Increased cooperation between countries is needed to ensure better regulation of online pharmacies, said authors of a new report - 'Online pharmacy operations and distribution of medicines', published by the International Pharmaceutical Federation's (FIP) Community Pharmacy Section.
The report presents findings of a global survey of pharmacy organisations covering various aspects, such as type of medicines supplied by these pharmacies in different countries, how the authenticity of online pharmacies can be verified, and the usage of e-prescriptions and shared patient health records.
Of the 79 countries responding to the survey, 51 per cent acknowledged that no regulation of online pharmacies exists.
A quarter of the respondents reported cases of irresponsible self-medication by consumers who had purchased medicines through online pharmacies.
A lack of regulation creates "an avenue for illegal pharmacies and may impact the overall quality of medicines and services offered to consumers," authors of
the report said.
Lars-Åke Söderlund, immediate past president of FIP's Community Pharmacy Section and co-editor of the report, said that the pandemic has increased preference for online services, including in the pharmacy sector.
Pharmacy technicians will soon be recognised as fully regulated healthcare professionals in North Ireland.
Work has begun to bring pharmacy technicians under statutory regulation by the Pharmaceutical Society of Northern Ireland, health minister Robin Swann has announced.
The public consultation was launched in March 2022 on a proposal to introduce statutory regulation of the Pharmacy Technician workforce in Northern Ireland.
The minister said: "This will be a key enabler to enhancing the contribution that pharmacy technicians can make to the delivery of healthcare across all settings.
It will allow the regulator to strengthen its role in protecting patients and promoting high standards, thereby enhancing the public's confidence and trust in
pharmacy practice."
He added: "While there are many practical issues to be worked through with stakeholders, and legislative change required, I have now instructed my Department's
officials to develop a detailed project plan to bring about the statutory regulation of pharmacy technicians by the Pharmaceutical Society of Northern Ireland".
Online pharmacies have to operate from bricks & mortar premises that are registered with the General Pharmaceutical Council, but recent cases show that, in
reality, the practices of online pharmacies are often very different to other pharmacies, and the regulation of online pharmacies is also different - and evolving
as issues arise.
For a start, the General Pharmaceutical Council (GPhC) is only one of the regulators taking an interest in online pharmacy services. Other regulators include the
Medicines and Healthcare products Regulatory Agency (MHRA) which enforces the advertising and promotion of medicines, and the Care Quality Commission (CQC) which
regulates prescribing services.
The different regulation of online pharmacies is attributable to the higher risk to patients and the public from medicines bought online. These risks often arise
from a combination of patients who do not tell the truth in order to obtain medicines and the nature of a transaction in which a pharmacist does not see patients
face-to-face.
"The GPhC has strong enforcement powers that it uses when it considers its premises standards have not complied with."
However, there are also things that go wrong because pharmacists have simply failed to act professionally or take sufficient care, as well as cases where things
have gone wrong through misfortune.
E-pharmacy, a digital platform also known as internet pharmacy or online pharmacy, has emerged as an escape route to longstanding queues at pharmacy stores
across almost all regions of the world, especially during the Covid-19 health crisis realm.
They have long been recognised to act promptly in public health response, like ensuring an effective medicine supply system, resolving and monitoring drug shortage
issues, educating about the proper use of PPE, promoting remote pharmacy services, and conducting drug evaluation and active surveillance.
These factors will support in easing the load on healthcare facilities during the ongoing pandemic, eventually adding value to patients and the healthcare system.
Overall, the e-pharmacy market size is expanding in terms of valuation on the back of regulations and standards laid by the respective governments.
As per a recent study by Global Market Insights, the global e-pharmacy industry accounted for a business share of $68 billion in 2021 with an anticipated growth
rate of 16.8 per cent through 2028.
The Council of Pharmaceutical Society NI acknowledged the contribution of pharmacy technicians in Northern Ireland on 'Pharmacy Technician Day' celebrated on
18 October.
The society said: "Today we mark Pharmacy Technician Day and wish to acknowledge the significant contribution Pharmacy Technicians and support staff make, as an
integral part of the pharmacy team, to patient wellbeing and care in Northern Ireland."
In June, Health Minister Robin Swann announced that he has approved work to begin to bring Pharmacy Technicians in Northern Ireland under statutory regulation by
the Pharmaceutical Society of Northern Ireland.
The public consultation was launched in March 2022 on a proposal to introduce statutory regulation of the Pharmacy Technician workforce in Northern Ireland.
