Liability for Dispensing Errors in Hong Kong

Abstract

The United Kingdom (UK) case R v Lee (2010) EWCA Crim 1404 resulted in a pharmacist being convicted for an inadvertent dispensing error and paved way for the decriminalisation of such errors by way of a due diligence defence enacted in 2018. In relation to Hong Kong (HK), what is its legal position for dispensing errors, and can it follow the decriminalising steps of UK? The primary objective of this paper is to explore whether and how HK can reach the normative position for a dispensing error legal regime: (1) I posit that the normative position for healthcare professional (HCP) liability for dispensing errors should prioritise the public interest of minimisation of future dispensing errors over the retribution of past wrongs; (2) I illustrate HK’s current position for the liabilities of HCPs on dispensing errors, focusing analysis on the relatively controversial aspects of HK’s criminal liability, referencing the landmark cases Hin Lin Yee v HKSAR (2009) 13 HKCFAR 142 and Kulemesin v HKSAR (2013) 16 HKCFAR 195 to assist my analysis of the requisite mental element for relevant statutory offences; (3) through comparison with UK’s development post-R v Lee and application of Rule of Law principles, HK’s current position is critiqued, coming to the conclusion that while there are compelling reasons for the decriminalisation of dispensing errors in HK, the prerequisite for this to happen is an overhaul of regulatory frameworks by significantly increasing levels of accountability.

Introduction

Pharmacist Lee in the United Kingdom (UK) dispensed the wrong drug. Later, the patient passed away, but the error did not cause the death (Chemist and Druggist (C + D) 2010; Cheston 2009; Royal Borough Observer 2010). She was nonetheless sentenced to 3-months’ imprisonment, with the judge stating that imprisonment was imperative to ‘mark [its] gravity’ (Pharmaceutical Journal 2009b).

This begs the question: are inadvertent mistakes per se of such ‘gravity’ to warrant imprisonment? That seems draconian — and the Court of Appeal (CA) concurs, quashing Lee’s conviction (R v Lee 2010). Subsequently, in response to calls for decriminalisation, in 2018, a Parliamentary order came into effect giving a defence for dispensing errors (Privy Council 2018).

Despite its significance towards legislative development, at an academic level, R v Lee and its aftermath remain rarely explored in UK’s legal context (Langley 2014, 87). Relating to Hong Kong’s (HK) legal context: ‘what criminal liabilities are there if the same thing happens in HK?’ This question is novel: academic discussions on medical errors primarily focus on civil liabilities and not criminal liabilities (Lam 2010; Badenoch 2013). It is also of growing social and policy interest in light of population aging and HK’s expansion of pharmacist roles, making it more important than ever to study the potential criminal liabilities of dispensing that pharmacists may become increasingly exposed to (Wong and Yeung 2019; Legislative Council of Hong Kong 2006; Legislative Council Panel on Health Services 2005; Pong 1999; Lam 2017, [162]). Stemming from this are the primary objectives of this paper:

• (i)exploring the Rule of Law, quality improvement philosophies, and good practices as guiding principles of a dispensing error legal regime, and positing that a regime in line with these guiding principles will be the normative position for dispensing error legal regimes;
• (ii)examining the liabilities for healthcare professionals (HCPs) under HK’s current regime;
• (iii)assessing whether the current liabilities in HK are compatible with the normative position as abovementioned; and, if not,
• (iv)exploring ways to better regulate dispensing errors.

Relating HK’s current regime to UK’s legal development, together with the guiding principles as mentioned above, I attempt a rounded look at all potential liabilities under HK’s regime, with a primary focus on criminal liabilities.

Introducing Dispensing Errors

Definitions

Medication errors can occur during any stage, generally segmented into (1) prescribing, (2) dispensing, and (3) administration (Williams 2007, 343).

Beso et al. (2005, 182–183) provide an encapsulating definition for ‘dispensing errors’: ‘deviation from an interpretable written prescription… [or] from professional or regulatory references, or guidelines affecting dispensing procedures’. In this paper, ‘dispensing’ includes all acts within the dispensary necessary towards giving the prescribed drugs to the patient. Categorically and granularly, this includes receipt of prescription; validity check of patient information; logging of prescription; legal/technical check; clinical check; label generation; stock selection; medication assembly; product labelling; completion of registers; self-checking/endorsing; final accuracy check; issuing of medication; and counselling (National Patient Safety Agency (UK) 2007; James et al. 2009, 9–10).

‘Error’ carries the plain and ordinary implicit meaning that it was inadvertent.

Prevalence

Approximately 4% of hospital patients experience medication error harm, and it kills approximately 98,000 people annually in the USA (Cox and Marriott 2000, 724; Ferner and Aronson 2000, 947). In HK, medication error and dispensing error-rates are rarely reported. Hospital Authority (HA), the public healthcare provider, only reports ‘serious untoward’ (SU) medication errors, defined as errors ‘which could have led to death or permanent harm’ (Hospital Authority (Hong Kong) 2020, Annex 1, Sect. 4.2). The number of HA dispensing errors may be estimated at approximately 621,000–7.3 million in 2018, and approximately 10–17 SU dispensing errors/year (Hospital Authority (Hong Kong) 2020, [37], [42–45]; Samaranayake et al. 2013, 432).

Types

Broadly speaking, dispensing errors fall under ‘label-error’ or ‘content-error’ (Flynn et al. 1999; Cox and Marriott 2000; James et al. 2009, 22; Chua et al. 2003, 803; Beso et al. 2005; Roberts et al. 2002; Ashcroft et al. 2005, 327). ‘Label-errors’ include errors on the labelled patient name, drug name, drug strength, drug quantity, dosage form, date, instructions, warnings, or address. ‘Content-errors’ include, against the prescription, supplying the wrong drug, dosage strength, dosage form, quantity, or an expired drug.

Causes

Medication errors, including dispensing ones, are usually due to slips or lapses in attention, and are non-deliberate (Langley 2014, 103; Williams 2007; Franklin et al. 2002, 1373; Flynn et al. 1999). Dispensing errors correlate with interruptions and distractions (Langley 2014, 104; Flynn et al. 1999), and lack of double-checking by a separate person increases error-rates (Cox and Marriott 2000; Spencer and Smith 1993; Beso et al. 2005). Other factors include manner of containers’ labelling and storage, culture, and over-reliance on others (Beso et al. 2005).

Impact of Dispensing Errors

Painting a broad brush, dispensing errors are significantly prevalent, causing heavy economic burden in healthcare costs in remedy, physical and mental harm, and also has wider societal detriment by undermining confidence towards HCPs and the healthcare system (Franklin et al. 2009, 7; Nair et al. 2010; Cox and Marriott 2000). The uncontroversial position is that it is more efficient to prevent errors ex-ante instead of remedying ex-post.

Guiding Principles for a Dispensing Error Legal Regime

The inconvenient truth is that dispensing errors will inevitably occur — that is when laws and regulations step in. Outcomes of laws are very important, and therefore critical to strike an appropriate balance. So, when should outcomes be available, and why? When faced with striking a balance, particularly when there are competing interests at play, it is desirable to understand regime objectives, justifications, and theoretical underpinnings, so that the outcomes are principled and just, instead of being decided by the flavour of the week. Here, I suggest that the ideas discussed in this section are the key ingredients to the normative position for dispensing error legal regimes.

