Group items tagged

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.

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 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.

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 General Pharmaceutical Council (GPhC) has called for comments and views on the recently launched consultation on selecting the appropriate mode of consultation when assessing a person's needs by pharmacy professionals including pharmacist prescribers. The guidance note sets out what the pharmacy professional or prescriber, in agreement with the patient, needs to consider when selecting the mode of consultation - such as face-to-face; video-link, video-chat, or other online platforms; telephone and online questionnaires - best suited to gaining the information needed to deliver safe and effective pharmacy care. The principles outlined in the guidance apply to consultations undertaken in all pharmacy settings, including those undertaken by online pharmacy services providers. "Our plan is to include the contents of this guidance note in the document: 'In practice: Guidance for pharmacist prescribers' when we undertake our next review," said the regulator.

The General Pharmaceutical Council (GPhC) has raised concerns over the rising risks related to online pharmacy services. It revealed over 30 per cent of its open Fitness to Practise (FtP) cases were related to online pharmacy, which is disproportionate to the sector of the market that online services occupy. The regulator has advised pharmacists and pharmacy owners providing online services that they should "not work with online providers who try to circumvent the regulatory oversight put in place within the UK to ensure patient safety". In the past five months, the Council has imposed seven interim orders on the registration of pharmacists who have worked for or with online prescribing services - after identifying serious concerns with their practice. It said: "These pharmacists were working as pharmacist independent prescribers for online services or were dispensing medicines prescribed online. Some of these pharmacists were the Responsible Pharmacist (RP) or the Superintendent Pharmacist (SP)."

Pharmacists with 'relevant experience in a pharmacy setting' can enroll for accredited independent prescribing course, as the General Pharmaceutical Council (GPhC) has decided to scrap the requirement of spending at least two years on the register and having previous experience in a specified clinical or therapeutic area before enrolling for the course. The GPhC Council meeting held on Thursday instead proposed that applicants must have "relevant experience in a pharmacy setting and be able to recognise, understand and articulate the skills and attributes required by a prescriber." This experience and awareness will act as the basis of their prescribing practice whilst training. The regulator noted that the majority of stakeholder organisations, including the Chief Pharmaceutical Officers, the Royal Pharmaceutical Society and the statutory education bodies, were in favour of removing the requirement in a consultation on the topic. They highlighted that a specific two-year period was not in itself a robust indication of whether an individual was ready to become a prescriber. They also highlighted that the rapidly developing roles in the profession meant more pharmacists were likely to gain the necessary experience more quickly than in the past. A smaller number of organisations and a larger minority of individuals were opposed, citing that a specific two-year period gave pharmacists the time they needed to develop experience and confidence before being ready to enrol on a course.

Within the last few weeks, at least six pharmacists have been subjected to interim order applications - either suspended or had significant restrictions placed upon their registration pending a full 'Fitness to Practise' hearing into serious allegations being made about their prescribing practices, the Pharmacists' Defence Association (PDA) has found. It said that there has been a "dramatic increase in action being taken by the pharmacy regulator (GPhC) against pharmacist prescribers associated with certain types of online prescribing services". It has warned pharmacist prescribers who work for online pharmacies about the specific risks associated with remote prescribing using a questionnaire-based model, typically with no direct prescriber/patient interaction. Common features that underpin the allegations include the following: Overreliance on a patient questionnaire to inform clinical decision making; No patient/prescriber interaction; Prescribing high risk medicines without adequate safeguards; Inadequate systems and processes leading to inappropriate prescribing; Very high volumes of prescriptions being authorised in short periods of time; and Prescribers/patient relationship established via an unregulated online portal.

British pharmacy chain Superdrug has announced plans to cease the sale of disposable vapes in all its UK and Ireland stores, citing the environmental impact caused by its disposal and popularity among young people. The pharmacy retailer will discontinue selling brands like Vuse GO and Flavaah Bars, with plans to completely clear out existing stock by the end of the year, the company said in statement. Superdrug, which previously sold 1,300 single-use vapes weekly, expects a potential impact on revenue stemming from this decision. The company has not yet started selling vapes online. "This decision was made to safeguard the environment," the company said on Sept.22, highlighting the risk of fires due to improper disposal of vapes, as many of them contain lithium batteries.

