A published audit (Birch and Culshaw, 2003) and personal experience provides evidence that midwives sometimes administer prescription-only medicines (POM) in the absence of an emergency without a valid instruction, breaching professional rules, standards and guidance. Birch and Culshaw (2003) identified drug errors due to absent and inaccurate prescriptions in the maternity setting and suggest widespread occurrence. This article explores the context and potential extent of this illegal practice, offering suggestions for supervisors to influence change and support safety, locally and nationally, aiming to stimulate debate and generate interest in this aspect of professional practice.
Background and context
The current guidance to midwives, Standards for medicines management (Nursing and Midwifery Council (NMC), 2007), is confusing, and based on a convoluted series of Acts of Parliament, secondary legislation, regulations and amendments (Table 1), which can lead to misinterpretation and variation in application (Forrester and Homeyard, 2010; NMC, 2012a; NHS Education for Scotland (NES), 2012).
|Medicines Act 1968||Primary legislation regulating the classification, licensing, manufacture and distribution of medicinal products|
|Misuse of Drugs Act 1971||Classification of harmful substances and penalties for illegal possession and supply|
|Misuse of Drugs (Safe Custody) Regulations 1973||Storage of substances classified under Misuse of Drugs Act 1971|
|Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980
||Supply of General Sales List and pharmacy-only medicines by midwives|
|Medicines (Prescription only) Order 1980/POM order 1983||Exemption to prescription-only medicines for midwives|
|Misuse of Drugs Regulations 1985/2001||Supply of controlled drugs|
|Medicinal Products: Prescription by Nurses and Others Act 1992||Creation of legal framework for non-medical prescribing|
|Prescription Only Medicines (Human Use) Order 1997 and subsequent amendments 2000; 2002; 2004||Amendments to midwives exemptions|
|Prescription Only Medicines (Human Use) Amendment Order 2000||Introduced patient group directions|
|Controlled Drugs (Supervision of Management and Use) Regulations 2006||Strengthened control introducing Accountable Officers and Local Intelligence Networks|
|Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006
||Extension of non-medical prescribing|
|Prescription-Only Medicines (Human Use) Amendment Order 2010||Amendments producing current Midwives Exemptions List|
|Medicines for Human Use (Miscellaneous Amendments) Order 2011||Further amendment permitting administration of Midwives Exemption drugs by student midwives|
|Human Medicines Regulations 2012||Amalgamation of Medicines Act 1968 and amendments with little change in practice|
|Controlled Drugs (Supervision of Management and Use) Regulations 2013||Amalgamation of previous legislation and extension of control following Health and Social Care Act 2012|
(May not be fully inclusive)
Much of the confusion focuses on the nature and role of a prescription as it relates to midwives in practice. An unpublished questionnaire conducted via the North West Local Supervising Authority (LSA) network and presented to the North West LSA meeting of the LSAMO with supervisors of midwives in October 2014, demonstrated poor understanding of concepts within medicines legislation and inconsistent practice across the region. Drug errors in maternity, as in wider health care, instigate professional (NMC, 2012b), corporate (Armitage et al, 2007) and litigation (NHS Litigation Authority (NHSLA), 2012) procedures, sometimes all three simultaneously, and can be disastrous for women (NHS National Patient Safety Agency (NPSA), 2011) and babies (Ghaleb and Wong, 2006).
Consideration of wider historic and modern professional issues provides a context in which to frame the present position of medicines management within midwifery practice. The inception of the Midwives Act (1902) brought ongoing conflict between professional autonomy and control (Kirkham, 2010). Regulation, imposed on working class midwives by a medically-led elite minority, sought public protection from dangerous practitioners (Donnison, 1977; Heagerty, 1996), by raising standards of practice and the status of midwives through education. However, Heagerty (1996) concludes that a subtext of early regulation and supervision was to change the nature of the midwife and her relationship with clients, demanding loyalty to the profession.
While the balance of both leadership direction and affiliation with women was restored somewhat with the publications of Changing Childbirth (Department of Health (DH), 1993), Maternity Matters (DH, 2007) and Midwifery 2020 (DH, 2010), autocratic leadership persists into the 21st century. A bullying culture within maternity, and its relevance to midwifery supervision is widely documented (Kirkham and Stapleton, 2000; Kirkham, 2007; O'Brien, 2011). The latest NHS Survey in England reported 23% of staff experienced bullying, harassment or abuse from line managers and other colleagues (DH, 2014).