Quality Improvement: Philosophy and Approaches

In error prevention, it is well-accepted that humans are fallible, and errors are expected even in the best organisations, where recent developments in the quality improvement field have shifted from a ‘person-approach’ to a ‘system-approach’ when conceptualising human error (Reason 2000, 768; Cox and Marriott 2000). Similar to other fields desiring reliability, the ‘system-approach’ has been well-adopted into healthcare (Reason 2000; Nair et al. 2010).

The modern ‘system-approach’, with an enlightened recognition that errors are predominantly morally blameless, premises upon a system’s ability to change individuals’ behaviour despite latent human fallibility. Errors are seen as consequences of a system rather than its causes. In conceptualising errors, the question should not be ‘who’, but ‘how’ and ‘why’. ‘System-approach’ focuses on building safeguards and defences, minimising errors and their effects by shaping the conditions and circumstances under which individuals work and make decisions.

Healthcare quality improvement seeks to bring about systemic changes driving overall healthcare quality improvements, where error-rate is a clear, objective, quantifiable, and measurable indicator.

Good Practice, Guidelines, and Culture

The first-line defence against dispensing error is good practices, where guidelines are regularly used (Williams 2007, 345). HK has the Good Dispensing Practice Manual (GDPM), issued by the HK Medical Association, and referenced to in the doctors’ regulator-issued code of conduct, whereas, ironically, the pharmacists’ code of practice is silent on good practices (Lam 2010, [8.2.1]; Hong Kong Medical Association 2016; Medical Council of Hong Kong 2016, [9.2]; Pharmacy and Poisons Board of Hong Kong (HKPPB) 2015).

Nurturing a reporting healthcare culture is also needed, where HCPs feel safe about reporting errors, in order to collect the data vital for quality improvement measures (Williams 2007; Langley 2014, 103; Health Foundation 2013).

Rule of Law

HK’s commitment to the common law and the Rule of Law is extremely important, being historically and constitutionally entrenched: regimes should be procedurally fair, being transparent and consistent; proportional; and exercise powers for right purposes (The Basic Law of Hong Kong 1997, Articles 8, 18, 84).

UK: Criminal Liability Developments

Against the backdrop of the guiding principles as discussed in the above section, UK’s dispensing error legal development is discussed to examine how its issues have been addressed, serving as a useful reference point for the analysis of HK’s legal position further below.

Pre-R v Lee

In the 1998 Peppermint Water case, the titular solution was compounded with 20 times the required amount of chloroform, resulting in the baby patient’s death (Langley 2014, 92). The pre-registration pharmacist and supervising pharmacist were charged under Medicines Act 1968 (MA) s.64 for ‘supplying a medicine not of the nature and quality specified’, resulting in fines (Pharmaceutical Journal 2000)^.

In the 2009 Prestatyn case, an antidepressant was wrongly supplied. The patient subsequently died. The dispenser and pharmacist were convicted under MA s.64 and fined (Langley 2014, 94; Mahoney v Prestatyn Magistrates’ Court 2009).

From these two cases, it can be seen that the prosecution was clearly willing to prosecute pharmacists for inadvertent dispensing errors, likely resulting in fines. Disciplinary proceedings held for these cases led to reprimands (Langley 2014, 92).

R v Lee

R v Lee showed significant departures from previous cases.

Facts

In 2007, pharmacist Lee properly generated the label for the prednisolone that patient Sheller was prescribed, but mistakenly placed the label on a box of propranolol instead. There was therefore a wrong supply of propranolol (when prednisolone should have been supplied). Sadly, patient Sheller later passed away. The coroner’s inquest determined that pharmacist Lee’s error did not cause patient Sheller’s death, with the coroner convinced that, instead of the dispensing error, it was more likely than not that patient Sheller’s underlying medical conditions was the cause of death (Chemist and Druggist (C + D) 2010; Cheston 2009; Royal Borough Observer 2010). One important factor in the coroner’s decision was that patient Sheller’s blood samples showed only trace amounts of propranolol (the drug given wrongly), and the effects of the propranolol were therefore likely to have been extremely minimal.

Trial

Lee was initially charged with gross negligence manslaughter, subsequently changed to charges under (i) MA ss.85(5)(b) and 91(1); and (ii) ss.64(1) and 67(1) (Langley 2014, 98).

The charge under s.85(5)(b), that ‘no person shall, in the course of a business carried on by him, sell or supply [medicine] labelled or marked in… a way that… (b) is likely to mislead as to the nature or quality… or… uses or effects’, was new and unusual. The maximum sentence for s.85(5)(b) and s.64(1) was identical: £400 summarily, and/or 2-years’ imprisonment on indictment. Based on precedents, the expected outcome was a fine.

In 2009, Lee plead guilty. Under s.85(5)(b), she was surprisingly sentenced to 3-months’ imprisonment (Pharmaceutical Journal 2009b). s.64(1) was allowed to lie on file.

Appeal

In 2010, Lee appealed, under s.85(5)(b), on whether she, a self-employed locum pharmacist, was capable of being ‘in the course of a business’ (R v Lee 2010, [23]). CA reviewed other sections of MA, including ss.52(1) and 106(2), finding that Lee, an ‘employee’, not an ‘employer’, was not capable of carrying on business under s.85(5)(b) (R v Lee 2010, [27–44], [46]). Lee’s s.85(5)(b) conviction was quashed, substituted with s.64(1), and sentenced to a £300 fine (R v Lee 2010, [46–54]; Pharmacists’ Defence Association 2010).

Issue: Consistency of Sentencing

There were hints that the trial judge took into account his own incorrect perception, stating that imprisonment was imperative to ‘mark [the offence’s] gravity’, even when there was no causative link (Murray 2009). It is unclear why the judge saw this case as being any ‘graver’ than Peppermint and Prestatyn, especially with the error being causative of death in Peppermint, while previous cases only resulted in fines.

Despite appropriately curing the injustice caused by the trial’s imprisonment, CA’s decision does not take away from the initial uproar, panic, and discomfort amongst the pharmacist community: that the punishment was disproportionate, counterproductive towards patient safety, and unreasonably increased pharmacist pressures and liabilities for fear of their imminent committing of an inadvertent dispensing error (Pharmaceutical Journal 2009a; The Pharmacist 2017b; Murray 2009). Moving forward, the CA’s decision was no guarantee that imprisonment will not happen again.

Taking a step back, regarding Lee’s legal liability, the only part of CA’s judgment which had meaningful impact was [52–54]:

the sentence [at trial] was manifestly excessive…what occurred was an error; it was, at worst, an isolated act of negligence by [Lee]. It was a dreadful error… But… did not… cause… death… s.64(1)… does not pass the custody threshold… The proper penalty is a fine. [emphasis added]

Here, CA made clear that Lee would have succeeded even if she appealed on sentence. For consistency, future sentencing should be mindful of R v Lee.