Pharmaceutical Press, the Royal Pharmaceutical Society publishing arm, has announced its partnership with Datapharm Ltd. Under the new partnership, Electronic Medicines Compendium (emc) the latest product to be added to MedicinesComplete, the online medicines information platform from Pharmaceutical Press. MedicinesComplete users can easily search emc information, with direct links to the trusted, clinical guidance from the British National Formulary (BNF). "emc through MedicinesComplete will include printable, ready-to-use patient information leaflets written by manufacturers to use at the point of care, and users will have access to an unlimited number of searches. In addition, emc will also include the full Summary of Product Characteristics (SmPC) document, which accompanies all regulator approved medicines in the UK," said the RPS. Available to all countries outside the UK, emc will be launched early next year on subscription through MedicinesComplete. UK access is available on request.

The Medicines and Healthcare products Regulatory Agency (MHRA) has maintained the prescription-only status of Aquiette 2.5mg Tablets for symptoms of overactive bladder, following a public consultation and the review of a reclassification application from the manufacturer Maxwellia Ltd. Aquiette, which contains the active ingredient oxybutynin, is used for the treatment of long-term symptoms of overactive bladder (OAB) in women aged between 18 and 65, such as the urgent need to urinate and frequent urination without pain. The regulator decided against the reclassification of Aquiette 2.5mg Tablets from a prescription-only medicine (POM) to a pharmacy (P) medicine, concluding that a medical prescription continues to be required to ensure the safe use of Aquiette. Since an OAB diagnosis requires medical supervision to ensure that the correct treatment is received, and other health conditions are not overlooked or left untreated, the MHRA said the decision would ensure that the medication is used safely and appropriately under medical supervision. "After taking on board the views of the many patients and healthcare professionals who responded, we have decided to refuse the reclassification of Aquiette 2.5mg Tablets for women with symptoms of overactive bladder (OAB)," Dr Laura Squire, MHRA chief healthcare quality and access officer, said.

Superdrug Online Doctors has made travelling easy ahead of Easter by introducing jet lag 'melatonin' tablets into its travel services portfolio to help those taking long haul flights. The company has seen an 287 per cent increase in demand for its travel services and products. Malaria treatment is up by 272 per cent, gut health products up by 317 per cent, jet lag melatonin tablets increasing by 900 per cent since launch and Period Delay services which offer more choice when it comes to the timing of periods up by 195 per cent year-on-year. Dr Sara Kayat, Superdrug's medical ambassador, comments: "Jet lag is a temporary sleep problem that affects people who travel across different time zones. It can occur when your internal clock, the function that lets your body know when to stay awake and when to sleep, is disrupted by a new time zone and puts your internal clock out of sync. Melatonin is a hormone we produce to help regulate our sleep cycles, and a synthetic version can be taken in the short term to manage jet lag."

The Pharmacist' Defence Association (PDA) has welcomed the General Pharmaceutical Council (GPhC) and the Pharmaceutical Society of Northern Ireland (PSNI)'s plan to ensure a more robust, fair and positive experience for trainees, provisionally registered and potential pharmacists who will be sitting the November 2022 assessment. "Many candidates at the latest (June 2022) assessment experienced significant delays, technical issues, inadequate invigilation, and disturbances in test centres around the UK as the newly appointed company BTL ran the high-stakes pharmacist examinations for the first time. The next online exam is due in November 2022 and the PDA welcome proposed improvements to be introduced before that sitting," said the association. For some, provisional registration was the accepted response from the GPhC, but for others, such as potential pharmacists who did not want the provisional role, those unable to find a suitable provisional post, or some that did not meet the criteria for provisional registration, they found themselves in financial difficulties through no fault of their own, having reasonably expected to have joined the register in the Summer.

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised the public to exercise caution when buying anti-choking devices online, ensuring these products are purchased from reputable sellers. As estimated by the regulator, more than 10,000 counterfeit or unbranded anti-choking devices have been purchased by the public within the last two years through listings on online marketplaces such as Amazon and eBay, as well as drop-shipping websites. People are cautioned that the use of such products poses a substantial risk of failure in clearing blockages and could exacerbate the situation by pushing obstructions further down into the airway passage. Dr Alison Cave, MHRA Chief Safety Officer, said: "Buying anti-choking devices that do not have a valid UKCA or CE mark increases the risk of receiving a product which does not include appropriate instructions and is either fake or does not meet the UK's regulatory requirements. "These products do not meet our strict quality standards and may put your health and safety at significant risk by failing to resolve or even worsening choking incidents."