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A B C D E F G H I J K L M N O P R S T V W Y

Pharmacy and the Law

A selection of articles for the pharmacy sector written by Richard Hough, a Partner and pharmacist in the commercial team, which are printed in pharmacy sector publications.

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Well, it’s a start...

Monday 30th April 2018

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New dispensing error legislation is a step forward in protecting pharmacists but is no panacea, says Richard Hough.

After a seemingly interminable wait, the Privy Council has finally approved legislation, which, once adopted, will introduce new defences to what most pharmacy practitioners rightly regard as unwanted, unnecessary and outdated criminal offences concerning dispensing errors that were first introduced into English law 50 years ago under the Medicines Act 1968.

The Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018 is due to come into force on 16 April. It aims to protect registered pharmacists, technicians and those working under their supervision in registered pharmacies from fear of criminal prosecution for having made inadvertent preparation or dispensing errors.

The law currently and unfairly considers all dispensing errors to be criminal acts, regardless of whether such errors were intentional or inadvertent and without any consideration of the severity of harm caused. Any person who is guilty of such an offence faces a fine, or imprisonment for up to two years. Notably and tragically, Elizabeth Lee and Martin White have each fallen foul of such offences.

The legislative changes mean that pharmacy professionals who make an inadvertent dispensing error and satisfy the conditions for the new defence will no longer face the risk of criminal prosecution, albeit their conduct will continue to be subject to the scrutiny of the General Pharmaceutical Council.

It is hoped, though this remains to be seen, that the new law will encourage error reporting, increase patient safety, and create a culture of openness among pharmacy professionals to learn from mistakes without the fear of criminal sanctions. So, what comfort does the new law bring?

Article 4 of the Order contains amendments to the Medicines Act 1968, and creates new defences to contraventions of sections 63 and 64 of that Act.

The offences in section 63 relate to adulteration of medicinal products for human use. If the product is not sold or supplied, in order to benefit from the new defence in section 67a, the defendant must prove that:
 

A. the person who adulterated the product either was a registered pharmacist or pharmacy technician who was acting in the course of his or her profession, or was acting under the supervision of such a registrant

B. the adulteration took place at a registered pharmacy

C. the defendant did not know that the product was being adulterated.


If the product is actually sold or supplied, in order to benefit from the new defence in section 67b, in most cases the defendant must prove (A) and (B) above plus:
 

D. the product must have been sold or supplied in pursuance of a prescription or directions, or be an emergency sale or supply of a Prescription Only Medicine in circumstances where a prescription could not be obtained without undue delay

E. if an appropriate person becomes aware of the mistake, all reasonable steps must be taken to ensure that the patient is notified of the mistake, unless the appropriate person reasonably forms the view that it is neither necessary nor appropriate to do so.

The offence in section 64 relates to the sale, or supply in pursuance of a prescription, of medicinal products for human use which are not of the nature or quality demanded by the purchaser or as specified in a prescription. The elements of the new defence in section 67c which apply in most cases, are similar to those in the new section 67b, namely as (A) and (B) above plus:

F. the sale or supply must have been in pursuance of a prescription or possibly directions, in the case of a sale, or be an emergency supply of a prescription only medicine in circumstances where a prescription could not be obtained without undue delay

G. if an appropriate person becomes aware of the mistake, all reasonable steps must be taken to ensure that the patient is notified of the mistake, unless the appropriate person reasonably forms the view that it is neither necessary nor appropriate to do so.
 

So, let’s be clear about this. Whilst the adoption of the new legislation and the statutory defences are to be welcomed, the regulations do not decriminalise dispensing errors, which could have been easily achieved if sections 63 and 64 had been repealed. So, pharmacists can still be guilty of a criminal offence if a dispensing error is made but will avoid conviction if he or she can prove to a court that the statutory defence is met.

And yet despite such a long wait, ambiguities still remain around the scope of the acts of “dispensing” and “supervision”, for which no statutory definitions have been provided. Also, the defences do not extend to errors made in respect of OTC sales, so pharmacists will remain at risk for such errors. Mislabelling (where the correct product is supplied but it is wrongly labelled) also still remains a criminal offence and, curiously, no statutory defence has yet been put forward in the regulations for this offence.

The new legislation is a step forward in protecting pharmacists but there is more distance still to be travelled on this highly contentious topic.

For more information on the topic, contact Richard on 0151 600 3302, or email him at richard.hough@brabners.com. You can also read the full article on the Independent Community Pharmacist website.


Reform or be damned?

Tuesday 27th February 2018

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Richard Hough explores the mooted reforms to professional regulation.

Towards the back end of last year, the Department of Health published its consultation on the Government’s plan to reform UK healthcare professional regulation. The consultation poses a variety of questions on the future of healthcare regulation and covers the central themes of protecting the public through more responsive and efficient regulation.

The backdrop to the consultation comes from the Government’s manifesto commitment to legislate to reform what it perceives as a currently outdated “historical patchwork” system of professional regulation of healthcare professions. The current system is seen as being inconsistent, outdated and becoming ever increasingly complex from the perspective of patients, professionals and the public. There are concerns that people are confused by which professionals are regulated by which body and to what standard they are assessed.

In pushing forward with reform, the four UK governments have the ambition to improve the protection of the public from the risk of harm from poor professional practise, and to have a more responsive and efficient regulatory system that will maximise public protection, as well as support workforce development to help overcome the obstacles of delivering healthcare in the future.