The General Pharmaceutical Council (GPhC) is mulling over introducing "differentiated fees options to cover the increased regulation needed for online pharmacies."
In papers published by the regulator ahead of its meeting on Thursday (December 9), it noted that with increase in number of online and distance-selling pharmacies, the regulation has become "potentially more complex and resource intensive."
It highlighted that service provided by online pharmacies pose a high risk "in terms of professional care and professional standards".
Only 63 per cent of the 187 inspections of online pharmacies since April 2019, met all standards, against the overall benchmark of 84 per cent, the GPhC said.
The independent regulator informed that swift enforcement action has been taken against 48 online pharmacies to address patient safety risks, including 40 conditions notices and 11 improvement notices.
The Pharmacists' Defence Association has called on the Scottish government to end unnecessary pharmacy closures and introduce emergency regulations to force
companies that operate Scotland's pharmacies to open on the days and hours they have agreed.
It is concerned that decisions made by some health boards in Scotland have now allowed pharmacy owners to close their pharmacies on Saturdays.
The PDA is worried that a pharmacy closure could have negative impact on patients and other parts of the NHS, including neighbouring pharmacies, addiction and mental
health services, and minor injury and A&E units.
The association claims that there are record numbers of registered pharmacists who are available to work and therefore a decision to close a pharmacy over staff
shortages is misleading.
"The business owners may claim there is a shortage of pharmacists, but when they actively cancel agreed hours of work it does not suggest there is a shortfall of
workers," said the PDA, adding: "These business decisions often include closing their pharmacies at very short notice, even when pharmacists are available and willing
to work."
The Pharmacists Defence Association (PDA) has welcomed the government's action of publishing 'AI Regulation White Paper' which will regulate the artificial
intelligence (AI) system used in pharmacy on Wednesday (29 March).
The Association had raised concerns about the risk of patient harm due to inappropriate use of so-called AI to include that seen in some of the pharmacy systems
undertaking clinical checks.
For some time, it has been receiving concerns from practicing pharmacists describing examples of the potentially detrimental impact of automation and online pharmacy
provision on patient safety and pharmacy practice.
As a result, it raised these concerns with regulators, Chief Pharmaceutical Officers, and parliamentarians in all four nations of the UK to urge action.
It said: "This is required not only to protect patients, but also the frontline pharmacists who could be blamed for potential harm caused by inappropriate use of so
called 'AI' systems implemented by their employer."
The PDA therefore, welcomes the announcement from the UK government that they intend to strengthen regulation of such technology, empowering existing regulators to
come up with tailored, context-specific approaches that suit the way AI is actually being used in their sectors; this will include pharmacy.
Pharmacy Supervision Practice Group, an organisations from across the community pharmacy sector, who have come together to look into the future "supervision" in
community pharmacy, have published their final report.
Over the course of nine collaborative and positive workshop-style discussions the Supervision Practice Group aimed to provide recommendations to reframe legislation,
regulation and professional standards and guidance to achieve a new vision for community pharmacy.
The group have produced a report which makes several recommendations on the subjects of:
* the legislation relating to "supervision";
* the temporary absence of the RP from the pharmacy;
* delegation;
* the preparation and assembly of medicines when the RP is not signed in.
The group have provided recommendations on which the Department of and Social Care and the regulators can draft specifically worded revisions to legislation and
regulatory standards. These specific legislative and regulatory changes that are proposed by government and regulators will be subject to a full consultation process.
The General Pharmaceutical Council is appointing a new Chief Pharmacy Officer to strengthen the professional voice within the senior leadership team. This
introduction is aimed at fostering a culture of enterprise leadership, inclusion and collaboration within the organisation, GPhC said in a statement.
According to GPhC, the Chief Pharmacy Officer will serve as the authoritative representative of the pharmacy regulator in public, within the pharmacy professions,
and increasingly in multi-disciplinary teams and collaborative regulatory work. "They will act as the executive lead on pharmacy inspection and regulatory insight,
providing professional leadership within the GPhC and collaborating closely with pharmacist and pharmacy technician colleagues across the organisation."
The Chief Pharmacy Officer, reporting to the Chief Executive and Registrar, will hold the highest professional position within the GPhC executive, providing pharmacy
leadership across the organisation, GPhC said.
The Pharmaceutical Defence Association (PDA) has urged health ministers of the UK to take a strict and necessary action against the unnecessary closures of
pharmacy.
