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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.

To help transform care for patients, the Royal Pharmaceutical Society (RPS) is calling on the General Pharmaceutical Council (GPhC) to remove the two-year post qualification wait for pharmacists before they are allowed to start their independent prescriber training. RPS proposes that entry to training should be based on whether pharmacists can evidence the necessary skills, knowledge, and experience to undertake the training, and not the length of time a pharmacist has been on the register. RPS president Claire Anderson said: "We've campaigned strongly for better use of pharmacist independent prescribers, who are becoming essential to multi professional teams in all health care settings. "We want to ensure pharmacy remains an attractive career and has parity with the other professions. Pharmacist prescribing is now moving from being a skill only associated with advanced specialist levels of practice to a more generalist scope, providing a workforce that's more flexible with a shared set of capabilities.

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)."

The Pharmacist's Defence Association (PDA) has raised concerns over the adoption of Digital Clinical Excellence (DiCE) guidelines for online prescribing of GLP-1 receptor agonists for weight management in adults. This follows a clash with expert recommendations commissioned by the General Pharmaceutical Council (GPhC) as the PDA "believes the final guidance conflicts with the expert opinion underpins the GPhC's prosecution strategy towards pharmacist prescribers under investigation." In a recent statement, the PDA highlighted the discrepancy between DiCE's guidance and the expert report employed by the GPhC to prosecute pharmacist prescribers using a questionnaire-based consultation model. This conflict has prompted the PDA to withhold its endorsement of the DiCE guidance as it differs from an expert report commissioned by the GPhC. The PDA's reservations stem from the inherent risks associated with questionnaire-based prescribing.

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.

The Royal Pharmaceutical Society (RPS) has urged the government to amend medicines legislation to allow pharmacists to make minor amendments to a prescription without any protocol being needed. RPS wants to see a change in the law that makes the whole process of supply of medicines easier and quicker, enabling pharmacists to use their knowledge and expertise in medicines to better support patients. "At present a prescription can only be changed by a prescriber, which causes unnecessary workload for GPs and delays for patients," said RPS. RPS President Professor Claire Anderson said: "We want to see all pharmacists across the UK able to supply a different quantity, strength or formulation of a medicine (for example changing capsules to tablets) when required, to avoid unnecessary bureaucracy and the need for an SSP to be developed, signed and authorised by a Minister. In effect it would mean that pharmacists can help patients straight away - it would future proof the problem to some degree.

The International Pharmaceutical Federation (FIP) has offered a new resource to help countries self-assess readiness of their regulations to enable pharmacist-delivered vaccination services and, where needed, to implement such regulations. Developed by FIP's Regulators Advisory Group, it covers broad pharmacist-led roles related to vaccination from supply chain management to administration and prescribing. "This new resource from FIP is based on the experiences of professional regulators in countries where pharmacy-led vaccination has been successfully introduced and regulated. With it, we aim to support regulators, policymakers and national organisations in developing strategies or enabling regulatory frameworks in countries where the pharmacy workforce has a limited role in vaccination strategies so that it can contribute further to the global imperative of improving immunisation coverage," said Brett Simmonds, group chair. The "Pharmacy-led vaccination services: Regulatory self-assessment and implementation tool" aims to help identify strengths and areas for improvement in order to inform vaccination policy and planning efforts.

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.

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.

To curb the supply issue of HRT medicine, the government has taken a further action by issuing SSPs for Oestrogel, Ovestin cream, Lenzetto transdermal spray and Sandrena gel sachets - with appropriate alternatives. The move aims to allow community pharmacists to supply specified alternatives to the prescribed HRT products without needing to seek authorisation from the clinician who has prescribed the medicine. The regulator said that the availability of Premique Low Dose has impoved 'thanks to SSPs issued on 29 April to restrict dispensing for Oestrogel, Ovestin and Premique Low Dose to three months' supply'. "Since these measures were implemented, further deliveries of all three products have been made, with Premique Low Dose returning to good availability this week. The manufacturers of Oestrogel and Ovestin, as well as suppliers of alternative HRT products, are taking action to increase UK supply." It added, "SSPs restricting prescriptions to a maximum of three months' supply will also be issued for substitute products, as a precautionary measure to ensure the supply of those substitutes is maintained."

Pharmaceutical Services Negotiating Committee (PSNC) has expressed its support for alterations in the Human Medicines Regulations 2012 to enable original pack dispensing (OPD) and supply of medicines containing sodium valproate by pharmacists. PSNC's support for changes was in response to the consultation on OPD, initiated by the Department of Health and Social Care (DHSC). The consultation had proposed regulatory changes to allow pharmacists to dispense (up to 10 per cent) more or less than the prescribed quantity of a given medicine in the manufacturer's original packs. Key aims of the proposal are to "support increased patient safety by ensuring patients receive the necessary information that is included in the original manufacturer's packaging about the safe and effective use of a product," DHSC said.

The General Pharmaceutical Council (GPhC) today decided to convene a new group, involving all the key stakeholders, focused on assurance of practice post-registration. The decision in today's (9 December) council meeting follows the recommendation of a working group chaired by council member and pharmacist Aamer Safdar on the role of the regulator in post-registration education and training. The new group will be tasked with articulating a set of guiding principles where patient safety is the overarching priority, after carrying out a horizon scanning exercise to pull together an understanding of the system wide approach currently in place. The working group noted that the wider approach, in relation to regulation of post-registration practice and not simply education and training, may require the GPhC reviewing and developing its own control measures, and involving patients and the public in the next stages of work. Reviewing the work on online pharmacy services, the council meeting supported the regulator's plans to continue to require pharmacy websites to be arranged so that a person cannot choose a prescription only medicine and its quantity before there has been an appropriate consultation with a prescriber.

Women in the UK will be able to purchase Gina 10 mg vaginal tablets without prescription from September from their local pharmacies, announced the Medicines and Healthcare products Regulatory Agency (MHRA). The Hormone Replacement Therapy (HRT) product, Gina 10 microgram vaginal tablets (containing estradiol) are used for the treatment of vaginal symptoms such as dryness, soreness, itching, burning and uncomfortable sex caused by oestrogen deficiency in postmenopausal women aged 50 years and above who have not had a period for at least one year. The decision to reclassify these vaginal tablets follows a safety review by the MHRA, independent advice from the Commission on Human Medicines (CHM), and a public consultation. The UK regulator sought views from patients, pharmacists, prescribers and a wide range of stakeholders including the Royal College of Obstetricians & Gynaecologists, the Faculty of Sexual & Reproductive Healthcare, the British Pharmacopoeia Commission and the British Menopause Society.