An audit of the prescription and supply of medicines by podiatric surgery teams in the UK

In the UK, ‘prescription only’ medicines are one of three distinct categories of medicine, reflecting the relative risk associated with their use (Borthwick et al, 2010). Designated as such within the terms of the Medicines Act (1968), prescription-only medicines (POMs) were initially intended to be issued by a very limited number of ‘approved prescriber’ professions, notably doctors, dentists and vets (Borthwick, 2008). At the time, nurses or allied health professionals (including podiatrists) were not considered potential prescribers. In the years since, it has become clear that advances in scope of practice and requirements in educational qualifications amongs these professions have shifted significantly (Borthwick and Maher, 2020).

One such example is the development of podiatric surgery in England, which would not have been possible without first securing access to medicines. Within this area, perhaps the most important class of medicines was local anaesthetics (Dagnall, 1995; Borthwick, 2001). Access to local anaesthetics allowed for the safe development of pain-free skin and nail surgery procedures but surgical techniques soon evolved and with that, the requirement for greater access to medicines. More advanced surgical techniques brought with them a need for post-operative analgesia, pre-operative antibiotic prophylaxis and perioperative thromboprophylaxis, to name a few. In the latter part of the 20^th century, there was then a pressing need to improve access to medicines.

For the UK podiatry profession, the first legal access to POM was granted in 1980 for four local anaesthetic medicines (Borthwick, 2008). Independent prescribing rights finally arrived in 2013 (Borthwick et al, 2017). In between, there have been various legal mechanisms made available to podiatrists to allow them degrees of access to POM, each falling short of full rights to access the required medicines.

Today, these mechanisms include ‘exemptions’ (short lists of POM approved for a specific profession – in the case of podiatry, two lists, one for sale/supply, one for administration), patient group directions, and the two varieties of prescribing, independent and supplementary. With the exception of patient group directions (PGDs), each require a separate educational basis, with acknowledgement of entitlement assigned through the use of ‘annotations’ to the official register of the regulatory authority, the Health and Care Professions Council.

The use of POM is, arguably, now a keystone to modern podiatric practice. Effective treatments provided in a single episode of care clearly prevent delays to patient care and reduce duplication of services – key requirements of contemporary healthcare practice across the Western world. The onus is therefore on skilled practitioners to maximise their use of these treatments to provide high-quality, timely and effective care. Failure to do so raises questions around ethical practice and professional responsibility.

A primary aim for the current study was to gain a greater understanding of the methods used by podiatric surgeons to access medicines in the UK. Within that, it is also relevant to establish the range and quantity of medicines used to support patient care, specifically in the context of those patients attending for foot surgery procedures. With the advent of independent prescribing, the authors were keen to identify whether prescribing was being adopted by a sub-speciality of the podiatry profession and whether alternate means of accessing medicines, such as PGDs or exemptions, remain relevant in clinical practice.

Methods

The Podiatric Audit in Surgery and Clinical Outcome Measure (PASCOM) is organised into an invasive domain (nail surgery, injection therapies and podiatric surgery) and a non-invasive domain (high risk, musculoskeletal and general podiatry). Within these domains, information is curated in episodes of care, which themselves are made up of multiple events, each of which is date- and time-stamped. These events include patient demographics (date of birth, gender) and referral source, a consultation event which captures ICD-10 (the 10^th revision of the International Statistical Classification of Diseases and Related Health Problems) diagnostic information. The treatment event records the provider location, procedure type, medical devices, medicines, anaesthesia type, ASA grade and details of clinician involvement. Other events relate to clinical investigations, injection therapies and post-treatment events. The latter allows for the collection of a pre-defined list of post-operative complications. The remaining events capture outcome data in the form of the Manchester Oxford Foot/Ankle Questionnaire (Dawson et al, 2006), the PSQ-10 patient satisfaction questionnaire (Rudge and Tollafield, 2003) and the NHS friends and family test (NHS England, no date). All three of these instruments can be completed via a secure online link accessed by email or alternatively via a paper form, which is then manually entered into the system by a registered user.

The PASCOM reporting suite generates reports in a standard HTML webpage format, which can be ‘printed’ as PDFs. Each report details the filtered date range, filters for centres and clinicians, treatment filters, total centres contributing data, total episodes of care included as a result of the above filters and the total number of treatments. The term ‘treatments’ refers to treatment events, which is a surrogate for admissions or day surgeries. For those reports where further interrogation of the data was required, they were exported to Microsoft Excel, which allowed for simple sorting and descriptive statistics. A full description of the PASCOM 10 reporting functions is available in the user guide (Maher, 2018).

