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In the pharmaceutical industry, maintaining high standards for water quality is crucial for ensuring product safety, efficacy, and compliance with regulatory standards. Water is a fundamental ingredient in drug manufacturing, and its quality directly impacts the production process and the end products. This makes adherence to water service compliance a legal obligation and a critical aspect of operational integrity. THE LEGAL COMPLICATIONS OF POOR WATER QUALITY Compliance with water quality standards in the pharmaceutical industry is mandated by regulatory agencies such as the MHRA, several regulations that set strict criteria for the types of water used, including purified water, water for injection, and sterile water. Failure to meet these standards can result in severe penalties, including product recalls, fines, and loss of manufacturing licenses. Regulatory compliance ensures the pharmaceutical companies adhere to legislations and avoid legal repercussions that can damage their reputation and financial standing

The Equality Act (which replaced the Disability Discrimination Act in 2010) is often cited as a reason for supplying medicines in a compliance aid. This is a complex piece of legislation, but, in essence, provides a statutory duty on businesses to make "reasonable adjustments" in relation to the service that they provide to take into account any relevant disability of a service-users. This statutory obligation might include the provision of a compliance aid where a patient would be at a "substantial disadvantage" without. However, the need to provide medicines in a compliance aid under the Equality Act needs careful consideration and is a balancing exercise. The NHS Terms of Service for community pharmacies in England state that medicines should be provided in original packs save in certain circumstances, which include because of patient needs.

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 Association of the British Pharmaceutical Industry (ABPI) has suspended the membership of Novo Nordisk for two years due to serious breaches of its Code of Practice. The action was taken by the ABPI Board following an investigation and appeals process conducted by the Prescription Medicines Code of Practice Authority (PMCPA) which found Novo Nordisk to be in breach of the ABPI Code of Practice, including Clause 2 which deals with actions "likely to bring discredit on, or reduce confidence in, the pharmaceutical industry". Having considered the case and requesting a further detailed audit of Novo Nordisk's compliance processes, the ABPI Board decided to suspend Novo Nordisk from ABPI membership. Susan Rienow, President-Elect, ABPI, said: "The ABPI Board has carefully considered the PMCPA's case report into Novo Nordisk and the subsequent audit of their compliance procedures. "The Board expressed significant concern about Novo Nordisk's compliance activities and the very serious issues identified. As a result, the ABPI Board have taken the decision to suspend Novo Nordisk from ABPI membership.

Compliance is a state of meeting the rules and regulations of any given program. When it comes to medical billing compliance, it is worthwhile to talk about it with America under the dark clouds of COVID-19, and healthcare dynamics continue to change as we speak.

Prescribing in pharmacies is an emerging opportunity, and I'm passionate about supporting proper governance arrangements for businesses. But does the governance and administrative burden reduce if your business is not doing the prescribing? Recently, I've come across several independent pharmacy businesses across the UK who have been approached by prescribing clinics to dispense medicines for their patients. While these partnerships can present lucrative opportunities, they also come with significant responsibilities and potential risks. Pharmacy owners and superintendent pharmacists must be fully aware of the guidance set by the General Pharmaceutical Council (GPhC) and ensure that all requisite checks are performed to maintain compliance and safeguard patient safety. The growing trend of prescribing clinic collaborations For one reason or another, private prescribing clinics are sprouting up all over the place, offering specialised services such as weight management, hormone therapy, or dermatological treatments. These are quickly becoming a prominent feature in our healthcare landscape. Many of these clinics lack in-house dispensing capabilities, leading them to seek partnerships with pharmacies to satisfy a growing number of consumers. In the current economic climate, these collaborations can offer a new revenue stream and an expanded patient base. However, with these opportunities come responsibilities that must not be overlooked.

Currently, the healthcare system is going through a critical phase that involves shifting paradigms, from the volume-based model to the value-based reimbursement system. All of this is intended to minimize healthcare costs and raise the quality of care.

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The full version of the Community Pharmacy Assurance Framework (CPAF) questionnaire is now available for selected pharmacies to complete. This follows a screening questionnaire in July, which all community pharmacies in England were asked to complete as part of the CPAF process. Pharmacies may be selected for the full, comprehensive CPAF questionnaire if, for example, they did not complete a screening questionnaire or if there are concerns about the pharmacy relating to patient safety. Some pharmacies may also be selected to validate their screening questionnaire answers. The NHS Business Services Authority (NHSBSA) said selected pharmacies have been contacted. It's mandatory to complete the survey which can be used as a training tool and for continuous monitoring of compliance against the community pharmacy contract.

Aspen has committed not to charge more for its six generic cancer drugs for the next 10 years in the UK, according to the Competition and Markets Authority (CMA). The CMA also clarified that "although these commitments were offered while the UK was a part of the European Union" they remain "legally binding". It added: "The CMA has now assisted the NHS to secure binding undertakings from Aspen, under the law of England and Wales, which enshrine the UK elements of the commitments and are enforceable by UK courts, including in relation to the supply of these drugs in Northern Ireland and Scotland." This allows NHS to monitor and ensure compliance by Aspen following the UK's exit from the EU. In 2017, the European Commission began an investigation into Aspen over concerns that the company had engaged in excessive pricing for 6 off-patent cancer medicines.

