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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.

The Medicine and Healthcare Product Regulatory Agency (MHRA) has recalled all pholcodine-containing medicines from the UK pharmacy due to concerns of its potential to cause a severe allergic reaction in some people having general anaesthesia for surgery. The decision was made following the conclusion of a review of post-marketing safety data by the MHRA. The Commission on Human Medicines (CHM) has considered the evidence of an increased risk of the very rare event of anaphylaxis when exposed to neuromuscular blocking agents (NMBA) and advised that pholcodine-containing medicines should be withdrawn. MHRA has advised pharmacists to consider recommending appropriate treatment alternatives for patients who present with a new dry cough or who are currently taking pholcodine. Royal Pharmaceutical Society (RPS) President Professor Claire Anderson said: "If you are taking a cough medicine (including tablets and syrups), check the packaging, label or Patient Information Leaflet to see if pholcodine is a listed ingredient - if it is, and you have any questions, you can talk to your pharmacist who can suggest a different medicine suitable for you.

Medicines and Healthcare products Regulatory Agency (MHRA) has urged the healthcare professionals to share their views on the consultation on 'how MHRA communicate with healthcare professionals to improve medicines and medical devices' safety'. Through this consultation the agency wants to review its approach to engagement with healthcare professionals to improve the safety of medicines and medical devices. "We want to ensure that healthcare professionals are receiving actionable information and guidance on safe use of medicines and medical devices that they can take into their working practice, providing timely advice to patients," said MHRA. "We need to improve the way we communicate with healthcare professionals. We want to hear from you to enable us to transform how we communicate with you and how we work together on our common goal of greater patient safety."

From over-the-counter flu tablets to crucial antibiotics and antidepressants, medicines are running scarce in UK pharmacies this year, causing concerns among patients, the government, and the wider pharma industry. Drug shortages have accelerated over the past year due to a clutch of problems including the after-effects of the pandemic on supply chains, the war in Ukraine, and soaring input costs weighing on manufacturers. More recently, a sudden spike in respiratory infections - another by-product of Covid-19 that neither pharma companies nor the government were able to predict - has deepened the crisis, with 70 commonly taken drugs out of stock in Britain as of February. The problem is not unique to the UK. In a recent survey of groups representing pharmacies in 29 European countries, three quarters said shortages were worse this winter than a year ago, with a quarter reporting more than 600 drugs in short supply. The US is also facing significant shortages of popular prescription drugs like amoxicillin and Adderall, an ADHD medication. To some extent, the current disruption is laying bare wider challenges facing the industry for several years that were only exacerbated by the pandemic. The over-reliance on foreign suppliers for most active pharmaceutical ingredients (APIs) is one of them. This model has left companies more susceptible to supply shocks, which have in turn increased in frequency and severity due to pandemic lockdowns, the war in Ukraine and other issues such as the shortage of shipping containers. Pharma's long and opaque supply chains, alongside regulatory complexities, also mean it is taking longer for drugmakers to reconfigure manufacturing and distribution in times of additional need.

British drugmaker AstraZeneca says it's confident that its new version of COVID-19 antibody treatment could protect immunocompromised patients against all known virus variants. Laboratory studies show the antibody, called AZD3152, neutralises all known variants of COVID-19 and AstraZeneca has support from regulators to make the treatment available by the end of this year, the company's vaccines head Iskra Reic said on Tuesday (April 18). AstraZeneca plans, pending more positive data and regulatory approval, to make the antibody available by the end of 2023. These types of therapies are most needed for people with compromised immune systems, either because of underlying conditions or because they are undergoing immune suppressing treatments. They account for nearly 2% of the global population. AstraZeneca's AZD3152, it new COVID-19 antibody, was acquired through a $157 million deal last year with British biotech start-up RQ Bio. The British drugmaker will likely make future investments like its current partnerships with RQ Bio but did not have any deals to announce, said Reic, a long-time AstraZeneca executive who has led the company's vaccines and immune therapies unit since it was formed in late 2021, during the pandemic.

The Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday (9 January) announced that the novel type 2 oral polio vaccine (nOPV2) has been quality-assured (prequalified) by the World Health Organization (WHO). Developed by a team including scientists from the MHRA, nOPV2 is considered a safer polio vaccine that helps to protect children from the disabling and life-threatening disease and lower the risk of vaccine-derived outbreaks. The vaccine received WHO Emergency Use Listing three years ago, and since then 950 million doses have been delivered worldwide. The UN health agency's decision to add it to the list of prequalified vaccines is based on the analysis of outcomes in vaccinated populations that has confirmed strong safety profile and effectiveness.

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 Medicines and Healthcare products Regulatory Agency (MHRA) is doubling down on its efforts to combat online pharmacy frauds, emphasising innovation, eradication of legacy systems, and cybersecurity in its updated technology roadmap. The online sale of medicines and medical devices is a "growing phenomenon offering convenience, anonymity, and lower prices " for the public. However the lack of robust cyber monitoring also "poses significant risks", as many online pharmacies are "unregulated, illegal, or fraudulent." According to the MHRA's recent report highlighting the impact of artificial intelligence on the regulation of medical products, the strategic themes of "fundamental to the successful deployment of AI" are essential for protecting consumers from fraudulent medical products.