Issue: Unfairness Towards Pharmacists

Whether or not harm manifests when errors occur depends on the drug involved and the patient’s condition, both matters of luck (Langley 2014, 105). Chances do not look good, since treatment drugs are often potent and potentially deadly. It is impossible for pharmacists to completely mitigate risks of harm, since these hazards are inherent to their core duty and its subject-matter. It has been observed that dispensing is the only routine healthcare activity that faces criminal sanction risk (Pearce 2019).

Therefore, it is doubtful whether criminalising dispensing errors is conducive towards the public interest of improving dispensing services. Criminalising dispensing errors is to prey on unavoidable human fallibility, and, since all pharmacists are likely to commit inadvertent errors at some point, criminalising errors can be said to penalise pharmacists solely for their occupation choice. It is therefore posited that such a legal position creates injustice and unfairness, in terms of treating a single profession in a manner significantly different from other healthcare professions.

Issue: Systemic Maleficence

R v Lee is also a classic representation of systemic maleficence, when the burden and consequences of systems failings all fall upon an individual. As a result, when errors occur, pharmacists are in dilemma, since error reporting, which although serves patient safety, is self-incriminatory. Criminalising errors, particularly with imprisonment, deters error reporting, despite reporting being vital for quality improvement. In this regard, criminalisation is contrary to public health (Murray 2009).

The prosecution is aware that indiscriminately prosecuting dispensing errors is sub-optimal, and post-R v Lee issued guidance outlining their framework in prosecuting dispensing errors (Langley 2014, 106; Pharmaceutical Journal 2010). The guidance framework takes into account the seriousness of errors and consequences, and also public interest factors reflecting good practices by considering culpability; actions during and after the incident; evidence of other dispensing errors; and remedial actions.

A narrow view of R v Lee may say that the injustice was sufficiently cured, and all is well since the ultimate outcome was similar to Peppermint and Prestatyn. However, a broader look at the legal proceedings showed insufficiently restricted discretion at its worst. The multiple charges, appeal, and overturned sentence created uncertainty, holding Lee in abeyance. At first, a judge found that she was an unprecedently guilty pharmacist. Awaiting appeal, she voluntarily resigned from the pharmacists’ register, became a church cleaner, and vowed never to practice again. CA saying ‘never mind, we take it back’ does not erase the psychological torment she went through. The faults of the legal system’s indecisiveness were ultimately and unfairly condensed onto Lee as a single person, forming lasting irreversible ramifications.

Such results seem inefficient towards public health interests, discouraging pharmacists from practising again because of a single mistake, and the unavoidable yet severe consequences deterring others from joining the profession.

Issue: Legislative Purpose

The justifications for criminalising MA s.64(1) have been weakened because of modern dispensing practices. Practices were vastly different when MA was drafted, where it was commonplace for pharmacists to compound medications (Langley 2014, 95). It was important for MA to protect consumers by controlling compounding, by having provisions prohibiting pharmacists’ tampering of medication compositions (Langley 2014, 102). Here, it is important to make note that MA s.64(1) is an absolute liability offence. An offence with absolute liability has no requisite mental elements, or, in other words, the mental state of the person committing the offence is irrelevant, meaning the prosecution will not need to prove any intention, knowledge, or recklessness of the person charged. For MA s.64(1), absolute liability was favoured likely to avoid evidential difficulties in proving that the medication defects were intentional or reckless.

However, with the modern practice shifting from compounding to assembly, the original legislative purpose is arguably deviated from when prosecuting the modern MA s.64(1) contravention. Nowadays, when pharmacists dispense in error, the drug is almost never compounded, but instead manufactured. The responsibility of drug quality control has largely shifted onto manufacturers, with their own regulatory requirements. Modern pharmacists have much less control over the nature and quality of the drug, lessening the need and justification for conviction when the drug’s nature or quality is affected. It is posited that this shift in compounding practices is one compelling point for decriminalising dispensing errors in the UK, and because of this, MA s.64(1) has overtime become irrelevant and redundant.

The Pharmacy (Preparation and Dispensing Errors — Registered Pharmacies) Order 2018

Since R v Lee, there have been calls for dispensing error decriminalisation (Langley 2014; Pharmacists’ Defence Association 2010; Murray 2009; Pharmaceutical Journal 2009a; Pearce 2019; Burns 2018; The Pharmacist 2017a, b). First, MA s.85, the offence Lee was originally convicted of at trial, was repealed by the Human Medicines Regulations 2012. Then, in 2018, 11 years after Lee’s error, The Pharmacy (Preparation and Dispensing Errors — Registered Pharmacies) Order 2018 (Order) came into effect giving a statutory due diligence defence for pharmacist dispensing errors. There was recognition that criminalising dispensing errors has been inhibitory towards quality dispensing, and hopes that the defence will help foster a learning culture, encouraging error reporting (The Pharmacist 2017b; Burns 2018; Andrews 2018).

The Order introduced defences for MA s.64 (the offence convicted by CA in R v Lee) and s.63 (a highly similar offence), available for registered pharmacists acting in the course of their profession. Defendants must prove that (a) the product was dispensed at a registered pharmacy; (b) the person who dispensed was a registered pharmacist, dispenser, or someone acting under their supervision; (c) the product was supplied under prescription or emergency supply; and (d) condition A or B. Condition A is that the person dispensing did not know of the error. Condition B is that persons involved, once they know of the error, took all reasonable steps to ensure the patient was notified.

Effectively, because of condition A, MA ss.63 and 64 no longer has absolute liability. Condition B may also be particularly useful, allowing the prosecution and courts to take into account mitigating factors.

Despite some criticism that the Order did not go far enough, it is a promising step, favouring systemic improvements over punishing individuals (Pearce 2019).

Hong Kong’s Regime

So, given the experiences in the UK and the similarities in legal systems with HK, what lessons might be learned for HK from the UK’s recent events in pharmacy law and practice? First, it is important to lay out the existing legal landscape in HK.

Here, one aspect of HK’s dispensing practice should be particularly highlighted: there is no separation of prescribing and dispensing. The liabilities are therefore relevant to all dispensing HCPs and not only pharmacists.

Criminal Liability: Common Law

Common law offences relevant to dispensing errors are under Cap. 212 (Cap. 212 Offences Against the Persons Ordinance (OAPO) 1865). This includes common assault, increasing in seriousness if causing actual bodily harm, more so when causing wounding or grievous bodily harm, and even further when there was maliciousness or intention to cause grievous bodily harm (Cap. 212 Offences Against the Persons Ordinance (OAPO) 1865 ss. 40, 39, 19, 17; Collins v Wilcock 1984; R v Ireland 1998; R v Venna 1976). These non-fatal offences all require intention or recklessness towards the harm, and are therefore unlikely compatible with inadvertent dispensing errors.

Dispensing errors may also constitute gross negligence manslaughter (Cap. 212 Offences Against the Persons Ordinance (OAPO) 1865, s.7). Although this is purely objective, with no need to establish subjective foresight of risk of death, it still has high threshold (HKSAR v Mak Wan Ling 2019). There must be negligence, together with the jury finding the breach to be so serious that it justifies criminal conviction (R v Adomako 1995).