PASCOM 10 data were extracted by the author on 20 January 2021 for the calendar year 2019. Owing to the live nature of the database, users may continue to upload retrospective records for 2019. Filters were applied to the PASCOM reporting dashboard to select podiatric surgery activity. Specifically, the reporting process excluded episodes of care where the sole intervention was either nail surgery or injection therapies. Although these procedure are performed by podiatric surgery teams, they are unlikely to be offered by podiatrists without surgical training. Within the reporting dashboard, the following reports were requested: the amalgamated report, which includes a pre-set series including invasive procedures, invasive fixations, invasive anaesthesia, invasive demographics, invasive medications, invasive post-treatment sequelae, invasive psq-10 and invasive MOXFQ. Additional reports were run for providers and referrals. Microsoft Excel format reports were run for invasive medication cohort, invasive medicines, and invasive procedures.

Results

Between the 1 January 2019 and the 31 December 2019, there were 11 189 admissions for podiatric surgery in England recorded on the PASCOM 10 database. A total of 103 surgery centres contributed data resulting in 18 497 recorded procedures or approximately 1.6 procedures per patient. Table 1 summarises the referral sources for this activity; most referrals originated with general practitioners, accounting for 77.4% of all referrals, while direct referral from podiatrists was also important (10.3%). Care was primarily offered in NHS settings accounting for 91% of recorded activity. Table 2 provides a summary. Females accounted for 76.3% of all patients with a mean age of 57.8 (s.d. 15.92) while males accounted for 23.7% with a similar mean age of 56.9 years (s.d 17.11).

Overall, 18 497 surgical procedures were recorded against 320 specific procedure codes. Table 3 provides a summary overview of the top 20 procedures. This list was achieved by compressing the 320 procedure codes into 79 simplified codes, whereby minor modifications of a standard surgical procedure were grouped. Over 94% of these procedures were performed under a local anaesthetic block, ranging from simple infiltrations through to advanced regional nerve blocks. To enable these surgical procedures to go ahead safely, 18 576 medicines were supplied, administered or prescribed from a list of 70 individual items which themselves derived from 15 broad classes of medication (Figure 1). Table 4 summarises the most commonly supplied medicines. Table 5 details the various methods used to access medicine, while Table 6 selects out those medicines defined by the Misuse of Drugs Act 1971 as controlled drugs (CD), which account for 28.7% of all recorded medicines.

Errors of commission or omission can occur when users input information on PASCOM 10. In the case of medicines, it was possible to, in reviewing the reports extracted from PASCOM-10, to apply UK law in the form of the Human Medicines Regulations 2012 and the Misuse of Drugs Act to determine clear and obvious errors in the recorded method of accessing medicines, where the chosen method is not legally available to podiatrists (Table 7). This allowed for error checking in three categories, independent prescribing, (where for example, it is not possible to currently prescribe a given medication); exemptions (POM-A and POM-S annotations) and over the counter (OTC) or pharmacy supply. Overall, 11% of records contained an error. The greatest number of errors occurred for independent prescribing at 20.4%.

Post-operative outcome data in the form of satisfaction, patient-reported outcomes and surgical complications or sequelae were recorded at 6 months post-operation and for completeness. Of relevance to the current study, 39% of patients described their pain medication as ‘excellent’ while 55% described ‘some discomfort’ and 4.3% described their pain medication as ‘ineffective’.

Discussion

Data extracted for the calendar year 2019 indicates what may be happening more widely in podiatric surgery and seems to demonstrate encouraging use of non-medical prescribing in preference to other methods of access. Table 5 suggests that access to POM by those using the PASCOM 10 system is mainly via independent prescribing (29%), with PGDs another popular choice (22.7%). Of course, there is a corollary to this apparent trend. The use of PASCOM 10 as a tool for recording such data is undertaken by podiatric surgeons and their teams, for the most part. At the time of study, 82 (80%) podiatric surgeons and their associated podiatry teams were contributing to the system. A total of 356 users were registered and actively contributing to PASCOM 10, but it is unclear how many of these practitioners recorded their medicines' data – a system limitation that makes the data more unclear. Further, it is not known how many of those 356 active PASCOM users are also annotated as independent or supplementary prescribers. It is known from November 2020 figures that there are 12 524 current registrant podiatrists, 10 246 of whom are annotated for the ‘exemption’ list of medicines (administration only), 6164 for the ‘exemption’ supply list, 445 as independent prescribers and 512 as supplementary prescribers (Health and Care Professions Council [HCPC], 2020). However, the drawback of this list is that it can only list how many podiatrists are eligible to use these medicines. It does not tell you how many actually use them in practice. Of equal importance for those podiatrists who are not contributing to PASCOM 10, there is no other nationally accessible record of their access to medicines.