NHS Trust failings provide further context for incongruity in health care, illustrating a leadership culture that tolerated poor standards, leading to low morale and declining professionalism among nursing staff; and where bullying was also a feature (Francis, 2013). Francis (2013) criticises regulatory bodies, including the NMC, for assuming that others would be aware of important information, recommending increased policing of standards and openness when things go wrong. In response the NMC has revised the Code (NMC, 2015a) for implementation on 31 March 2015 and developed a model for revalidation of nurses and midwives, now under pilot, for introduction on 31 December 2015 (NMC, 2015b). Further action will reflect and strengthen professionals' duty of candour with guidance to be published in March 2015 (NMC, 2015c).
Failures at one maternity service caused the Parliamentary and Health Service Ombudsman (2013) to recommend change in the way midwives are regulated and a subsequent NMC-commissioned review of midwifery supervision was carried out by the King's Fund (NMC, 2014a). The NMC's acceptance of the King's Fund's (2015) key recommendation will eventually entail removal of statutory supervision from midwifery regulation following legislative change (NMC, 2015d). The King's Fund (2015) while acknowledging the strategic oversight, professional leadership and advocacy for women, independent of health care providers that the current system of supervision supports also highlights the risk of losing these benefits (including those pertaining to medicines management), engendered by the recommendation. Furthermore, the potential for autonomous midwifery supervision, highly valued by midwives themselves (King's Fund, 2015), to offer a strong foundation for their revalidation process (Foster, 2014) is also threatened.
Against this backdrop, supervisors must continue to support and guide midwives, seeking to prevent unacceptable practice, raise standards and safeguard mothers and babies (NMC, 2014b). The issue of medication administration is one of a range of dilemmas.
For nurses, medicine administration is central (Mayo and Duncan, 2004; Ulanimo et al, 2006) and reduction of errors benchmarks effective leadership (Kenmore, 2008). The same standards are expected of midwives (NMC, 2007), but in midwifery publications, administration issues, as distinct from pharmacology, are rarely published other than to explain the perplexing guidance (Griffith et al, 2010; Forrester and Homeyard, 2010). Lacking charisma compared to contemporary professional matters, such as woman-centred care and the normality agenda, the subject is perhaps uncomfortable for midwives, harking back to the medical model and control (Donnison, 1977).
Midwives, medicines and legislation
The Medicines Act (1968) provided a licensing system for supplying medicines. Previously, drug production and prescription was restricted by a patchwork of legislation pertaining to specific substances and their uses (The Royal Pharmaceutical Society, 2011). Despite controls, midwives could exercise autonomy when caring for women and administering medicines (Berkeley, 1946; Allison and Kirkham, 1996).
The Medicines Act (1968) and amendments, now amalgamated into the Human Medicines Regulations (2012) (Table 1), includes a list of midwives exemptions (ME) to POM rules, which, with general sales list (GSL) and pharmacy (P) medicines, restrict midwives to the supply and administration of a limited range of drugs subject to local arrangements in addition to local patient group directions (PGD) (NMC, 2007). Additional amendments permit non-medical prescribers (Griffith et al, 2010). A minority of midwives and nurses are qualified prescribers (NMC, 2008) and subject to specific standards relating to this function (NMC, 2006). Further legislation pertains to controlled drugs with special rules for supply, possession and administration under exemption for midwives. Rules specific to student midwives also apply to ME, controlled drugs and PGDs (NMC, 2007; 2009b; 2011a; 2011b).
The plethora of different categories of medications, conflicting guidance and local interpretation causes variations in policy and leads to confusion (NES, 2012). Local policy can override ME, and PGD development is resource-intensive and locally-managed. A consequence of complicated legislation and local variation is poor understanding of the concepts and differences between PGD and ME, and uncertainty as to when a prescription is, or is not, required. By negotiating this tangle in light of the existing evidence and its relevance to midwifery practice, supervisors of midwives fulfil their role in guiding midwives and protecting families (Deurden, 2005; Kingscott, 2010; NMC, 2014b).
Medication error and reporting
Medication errors and their potential for harm feature prominently in landmark adverse event publications internationally (Wilson et al, 1999; DH, 2000; Kohn et al, 2000); however, little evidence relates specifically to maternity care. As the majority of UK births occur in the acute hospital setting (Redshaw et al, 2011), this is where most medication is given by midwives. International systematic reviews examined prescription errors (Lewis et al, 2009) and drug administration errors (Keers et al, 2013) in hospitals. Both categories of error are relevant to midwives. Error rates varied widely, affecting up to 50% of admissions, and gross under-reporting, found in these studies (Lewis et al, 2009; Keers et al, 2013) also featured in wider health care settings (Kohn et al, 2000). Error types, as elsewhere, were due to system and human factors (DH, 2000; Kohn et al, 2000; Reason, 2000). Up to 60% of American nursing studies demonstrated under-reporting (Mayo and Duncan, 2004; Ulanimo et al, 2006) due to a lack of perception of error or harm and fear of reprisal (Lewis et al, 2009; Keers et al, 2013). This was corroborated in the UK despite a systems approach to risk management in pursuit of a safety culture (DH, 2000; NPSA, 2004; Williams, 2007). Errors resulted from checking violations, distractions, tiredness and poor knowledge of medication or equipment (Birch and Culshaw, 2003; Mayo and Duncan, 2004; Ulanimo et al, 2006).
