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 first big breakthrough in 30 years of Alzheimer's research is providing momentum for clinical trials of "cocktail" treatments targeting the two hallmark
proteins associated with the mind-robbing disease, according to interviews with researchers and pharmaceutical executives.
Drugmakers Eisai and Biogen reported in September that their therapy lecanemab could slow progress of the disease by 27% over 18 months compared with a placebo.
The finding validates the theory that clearing the amyloid protein that forms clumps in the brains of Alzheimer's patients could slow or halt the disease and has
strengthened the support from some scientists for simultaneously targeting another notorious protein linked to Alzheimer's: tau.
Eisai and Biogen are scheduled to present full data from their lecanemab study on Tuesday at the Clinical Trials on Alzheimer's Disease conference in San Francisco.
The U.S. Food and Drug Administration is expected to make a decision by early January on the companies' application for accelerated approval.
If approved on an accelerated basis, the companies said they would immediately apply for full U.S. regulatory approval which could help secure Medicare coverage.
Millions of people take dietary supplements every day, hoping to improve their health in some way. But how much do you know about these supplements? Are they safe? Do they work? And are there any risks associated with taking them?
Here are six important things to know about dietary supplements if you're one of the people who take them.
NOT ALL SUPPLEMENTS ARE REGULATED
Since dietary supplements are not drugs, they do not need to be approved by the Food and Drug Administration (FDA) before they can be sold. This means that some
products may not contain what is stated on their labels or may even include ingredients that could be dangerous. Therefore, it's important to always read labels
and do your research before committing to one.
Furthermore, make sure you purchase your supplements from a reputable source. This means that you should look for companies that have been independently tested and
certified to provide high-quality products.
MAKE SURE THE SUPPLEMENT IS RIGHT FOR YOU
Before taking any dietary supplement, check with your doctor or healthcare professional first. This is especially important if you have a medical condition or are
on medication, as certain supplements may interact in unwanted ways. Just because something is labeled as "natural" doesn't necessarily mean it's good for you or
that you even need to take it. Before taking any supplement, talk to your doctor about whether or not it could be beneficial for you and how much you should take.
The Royal Pharmaceutical Society (RPS) Scotland the BMA's Scottish GP Committee has called for improvements to the pharmacotherapy service.
The joint statement released by the organisations on Friday (13 January), has recognised that much progress has been made but states that further improvements are
needed to fully maximise the benefits of the service.
It highlighted the need for better use of skill mix, including more clearly defining roles and responsibilities; improved IT enablers to reduce administrative burden;
and further developing a tandem model of working comprising hubs with in-practice activity
The two organisations state that inadequate funding and workforce shortages are a real threat to the pharmacotherapy service.
They have urge Scottish Government to reconsider its recent decision to reduce funding for training pharmacy technicians.
Clare Morrison, RPS Director for Scotland, said: "In the statement, we stress that the use of pharmacists' clinical skills must be maximised.
Sun Pharma has announced that it will acquire all outstanding shares of Concert Pharmaceuticals through a tender offer for an upfront payment of $8.00 per
share of common stock in cash, or $576 million in equity value.
The upfront payment of $8.00 per share of common stock in cash represents a premium of approximately 33% to Concert's 30-day volume weighted average price as of
January 18, 2023, the last trading day prior to today's announcement.
Concert is a late-stage biotechnology company pioneering the use of deuterium in medicinal chemistry. Concert has an extensive patent portfolio, including its lead
product candidate deuruxolitinib - an oral inhibitor of Janus kinases JAK1 and JAK2 for the treatment of Alopecia Areata, an autoimmune dermatological disease - which
is in late-stage development.
It has completed the evaluation of the efficacy and safety of deuruxolitinib in adult patients with moderate to severe Alopecia Areata in its THRIVE-AA Phase 3
clinical program and two open label, long-term extension studies are ongoing in North America and Europe. Sun Pharma's immediate focus would be to follow Concert's
plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the first half of 2023.