Criminal Liability: Presumption of Implied Mens Rea Under Statutory Interpretation

In statutory offences with external elements (actus reus) that are silent on whether there is a corresponding mental element (mens rea), an issue is whether the defendant’s knowledge, belief, or intention of the actus reus is required. This issue is particularly key here, given that this paper’s focus is on inadvertent dispensing errors, and mens rea is an important determining factor, since if an offence requires some sort of mens rea then an inadvertent error will unlikely constitute the offence.

R v Lee noted that Lee was charged under MA s.85(5)(b), that the labelling was ‘likely to mislead as to… nature or quality… or… uses or effects’; and not s.85(5)(a), that the label ‘falsely describes the product’, where s.85(5)(a)’s requirement of ‘falsely’ describing may involve issues of mens rea (R v Lee 2010, [20]). The implication is that s.85(5)(b) likely has absolute liability, while s.85(5)(a)’s circumstance element of ‘false’ labelling has a possibly implied mens rea of knowledge or belief of falsity.

For the implied mens rea of HK statutory offences, the HK case law has developed its own analysis method, with five Alternatives (HKSAR v Hin Lin Yee 2009; Kulemesin v HKSAR 2013):

• Alternative 1, the starting point, is where presumed mens rea is not displaced, and must be proven beyond reasonable doubt.

• Alternative 2 shifts the burden of proof, where prosecution does not need to prove the implied mens rea, but defendants may raise evidence that there was no requisite mens rea.

• Alternative 3 is similar to 2, except defendants must prove lack of requisite mens rea on the balance of probabilities.

• Alternative 4 is where mens rea presumption has been displaced by clearly inconsistent statutory defences.

• Alternative 5 is absolute liability.

Although Alternative 1 is the starting point, it should not be viewed in isolation, and there must be an examination of whether other alternatives are more suitable (Kulemesin v HKSAR 2013, [104]; Hin Lin Yee v HKSAR 2010, [45]). Alternative 1 is not ideal when it is unreasonably difficult for the prosecution to prove the presumed mens rea (Kulemesin v HKSAR 2013, [103]).

Inferring Alternative 5 will not be done lightly and must be highly compelling. A typical situation for application is when ‘quasi-criminal’ or ‘mere regulatory offences’ (such as for public health) imposes minor penalty (Kulemesin v HKSAR 2013, [92–93]). However, being regulatory per se is not sufficient justification, and absolute liability has to serve some useful purpose. Serious criminal liability and professional ramifications steer away from Alternative 5, tending towards Alternatives 3, 2, or even 1 (Kulemesin v HKSAR 2013, [86]).

Alternative 5 may also be imposed when an offence is extremely socially unacceptable, and was applied for the offence of intercourse with a girl under 16 years old (So Wai Lun v HKSAR 2006; Cap. 200 Crimes Ordinance 1971, s.124).

Because of the alternatives providing multiple possible outcomes in predicting the likely implied mens rea position that the HK court will choose for specific offences, it is difficult to summarise any general position for the mens rea for HK dispensing error statutory offences. As such, the ‘Criminal Liability: Cap. 138 Pharmacy and Poisons Ordinance & Cap. 138A Pharmacy and Poisons Regulations’ section and the ‘Criminal Liability: Cap. 132 Public Health and Municipal Services Ordinance’ section will be dedicated to analysing the relevant statutory provisions in order to determine the likely mens rea position for each offence.

Criminal Liability: Cap. 138 Pharmacy and Poisons Ordinance & Cap. 138A Pharmacy and Poisons Regulations

The Pharmacy and Poisons Ordinance (PPO), and the Pharmacy and Poisons Regulations (PPR) are the main relevant statutes in regulating dispensing errors. Note that ‘pharmaceutical products’ and ‘poisons’ within PPO and PPR are analogous in meaning to ‘medicines’ and ‘drugs’ for the purpose of this paper, and ‘authorised seller of poisons’ includes registered pharmacists.

According to Prescription (PPR r.9(1))

PPR r.9(1) states that ‘no person shall sell [prescription only medicines (POMs)], except [according to] prescription…’. This catches ‘content-errors’, and persons selling POMs without any prescription at all.

For r.9(1)’s implied mens rea of knowledge or belief that the medicine was not sold in accordance with prescription, since no statutory defences are available, Alternative 4 is inapplicable.

For Alternative 5, even the worst way of contravening r.9(1) (by selling POMs without prescription) will not be at the same level of unacceptability as So Wai Lun. Although r.9(1) is technically a public health regulatory offence, it also does not seem to fit with the type of ‘mere regulatory offence’ imposing minor penalty appropriate for Alternative 5. Under r.40 and PPO s.34, contravention of r.9(1) is punishable up to $100,000 and 2-years’ imprisonment (Cap. 221 Criminal Procedure Ordinance (CPO) 1899, Sch 8). As reference, Cap. 313 s.72, punishable up to $200,000 and 4-years’ imprisonment, was found not ‘merely regulatory’ precisely because it involves serious criminal liability and professional ramifications (Kulemesin v HKSAR 2013, [86]; Cap. 313 Shipping and Port Control Ordinance 1978). Granted, both the fine and imprisonment of r.9(1) are half of Kulemesin’s, but is nonetheless a substantial criminal liability which may lead to disciplinary sanctions (Cap. 138 Pharmacy and Poisons Ordinance (PPO) 1970, s.15(1)(c)(i)).

Even if r.9(1) is ‘merely regulatory’, absolute liability is only imposed if it serves a useful purpose. From R v Lee and subsequent development, there are strong arguments that criminally punishing inadvertent errors is against public health interests, and it is therefore suggested here that, from a utilitarian standpoint, absolute liability is undesirable for r.9(1).

With respect to Alternative 5, two additional situations outside of dispensing errors deserve to be examined. First, absolute liability for r.9(1) will be of no use in regulating lay persons selling POMs, as this is already regulated by PPO s.21, under which POMs can only be sold in pharmacies by a pharmacist, or under s.28(1) exemptions (supplies by doctors and dentists). Second, in situations where HCPs sell POMs without any prescription, absolute liability is still overly harsh in disallowing all defences. For example, and as illustration, if a pharmacist honestly and reasonably believed that an excellently forged prescription was real, it is unreasonable to criminally punish him/her for failing to spot forgeries, as this is something outside his/her expertise and in any event is not morally culpable. Overall, Alternative 5 seems inappropriate.

Alternative 1 is implausible in two ways. First, it excludes dispensing errors, since the person dispensing would not have known of the ‘content-error’ at time of dispensing. Second, in situations without any prescription at all, applying Kulemesin, Alternative 1 is inappropriate because of difficulties for prosecution to firmly prove that the person selling knew or believed there was no valid prescription, and instead easier for the person to explain why they thought there was a valid prescription (Kulemesin v HKSAR 2013, [103]).

Between Alternatives 2 and 3, Alternative 2 was applied for Kulemesin, and r.9(1)’s lighter penalty may point to Alternative 3. Alternative 3 requires defendants to prove on the balance of probabilities that they had the honest and reasonable, but mistaken, belief that the sale was according to prescription. The crux will likely be whether their belief was reasonable, where if an HCP was following good practices but lapsed in attention, it should be that, given his knowledge, it was reasonable for him to believe that there was no error. On the other hand, if he did not follow good practice procedures, his belief might have been unreasonable.