Concerned over the rising number of pharmacy closures, PDA has written an open letter to health secretary Steve Barclay; Robin Swann, health minister for Northern
Ireland; Eluned Morgan, minister of health and social services for Wales; and Humza Yousaf, the Scottish health secretary.
In its letter, PDA said: "The minister of health must now ensure the regulation of poor business behaviours and be prepared to take over rogue pharmacies, however
large their corporate owner may be. If patients' access to NHS services is to be protected from the consequences of avoidable full or part-day pharmacy closures."
The association believes it is only a matter of time before serious harm to patients' health will be caused by the decisions of mainly large chains of pharmacies to
close some of their branches for all or part of a day, instead of engaging an available pharmacist to cover their agreed opening hours.
"While a small number of unforeseen closures have always occurred from time to time in pharmacies for genuine reasons, the indiscriminate scale at which closures
have now become commonplace seems to have evolved over the last 20 months."
There is clear evidence that the majority of distance selling pharmacies are operating in breach of their NHS contracts, and a failure to properly
regulate 'pseudo' distance selling pharmacies is leading to local pharmacy closures, the Company Chemists' Association has reported.
According to the CCA's recent findings, 72 per cent of DSPs dispense over 50 per cent of their prescriptions to patients within a single postcode area within
10 miles of the pharmacy.
"Operating within constrained geographical regions, pseudo-DSPs achieve reduced overheads and operational costs by focusing on localised marketing and medicine
delivery. They compete against local brick-and-mortar pharmacies, causing them to lose vital trade," the CCA claimed, based on its recent survey - The Impact of
Pseudo Distance Selling Pharmacies.
"As per their terms of service, DSPs are obligated to provide prescription delivery nationwide, extending beyond local patients," said the CCA, adding that the
financial savings resulting from the lack of patient access are balanced by the necessity to function on a national scale.
The Royal Pharmaceutical Society (RPS) has called pharmacy employers and pharmacy trade unions to come together to a round table meeting to agree on principles
for a way forward that ensures patients benefit consistently from access to high quality, adequately staffed, safe pharmacy services.
It has also urged the governments, NHS organisations and individual pharmacy teams to define clear prioritisation plans, which can be embedded in organisational
business continuity plans which set out the pharmacy services that are essential and must always be provided and can be de-prioritised at specific levels of
pressures.
The challenges for pharmacies are compounded by the escalating cost of living crisis. With unprecedented levels of burnout among pharmacists, pharmacy closures
and the potential for strike action, RPS has called for three things- 'professionalism, respect and prioritisation.'
The Council of Pharmaceutical Society NI (PSNI) has introduced an 8-week public consultation on proposed Guidance on Pharmacy Staffing Levels within registered
premises.
The principle-based Guidance seeks to assist Pharmacy Owners and Superintendents to ensure that each pharmacy has enough appropriately skilled and qualified staff
to provide safe and effective pharmacy services to the public. All registered pharmacies will have to meet the standards set out in the Premises Standards, when
commenced.
PSNI said: "The proposed Guidance should also help ensure a working environment that will facilitate pharmacists to meet their professional obligations under the
Professional Standards of Conduct, Ethics and Performance for Pharmacists in Northern Ireland (2016)."
"Whilst other health regulators have primary responsibility for systems regulation outside of regulated premises, we consider that the principles outlined in this
Guidance, will be helpful for managers working with pharmacy teams in different settings."
The Pharmacy Supervision Practice Group consisting of members from AIMp, APTUK, CCA, NPA, PDA, PFNI and RPS held its fourth workshop to continue discussions
on the future modelling of pharmacy practice.
The ideas around 'supervision' shared by the organisation earlier formed the basis of the discussion during the workshop and helped to expand understanding of where
there was consensus and disagreement.
Examples of ideas explored during the workshop include: the extent to which a pharmacist should supervise the medicines assembly process, the purpose and extent to
which a pharmacist might be absent from the pharmacy and how this might affect patient safety as well as the nature of whether fixed rules versus a broad framework
were preferable for future practice.
Chair of the group, Dr Michael Twigg, Associate Professor of Primary Care Pharmacy, University of East Anglia, said "Once again the sector bodies have come together
in a collaborative and positive manner to explore the concept of 'supervision' in the context of current and future community pharmacy practice. This session provided an opportunity to constructively challenge assumptions and viewpoints within the group with the aim of moving the discussion forward."
As part of the session, the DHSC, GPhC and PSNI gave an overview of the difference between legislation, regulation and guidance which was helpful to inform the
group's thinking. Each of the organisations have been asked to use the conversation to refine the ideas presented in advance of the next workshop.