Rowlands Pharmacy has joined hands with healthcare software company HasHealth for an enhanced digital proposition to facilitate seamless delivery of a raft of
clinical services including flu and travel vaccinations.
The new system is now available across 400 Rowlands pharmacies across the UK.
The partnership comes as Rowlands Pharmacy strives to provide patients with a seamless booking experience whilst minimising time-consuming administration for pharmacy
staff, with its waiting list, medical pre-screen questionnaires and resource management capabilities, the company said in a statement.
HasHealth offers a virtual healthcare software solution that allows community pharmacies to schedule, manage, and communicate with patients easily online. It combines
its cutting-edge video technology with booking and management software, which can be adapted to any clinical service.
Nigel Swift, managing director at Rowlands Pharmacy, commented: "We pride ourselves on listening to our staff, based on feedback we knew we could do better with our
digital proposition for clinical services and flu vaccinations in particular.
The Pharmaceutical Services Negotiating Committee (PSNC) has notified that it is now mandatory to attend face-to-face training for both injection technique
and basic life support training periodically for pharmacists and other vaccinators providing the annual flu vaccination service.
"Community pharmacy contractors are required to demonstrate that all vaccinators, including pharmacists, providing the flu vaccination service in their pharmacy
have the skills needed to do so," said PSNC.
Prior to this change, pharmacists and other vaccinators needed to undertake a refresher face-to-face training for both injection technique and basic life support,
including administration of adrenaline, every three years.
Vaccinator needs to evidence competence
PSNC said: "Contractors and vaccinators will now need to consider when it would be appropriate to attend refresher training or if ongoing competence of an individual
vaccinator can be evidenced, without the need for face-to-face training.
"An individual's continued competence may be influenced by their prior experience vaccinating patients, including the overall number of vaccines administered and
the regularity with which they administer vaccines."
The Pharmacists' Defence Association (PDA) has urged pharmacists working in Covid-19 vaccination role to report any concerns about the needles and syringes
supplied with the Moderna Spikevax Bivalent vaccine.
The association has heard reports of bending when vaccinators pierce the top of the vial containing the Covid-19 vaccine doses, needles falling out during manipulation
and appearing to be bent even before removal from the packaging.
PDA has advised its members who are working in a Covid-19 vaccination role "to report any concerns via the Yellow Card medical device reporting system, and to keep up
to date with NHS clinical updates for ongoing information and guidance."
Current advice from the NHS includes sharing of video and poster resources (available on FutureNHS) which have been produced by the supplier to support the
introduction of the new administration needles and syringes for Spikevax Bivalent.
This is following a switch from BD Flu+ 23G x 25mm 1ml syringe combined needle and syringe (CNS) to the Owen Mumford Unifine Safety Retractable Needle 25G x 25mm &
1ml Syringe.
Pharmanovia, the lifecycle management company has signed a licence and supply agreement with Aquestive Therapeutics for its patented diazepam buccal film
formulation across the EU, UK, Switzerland, and Norway, as well as countries in the Middle East and North Africa (MENA)- up to 48 markets in total.
Aquestive Therapeutics has been granted tentative approval by the US Food and Drug Administration (FDA), for its diazepam buccal film for the acute treatment of
intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual
seizure pattern in patients with epilepsy 12 years of age and older.
Pharmanovia will be responsible for seeking appropriate regulatory approval across EU and MENA.
Pharmanovia CEO, James Burt commented: "Pharmanovia and Aquestive are aligned in our mission to find new and innovative ways to enhance and revitalise iconic
medicines. We have extensive experience with diazepam through the Valium brand and, together with Aquestive's unique PharmFilm technology, we're intending to bring
a novel alternative diazepam delivery option to caregivers and patients at a time of critical need."
The National Pharmacy Association (NPA) and BeWell are working together to help provide efficiencies and productivity that address the growing pressures within
community pharmacy.