On Alternative 2, HCPs may defend by simply testifying to their subjective belief of complying with r.9(1), where the prosecution may rebut if HCPs did not follow procedures, meaning their belief had no reasonable basis. However, in situations where there was no prescription at all, prosecution faces similar evidentiary difficulties as Alternative 1. In light of this and r.9(1)’s maximum penalty being lighter than Kulemesin’s, Alternative 3 seems more appropriate, and is conducive towards public health by encouraging adherence to good practices.

Hospital Dispensing (PPR r.22 and r.23)

Under PPR r.22(1)(a), only r.16 labelling requirements for specific articles and Part 5 – ‘Special Provisions with respect to Institutions’ (rr.22 to 24) is applicable for hospital dispensing.

Contraventions of the below discussed hospital dispensing provisions, namely rr.22(2), 22(5), 23(1), 23(2), and 23(3), will be, according to r.40 and PPO s.34, offences punishable up to $100,000 and 2-years’ imprisonment.

r.22(2), similar to r.9(1), requires supplying in accordance to prescription, except that r.22(2) is wider, applying to all medicines and not only POMs. Presumed mens rea will be similar to r.9(1), meaning Alternative 3 is likely most appropriate.

Under r.23(1), no medicine shall be supplied for in-patient use except in accordance with rr.23(2) and 23(3). r.23(2) states that in-patient supplies must be according to written orders. Since r.23(2) intends on catching ‘content-errors’, same as r.22(2) and r.9(1), Alternative 3 is again likely appropriate. r.23′s ‘written orders’ only make sense if the legislature intended for efficiency and simpler format, exempting in-patient use from prescriptions with stricter requirements, of which some requirements are not particularly relevant for in-patient use.

Two issues stand out for r.23(2). First, the requirements for a legally valid ‘written order’ are unclear. There is no definition except by description under r.23(2): ‘signed by a [doctor, dentist], or [persons authorised]…’. A doctor writing on tissue paper ‘give any medication, I don’t care’, signed, fits this description. Even if the legislative intended for simpler requirements compared to prescriptions, surely r.23(2)’s description cannot be the exhaustive requirements for written orders. Second, on literal reading, in-patient supply is not exempted from r.22(2). This means, reading rr.22(2) and 23(2) together, technically, in-patient supplies require both prescription and written order. This seems incompatible with the ostensible legislative intent, and, from a common-sensical practical standpoint, is unnecessarily convoluted. Unless, prescriptions fulfil all legal requirements of written orders, meaning they can potentially be one and the same document; but, if they have the same legal requirements, then r.23(2) is redundant.

r.22(5) requires hospital dispensing to ‘be clearly labelled with instructions for use in either English or Chinese’ [emphasis added]; while r.23(3), specifically for in-patient use, requires ‘container[s] … labelled with words describing… contents’ [emphasis added]. For silent mens rea, again, there will be similar considerations in seriousness of penalty and evidentiary difficulties, and Alternative 3 likely most appropriate. On literal reading, r.23(3) does not exclude r.22(5), so both apply for in-patient supply, creating curiosities. Because r.22(5) expressly requires instructions ‘in either English or Chinese’ but s.23(3) does not, s.23(3)’s silence on language requirement may be interpreted as allowing in-patient medications to be labelled in any language for content labelling, since, if not then, r.22(5)’s requirement of ‘English or Chinese’ instructions becomes redundant. Similarly, r.22(5)’s requirement to label ‘clearly’ is absent in r.23(3): does this mean content labelling can be unclear? If not, what’s the point of the word ‘clearly’? The plausible explanation is that Part 5 was poorly drafted.

Labelling for Non-hospital (PPO ss.27, 28, and PPR r.31 and 38)

Most PPO and PPR non-hospital labelling provisions regulate manufacturers and not HCPs: except as provided by PPR, PPO s.27 labelling requirements are exempted for doctors, dentists, pharmacies, and pharmacists (Cap. 138 Pharmacy and Poisons Ordinance (PPO) 1970, ss.28(1)(a), 28(1)(c)); and PPR rr.38(1) and 31 requirements are exempted for prescriptions (Cap. 138A Pharmacy and Poisons Regulations (PPR) 1978, r.38(2)(a)).

Therefore, the only labelling requirements applicable for non-hospital HCPs will be PPR r.16 for specific articles, and PPO s.28(2) for labelling the name and address of the person supplying or dispensing. For reasons similar to those of the offences discussed above, Alternative 3 is likely the most appropriate for implied mens rea. Both r.16 and s.28(2) carry the maximum penalty of $100,000 and 2-years’ imprisonment (Cap. 138A Pharmacy and Poisons Regulations (PPR) 1978, r.40; Cap. 138 Pharmacy and Poisons Ordinance (PPO) 1970, ss.33, 34).

Nothing else is legally required to be labelled, but, as we will see, voluntarily providing additional information on labels may be unlawful when false or misleading.

Issue: Agency and Prosecution Uncertainties

It is uncertain who can be prosecuted under PPO and PPR. Under PPO s.2, ‘sell’ includes supplying and dispensing, with or without payment; ‘dispense’ means supplying according to prescription; and ‘supplying’ covers dispensing not on prescription (capturing hospital dispensing).

When dispensing errors occur, it stands to reason that the person with legal power to sell, dispense, and/or supply will be the person most likely in contravention, as provisions typically have operative verbs of ‘sell’, ‘dispense’, or ‘supply’. However, there may be multiple persons with legal power. For example, in a community pharmacy, both pharmacist and pharmacy have the power to legally dispense. Likewise, hospitals may dispense. It is also uncertain whether the offences extend to capture agents involved in dispensing, such as dispensers or doctors’ assistants. In such cases, who will be prosecuted? Will it be everyone applicable, or only the ones most proximal? Will differences in prosecution treatment be fair or justified? In considering public interest in prosecuting relevant actors, what factors will be weighed? Here, these are unclear, unlike the UK where there is dispensing error prosecution guidance (Pharmaceutical Journal 2010). HK’s exercise of prosecution discretion does not seem prescribed in a sufficiently predictable way, without safeguards guaranteeing consistency, creating difficulties for persons dispensing to plan their actions or understand their potential liabilities when participating in dispensing.

Criminal Liability: Cap. 132 Public Health and Municipal Services Ordinance

Not of Nature, Substance, or Quality Demanded (PHMSO s.52(1))

The Public Health and Municipal Services Ordinance (PHMSO) s.52(1) is the counterpart to MA s.64(1), being an offence to sell, to the prejudice of a purchaser, any drug which is not of the nature, substance, or quality demanded, thus catching ‘content-errors’. For ‘a drug to which any substance has been added, or from which constituent has been abstracted, other than a drug thereby injuriously affected in its quality, constitution or potency’, ss.53(1) and 53(2) provides defence if ‘the operation… was not carried out fraudulently, and… article was sold [with a visible] notice… stating explicitly the nature of the operation’. If the drug contains extraneous matter, s.53(3) gives defence when its presence was an ‘unavoidable consequence of the process of collection or preparation’. Maximum penalty for s.52(1) is $10,000 and 3-months’ imprisonment (Cap. 132 Public Health and Municipal Services Ordinance (PHMSO) 1960, s.150).