As it currently stands, the body responsible for the independent regulation of pharmacy professions within Great Britain is the General Pharmaceutical Council (GPhC). Created in September 2010 after the Pharmacy Order 2010, the GPhC is responsible for the regulation of pharmacists, pharmacy technicians and pharmacy premises within England, Scotland and Wales.

The stated purpose of the GPhC is to set and promote standards for the safe and effective practise of pharmacy at registered pharmacies, maintain a register of pharmacists, pharmacy technicians and pharmacy premises and to establish fitness to practise requirements. This purpose is met through approving the necessary qualifications and training for pharmacists, pharmacy technicians and pharmacy support staff, inspecting registered pharmacies to ensure that they are meeting the mandatory standards and to subsequently investigate concerns and take action against pharmacy professionals who do not meet these standards.

Notable impact

It is likely there will be a notable impact on pharmacy regulation in the UK if reform plans are adopted. These plans could see a reduction from nine to “three or four” healthcare regulatory bodies, which will operate across the UK, with the consultation stating that research suggests that “efficiencies begin to accrue when a regulatory body has a registrant base of between 100,000 and 200,000.”

Based on 2015/16 figures, the GPhC has 89,377 registrants and thus is one of five healthcare regulatory bodies that falls under the 100,000 threshold. The belief is that a reduction in the number of healthcare regulators would ease the burden in costs of the healthcare professional regulatory system and would allow for a more consistent approach to regulation to be adopted.

It is proposed that the Professional Standards Authority for Health and Social Care (PSA), which is responsible for reviewing the work of the regulators of health and care professionals, will take on the role of advising the UK governments on which groups of healthcare professionals should be regulated, as the PSA is considered to be “better placed to provide advice on the regulation of professions.”

The Government hopes that the reconfiguration of the healthcare professional regulatory bodies will lead to more effective public protection through a clearer system of professional regulation and will dispel the current confusion about which organisations are relevant to which matters. Furthermore, it is being put forward that a reduction from nine regulators to three or four would enable the system to be much cheaper to run and would maximise economies of scale.

End of the GPhC?

If the reform plans are adopted, this could spell the end of the GPhC in its present capacity. The consultation discusses the benefits of increased collaborative working (in IT and HR for example) that would accommodate a more cost-effective approach. Similarly, joint working could extend to data sharing between the regulators about the number of fitness to practise referrals, for example, and the benefits of having a shared online register is also discussed.

In response to the consultation, the Pharmacists’ Defence Association (PDA) wants to see a proposal for regulation that “is fair, transparent and effective in how it protects patients and their health.” The PDA explained that, following its Freedom of Information Act request, it had discovered that the GPhC had never issued an improvement notice to a pharmacy owner or brought a fitness to practise case against a registrant for a failure to comply with the Standards for Registered Pharmacies, yet had commenced disciplinary proceedings against more than 3,500 individual registrants since its formation in 2010.

The GPhC’s chief executive, Duncan Rudkin, has said that the consultation provides the opportunity to discuss how regulation “can best protect and assure patients and the public, and support the professionalism of all health professionals.” The GPhC intends to expand on the issues raised in the consultation once it has considered all the implications and questions posed, but it intends “to play an active part in the discussions.” However, it is fair to assume that the turkeys will not be voting in favour of Christmas...

For more information on the topic, contact Richard on 0151 600 3302, or email him at richard.hough@brabners.com. You can also read the full article on the Independent Community Pharmacist website.


Play your cards right

Monday 22nd January 2018

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When it comes to FTP hearings, a recent Supreme Court decision is likely to make decisions about dishonesty a lot easier, says Richard Hough.

A recent Supreme Court decision is likely to impact the rules on the test for dishonesty, which is applied in General Pharmaceutical Council (GPhC) fitness to practise (FTP) hearings. For pharmacists accused of dishonesty, the recent decision may mean that such a finding will be more easily made.

The case of Ivey v Genting Casinos involved a professional gambler, Ivey, playing a variant of baccarat at a London casino owned by Genting. Ivey manipulated a croupier into arranging cards so that tiny variations in pattern on one edge were visible. Having established this advantage, Ivey went on to win £7.7m. The casino refused to pay out, and Ivey brought an action for his winnings, claiming that his actions were no more than a legitimate attempt to win the game. The Supreme Court found that the ‘edge-sorting’ technique used by Ivey was cheating, regardless of Ivey’s beliefs that it was legitimate.

The most far-reaching point to emerge from the case, however, was the judicial consideration of the established test for dishonesty, which comes from the 35-year- old criminal case of R v Ghosh.

Ghosh test
The Ghosh test for dishonesty is in two limbs: Whether the conduct of the defendant was dishonest, judged by the objective standards of ordinary reasonable and honest people (the objective limb); and

If so, whether the defendant must have realised that ordinary honest people would regard the conduct as dishonest (the subjective limb). The defendant is only to be convicted of dishonesty if both limbs are satisfied.

The Supreme Court recognised that the subjective limb was included to preserve the principle that when making a finding of dishonesty, the defendant’s state of mind must be considered. However, the court also raised a number of concerns with this part of the test, key amongst which was that “it has the unintended effect that the more warped the defendant’s standards of honesty are, the less likely it is that he will be convicted of dishonest behaviour.” That is to say, the subjective limb of Ghosh allows for the least honest people to be judged by their own, lower, standards of honesty.

The GPhC had already recently moved away from this criminal dishonesty test and had opined that the Ghosh test is “not appropriate, open to interpretation and outdated”. However, this was based on different reasoning to the Supreme Court in Ivey. The GPhC was more concerned with the difficulties in applying a civil standard of proof (“the balance of probabilities”) to a test formulated in a criminal case, to which the criminal standard of proof (“beyond reasonable doubt”) would ordinarily be applied.

