely in inpatient or in both settings.
Figure 1 provides a summary of the prescribing status of project participants before the implementation of formularies and after 6 and 12 months of use. When formularies were issued, nine participants were already prescribing independently and had been recruited to the project in order to evaluate the value of formularies on their existing practice. The other 11 participants were either non-active (n= 8) or SP (n= 3).
Twelve months after the introduction of formularies, all participants who were already prescribing independently had remained active; all of those who were inactive at the beginning of the project had become IPs and two of the three SPs had made the transition to IP. The only non-active prescriber at that stage had previously been SP and had stopped prescribing following changes within their service.
Clear boundaries and information
All interviewees commented on the clarity provided by the formularies: the list of medications removed any uncertainty about each prescriber's area of competence and was seen to increase their confidence:
I think the formulary is our safety net, it is all printed out, all the interactions are there, without having to trawl through things you have it all at hand. Also it is trust policy so you are working within the guidelines for that.
Interviewees described using the formulary as a reference document, but for complex cases they would also access the BNF and/or advice from a medical colleague:
I use the formulary first and foremost and if there is anything else I am not sure of, I will look in the BNF in case something has been missed, but there isn't, but my first thing is the formulary.
On the whole, formularies were considered useful both as lists of medications available for each prescriber and as a centralized source of information for each medication.
Transition from SP to IP
Formularies were considered particularly helpful by both those who had been SP for extended periods of time but had found it difficult to become independent, and by those who only recently started prescribing:
I was a supplementary prescriber before and having the formulary has enabled me to be an independent prescriber in that formulary, so it has significantly changed things.
I have become independent but I think that confidence has come from having the formulary initially.
In other instances, the formularies represented a helpful, but not determining factor in becoming independent:
I think we would have done, I don't think we would have done as quickly but I think [ . . . ] with the team structure changing [ . . . ] we have got to adapt.
The formularies were a means by which interviewees enhanced their prescribing confidence, supporting them to work towards IP practice. In the first phase of interviews, three NPs revealed that they had started prescribing independently, but that this had been limited; although they took formal responsibility for the prescription, they sought advice from a medical prescriber and initiated a clinical management plan for all patients on their caseload. In this respect, their ‘independent prescribing’ closely resembled their previous SP practice, rather than reflecting a new mode of prescribing. The second phase of interviews revealed significant changes for these three particular prescribers:
I am more confident in getting on with it. There are still discussions with the medics, but I feel more confident about going away and making the decision about medication on a day to day basis, I don't need to keep checking.
With experience, all three respondents had become more confident and had developed a truly independent practice without the routine need for medical support: advice was only required in particularly complex situations and regular clinical supervision was seen as sufficient to deal with most common situations.
Shared decision making
During the second phase of interviews, one of the respondents revealed that they used their formulary in order to discuss medication with service users:
It's been useful to have that with me, and I have used it with patients to show them some of the information.
The utilization of formularies to enhance the information provided to service users had not been anticipated by the project team: formularies have the potential to be used as a shared decision-making tool. All second-phase interviewees were subsequently asked to indicate whether they had used the formularies directly with service users. Five nurses indicated that they had done so and four felt that they would in future consultations:
I would be happy to get [the formulary] out and go through it with patients, show them what it says about the medication they are taking.
Interviewees who had already used formularies in this context indicated that it was a good starting point for discussion. None of the respondents believed that formularies could or should replace leaflets or specialized shared decision-making instruments; they indicated that it was an additional means of communication that could generate further discussion.
Very few barriers were identified. Five respondents indicated that despite the multidisciplinary approach used to identify drugs for inclusion, some medications had been omitted from formularies:
It has restricted [IPs] and they have found they have wanted to prescribe things that aren't in the formula and I think initially when we did it, and we looked at all the drugs we used, we obviously missed a few out that we do not always think about.
A minority of interviewees (n= 4) also indicated that the format of the formularies did not match individual preferences: some of them wished for a font larger and easier to read, others for a smaller document (A5 instead of A4). Prescribers drew comparisons between their personal formularies and the BNF, but their preferences for either varied:
The BNF fits into my bag better; it is a better size to carry around and because I was prescribing from the BNF before and I have continued to do that. [ . . . ] I would definitely carry it around with me and use it if it was in a better format, because I would use it in the same way as I use the BNF.