Drug Unfit for that Purpose (PHMSO s.54(1)(a))

s.54(1)(a) creates an offence on selling any drug intended for use by man but unfit for that purpose, catching ‘content-errors’. Maximum penalty is $50,000 and 6-months’ imprisonment (Cap. 132 Public Health and Municipal Services Ordinance (PHMSO) 1960, s.150).

False Labelling (PHMSO s.61(1))

s.61(1) is the counterpart to MA s.85(5). PHMSO s.61(1) makes it an offence to:

[give] a label… which (a) falsely describes… the drug; or (b) is calculated to mislead as to its nature, substance or quality… unless he proves that he did not know, and could not with reasonable diligence have ascertained [the error]. Thus, s.61(1) catches ‘label-errors’. The maximum penalty of s.61(1) is $50,000 and 6-months’ imprisonment (Cap. 132 Public Health and Municipal Services Ordinance (PHMSO) 1960, s.150).

Key distinctions between s.61(1) and MA s.85(5) make them fundamentally different. First, s.61(1) does not have the ‘course of a business’ requirement, so s.61(1) may be contravened by non-‘employers’. Second, the ‘mislead’ limb of s.61(1)(b) is more difficult to establish compared to MA s.85(5)(b), because MA s.85(5)(b) requires ‘likely to’ mislead, while s.61(1)(b) has the wording ‘calculated’ to mislead, requiring intention. Third, unlike MA s.85(5)(b), s.61(1) contains the defence of not knowing or could not reasonably have known of the error.

Although s.61(1) may be harder to convict compared to MA s.85(5), rational HCPs should still label only the bare minimum legally required to avoid unnecessary criminal liability, potentially custodial. That typically means labelling only the name and address of the person supplying or dispensing under PPO s.28(2), without voluntarily labelling any additional information such as drug name, strength, quantity, and directions for use, because, although such information is extremely useful for patients, any mistakes where HCPs cannot prove they did not or could not have reasonably known about the error may mean conviction under s.61(1). This seems inconsistent with patient-care.

Agency (PHMSO s.73)

s.73 means persons selling, and also agents, will be under the same liability for all PHMSO offences abovementioned (Hin Lin Yee v HKSAR 2010, [3], [30]). In Hin Lin Yee, both the doctor selling and his assistant who dispensed were convicted. When and how prosecution exercises discretion for PHMSO is unclear.

PHMSO Mens Rea

Hin Lin Yee held that Alternative 4 is applicable for s.54(1)(a), since ss.70 and 71 provide defences when contravention was due to some other person, or when the drug was purchased lawfully with a valid warranty. This reasoning is likely extendable to ss.52(1), since ss.53(1), 53(2), and 53(3) are its statutory defences, with ss.53(1) and 53(2) including mens rea, and s.61(1) with the statutory defence of not knowing. Presumed mens rea is therefore incompatible, and Alternative 4 is likely most appropriate.

Issue: Hospital Dispensing Uncertainties

It is uncertain whether PHMSO offences apply to hospital dispensing errors. This turns on whether hospital dispensing constitutes ‘selling’. Interpretation of ‘sale/sell’ under PHMSO s.2 is unhelpful, only saying that it ‘includes disposal by barter or raffling’. If, borrowing from PPO s.2, ‘sell’ includes supply with or without payment, then PHMSO offences are applicable for hospital dispensing.

Without relying on PPO, ‘selling’ means an exchange of consideration. In community pharmacy, there is a sale when patients pay to receive dispensing, a combination of the pharmacist’s service plus the prescribed medication as goods. Out-patient dispensing is similar, where after receiving the prescription, patients may visit the out-patient pharmacy for dispensing, where he/she is essentially paying for the same things as community pharmacy patients, and therefore, a sale took place. The in-patient situation is more ambiguous, where at the point of medication supply, patients are not necessarily paying then and there. However, it might still be argued that, technically, when patients are discharged and pay hospital bills, part of that payment goes towards their in-patient medications, meaning there is/was a sale, even if calling in-patient supply a ‘sale’ strains its plain ordinary meaning.

If PHMSO applies to hospital dispensing, then, applying s.73, HA as the seller, and every agent in between HA and the person dispensing, may theoretically be prosecuted.

Issue: Public Interest, Legislative Intent

Similar to MA, it is doubtful whether PHMSO’s criminalisation of dispensing errors serves public interests. Although s.61(1) has a defence similar in effect to the UK’s Order, it does not extend to other provisions. Even with defences available, it is uncertain whether judges, without specialised knowledge, are sufficiently qualified or in appropriate position to adjudge matters involving examination of reasonable dispensing practices.

Also, similar to MA’s original legislative purpose in controlling compounding, PHMSO controlling the nature, substance, quality, and purpose of the drug reflects similar intentions. It is likely that many PHMSO provisions and amendments were ‘me-too’ copies from MA. Modern dispensing practice being incompatible with legislative intention is even more compelling for HK, where compounding is virtually non-existent in community practice, and extremely rare and subject to manufacturing regulations in hospitals.

Criminal Liability: Further Issues

Concurrent Liabilities

The multiple potential criminal provisions that HCPs can be prosecuted under on occurrence of a dispensing error causes uncertainty on the number of charges they will face. As per R v Lee, it is possible to bring multiple charges against a single error. However, is this fair or proportionate? For example, for in-patient errors, pharmacists possibly contravene PPR rr.22(2), 23(2), 23(3), PHMSO ss.52(1), 54(1)(a), and 61(1), six offences in total. Will prosecution charge the one most likely to succeed, offences in the alternative, or all at the same time? The freedom to elect PPR charges also circumvents the protection from PHMSO’s statutory defences.

Also, if multiple charges are brought for a single error, how will the courts exercise their discretion? Note that, unlike UK, HK has no ‘lie on file’ option, meaning charges must either be convicted or be acquitted. Will courts consistently only convict one offence and acquit the rest? If so, how will they pick which offence to convict? Or, will all offences proven be convicted? Does this mean that a hospital pharmacist can potentially be sentenced to 7-years 3-months’ imprisonment for a single error (for the combined maximum term of the 6 offences abovementioned: 2 years for each of PPR rr.22(2), 23(2), and 23(3); 3-months for PHMSO s.52(1); and 6-months for each of PHMSO rr.54(1)(a) and 61(1))? How will courts exercise discretion in sentencing? Granted, judicial discretion in this regard is subject to the totality principle. However, the situation still gives potential unpredictability, inconsistencies, and disproportionate punishments. Such concerns are not purely theoretical, as per R v Lee.

In-patient errors may lead to six possible offences. On the other hand, community practices will only be exposed to four offences under PPR r.9(1), PHMSO ss.52(1), 54(1)(a), and 61(1). How it is fair that hospital pharmacists are exposed to more offences and heavier punishments? This distinction between hospital pharmacists and everyone else has no obvious purpose.

Discrepancies in Outcomes

Let us imagine concurrent liability uncertainties are somehow minimised. There are still problems with discrepancies of outcomes, since the offences under PPO, PPR, and PHMSO carry different maximum sentences, ranging from $10,000 to $100,000 and 3-months’ to 2-years’ imprisonment. Which offence chosen to be charged and/or convicted may mean significantly different outcomes.