The GPhC found that a variant of the Ghosh test from a civil case, Twinsectra v Yardley, was more appropriate. The Twinsectra test maintains the same objective limb as Ghosh, but its subjective limb is: “whether the defendant realised that ordinary and honest people would regard the conduct as dishonest”.

State of mind
Having analysed the Ghosh test and found it wanting, the judgment in Ivey explains how dishonesty will be judicially assessed from now on, following an established line of reasoning from Royal Brunei Airlines v Tan and the Privy Council decision in Barlow Clowes International Ltd v Eurotrust International Ltd. The court makes clear that there is still some relevance for the defendant’s actual state of mind, in that “in order to determine the honesty or otherwise of a person’s conduct, one must ask what he knew or believed about the facts affecting the area of activity in which he was engaging.”

The court explains the principle by way of an example. If a person came to England from a country where public transport was free and on their first day here travels on a bus and alights without paying, are they dishonest? The Supreme Court’s answer was that no, this person is not dishonest because they genuinely believed that public transport is free. The situation is the same as for a child, who does not understand the rules, or a person who makes an innocent mistake about the validity of their ticket.

The important distinction is between making allowances for the subjective beliefs of the defendant regarding the facts or circumstances surrounding his conduct, and allowing the subjective beliefs of the defendant regarding the appropriate standard of honesty to affect the outcome of the case. The new test may therefore be stated as:

1. What was the actual state of the defendant’s knowledge or belief as to the facts; and

2. Given the answer to the first limb, was the conduct dishonest by the objective standards of ordinary decent people?
 

It remains to be seen whether the GPhC will update its guidance to reflect the direction taken in the new Supreme Court decision. If so, it should make it easier for a finding of dishonesty to be made against pharmacists by GPhC FTP committees.

Once the pharmacist’s knowledge is established by the committee, the pharmacist’s actual conduct would only need to be judged against the ordinary standards of decent people. There is no longer any requirement for the pharmacist to appreciate that what they have done would be seen, by those standards, to be dishonest.

For more information on the topic, contact Richard on 0151 600 3302, or email him at richard.hough@brabners.com. You can also read the full article on the Independent Community Pharmacist website.


Safe and sound

Monday 11th December 2017

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Richard Hough discusses the consultation on the regulation of unregistered pharmacy staff

On 11 October 2017, the General Pharmaceutical Council (GPhC) concluded a 12-week consultation on guidance for pharmacy owners about ensuring a safe and effective pharmacy team. The GPhC regulates pharmacists, pharmacy technicians and registered pharmacy premises. However, many pharmacy staff are unregistered and outside the scope of GPhC regulation, including delivery drivers, dispensers and medicines counter assistants and some pharmacy managers.

The consultation guidance is intended to support the GPhC’s standards for registered pharmacies by focusing on unregistered pharmacy staff. Pharmacists have a professional obligation to ensure that dispensing, pharmacy and medicines counter assistants are competent for the areas in which they work. The guidance does not affect the accountability of individual pharmacists, but provides that pharmacy owners should be jointly responsible for ensuring that unregistered staff are competent for their roles. The guidance is to replace the GPhC minimum training requirements that were approved in 2011.

Other policies for support staff have been in place since 2010, but these are now viewed as outdated and inconsistent with the modern approach to quality governance and teamwork. The consultation document states that the current framework fails to reflect the diversity of roles within pharmacies, and a more flexible outcome-focused approach is necessary to address the needs of current and future patients.

The GPhC’s regulatory powers do not extend to unregistered staff and its statutory powers of accreditation for training courses are explicitly for courses leading to a regulated position. The GPhC proposes that pharmacy owners should be responsible for selecting appropriate training for staff, but be accountable to the GPhC for their decisions.

The guidance (summarised below) is based upon the GPhC’s principle that “staff are empowered and competent to safeguard the health, safety and wellbeing of patients and the public”, and focuses on pharmacy owners’ responsibility for unregistered staff.

Governance
Pharmacy owners should ensure that staff numbers and roles are appropriate for the services they provide (including suitable plans to cover absences) and that everyone in the team knows their own, and each other’s, duties and responsibilities. Pharmacy owners should be open to innovation and the development of roles in line with the evolving nature of modern pharmacy practices. Effective risk management procedures should be implemented and all staff should know how to assess and reduce risks in their roles. Unregistered staff should work only within the limits of their competence and refer to pharmacy professionals where necessary, and everyone in the team should be able to raise safety concerns or suggest improvements. All staff should uphold the principles of confidentiality and privacy and should understand their responsibilities for record keeping and the storage and sharing of information.

Training, skills and development
Pharmacy owners should ensure that all staff are appropriately trained and that training records are retained. Training requirements should be flexible to address the needs of patients (both generally and specifically in the local area). Role-specific inductions and competency assessments should be undertaken for all new staff to identify training needs, and those dispensing or supplying medicines must meet the minimum training requirements. Unregistered staff requiring training to achieve competency should be enrolled on appropriate courses within 3 months of starting. Continuous learning and development for all staff is also vital. Pharmacy owners should ensure that procedures are in place to identify and address skills gaps at an individual and team level so that the knowledge and skills of all staff are up-to-date and appropriate for the services provided. Interpersonal skills are also important in providing the quality of care that patients expect. Pharmacy owners should ensure the provision of compassionate care which is adapted to the needs of the patient, identifying vulnerable patients and acting accordingly and taking steps to overcome communication barriers.