I think it is easier to read [than the BNF], it is a good guide and useful to have it in front of you. There is really good information within it.
Despite the overall positive responses to the introduction of formularies, it was observed that these would be insufficient unless accompanied by support from team members. Furthermore, all but one respondent felt that newly qualified nurse prescribers should gain experience and confidence as a SP before progressing to IP practice:
I have had 3 years to become comfortable. I think it would be a bit difficult with the new nurse prescribers, I know they will have the supervision and the support, but I feel a lot more comfortable now and I think that that is the time factor, it has given us time to adjust to things.
Definitely supplementary leading into independent, because I think you need to learn the assessment process and there is other training that I have done since being a non-medical prescriber on diagnostic assessment and things like that which have been really valuable.
The SP role was regarded as a ‘trial period’ within which nurse prescribers could develop their confidence and assure others of their safety:
I would prefer them to be supplementary for a while, to see how they are and look at the decisions they are making.
People coming in newly trained I would like to see what they have learnt, what they know, what other training do they need. That can take people 3 or 4 months, others it could take longer.
Supplementary prescribing continued to be valued by respondents despite their capacity to prescribe independently. Beyond its relevance in the context of controlled drugs, SP was also seen to promote team communication and multidisciplinary approach.
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The main limitations of this project relate to its local nature and to the fact that a number of governance structures were implemented in the organization shortly before the development of the formularies. The introduction of formularies within this trust began with those nurses who were felt to be in a strong position to become active IP because there was a clear role for nurse prescribing within their service and they had the support of their team to develop their roles. Formularies were not developed as the sole method but as a resource to encourage transition from SP to IP and help ensure good practice in existing IPs.
This study found that formularies were valued by nurses to support their transition towards IP, but also as a source of information to enhance and encourage good prescribing practice. Although formularies were felt to have been instrumental in developing prescribing practice in some cases, it was clear that their implementation would not replace team support or SP experience. The study highlights the need for organizations to adopt a strategic approach to plan the future for NMP, a finding in line with other research published recently (Latter et al. 2011).
One of the consequences of the project work described in this paper was a renewed interest in the potential of NMP in mental health and a significant increase in the numbers of nurses undertaking prescribing training. As numbers increase, so does the need to ensure that appropriate governance and safeguards are in place. Methods by which independent MHN prescribers can be supported in practice warrant further investigation. There is also the need to further develop outcomes research in this area, with a particular focus on the role of nurse prescribers in promoting adherence among those with severe and enduring mental illness.
Latter et al. (2011) concluded recently that service users do not have a particular preference for nurse or doctor prescribers, but certain attributes within prescribing consultations are particularly valued, including the ability to listen to service users' views and provide good information. Earle et al. (2011) reported that although service users were generally positive about nurse prescribing, improvement could be made with regards to sharing information about medications. Formularies could be used to enhance shared decision making and to promote concordance.
As well as helping nurses to develop their confidence and competence to prescribe, formularies could be employed within continued professional development. Regular reviews of the formularies could provide the opportunity to ensure that IPs are fully aware of any potential changes or development in relation to all medications included in their formularies. This may also be the means by which they review and develop their practice, in close collaboration with their teams and prescribing colleagues.
By their very nature, formularies have limitations: if they are used strictly, they limit each prescriber to a clearly defined set of medicines. If each formulary does not reflect accurately the clinical area and needs of the prescriber, they could become cumbersome and detract from the value of nurse prescribing. Conversely, if a clear process is in place to enable nurses to alter their formularies, discussion about practice could be encouraged and lead to enhanced practice. Formularies need to be reviewed regularly to take into account each prescriber's needs and expertise but also to reflect national guidelines and new developments.
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Individual and team formularies appear to be useful tools on several accounts. They set clear boundaries around what each prescriber is able to prescribe independently, thus enhancing safety for patients and confidence for prescribers. Formularies could be particularly useful to introduce IP in contexts such as crisis resolution and home treatment services, where nurses are unlikely to get the opportunity to develop prior experience of SP.
Formularies can be used to provide information to service users and promote shared decision making, which in turn could improve treatment concordance and adherence to medications. They also have the potential to be used as a basis for continual professional development and to promote consistent practice, taking into account national developments as well as local expertise.
There is no indication that nurse prescribers feel unduly restricted by formularies if these are carefully developed and reviewed, and if clear procedures are in place to make appropriate and timely changes.