Let us further imagine that maximum sentence discrepancies are minimised by the prosecution making it clear that they will pick the offence with the heaviest sentence, leaving flexibility for courts. In-patient errors are still problematic, since PPR rr.22(2), 23(2), and 23(3) carry the same maximum of $100,000 and 2-years’ imprisonment. Here, the offence charged and/or convicted is not unimportant, since names and content of offences carry social stigma, and an appropriate label accurately reflecting wrongfulness of the conduct is important for proportionate and non-arbitrary punishment.

Sentencing Uncertainties

Even when imprisonment is a possible sentencing option, UK’s position has consistently been that inadvertent dispensing errors, regardless of seriousness of the subsequent harm, does not justify imprisonment. HK’s stance is unknown.

Disciplinary Liability

Background

Broadly speaking, disciplinary liability’s purpose is as quality control for professional practices. Pharmacy and Poisons Board’s (PPB) Code of Professional Conduct (CoPC) seeks to ensure ‘patient-centred care to enable patients and the public to maintain good health and high quality of life through [responsible, safe and effective use] of medications’ (Pharmacy and Poisons Board of Hong Kong 2017, 2). HK Medical Council’s (MCHK) function is protecting the public, promoting trust, ensuring good and ethical standards and practices, and providing general guidance to doctors (Wai et al. 2016, 150).

As per Lord Diplock, ‘the purpose of disciplinary proceedings against [convicted HCPs] is not to punish… a second time… but to protect the public… maintain… high standards and good reputation’, but it should be noted that it nonetheless has incidental punitive effect (Wai et al. 2016, 155; Ziderman v General Dental Council 1976).

The usual disciplinary framework is that on complaint or conviction, an inquiry will consider sanctions. Possible outcomes include censure, warning, or removal from register.

Pharmacists

PPB’s Code of Practice (CoP) stipulates that all labelling should include the patient’s name, dispensing date, dispensary name and address, medicine name, dosage, directions, and precautions (Pharmacy and Poisons Board of Hong Kong (HKPPB) 2015, Appendix A). It also guards against ‘content-errors’, stating that POMs must be in accordance with prescriptions (Pharmacy and Poisons Board of Hong Kong (HKPPB) 2015, c.3.1(b)).

Doctors

Similar to PPB-CoP, MCHK-CoPC stipulates labelling requirements, and, additionally, to dispense all medicines according to prescription, and also advises GDPM observance (Medical Council of Hong Kong 2016, c.9.2, 9.4, 9.5).

Dentists

Dental Council’s Code of Professional Discipline stipulates mandatory labelling requirements, without any mention of dispensing according to prescription (Dental Council of Hong Kong 2019, c.13).

Discrepancies in Coverage

The Codes all have slightly different coverage. For example, POM ‘content-errors’ breach the pharmacists’ and doctors’ Codes but not dentists’. ‘Content-errors’ for prescribed non-POMs breach only the doctors’ Codes. It is curious that for the same error, we can point to specific breaches for some HCPs but not others. The potential harm is the same regardless of which profession dispenses in error, so why should Codes be any different in this regard? Does this imply that patients should expect differing levels in dispensing quality? Doctors have the strictest Codes for dispensing, does that mean patients should not expect the same quality from pharmacists’ dispensing? Fostering such a public perception neither seem conducive towards HK’s policies nor does it make sense with respect to public health.

Civil Liability

Negligence

Civil liability serves primarily as compensation. On negligence, compensation seeks to, as far as money can, place the victim in a position as if it never happened. To establish negligence, there must be a duty of care where its breach caused non-remote harm.

HCPs owe a duty towards patients (South Australia Asset Management Corp v York Montague Ltd 1997). Whether a dispensing error was a breach objectively enquires whether the HCP acted reasonably (Nettleship v Weston 1971). HCPs are not in breach merely because a body of opinion takes contrary view, so long as they were acting in accordance to a practice accepted as proper by a responsible body of HCPs (Bolam v Friern Hospital Management Committee 1957). However, if a particular practice is not capable of withstanding logical analysis, or if there is a failure in disclosing risks, then HCPs cannot rely on that body of opinion (Bolitho v City and Hackney Health Authority 1998; Montgomery v Lanarkshire Health Board 2015).

Causation is generally established if, on the balance of probabilities, but-for the error, the harm would not have occurred (Barnett v Chelsea & Kensington Hospital Management Committee 1969; Chester v Afshar 2005).

Dispensing errors only lead to liability if its particular type of harm was reasonably foreseeable (Overseas Tankship (UK) Ltd v Morts Dock & Engineering Co (The Wagon Mound) (No. 1) 1961). Only the type has to be foreseeable, neither the extent nor the specific manner (Hughes v Lord Advocate 1963; Jolley v Sutton London Borough Council 2000). If the harm’s type is foreseeable, but the harm suffered is more serious than expected because of a pre-existing condition, it will still be considered a non-remote consequence (Smith v Leech Brain & Co 1962).

Vicarious Liability

Through vicarious liability, patients may possibly claim against employers, likely with deeper pockets and/or insurance, meaning a greater ability towards compensating their entire claim amount (Poon Chau Nam v Yim Siu Cheung 2007; Various Claimants v Institute of the Brothers of the Christian Schools 2012; Cox v Ministry of Justice 2016; Lister v Hesley Hall 2001; Ming An Insurance Co (HK) Ltd v Ritz-Carlton Ltd 2002).

Exemptions

Contracts may modify HCPs’ obligations. However, negligent dispensing errors causing death or personal injury cannot be contractually exempted or restricted (Cap. 71 Control of Exemption Clauses Ordinance (CECO) 1990, s.7(1)).

Bigger Picture: Interaction Between Criminal and Disciplinary

There are issues with consistency, transparency, and proportionality within the criminal regime, and inconsistencies in disciplinary regimes. When they interact, the issues are amplified.

The legal position of this interaction seems unclear at places. The maxim that ‘a person ought not to be punished twice for the same wrong’ does not apply to disciplinary proceedings, meaning that convictions do not automatically preclude disciplinary sanctions (R v Statutory Committee of Pharmaceutical Society of Great Britain, ex parte Pharmaceutical Society of Great Britain 1981; Wai et al. 2016, 155). However, how the punitive effects of convictions are weighed in deciding appropriate disciplinary sanctions (which are inevitably also punitive) is unclear. Similarly, while the UK is clear that remedial disciplinary actions will be factored in considering prosecution, HK’s position as to how disciplinary sanctions are weighed in prosecuting and sentencing is uncertain (Pharmaceutical Journal 2010).