Management
Pharmacy managers need not be registered pharmacists, but have a significant influence on culture and practices within pharmacies. Pharmacy owners should assess and ensure the competence, skills and experience of their managerial staff so that they can carry out their roles without compromising safe and effective care. Managers should understand the relevant legal and regulatory frameworks and the obligations and responsibilities of different members of the pharmacy team, as well as the need for pharmacy professionals to prioritise patient safety and wellbeing.

What’s next?
The GPhC aims to agree the new framework by the end of 2017 after having considered responses to the consultation. The overarching theme of the guidance, and the direction in which the GPhC appears to be steering the regulatory framework, is that pharmacy owners need to take charge of their businesses at all levels and, above all, must be responsible and accountable to the GPhC for the safe and effective provision of pharmacy services by the whole pharmacy team. The current policies and minimum training requirements continue to apply in the meantime.

For more information on the topic, contact Richard on 0151 600 3302, or email him at richard.hough@brabners.com. You can also read the full article on the Independent Community Pharmacist website.
 


Going against the grain

Wednesday 18th October 2017

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Richard Hough, Pharmacy Lawyer suggests that, counter-intuitively, the pharmacy cuts could actually lead to business expansion.

The negative impact on balance sheets nearly a year after the government imposed significant funding cuts on community pharmacy has seen a number of our clients approaching us with a view to exploring ways of mitigating the effect of the cuts. 

Of course, there are many reactive ways of mitigating the effect of reduced funding to maintain profitability, often negative in nature and which mainly involve either the most drastic option of deciding to cut their losses and sell up or the rather less drastic option of staying put and implementing cost-cutting measures. 

However, not all actions need to involve cutting overheads yet further. Perhaps counter-intuitively in response to the funding cuts, we continue to see a trend of smaller independent pharmacies approaching us with a view assisting them with their expansion plans. The three most common options explored are: 
• Formation of a corporate joint venture 
• Entering into a contractual joint venture 
• Mergers 

Corporate joint ventures 
The formation of a new corporate vehicle (most commonly, a limited company or a limited liability partnership) allows two or more existing pharmacies to work together and collaborate by sharing costs, resources and facilities. The corporate joint venture entity is often adopted in order to perform a particular function or undertake a project or for a limited length of time in order to ring fence liability accordingly. For instance, the formation of a new corporate vehicle could allow the new legal entity to bid for enhanced and locally commissioned service contracts while ensuring that the primary pharmacy operating businesses, which will be shareholders in the joint venture entity, remain largely protected. 

On a practical level, a new corporate vehicle poses considerable governance issues, which the parties must work through. Generally, each of the parties will have contributed assets to the corporate vehicle and in return will require due influence upon the ongoing management of the venture. This is not always easy. 

Contractual joint ventures 
This option does not require the creation of a new legal entity, as with the corporate joint venture. The parties remain independent pharmacy contractors, which have agreed to collaborate with each other by entering into a legally binding contract pursuant to which each entity is contractually obliged to perform certain services for one or more of the other parties. Such obligations may include sharing premises and staff, which allows the parties to streamline administrative functions such as payroll and back office support. The contract would include how financial liabilities would be shared and how decisions would be taken. Under such contractual joint venture arrangements, again it may be possible for one or more of the contracting pharmacies to bid, as lead entity, on behalf of the other parties for locally commissioned services. 

While a direct contractual arrangement avoids the parties having to negotiate the complex areas of governance necessary to successfully operate a corporate joint venture, it may in some cases prove to be a less secure arrangement between the parties. In particular, the primary pharmacy operating businesses are not ring fenced from liabilities incurred under the contract, which will be borne by the relevant primary business, in its capacity as one of the parties to the contract. 

From a commissioning perspective, both of the first two methods of collaboration allow those pharmacies involved to cover a wider geographical scope and potentially achieve economies of scale, which can be passed onto the commissioner. In a market where funds are limited and margins are tight, this is a very attractive proposition for commissioners. From an administrative perspective, each of the joint venture models allows commissioners to contract with one provider to cover a range of services. 

Mergers 
The final option is for one or more pharmacy businesses to merge with each other in order to create a larger organisation. New legislation came into effect in December 2016 that affords protection to two pharmacies that choose to consolidate into a single existing site where such consolidation does not create a gap in service provision. A merger involves all trading activities, assets, liabilities and capital of the two existing entities being held together with the merged entity serving the same joint customer base. 

The cost reductions involved in streamlining the business can make this an attractive option. The pharmacies will inevitably need less staff and, as such, be able to reduce their wage bills. In addition, there will be more scope to make operational and dispensary efficiencies through automation, streamlined supply chains and perhaps having access to huband- spoke dispensing. 

Despite the potential operational advantages, a merger involves sacrifice. Each party will almost certainly have less autonomy and be required to sacrifice its previous control and flexibility. Governance of the merged entity can prove more complex and sometimes contentious. 

We are certainly seeing a growing trend in pharmacies choosing to collaborate in one form or another. There are many pros and cons to be carefully considered when deciding which is the best option for each pharmacy. Circumstances will dictate which is the most appropriate. It is important to take advice from both solicitors and accountants and reach a decision that is bespoke to the pharmacy in question.

Richard Hough is partner, pharmacist, and head of healthcare at Brabners LLP. Contact him on 0151 600 3302, or at richard.hough@brabners.com.


Is there a doctor in the house?