A current concern for the profession is the complex issue of access to CDs. Medicines classed as controlled accounted for 28.7% of all medicines recorded on PASCOM 10 in 2019. It is presently at the forefront of activity to extend the legislative rights of podiatrists in the UK. Podiatrists can currently supply codeine phosphate (POM-S annotation) and can prescribe several schedule five controlled drugs including the analgesic dihydrocodeine, however, PASCOM 10 data indicates that a total of 797 medicines were requested from a GP; it is interesting to note that over half of these requests (56.3%) were for CDs. Though access to medicines has greatly improved, podiatrists still find they are limited in their ability to manage pain pharmacologically. This is not a minor point to be dismissed; podiatric surgery satisfaction data reveals that 4.3% of patients felt their pain relief after surgery was inadequate while 55% experienced some discomfort. This indicates there is still room for improvement in pain management. Yet for the most part, independent prescribing has not proved helpful in this regard, with prescribers instead turning back to their exemptions list medications or perhaps worse, seeking prescriptions from GPs or other medical colleagues such as anaesthetists. The situation is not dissimilar to that faced by nurses and pharmacists in the early years of their non-medical prescribing before gaining full access to CDs. Access to scheduled CDs for the benefit of patient care remains a pressing concern for several professions in the UK, including physiotherapy, radiographers and paramedics (Gallagher, 2021).

What is of critical importance here is that independent prescriber podiatrists are unable to prescribe every medicine that they may require. The legislation does not always set in stone rights to access every medicine needed. Things also change. Medicines may be reclassified, being moved from one category of medicine to another, more restricted category, thus altering access rights in the process. Tramadol is one such example. Available to independent prescriber podiatrists as a useful opioid drug for use in the management of pain, it was reclassified in 2014 from a prescription-only medicine to a CD. Overnight, IP podiatrists no longer had access rights to it. CDs require Home Office approval and access authority must also be granted under the Misuse of Drugs Act (1971) and its regulations (2001) as well as those of the Medicines Act (1968) via the Human Medicines Regulations (2012). Amendments to the legislation are required to put right the problem inadvertently created by the reclassification of Tramadol.

Currently, a bid to add four further CDs to the list of CDs available to independent prescriber podiatrists is underway, with the public consultation phase recently concluded. It seeks to add Tramadol to the list, thus reinstating its position as part of the repertoire of medicines accessible by IP podiatrists. As the same fate befell gabapentin and pregabalin, they, too, are added to the list in the hope that access will be reinstated. Only morphine sulphate is a novel addition to the list for approval (NHS England, 2020). This exemplifies and typifies the problems of limited access to required medicines. Each mechanism is limited in ways that ensure podiatrists are unable to fully respond to patient needs and are less able to adapt quickly to changing workforce demands.

So has independent prescribing proved to be a saviour, improving access to care at the right time in the right place and reducing the burden on primary care doctors? There are certainly examples of independent prescribing making a difference–better access to antibiotics being an obvious example but while the profession faces the continued limitation of access to controlled drugs, inefficiencies in the system will continue and ultimately patient care will be impacted. There is then a well-defined need for expansion of prescribing rights in podiatry and perhaps parity with nursing colleagues if the original aims of the project are to be met.

In many respects, the profession in the UK has perhaps reached a watershed moment. As a prescribing profession–at least among its advanced clinical practitioners–it is arguably justified in asking for its IP status to be exactly that: independent. As a recognised independent prescriber, a podiatrist can make a diagnosis, and decide upon and initiate a management plan (which may include POMs). It is not helpful to be limited to a rigid, fixed list of POM (via exemptions of PGDs) or controlled drugs (which are themselves prescription-only medicines, but with additional safeguards required). If podiatrists are suitably educated, trained and assessed as competent to prescribe, should they not then be granted full authority to access whatever medicine is required?