In the pharmaceutical industry, maintaining strict hygiene standards is paramount to ensure the safety and efficacy of products. One of the critical components in achieving this goal is the utilization of sanitary clamps. These clamps play a vital role in securing various connections within pharmaceutical equipment, preventing contamination, and upholding sterile conditions. In this article, we delve into the reasons why sanitary clamps are indispensable for maintaining hygiene in pharmaceutical settings. Contamination Prevention Sanitary clamps serve as a crucial barrier against contamination in pharmaceutical environments. With stringent regulations governing pharmaceutical manufacturing, any compromise in hygiene can result in significant consequences, including product recalls and compromised patient safety. Sanitary clamps are designed to create secure and airtight connections between pipes, hoses, and other components, effectively sealing off potential entry points for contaminants such as bacteria, viruses, and particulate matter. By minimizing the risk of contamination, these clamps help pharmaceutical companies uphold the integrity of their products and adhere to regulatory standards. Moreover, the design of sanitary clamps ensures ease of cleaning and sterilization, further reducing the risk of cross-contamination between batches. Unlike traditional fastening methods that may harbor bacteria or residue, sanitary clamps feature smooth surfaces and minimal crevices, making them easier to sanitize. This not only enhances hygiene but also promotes efficiency in the cleaning process, allowing pharmaceutical manufacturers to maintain high levels of cleanliness without compromising production timelines. Overall, by preventing contamination and facilitating thorough cleaning, sanitary clamps play a crucial role in safeguarding the quality and safety of pharmaceutical products.

In a significant leap forward in the fight against HIV, the Medicines and Healthcare products Regulatory Agency (MHRA) has given the green light to two groundbreaking formulations of cabotegravir. Apretude 30 mg film-coated tablets and Apretude 600 mg prolonged-release suspension for injection are now authorized for preventing sexually transmitted HIV-1 infection in adults and adolescents weighing at least 35kg at increased risk. This approval marks a pivotal moment in HIV (human immunodeficiency virus) prevention, offering an alternative to existing standard pre-exposure prophylaxis or PrEP treatments. HIV, a virus notorious for compromising the immune system, has long been a global health concern. Cabotegravir, a member of the integrase inhibitor group, works by blocking a key enzyme necessary for the replication of HIV-1, thereby reducing the virus's ability to spread.

American pharmaceutical giant Pfizer has received marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for its medication Etrasimod, marketed as Velsipity, used to treat people with moderately to severely active ulcerative colitis. Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) that causes inflammation and ulcers (sores) in the lining of the large intestine (colon) and rectum. The approved recommended dose for Velsipity is one 2 mg tablet to be taken once daily. For the first three days, it is advised to take the medication with food, and subsequently, it can be taken daily either with or without food. According to the regulator, the approval of the medication is based on evidence from two clinical studies, which showed that 26 per cent of patients taking etrasimod achieved clinical remission after 12 weeks of treatment compared with 11 per cent of those receiving placebo. The studies included more than 740 patients aged 16 years and over for whom standard treatment or other treatments did not work well enough or could not be used.

The Royal Pharmaceutical Society (RPS) on Wednesday announced that it is spearheading a new project, which aims to delve into the root causes of the growing challenge of medicines shortages across the United Kingdom and provide solutions to mitigate its impact on patients and pharmacy practice. A newly formed advisory group, chaired by RPS Fellow Dr. Bruce Warner, is set to convene later this month. The group will have experts from primary and secondary care, patient advocacy groups, the pharmaceutical industry, suppliers, regulatory bodies, governmental representatives, and NHS officials. The group aims to formulate a robust report to provide expert thought leadership and support for the wider debate on UK policy. Their work will be informed by a thorough literature review, stakeholder interviews, online RPS member events, and patient stories.

The latest formulation of XGEVA (denosumab) is now available to patients in the UK, offering a more convenient treatment option for bone metastasis. It is the first product to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new International Recognition Procedure (IRP). Denosumab (XGEVA) is used to prevent serious bone-related complications resulting from bone metastasis in adults and to treat giant cell tumour of bone in both adults and adolescents. The medicine was authorised on 29 February 2024 as a 120 mg solution for injection in a prefilled syringe. In contrast to the current vial presentation, this simplifies the administration process, reducing the volume of liquid injected and lowering the risk of dosing errors. The product was authorised in 30 days by the MHRA, thanks to the new IRP that facilitated a rapid approval process.

The Medicine and Healthcare products Regulatory Agency (MHRA) has cautioned men on valproate to talk to their healthcare professional about their treatment, if they want to start a family in the next year. The warning came after a new study, commissioned by the European Medicines Agency, suggested that children fathered by men who took the anti-seizure medicine in the three months prior to conception may be at higher risk of developing neurodevelopmental disorders. Around five in 100 children born to fathers treated with valproate around conception were diagnosed with a neurodevelopmental disorder, compared to three in 100 children whose fathers were taking other antiseizure medicines (lamotrigine or levetiracetam). However, the risk is believed to be much smaller than the risk associated with valproate in pregnancy.