Tuesday 17th October 2017

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Richard Hough, Pharmacy Lawyer examines the potential pitfalls of collaborative working practices

The General Pharmaceutical Council (GPhC) recently published a joint statement alongside eight other health and care professional regulators to give new guidance on “avoiding, declaring and managing conflicts of interest”. This statement comes at a prudent time, with NHS England stating in April last year that it would boost funding by £112m to facilitate collaborative working practices including the employment of a projected extra 1,500 pharmacists in GP practices by 2020. Indeed, the move to the adoption of more collaborative working between the healthcare professions has been welcomed by many, with benefits of increased efficiency and an easing of pressure on GPs. However, this “increasing move towards multi-disciplinary teams” is not without its pitfalls.

Joint ventures
Historically, pharmacies have operated independently from influence by GPs, with patients free to choose where their prescription is dispensed based on proximity and service. Recently, however, we have advised a number of pharmacists who have sought to protect (a defensive move) and/ or grow (an aggressive move) their business by forming joint venture-type arrangements with GP practices. Such arrangements can easily lead to conflicts of interest and unlawful behaviour.

For example, a GP may choose to recommend to a patient a pharmacy in which it has a financial interest, on the basis that the GP would directly benefit from the pharmacy’s increased business. The conflicts of interest can range from something as seemingly innocent as a misjudged suggestion from a GP’s receptionist, to the more serious matter of GPs lying to patients about their options. Both of these examples represent placing financial or personal gain above patient care – a clear conflict of interest for the doctor.

Previous guidance was limited to the General Medical Council’s advice on ‘financial and commercial arrangements and conflicts of interest’, which encouraged honesty and instructed doctors to tell patients about any financial or commercial interest they might have when referring a patient. This guidance does little to help pharmacists, particularly those working for doctors in a GP practice.

Clarifications
The recent GPhC’s joint statement attempts to gives clarification to pharmacists and other healthcare professionals on what does, or does not, constitute a conflict of interest and includes the following expectations:
• Put the interests of people in their care before their own interests, or those of any colleague, business, organisation, close family member or friend.
• Maintain appropriate personal and professional boundaries with the people they provide care to and with others.
• Consider carefully where conflicts of interest may arise – or be perceived to arise – and seek advice if they are unsure how to handle this.
• Be open about any conflict of interest they face, declaring it formally when appropriate and as early as possible, in line with the policies of their employer or the organisation contracting their services.
• Ensure their professional judgement is not compromised by personal, financial or commercial interests, incentives, targets or similar measures.
• Refuse all but the most trivial gifts, favours or hospitality if accepting them could be interpreted as an attempt to gain preferential treatment or would contravene your professional code of practice.
• Where appropriate, ensure that patients have access to visible and easy-to-understand information on any fees and charging policies for which you are responsible.

The joint statement also includes the following case study on prescription direction to accompany the guidance: Dr Williams is a GP in a private practice whose employer owns a local pharmacy. She has been instructed to encourage patients to take their prescriptions there as they will get “better service and faster processing times”. Dr Williams realises that she must always put the interests of her patients before her own or her employer’s interests, and that it would be inappropriate to make recommendations. She knows that directing prescriptions to her employer’s pharmacy would be likely to constitute a conflict of interest. The responsible course of action taken by Dr Williams is to make sure her patients know and understand that they can choose where to get their prescription. When advice is sought, she would continue to give a range of options and, if any patients asked her about that particular pharmacy, she would be open and honest about her employer’s interest in it.

Those pharmacy businesses which have GP involvement should ensure that staff are aware of and abide by such guidance on conflicts of interest, as competing businesses will be keen to ensure that professional standards and regulatory requirements are not breached. Gifts, for example, should not be offered to any staff within the GP practice, no matter how trivial. Personal boundaries between colleagues should be maintained and relationships should be professional at all times. It is important to remember that professional judgement may also be compromised by personal interest, in addition to financial or commercial.

The joint statement represents a shift in regulatory focus towards highlighting the potential dangers of adopting collaborative working practices and engaging joint ventures between pharmacies and GP practices. The GPhC’s statement makes it clear that in cases of conflict the best course of action is to be honest and when in doubt, we would always recommend seeking expert legal advice.

Richard Hough is partner, pharmacist, and head of healthcare at Brabners LLP. Contact him on 0151 600 3302 or email richard.hough@brabners.com


Are you malware aware?

Tuesday 17th October 2017

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Richard Hough, Pharmacy Solicitor advises on the best digital defence when it comes to patient data protection

The cyber attack on the NHS computer system earlier this year, in which hackers spread ransomware called WannaCry, created havoc for healthcare professionals and patients alike. Hospitals and GP surgeries were among numerous health service organisations hit by the ransomware attack. It also affected an estimated 200,000 computer systems of other organisations in 150 countries around the world.

Those hospitals and doctors’ surgeries whose computer systems were affected were forced to turn patients away, putting yet further strain on pharmacy resources. The ransomware, which scrambled data on computers and locked out users, demanded payments of between $300 to $600 in order to restore access. It was only due to the actions of Marcus Hutchins, a 22-yearold self-taught programmer from Devon, that the ransomware attack was prevented from creating further havoc by triggering a “kill switch”.

Gone phishing
So what is ransomware and what is its relevance to an increasingly digitally-reliant pharmacy profession? Ransomware is a type of computer virus (often called malware) that is frequently delivered via emails, which trick the recipient into opening attachments and releasing the malware onto their computer system in a technique known as phishing. Once the recipient’s computer has been infected, it locks up the files and encrypts them in a way that prevents access to them. It then demands payment in order to regain access. Because malware is spread by faceless criminals, there is no guarantee that, even after payment, access to your files will be restored.