Despite limited maternity-specific information, some UK statistics pertain. The NMC Annual Fitness to Practise Report 2011-2012 (NMC, 2012b) lists drug administration separately to prescribing errors and while some cases may refer to the same individual (midwife or nurse), the combined number equates to 12.5% of cases. Subsequent reports do not provide comparable information (NMC, 2013a; 2014c). Drug administration errors, medicine errors and failure to follow medicines management policies comprise three of six most common themes for local action plans and LSA practice programmes following supervisory investigation (NMC, 2013b). From 2000–2010, 83 successful maternity claims related to drug errors and financial awards amounted to £8 759 430 (NHSLA, 2012). There were 175 572 medication incidents reported in England and Wales from April 2013 to March 2014, the third most common incident type in acute hospitals as well as in all care settings (NPSA, 2014a). Medication incidents are most often due to omitted or delayed administration, wrong dose or wrong drug (NPSA, 2012). The majority caused no, or minimal, harm, 3583 resulted in moderate harm and 211 in severe harm or death (NPSA, 2014a). Rates of reporting vary widely and the figures for maternity are included in those for organisations as a whole (NPSA, 2014b).
Lethal crimes, such as those committed by Allitt and Shipman, are thankfully rare but not preventable (Clothier, 1994; Harman et al, 2007) and midwives, like other health professionals are in a position to administer medication illegally. While a tiny minority of practitioners will ever harbour malicious intentions, clearly, there are occasions when midwives fall foul of medicines regulations (NMC, 2013b). It is, therefore, relevant for supervisors of midwives to consider the circumstances in which this occurs.
Illegal drug administration by midwives
Birch and Culshaw (2003) found that POMs medication had been administered when prescriptions were absent or incorrect and suggested that this is a hidden phenomenon in maternity care. In order to determine how widespread this practice is, a multi-centre study, willing participation and interest among professionals and academics, would be required. Medicine administration without a valid instruction or exemption can only be detected when it has either been documented by the midwife; or, when no documentation exists, it becomes apparent following investigation of a reported incident. The specific circumstances in which this occurs will vary and it is feasible that a midwife may believe she is within current guidance due to the confusion surrounding the literature and guidelines. Consideration of the available literature, statistics and background context offers a range of possible factors that contribute to this choice of action by midwives and which may operate simultaneously.
Many instances of drugs given without a valid instruction, documented or not, can go unreported and undetected; however, some will be identified through incident reporting and investigation systems whether directly or indirectly related or unrelated to the medicine administration (NPSA, 2010). Where midwifery practice is concerned supervisory input is indicated (NMC, 2012c). A local supervisory investigation revealed that this was occurring and a subsequent audit confirmed it was common practice within the unit matching Birch and Culshaw's (2003) published experience.
A lateral view of a range of potentially contributory factors and their influence on this aspect of midwifery practice highlights the need for greater examination. As midwifery regulation and maternity providers respond to recent concerns over practice standards it is to be hoped that the available up-to-date evidence will diminish. However, non-adherence to safeguards put in place for public protection is a risk that must be addressed.
Supervision, medicines management and clinical governance
The current Midwives rules and standards (NMC, 2012a) formally define the interface between risk management and supervision so that incidents involving midwifery practice are reported to supervisors. Supervisory investigation supports safer midwifery practice by prompting action plans for individual practitioners, identifying contributory factors and recommending system changes to maternity and governance leads (NMC, 2012c; Local Supervising Authority Midwifery Officers (LSAMO) Forum UK, 2013a).
Medicines management in maternity is a multidisciplinary issue (Birch and Culshaw, 2003) involving a range of professionals, including GPs, obstetricians, anaesthetists, neonatologists, pharmacists, educators, nurses and IT personnel as well as midwives. Strong links between governance and supervision were recommended for safe maternity care (King's Fund, 2008; Richards, 2011), and the NMC (2012c) ratified this. The supervisor is, at present, able to influence medicines management systems in hospitals and in the community, advocating for women and babies and their midwives.