Pharmanovia, a global pharmaceutical company has announced increased targets to divert 40 per cent of its air shipments to sea in 2023, and 75 per cent by the end of 2028. It has made the pledge as it revealed the significant progress made towards achieving its ambitious science-backed ESG initiatives in its new Sustainability Report. Its industry-leading air-to-sea pilot scheme, which focused on its Spain-to-Australia freight route, cut an estimated 470,000kg in potential CO2 emissions in 2022 - reducing Scope 3 upstream transport emissions by 18 per cent. This initiative demonstrates Pharmanovia's role as an industry leader on carbon reduction and follows a recent report which stated just 16 of 500 pharmaceutical companies measured their entire Scope 3 emissions. The new Sustainability Report reveals that the Scope 2 emissions decreasing by 13 per cent in 2022, due to lower direct electricity demand within the office space. The company's packaging audit seeing a 52 per cent increase in the percentage of products packed with at least one fully recyclable component, up from 12% in 2021 to 64 per cent in 2022 Strong progress in an initiative which saw Pharmanovia set ESG goals all employees across its global offices as part of annual performance awards. Employees achieved a 98 per cent completion rate of the compliance training, including ESG modules

In a rapidly evolving and competitive landscape, the pharmaceutical industry faces unique challenges when it comes to marketing its products and services. With stringent regulations, complex target audiences, and a need for trust and credibility, pharma companies need to employ effective marketing strategies to stand out in the crowd. In this blog article, we will explore some key marketing strategies for the pharma industry that can help boost their visibility, engage their target audience, and drive business growth. UNDERSTANDING THE UNIQUE LANDSCAPE The pharma industry operates in a highly regulated environment, where compliance and ethical considerations play a crucial role. Before diving into marketing strategies, it is essential to have a deep understanding of the industry's dynamics and the target audience. Researching the market, identifying patient needs, and studying the competitive landscape are vital steps in developing an effective marketing plan. EMBRACING DIGITAL TRANSFORMATION Digital transformation has revolutionized marketing across industries, and the pharma sector is no exception. Embracing digital channels and technologies can significantly enhance the reach and impact of marketing efforts. Pharma companies can leverage social media platforms, create engaging content, and build online communities to connect with patients, healthcare professionals, and other stakeholders. Implementing robust digital marketing strategies allows for personalized messaging, real-time communication, and targeted campaigns that resonate with the target audience.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Committees of Advertising Practice (CAP) have issued a joint enforcement notice about the 'illegal' advertising of Kenalog injections on digital platforms. The notice warns all organisations offering Kenalog as a 'hay fever treatment' to stop advertising it in any of their social media or website advertising. "Kenalog is a prescription-only medicine (POM), which must not be directly or indirectly advertised to the public. Kenalog is not licensed for the treatment of hay fever in the UK, although it is offered by some beauty and aesthetics clinics, under the personal responsibility of an individual prescriber, and advertised widely on social media," said MHRA. "Now, advertisers must ensure that all references to Kenalog in the text, images or emojis on social media are removed, as well as commonly-used descriptive phrases for the jab such as 'hay fever injection' or hay fever jab' or any account names, testimonials or memes by 29 August 2022." After this date, the CAP's compliance team will remove non-compliant ads using targeted software and those who continue to promote it may be referred to the MHRA for further enforcement action.

Patient safety should remain a top priority in any healthcare setting. People should always receive the right advice, and pharmacists aren't 'GPs on the cheap.' Staff should be fully trained, and medical equipment should be correctly maintained at all times. In turn, this helps create a safer environment for patients and professionals alike. In this article, we'll discuss some of the factors that can enhance patient safety in healthcare settings. AUTOMATION AND MONITORING Automating processes within a facility can help streamline operations. This has the potential to reduce or eliminate human error that could result in serious injury or death. In addition, automated systems often provide instant alerts when something goes wrong - allowing medical staff to react quickly and appropriately. Automated solutions can help facilities achieve hand hygiene monitoring standards, and it's possible to schedule a demo and see their outcomes. They can reduce staff sick time and HAIs, as well as Joint Commission citations and associated costs. Monitoring helps ensure compliance with safety protocols. It's essential for improving patient safety and gaining data on all aspects of a facility's operations. It also helps organizations track the effectiveness of their protocols and procedures over time. This helps them constantly evaluate and refine their policies, to maximize patient safety benefits. ADEQUATE STAFFING In order to provide quality care, it's essential to have enough staff on hand to meet patient needs and ensure all protocols are being followed. Without this, healthcare providers may struggle to provide prompt, efficient care - which can put patient safety at risk. Adequate staffing levels should be determined by a variety of factors. They include patient numbers, the complexity of care required, and the size and layout of the facility.