So how did WannaCry wreak its havoc? It did so by exploiting a vulnerability in the operating system Microsoft Windows for which Microsoft released a patch to fix the vulnerability in March. However, not every computer user is diligent in installing regular updates and patches on their computers when prompted to do so, which means that the system can remain needlessly vulnerable to a potential malware attack. Such complacency plays right into the hands of hackers, allowing them access to the computer system to spread their chaos.

It is possible to remove malware from a computer with advanced anti-virus software or by putting the computer into safe mode and manually removing the infected files. However, as anyone who has previously suffered a catastrophic computer meltdown at the hands of a virus or other malware will testify, with computers, as in healthcare, prevention is often better than cure.

Cyber security measures
In light of this recent malware attack, it may be worth revisiting a report published earlier this year by the Information Commissioner’s Office (ICO), which among other things oversees the protection of personal data and the promotion of cyber security. This report related to its findings from its work relating to community pharmacies. It sought to promote good data protection practices and guidance for the community pharmacy sector.

The report noted encouragingly that, while there was a wide variation across individual pharmacy organisations, “generally staff and organisations have a good awareness of the requirement to keep personal data safe and confidential and are motivated to do so”.

The study sets out the areas where community pharmacies are doing well, as well as highlighting the common problems and areas for improvement, and includes further guidance and advice to help community pharmacies improve their information governance and data protection practices.

With the expansion of services being offered within community pharmacy, and the recognition that pharmacies and their staff process a “significant amount of highly sensitive personal data”, getting data protection practices right is of paramount importance. Failure to do so can lead to serious consequences, ranging from an ICO investigation and heavy fines to reputational damage and serious loss of business.

One of the main observations was that it was “rare for an organisation to be consistently successful” in all the areas of data processing. Ongoing training was identified as one of the hardest to achieve successfully in smaller businesses where resources may be more limited, but was highlighted as a key area of focus to ensure staff maintain good cyber security and data protection practice.

Be prepared
The report made a number of recommendations for improvement, which if implemented will ensure good data protection practice within pharmacy businesses and minimise the risk of them suffering a cyber attack: • Ensure that all computers that process sensitive personal data, and are connected to a network, are upgraded to a supported operating system.
• Ensure no networked computers are unprotected from cyber attacks or malware.
• Implement a mechanism for “safe haven” procedures to maximise the secure use of fax machines where there are no other alternatives and their use remains necessary.
• Rollout the use of individual user logons for all systems that contain patient identifiable data to enable a full audit trail of view and change events to a patient’s record.
• NHS Smart Cards should only be used by the registered holder.
• Policies and procedures need to be in place to:
o control the removal of personal data from the pharmacy
o monitor staff for compliance with standards
o identify which records are to be retained and destroyed securely o ensure compliance with marketing consent legislation and the relevant record keeping required.

Richard Hough is partner, pharmacist, and head of healthcare at Brabners LLP. Contact him on 0151 600 3302 or email richard.hough@brabners.com


Parallel worlds

Monday 22nd May 2017

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Independent Community Pharmacist magazine article - May 2017

Press clipping: Pharmacy and the Law Copyright CIG Ltd.

The United Kingdom’s vote to leave the EU last June and Theresa May’s recent decision to trigger Article 50 will, to put it mildly, create one or two legal issues for the UK, or to put it more accurately, will create the mother of all legal messes.

Good news, at least, for the lawyers, you might say. However, one such legal issue, which pharmacy proprietors might need to consider, is the potential impact that Brexit will have on the parallel import of pharmaceutical products.

The dispensary shelves of community pharmacies up and down the country contain numerous parallel import products. The business of buying and selling parallel imports, insofar as it relates to community pharmacy, encompasses the trading of genuine pharmaceutical products at the different prices that can be obtained in the different Member States of the EU.

A manufacturer of a particular pharmaceutical product will be prepared, for economic, commercial, business or other considerations, to put its product on the market of one Member State at a materially lower price than it is prepared to do so in another. The price differential, together with the fundamental principle of free movement of goods within EU Member States, creates a demand from purchasers within territories where the prices are set high, which can be met by sellers located in territories where prices are set low.

Trade mark law

European trade mark law is central to the business of parallel imports. Parallel imported products of the type that are commonly found in community pharmacy dispensaries are all protected in some way or another by trade mark rights.

Trade mark rights are territorial in nature, affording the trade mark owner the exclusive right to commercially exploit its products under that brand within a particular territory. So, if another trader attempts to commercially exploit a trade mark owner’s product (using it in the course of business) by trading it under the owner’s brand, it would, but for the doctrine of “exhaustion”, as provided for in Article 13.1 of the European Trademark Regulation, be in breach of the trade mark owner’s rights. Article 13.1 states: “A Community trade mark shall not entitle the proprietor to prohibit its use in relation to goods which have been put on the market in the Community under that trade mark by the proprietor or with his consent.”

Therefore, once a product labelled with a trade mark has been sold by the trade mark owner or with its consent, the trade mark right is said to be “exhausted” and can no longer be enforced by the owner.

However, the effect of exhaustion of trade mark rights is limited to such goods that were first distributed to the market within the EU and also Iceland, Liechtenstein and Norway, together the EEA. Therefore, any imported pharmaceutical product from outside the EEA, which is put on the market within the EEA without the consent of the trade mark owning pharmaceutical company immediately constitutes trade mark infringement.