In theoretical terms, it may be possible to argue that there are vestiges of medical dominance casting shadows over the recognition and legitimacy of non-medical prescribing (Willis, 2006). In addition, Bourdieu (1989) described the phenomena of ‘symbolic violence’, a concealed exercise of power designed to deny others legitimacy in the domain over which the dominant group presides. Deploying such theory might lead one to suggest that, hidden behind the cloak of legitimate concerns over governance, non-medical prescribing is subtlety constrained. Nevertheless, concerns over a burgeoning ‘opioid epidemic’ seem to give credence to a need to limit wider use or at the very least to put in place appropriate safeguards against abuse. Nor is the argument for access easily supported when rare instances of illegal dispensing of controlled drugs by podiatrists arise – to date uniquely in the USA, where access to opioid medication by podiatrists is widely available (Kelman, 2020).

PASCOM 10 has been used by podiatric surgeons in various formats for more than 25 years, but a number of concerns persist concerning the validity and reliability of data held within the system. Flaws in the design of the PSQ-10 questionnaire have been highlighted previously, uneven weighting of questions tends to result in clustering, which skews towards higher scores or better satisfaction (Rudge and Tollafield, 2003). The questionnaire's ability to reflect all dimensions of patient satisfaction has also been challenged (Maher, 2016). PASCOM 10 is often regarded as a service evaluation tool, and used as such, yet it has been suggested that PASCOM 10 is a poor fit for current models of service evaluation such as Donabedian's model or Maxwell's dimensions of quality (Maxwell, 1984; Donabedian, 1998; Maher, 2016). PASCOM 10 does align well with the principles of the SERVQUAL model proposed by Parasuraman et al (1985). At a local level, PASCOM 10 can yield useful information to support service evaluation, but the lack of a mandatory agreed methodology suggests a risk of significant disparity when datasets are reviewed at a national level. In addition, despite early attempts to test the PSQ-10 patient satisfaction questionnaire and the inclusion of other validated PROMS, there has to date been no attempt to test the fitness of PASCOM 10 for its intended use. Despite its continued popularity amongst podiatric surgeons, there is then a real and urgent need for research to confirm both the validity and reliability of PASCOM 10 as a clinical service evaluation and audit tool.

Registered users are free to enter data into PASCOM 10 as they choose. The system is intended for contemporaneous use, but can also be used retrospectively (Maher, 2018). As such, there is likely considerable variance with the risk of errors of commission or omission and decision making around what data to include or exclude and when to enter that information. Inputting errors are a persistent problem with users of healthcare registries (Hlaing et al, 2006; Kosy et al, 2013), but it is possible to design databases to minimise errors (Rasmussen et al, 2017). Errors were evident in the current study when comparing recorded methods of accessing medicines against the options legally open to podiatrists in the UK. An error rate of 11% for recording the route of accessing medicines indicates that at the very least, further work is required to validate the data contained within the PASCOM 10 database.

Conclusions

By way of PASCOM 10, the current study has demonstrated the range of medicines accessed by podiatric surgeons and their teams to support patient care perioperatively. Routes of accessing these medicines have also been identified. Encouragingly, independent prescribing appears to be a frequent choice for accessing certain medicines. Of note, it appears the management of postoperative pain could be improved with wider access to controlled drugs, namely opioid analgesics. There remains some uncertainty about access to medicines by those podiatrists who do not contribute to PASCOM 10. This study has also highlighted some concerns regarding the frequency of errors with the PASCOM 10 database and the ability of users to enter erroneous data. But it should not be dismissed as valueless – on the contrary, PASCOM 10 can provide revealing data on prescribing in podiatric clinical practice that is unique in the UK, though more work is required to ensure the validity of the dataset.

Key Points

• Podiatrists can access medicines through a range of legal mechanisms including independent prescribing
• Podiatric surgeons routinely access a range of medicines to support patient care
• The College of Podiatry actively collates data on medicines via it's bespoke audit system; PASCOM-10
• In 2019 over 18,000 medicines were accessed by podiatrists to support patient care
• The most common categories of medicines were analgesics, antibiotics, anti-inflammatories and anticoagulants
• Limited access to controlled drugs restricts the options for managing acute post-operative pain.