Titan PMR has been accredited by the NHS to provide electronic prescription services (EPS) to dispensing doctors. Over 1,000 of these doctors, who provide a vital service to almost 10 million people in rural communities, can now offer their patients the same level of benefits and efficiencies that electronic prescriptions and Titan PMR have brought to pharmacies around the UK. These features will also increase efficiency for dispensing doctors, who will reduce dispensing errors and improve organisation, increasing their capacity while enjoying the ability to integrate with other technologies. After a full year of testing, including six months of compliance testing at a practice in Cumbria, the new accreditation for Titan also has potential to help the NHS fulfil its target of all prescriptions being issued electronically. Currently written paper prescriptions from dispensing doctors account for around seven per cent of the total prescriptions in England - around 6.5 million each month. "Until now dispensing doctor surgeries have basically been in the digital dark ages when it comes to dispensing medicines," said Tariq Muhammad, a tech entrepreneur and CEO of Bristol-based Invatech Health, which developed Titan PMR.

The UK GDP Association has been established as a non-profit organisation, operating as a Community Interest Company (CIC), with a focus on providing a broader support network, particularly for small and medium business enterprises and pharmacy wholesalers. In addition to delivering commercially viable Good Distribution Practice (GDP) consultancy services for simple models with smaller budgets, the association aims to function as a networking platform for Responsible Persons in the UK. As members of the association, companies and individuals can gain multiple benefits that will add value to their business through access to knowledge, discounted training, consultancy services, audit and inspection support, as well as resources like document templates for risk assessments, CAPA, deviations, and more. Moreover, members can enjoy the benefit of a like-minded support network via a dedicated GDP community hub, providing a platform for discussions, seeking advice, and fostering new relationships. "Our mission is to ensure that patient safety, GDP compliance, and excellent quality is paramount in all organisations, regardless of budget," the company said.

A new bill was introduced to Parliament on Wednesday (20 March) to prohibit the sale of tobacco to children under the age of 15, delivering on the Prime Minister's commitment to create a smokefree generation. The Tobacco and Vapes Bill aims to protect future generations from the harmful impacts of smoking, thereby saving thousands of lives and billions of pounds for the NHS. The bill will also introduce new powers to restrict vape flavours and packaging deliberately targeted towards children, as well as allow the government to change how they are displayed in shops, moving them out of sight of children and away from products that appeal to them, like sweets. Additionally, enforcement officers' powers will be strengthened with 'on the spot fines' of £100 to ensure compliance with the new laws. This complements the existing maximum fine of £2,500 that local authorities can already impose. It will also become illegal to provide free samples of vapes to children under the age of 18.

There is a clear opportunity for community pharmacists and their teams to lead best practice when it comes to supporting the ongoing health needs of older people. As the global population continues to age, the demand for specialised healthcare services tailored to the elderly is rapidly increasing. Community pharmacists, with their accessible locations and frequent interactions with patients, are uniquely positioned to play a pivotal role in addressing this growing need. The ageing population presents a complex set of health challenges, including multiple chronic conditions, polypharmacy, and increased susceptibility to adverse drug reactions. Community pharmacists, armed with their extensive knowledge of medications and their effects, can serve as the first line of defence in managing these issues. By leveraging their expertise, they can implement best practices that not only improve the quality of life for older individuals but also reduce the burden on the broader healthcare system. One of the primary areas where community pharmacists can make a significant impact is in medication management. As people age, they often find themselves taking multiple medications for various conditions. This polypharmacy can lead to dangerous drug interactions, side effects, and compliance issues. Community pharmacists can lead the way in implementing comprehensive medication reviews, ensuring that each patient's drug regimen is optimised for their specific needs and minimising potential risks.

Over the last few years pharmacy and the role of pharmacy teams has changed dramatically. The introduction of technology and the integration of artificial intelligence (AI) within systems that provide healthcare and support to pharmacies holds great promise; for improving access to health, supporting patient outcomes, and optimising operational efficiency. Currently, the potential use of AI could span the whole of the medicines value chain, from AI-driven drug discovery to personalised medicines and automated dispensing systems. However, the rapid advancement of AI technology does raise several ethical concerns. This article will explore these concerns and how they can be addressed. In previous articles, I have discussed what underpins artificially intelligent machines and the importance of data. Datasets are the foundation on which AI algorithms learn and generate conclusions. The first step to understanding the potential ethical implications of AI across the pharmacy sector is to understand the data that is held within these foundational datasets. Patient privacy and data security AI systems in and outside of the pharmacy sector, which support patient care, rely heavily on vast amounts of medical data (patient medical records, PMR data, etc). However, the collection, storage, and use of such sensitive data can possibly bring significant privacy concerns. GDPR compliance is essential within the UK and ethical questions arise around data ownership, patient consent, and the possibility of data and cybersecurity breaches. As frontline healthcare professionals, we need to be able to support our patients when questions are asked about their data. For example, how can patients be sure their data is used only for its intended purposes? Is anonymised data truly safe from de-identification techniques that could expose private information?