So, the future availability of parallel imports of pharmaceutical products will depend on the post-Brexit trade model with the EU adopted by the UK, the three main contenders being:

  • “Norwegian model”. Norway has full access to the European Single Market. In return, it is obliged to make a financial contribution and accept a whole range of EU regulations. If the UK adopts a similar model, it will stay closely connected to the EU with the advantage of full accessibility to the European Single Market. Choosing the “Norwegian model” would imply that the doctrine of exhaustion would continue to apply to the distribution of parallel imports in the UK.
     
  • “Swiss model”. Switzerland’s relationship with the EU is governed by numerous bilateral treaties, under which Switzerland has achieved broad access to the European Single Market and is able to trade in most goods. In the event that the UK re-joins the European Free Trade Association (EFTA), it would still have partial access to some elements of the Single Market but also have the freedom to independently reposition its own free trade policy to focus on non-EU countries. Therefore, in order to allow parallel imports from the UK, it would also have to negotiate separate bilateral agreements with the EU on the treatment of trade mark rights, including the scope of the exhaustion of such rights for cross-border trades.
     
  • “Hard Brexit”. The current Tory government favours a “hard” Brexit – leaving the Single Market and trading with the EU as if the UK were any other non-EU country. If the UK leaves the EU without joining (or re-joining) associations such as EFTA, the doctrine of exhaustion will cease to apply, as would therefore the legal basis for both parallel imports into and out of the UK. Brexit negotiations will no doubt begin in earnest after the outcome of next month’s general election, pursuant to which, depending on which model we end up adopting, legal parallel imports may no longer be found on UK pharmacies’ dispensary shelves and further impacting contractors’ profit margins.

For more information please contact: 



Richard Hough
Partner and Head of Healthcare at Brabners LLP
Tel:  0151 600 3302
Email: richard.hough@brabners.com

 


Bullying in the workplace

Tuesday 31st January 2017

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Independent Community Pharmacist magazine article - January 2017

Press clipping: Pharmacy and the Law Copyright CIG Ltd.

According to a 2015 report by the Advisory, Conciliation and Arbitration Service (ACAS), workplace bullying is on the rise, with about 20,000 calls relating to bullying being made each year to ACAS alone. Regrettably, bullying of staff members by pharmacy owners, managers, supervisors and work colleagues also occurs in community pharmacies.

Pharmacy owners should not underestimate the impact that workplace bullying can have on their businesses. Bullying and harassment can, if left unchecked or badly handled, create serious problems for the pharmacy, including poor morale and poor employee relations, loss of respect for managers and supervisors, poor performance, absence, and damage to the business’s reputation.

In addition, pharmacy owners should be aware that workplace bullying can result in an employment tribunal claim or court cases, and payment of unlimited compensation to victims. It is therefore in your interests to promote a safe, healthy and fair environment in which your staff can work.

Bullying defined

Bullying may be characterised as offensive, intimidating, malicious or insulting behaviour, an abuse or misuse of power through means that undermine, humiliate, denigrate or injure the recipient.

Behaviour that is considered bullying by one person may be considered firm management by another. Most people will agree as to what constitutes extreme cases of bullying and harassment but it is often the grey areas that cause the most problems. It is good practice for employers to provide their staff with examples of what constitutes unacceptable behaviour, including:

  • Spreading malicious rumours, or insulting someone by word or behaviour
  • Ridiculing or demeaning someoneExclusion or victimisation
  • Unfair treatment
  • Overbearing supervision or other misuse of power or position
  • Deliberately undermining a competent worker by overloading and constant criticism
  • Preventing individuals progressing by intentionally blocking promotion or training opportunities.

Unless bullying amounts to conduct defined as harassment in the Equality Act 2010, it is not possible to make a complaint to an employment tribunal. The Act uses a single definition of harassment to cover the relevant protected characteristics. Employees can complain about behaviour that they find offensive, even if it is not directed at them.

Harassment is defined as: “Unwanted conduct related to a relevant protected characteristic, which has the purpose or effect of violating an individual’s dignity or creating an intimidating, hostile, degrading, humiliating or offensive environment for that individual”. The relevant protected characteristics are age, disability, gender reassignment, race, religion or belief, sex, and sexual orientation.

An employee can make a complaint against their employer if they are harassed by someone who doesn’t work for that employer, such as a customer. As an employer, once you are aware of this unwanted behaviour, you should take reasonable and proportionate action to address it.

Pharmacy owners owe their employees a ‘duty of care’. If the mutual trust and confidence between employer and employee is broken, for example, through bullying and harassment, an employee can resign and claim constructive dismissal at an employment tribunal on the grounds of breach of contract.

Breach of contract may also include failure to protect an employee’s health and safety at work. Under the Health and Safety at Work Act 1974, employers are responsible for the health, safety and welfare at work of all employees.

Employees can also bring a negligence claim on the grounds that their employer has failed to protect them from bullying, which has led to personal injury (normally in such cases, psychiatric illness).

Prevention

Addressing bullying in the workplace can be difficult. However, making a grievance procedure or dignity-at-work policy accessible certainly helps; employees will know what to do if they think they are being bullied, which, in most instances, is to bring it to the attention of their managers.

Policies for owner-managed or small- chain pharmacies do not need to be over elaborate, and might be included within other personnel policies, but a checklist for a specific policy on bullying and harassment could include:

  • A statement of commitment from senior management
  • A clear statement that bullying and harassment is unlawful and will not be tolerated
  • The steps which the organisation takes to prevent bullying and harassment
  • Responsibilities of supervisors and managers
  • Confidentiality for any complainant
  • Reference to grievance procedures (formal and informal), disciplinary and investigation procedures including timescales for action, and counselling and support availability
  • Training
  • How the policy is to be implemented, reviewed and monitored.