Recently, the English Health Secretary has talked about introducing a 'Pharmacy First' model similar to that which exists in Scotland. This would be a win-win
outcome providing people with better access to essential healthcare support, advice and treatment whilst relieving strain on other parts of the NHS, not least GPs
and A&E.
It is a no-brainer and yet despite a few media headlines there are still no firm proposals on the table to make this a reality. It surely cannot be right that you
can receive a broad range of patient care services in Scotland which are not available in England. It works well in Scotland, Wales is keen to develop more
pharmacy-based services and Northern Ireland, leaving aside the current funding dispute, has had a minor ailments service for many years.
If the English Health Secretary is sincere in his interest in adopting an English version of the Scottish model, then there are critical aspects he needs to
consider.
Firstly, start with the patient journey through the healthcare ecosystem from illness prevention through to long-term condition management. What is the role of
community pharmacy and how do we guide people to seek support from the most appropriate healthcare professional?
What is the vision for community pharmacy delivering patient care in the next decade?
The lesson from Scotland is that the government needs to sit down with the sector and map that out together. There are no quick fix overnight solutions. This needs
to be a long-term commitment backed by adequate funding. Supervision regulations need to change and there needs to be a thought through workforce strategy which
avoids community pharmacy shortages as that does nothing to deliver improved patient outcomes.
The Pharmacists' Defence Association (PDA) has advised its member to check their understanding of what activities can legitimately take place when no RP is signed in at the pharmacy or the absence provisions are used.
The advisory to its member was followed after noticing a considerable talk on social media about compliance with the Responsible Pharmacist (RP) regulations which
also included unauthorised activity occurring when no RP is signed in.
"There have been comments made that some pharmacists and pharmacy team members may fear repercussions from challenging or whistle-blowing about such behaviour," PDA said.
"To assist members with the interpretation of the RP regulations, the PDA has made available a legal briefing note about the RP regulations produced by a specialist
pharmacy regulation law firm."
It further added: "Non-compliance with the regulations by pharmacy teams should be reported to the pharmacy superintendent."
The General Pharmaceutical Council (GPhC) has launched a new draft 'Equality Guidance' for pharmacies to tackle discrimination and make sure that everyone can access safe and effective person-centred pharmacy care.
GPhC's consultation is seeking views on "the structure and language of the guidance, if anything is missing and the impacts on patients and members of the public, pharmacy staff, pharmacy owners, and individuals or groups sharing any of the protected characteristics."
The regulator said the draft guidance is designed to support pharmacy owners to:
demonstrate that they are meeting our standards for registered pharmacies
fulfil their legal and regulatory duties in relation to equality
help protect the rights of individuals
advance equal opportunities for staff, patients and the wider public
help improve the experience and healthcare outcomes of patients and members of the public.
A BBC investigation has found 20 UK online pharmacies selling prescription-only medicines without adhering to the regulatory standards, such as checking
for GP approval or patient's medical records.
The news organisation was able to purchase over 1,600 restricted pills, including anti-anxiety drug, painkiller and sleeping medication, from these regulated
online pharmacies easily by providing false information.
However, the report didn't mention the names of the drugs as "they can be dangerous when taken without medical guidance."
Some pharmacies were also found selling high-risk and potentially addictive medicines, including benzodiazepines and antidepressants, based on online questionnaires
and did not require further checks.
The General Pharmaceutical Council (GPhC), which regulate online pharmacies in the UK, states that selling and supplying medicines at a distance brings
"different risks which need to be appropriately managed to protect patient safety."
The Department of Health and Social Care has updated the list of community pharmacies eligible for the Pharmacy Access Scheme (PhAS) and approved 43 cases
out of 63 applications, bringing the the total number of eligible pharmacies in England to 1,445.
Earlier this year, NHS England and NHS Improvement (NHSE&I) invited community pharmacy contractors to apply for a review if they believed there were any inaccuracies
in relation to pharmacy premises addresses or unforeseen circumstances affecting access, such as a permanent roadblock.
Submitted applications were reviewed by the relevant NHSE&I regional pharmacy contract team, and determined by the relevant pharmaceutical services regulations
committees (PSRC).
Due to the workload pressures seen over winter, the review deadline was extended, giving contractors applying for a review two full months to complete their
applications. This also pushed back the announcement of the outcome of the review, but where an application has been successful, PhAS payments will be backdated
to the start of the scheme.