One particular dispensing error incident suggests that HK’s prosecution gives extremely high weight to disciplinary sanctions. In 2005, Dr Ronald Li gave the wrong diabetic drug to 152 patients with stomach problems (Lam 2010, s.5.4.1). As a result, 65 patients suffered hypoglycemia, of which 18 were hospitalised and 4 died (Chen and Cheng 2005). At least two deaths were caused by Li’s errors (SCMP Reporter 2007b). Li’s assistant, who carried out the actual dispensing, ordered the wrong drug, and Li only realised the error 4 months later on hospital complaints (SCMP Reporter 2007a). This was an egregious and intentional abrogation of Li’s professional duties, and not simply a single inadvertent error, but 152 repeated errors. Li was personally liable for dispensing, but the facts suggest that he never bothered checking even once. This is a clear-cut example of when public interests point strongly towards prosecuting. A disciplinary inquiry was held, where MCHK hugely downplayed the error by merely acknowledging that Li was convicted of 3 unrelated record keeping offences — when his error was clearly so much more than that (Medical Council of Hong Kong 2006). The disciplinary sanction issued was a removal from the register for 1 month, suspended for 1 year, which was disproportionately light. Even more surprising, Dr Li was never prosecuted for his dispensing errors, even with a compelling case for gross negligence manslaughter, and almost certainly contraventions of PPR r.9(1), PHMSO, ss.52(1), 54(1)(a), and 61(1).

The crucial question here is why no charges were pressed for Dr Li’s dispensing errors, in such a clear-cut case of high public interest, particularly when disciplinary sanctions were light and for unrelated offenses. If such a serious case does not pass prosecution threshold, all dispensing error offences seem in practice redundant.

Potential Solutions for Hong Kong’s Regime

Modifying Criminal Liability

First, in reading this paper’s following proposition on whether the modification of dispensing error offences under PPO, PPR, and PHMSO is appropriate, it is important to remember that gross negligent manslaughter and common law bodily harm offences are still always available.

Defences

As already argued in this paper, criminalising inadvertent dispensing errors is against public interest, and it is appropriate to introduce mens rea defences to remedy this. Additionally, for provisions like PPR r.9(1), it is currently unclear which alternative will be applied for implied mens rea. One way to clarify will be to extend statutory defences similar to PHMSO s.61(1)’s to all dispensing error offences. So that, on extension, it becomes a defence for all relevant offences to prove that the dispensing person could not with reasonable diligence have known about the error. Similar in effect will be to enact provisions like the UK’s Order.

Decriminalisation

Going further, it is suggested that the decriminalisation of lawful dispensing can also be considered. It is argued that decriminalisation will also reflect the prosecution’s real-life practice, since, as already pointed out, dispensing errors are never prosecuted.

In the Absence of Criminal Liability

The defences and decriminalisation must be considered together with the effects of punishments left available, meaning the disciplinary regimes’ reach must be examined on whether it is capable of supporting changes towards criminal liability. It is the argument of this paper that several inherent deficiencies, discussed immediately below, suggest that HK is not ready for decriminalisation.

Opaque Disciplinary Sanctions

It is posited that PPB’s disciplinary proceeding has an opaque sanctioning framework. While sanctioning options are mentioned under PPO s.15, there is no indication of when sanctions will be exercised, and which is appropriate for what situations. In comparison, UK’s pharmacist regulator, the General Pharmaceutical Council (GPhC), has an extremely comprehensive 36-page guideline on disciplinary hearings and sanctions, with an entire section dedicated to factors weighed in sanctioning, and another section outlining applicability of different sanctioning options (General Pharmaceutical Council (UK) 2017 ss. 5, 4). Additionally, PPB does not publish disciplinary outcomes, different to MCHK and GPhC (Pharmacy and Poisons Board of Hong Kong 2020; Medical Council of Hong Kong, n.d.; General Pharmaceutical Council (UK), n.d. a).

The argument therefore is that none of HK’s disciplinary frameworks has GPhC’s comprehensiveness, transparency, and detail. GPhC’s level of detail is requisite for decriminalisation, in order to guarantee proportionate accountability in absence of criminal liabilities.

Light-Touch Regulatory

In light of Dr Ronald Li, this paper posits that HK’s self-regulating disciplinary frameworks are light-touch and riddled with protectionism, to the detriment of public health interests. More duties should be attached to HCPs in order to generate patient-care serving behaviour. For example, for reporting culture, the US Medical Error Reduction Act would have made reporting of medication errors mandatory. Regulators can also mandate professional indemnity, minimising the fear of exposure to negligence claims acting as a deterrent towards reporting (General Pharmaceutical Council (UK), n.d. c).

Separation of Dispensing and Prescribing

This paper further argues that harmonisation of dispensing standards is needed, failing which there is inconsistent dispensing quality. There are several different possible approaches.

First, by far the most popular amongst pharmacists and well-accepted by the public, is separating dispensing and prescribing (Pong 1999; Ann and Benitez 2005). The exclusive dispensing role is best given to pharmacists, since pharmacists have more extensive experience and knowledge in this area relative to doctors (Cheung 2015). This approach has the additional benefit of reducing conflicts of interests in medication choice when prescribing and dispensing are by the same person. However, there has been pushback that there are not enough pharmacists to support separation (Legislative Council Panel on Health Services 2005).

Second, to have all dispensing-related sanctions conducted by the same body, using harmonised standards to assess potential breaches, this can be by a joint-HCP committee, or to have all dispensing-related proceedings conducted by PPB. However, this approach seems unlikely given the convoluted legislative changes required, and the protectionism mindset of regulators and professional bodies likely meaning that none will be willing to cede their self-determining powers.

Regulatory and Disciplinary Reform

As this paper has laid out, there is utility and need for expanding pharmacist’s dispensing role. However, this paper’s argument is that, unfortunately, the current legal regime, particularly for pharmacists’ disciplinary proceedings, is incapable of supporting any meaningful changes towards dispensing and its criminal liabilities, since there are neither assurances towards effective accountability nor clear detailed iterations of dispensing practices to guide professionals and the public.

Therefore, this paper takes the position that the prerequisite for decriminalisation and expansion of pharmacists’ role is to overhaul PPB’s framework under Rule of Law principles.

Managerial Liability

Dispensing error liabilities currently and typically concentrate on individuals. Since errors are inadvertent, sanctioning individuals unlikely drives systemic changes. This paper suggests that, to improve systems, there must be appropriate motivations at the management level.

Pharmacy owners, registered under PPB, are held to similar standards as pharmacists. On the other hand, there is seemingly little liability for hospital management. Compensation-based accountability is ineffective, since vicarious liability and insurance shields individuals from being personally liable for compensation, thus being inefficient towards motivating change. From an economical perspective, it might more cost-efficient for the hospital management to compensate errors instead of overhauling systemic practices.

Possible non-compensation-based accountability for promoting healthcare culture may be a personal professional duty in dispensing management, like GPhC’s superintendent pharmacist framework (General Pharmaceutical Council (UK), n.d. b, 2010; Pharmaceutical Journal 2014; Jarrold 2018; Howard 2019). Superintendent pharmacists must ensure arrangements in relation to dispensing support pharmacist compliance with legal and professional duties, with breaches triggering sanctions for both the superintendent and dispensing pharmacist.

Conclusion

No doubt, it is difficult to strike appropriate balance in serving the interests of collective health and patient-care. Hopefully, this paper is of scholarly contribution in (1) providing compelling reasons towards modifying dispensing error criminality, and (2) identifying prerequisites for decriminalisation and pharmacists’ dispensing role expansion: through overhauling the regulatory framework, focusing on accountability.

Data Availability

Not applicable.

Declarations

Competing Interests

The author declares no competing interests.