The Medicines and Healthcare products Regulatory Agency (MHRA) on Monday (29 January 2024) approved the medicine Rezzayo (rezafungin) to treat invasive candidiasis, an infection caused by a yeast called Candida. Invasive candidiasis can pose a serious health risk as it can affect the blood, heart, brain, eyes, bones and other parts of the body. Napp Pharmaceuticals Ltd was granted the marketing authorisation for the medicine based on phase 3 clinical trial data. In the randomised, double-blind, controlled study, more than half of the invasive candidiasis patients who were given a weekly dose of rezafungin were cured at day 14. Among 94 patients who were given a daily dose of caspofungin (another antifungal treatment), 57 of them were cured during the same time.

In a recent minute of meeting, the General Pharmaceutical Council (GPhC) explored the implications of its unique authority under the Regulation of Investigatory Powers Act (RIPA), granting powers for covert surveillance. Although never utilized, the GPhC is obligated to maintain appropriate policies for such actions. During a recent meeting, the pharmacy regulator discussed that the use of RIPA be brought to a future Council workshop to discuss issues including the "ethical implications of having and using the powers, the possible use of RIPA in online pharmacy investigations and retaining the powers to deal with future scenarios as yet unknown". Led by Chief Executive and Registrar, Duncan Rudkin, the discussion underscored the importance of having robust oversight mechanisms in place. The inspection report provided assurance that the GPhC's policies align with regulatory requirements.

Global logistics company, JAS has received the Wholesale Distribution Authorisation (WDA(H)) license from the UK's Medicine and Healthcare Products Regulatory Agency (MHRA) for its Pharma and Healthcare Division. In a press release issued on Thursday (22 February), the company said that securing the license empowers its UK healthcare division to "seamlessly connect" with its more than 40 GDP (Good Distribution Practice) certified overseas stations, strengthening its capabilities for handling pharmaceutical shipments. Headquartered in Atlanta, Georgia, USA, the company boasts a team of over 7,000 professionals, with operations spanning over 100 countries. Adrian Frodsham, Regional Director for JAS, said that they were granted the WDA(H) license after a "stringent audit process." "JAS UK's pharma and healthcare division prides itself of offering innovative solutions for the international delivery of pharmaceutical products, further enhancing the growth of our pre-established healthcare division," he added.

Britain's drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) on Monday announced that fluoroquinolone antibiotics must only be administered when no other antibiotics are appropriate for use. It elaborated that fluoroquinolones given systemically (by mouth, injection, or inhalation) should only be prescribed "when other recommended antibiotics have failed, will not work due to resistance, or are unsafe to use in an individual patient." Previous regulations on fluoroquinolones stated that this class of antibiotics should not be prescribed for mild to moderate or self-limiting infections, or non-bacterial conditions. Further restrictions have been introduced after receiving reports from patients who have experienced long-lasting or disabling reactions following use of fluoroquinolones, the MHRA revealed. Dr Alison Cave, MHRA Chief Safety Officer, said: "Patient safety is our top priority. We have listened to the experience of patients regarding long-lasting and potentially irreversible adverse reactions following use of fluoroquinolone antibiotics, in some cases prescribed for mild-to-moderate infections.

Eli Lilly's weight-loss medicine Mounjaro, also known as tirzepatide, will be available in the UK within weeks as a four-dose pre-filled injection pen. The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the drug to treat adults with type 2 diabetes and for weight management in obese patients. Branded as Mounjaro KwikPen, the injection is to be used together with a reduced-calorie diet and increased physical activity, the regulator said. "The public health importance of safe and effective treatments to help manage diabetes and obesity, which can have a significant impact on people's health, is clear. "This approval enables access to the approved Mounjaro pen in a more convenient presentation of a month's treatment, of one dose per week," said Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access.

The Medicines and Healthcare products Regulatory Agency (MHRA) has reclassified codeine linctus, a medicine used for the treatment of dry cough, from a pharmacy-only medicine (P) to a prescription-only medicine (POM) owing to the risk of dependence, addiction, and overdose. This implies that the dry cough syrup, which is also known as codeine oral solution, can only be dispensed upon the submission of a prescription at a pharmacy, rather than being accessible over the counter upon request. Patients are cautioned that as an opioid medicine, codeine can be addictive, and the risk of addiction may increase, particularly with prolonged use over an extended period. According to the medicines regulator, codeine is converted into morphine by the liver enzyme CYP2D6. In individuals identified as ultra-rapid metabolizers, this conversion from codeine to morphine occurs at a faster rate than in others. "If you want to stop taking it and have been taking codeine linctus for a long time, then it is important to reduce the amount you take slowly with the help of your prescriber," the agency said in its drug safety update issued on Tuesday, 20 February.