Good practice requires that all allegations of bullying are investigated thoroughly and impartially. The investigation should include interviewing the employee who raised the allegation, the alleged perpetrator, and any possible witnesses to the alleged events, who would normally be co-workers. Having done so, you should report back to the employee on your findings. You should establish with the employee what steps can be taken in the future to ensure that they are supported and comfortable at work.

A proactive approach helps protect your business from problems in this area. Setting a good example and disseminating clear guidance communicates to all staff that bullying and harassment are unacceptable.

For more information please contact: 



Richard Hough
Partner and Head of Healthcare at Brabners LLP
Tel:  0151 600 3302
Email: richard.hough@brabners.com
 


Pharmacist work place pressure

Tuesday 13th December 2016

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Independent Community Pharmacist magazine article - November 2016

Press clipping: Pharmacy and the Law Copyright CIG Ltd.

Negative publicity surrounding pharmacy in an article published by the Guardian earlier this year has prompted the General Pharmaceutical Council to look into issues of workplace pressure which affect pharmacy professionals.

The Guardian article restricted its findings to the practices of one particular pharmacy chain but a survey undertaken by the Pharmacists’ Defence Association’s survey, and reaction to it, indicates that the issue of workplace pressure suffered by pharmacy professionals is widespread.

For a number of years now, changes to the pharmacist’s role, pressures to meet business targets, staff shortages, long working days with no opportunities for rest breaks, and an increasing administrative burden, have left pharmacists struggling to cope with burgeoning workloads and have led to concerns that patient safety is being compromised.

The article highlighted medicine use reviews (MURs) as an example of how financial targets were being inappropriately set by some employers. Many employers construe the annual MUR limit, which was set to prevent the system from being abused, as a target. The pressure on pharmacy professionals to meet this target has led to some pharmacists performing MURs inappropriately and in some cases falsifying MURs.

In addition to the financial targets, the staffing levels, workload and unavailability of rest breaks not only increases the pressure on pharmacy professionals but also increases potentially unsafe practices such as “self-checking”. This results in an environment where dispensing errors are more likely to occur, which threatens the safety of patients.

In addressing this issue, pharmacy owners and pharmacists should take into consideration the following applicable guidance and legislation.

Standards of Conduct, Ethics and Performance (the Standards)

The Standards state that a pharmacy professional must make patients their first concern. They also state that professional judgement should not be affected by personal or organisational interests, incentives, targets or similar measures. In other words, inappropriate financial targets imposed by management within pharmacy businesses not only increase the pressure on pharmacy professionals but, in attempting to meet those targets, registrants may be in breach of the Standards.

Working Time Regulations 1998 (WTR)

The lack of rest breaks and excessive working hours, which many pharmacy professionals endure, are not compliant with the WTR. The WTR introduced rules of general application limiting working hours and providing for rest breaks and holidays. In relation to pharmacy practice, an employer's obligations under the WTR are as follows:

  • Take all reasonable steps in keeping with the need to protect workers' health and safety to ensure that each worker's average working time (including overtime) does not exceed 48 hours per week.
  • Give workers "adequate" rest breaks where the pattern of work is such as to put their health and safety at risk, in particular where work is monotonous.
  • Allow workers the following rest periods unless they are exempt, in which case compensatory rest will usually have to be given:
    • 11 hours' uninterrupted rest per day;
    • 24 hours' uninterrupted rest per week (or 48 hours' uninterrupted rest per fortnight); and
    • a rest break of 20 minutes when working more than six hours per day.

Often it is difficult for pharmacy professionals to take a 20 minute break due to customer expectation that a pharmacist will always be present during a pharmacy’s opening hours and the commercial pressures to meet these expectations.

Pharmacy owners must ensure that workers can take their rest breaks but are not required to force workers to take them. Workers can elect to work through a rest break provided they do not risk their own or others’ health or safety and if they do so, it is the employer’s responsibility to ensure that compensatory rest is allocated.

Medicines Act 1968

Under the Medicines Act 1968, pharmacists can still commit a criminal offence through making an inadvertent dispensing error.

Experts on medical safety all agree that the threat of criminal liability constitutes a disproportionate response to human errors, making dispensing practice less safe and more defensive, with errors going unreported. Consequently, effective clinical governance and risk management are significantly affected.

There has been a long-standing call for the repeal of the relevant provisions of the Medicines Act. Many commentators consider that, where action is required, it should be the GPhC, exercising its regulatory powers, and not the criminal courts, who should have the powers to deal with the issue.

On 12 February 2015, the Department of Health published a consultation seeking views on the draft Pharmacy (Preparation and Dispensing Errors) Order. The consultation ran until 14 May 2015 and proposed to “redress imbalances between legislation and regulation.” However, a report on the responses to the consultation questions has yet to be published.

It is clear that common working practices within the profession constitute breaches of both the Standards and WTR and contribute to workplace pressure, which is detrimental to pharmacy professionals and puts patients at risk. Pharmacy professionals who are put under this pressure are far more likely to make an honest human error and run the risk of facing criminal sanctions.

Pharmacy owners, employees and locum pharmacists must each take responsibility for decreasing avoidable workplace pressure and continue to push for reform of the Medicines Act 1968.

For more information please contact:


Richard Hough

Partner and Head of Healthcare at Brabners LLP
Tel:  0151 600 3302
Email: richard.hough@brabners.com


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