Birch and Culshaw (2003) identified a need for greater cooperation and education within the multidisciplinary team and that inadequate policies, bureaucratic responsibilities and inaccurate prescribing contributed to administration of medication without a valid prescription by midwives. Synthesis of professional background and contexts against which this occurs supports their case that similar problems are widespread. Due to the range of medicines legislation as it applies to midwives and differing practice settings (Healthcare Commission, 2008; Redshaw et al, 2011), it is likely that solutions will vary between individual drugs and care providers.
Promoting change through supervision
Local extent of medicines-related practice issues can be identified through audit, a supervisory function (LSAMO Forum UK, 2013b) providing evidence of current practice against national guidelines, standards and local recommendation (Bullivant and Corbett-Nolan, 2010). A lack of attention to the importance of audit contributed to problems at Mid Staffordshire NHS Foundation Trust (Francis, 2013). Encouraging midwives to disclose the circumstances in which they administer POMs without a prescription in a non-punitive, supportive manner, promoting the courage advocated by compassion in practice (DH, 2012) will identify themes for audit. Acting on confidences demonstrates to midwives how supervision is an effective resource by making a difference (NMC, 2009a). A pilot audit by supervisors can provide evidence that problems exist; however, to determine the extent within an organisation may demand resources beyond those available to a supervisory team, requiring leadership by supervisors within the multidisciplinary, clinical governance arena (Warwick, 2009; NMC, 2014b).
MEs define a range of drugs and circumstances in which they can be administered (NMC, 2011a, 2011b. Supervisors of midwives can recommend that local systems and protocols support their consistent use by adhering to national standards. PGDs, not required for ME (NMC 2011a), allow midwives to administer POM without prescription in specific locally-agreed circumstances (NICE, 2014b) for example antibiotics for Group B Streptococcus (NICE, 2012); or emergency anti-hypertensive drugs in remote areas (NES, 2012). Supervisors can promote safety by influencing the provision of appropriate means for more effective midwifery practice. However, administration of drugs under a PGD by students is not permitted (NMC, 2009b; NICE, 2014b) and can therefore limit active participation. Contribution by supervisors to medicines management training and development, specific to midwives, can address issues relevant to local practice in light of national standards and guidance (NMC, 2014b).
Self-administration of POM reduces waste, empowering patients (Darracott and Johnstone, 2012) consistent with the supervisory principle of services responsive to women's needs (NMC, 2014b). Consultation by supervisors with service users promotes supervision to women and can indicate desirability when presenting a case to clinical governance teams.
Supervisors may recommend midwives to train as independent prescribers (Griffith, 2009; NICE, 2014b), extending their roles and freeing up doctors' time. Midwifery 2020 (DH, 2010) suggests that this be included in future pre-registration training. In the community setting, midwives could prescribe antibiotics for uterine infection, hastening effective treatment for one of the leading cause of maternal death (Knight et al, 2014). However, some argue that taking on traditionally medical roles dilutes the midwife's position as the woman's advocate (RCM, 2011), meriting local consideration by supervisory teams.
Supervisors of midwives play a strategic role in the pre-registration education of midwives (NMC, 2009c). Yearly and Rogers (2011) illustrate how a supervision tactic within the University of Hertfordshire helped resolve confusion regarding students following changes to ME in 2010 (NMC, 2010); a Midwives Exemption Workbook was subsequently developed and has been adapted for use elsewhere. Further clarification from the NMC (2011a; 2011b) resolved the issue in question at the time.
The ME list is reviewed by the MHRA every 3 years. Extension of the list could mean that fewer commonly used drugs in midwifery would need to incur local PGD development, enhancing midwives' ability to provide a responsive service to women. This would also promote greater involvement for student midwives, increasing readiness for post-registration practice. By engaging in the review process, supervisors of midwives contribute to national policy.
Networking on medicines management issues within LSAs, with midwifery education institutions and with national bodies (NMC, 2014b) such as MHRA will help supervisors to fully understand local issues. Promotion of issues within academic institutions is needed to stimulate research and provide greater insight through evidence relevant to midwifery. With this level of knowledge there can be informed national debate to identify how best to support safer practice throughout the UK.
The potential seriousness of drug error cannot be overestimated. Medicines management for midwives is complex and deserves greater attention. Supervisors of midwives are well-placed within organisations to prevent many drug administration-related problems that occur locally and daily; however, there is a national need for consistent advice, clearer policy and evidence specific to maternity care. Using the existing framework for supervision and networking with the range of stakeholders provides a way to generate interest aimed at influencing medicines policy in pursuit of high practice standards both locally and nationally. A greater emphasis on medicines management and administration in midwifery care supports the primary aim of supervision to ensure safety for mothers and babies.