BeWell's Pharmacy Management Platform provides robust solutions that include Patient Relationship Management, Omnichannel Communications and Engagement, Services
and Bookings Management, access to patient records, NHS Login supported Patient Application, and repeat prescription capabilities for Pharmacy Website and Patient
App that include integrations with Surgery Online Services.
This single interoperable platform is also integrated with pharmacy PMRs, connecting back office and administrative functions with front-of-house digital patient
experiences. In line with the NPA's vision, BeWell has taken a leading role in formulating a unique ecosystem of pharmacy partners uniting marketing agencies,
PGD-based service providers, and delivery method partners - integrating their capabilities within the BeWell platform.
Health secretary Sajid Javid and chancellor of the exchequer Rishi Sunak have both resigned on Tuesday (July 5) after a slew of scandals undermined the
government of prime minister Boris Johnson.
Javid and Sunak sent resignation letters to Johnson within minutes of each other in which both took aim at his ability to run an administration that adhered to
standards.
The resignations came as Johnson was apologising for appointing a lawmaker to a role involved in offering pastoral care, even after being briefed that the politician
had been the subject of complaints about sexual misconduct.
In his resignation letter to Johnson, Javid said "it is clear to me that this situation will not change under your leadership - and you have therefore lost my
confidence too".
He was appointed to lead the Department of Health and Social Care in June 2021, when his predecessor Matt Hancock quit after being caught having an affair with an
adviser, in breach of social distancing guidelines.
British health agencies have secured funding to develop a standardised approach to test the performance of vaccines being used or in development against
monkeypox, days after the World Health Organization labelled the growing outbreak a global health emergency.
The Coalition for Epidemic Preparedness Innovations (CEPI) said it would give up to $375,000 to the Medicines and Healthcare products Regulatory Agency (MHRA) and
Health Security Agency (UKHSA) to develop standard tools to assess the strength and duration of immune responses generated by current vaccines, and for tests used
to detect monkeypox antibody levels.
Apart from administration fees, these tools will be made freely available to the global scientific community, paving the way for a common standardised assessment
between countries documenting vaccine performance against monkeypox, CEPI said.
Until this year, the viral disease has rarely spread outside Africa where it is endemic. But reports of a handful of cases in Britain in early May signalled that
the outbreak had moved into Europe. So far, there have been more than 16,000 confirmed cases of monkeypox in more than 75 countries.
The pharmaceutical industry is one of the most important and valuable industries in the world. It is responsible for developing and producing medicines that
improve and save lives. However, there are some things you may not know about this fascinating industry. In this blog post, we will discuss six interesting facts
about the pharmaceutical industry!
1. THE MANUFACTURING PROCESS OF PHARMACEUTICALS IS HIGHLY REGULATED
All pharmaceutical products must go through a rigorous manufacturing process before they can be made available to patients. This process is heavily regulated by
various government agencies to ensure that the medicines are safe and effective. The pharmaceutical manufacturing process usually involves multiple steps, including
the preparation of raw materials, the manufacturing of active pharmaceutical ingredients (APIs), and the packaging and labeling of finished products. To ensure
patient safety, all pharmaceutical companies must adhere to strict regulations set by government agencies such as the Food and Drug Administration (FDA). These
regulations are designed to protect patients by ensuring that medicines are safe and effective.
The global company in information and data analytics, Elsevier launched a platform, PharmaPendium for drug candidates.
It is an effective tool that provides data including complete Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval packages for
drug development.
The platform is supported by the FDA, the Medical Devices Agency (PMDA) and the top 20 global pharma companies.
Olivier Barberan, Director of Translational Medicine Solutions spoke about how "improved access to highly relevant data plus predictive tools enhances regulatory
success, safeguarding the massive investments of pharma companies."
"Translation of preclinical research findings to humans in an efficient but safe way is one of the greatest challenges facing drug developers. We designed the
new PharmaPendium to solve this," he added.
The US Food and Drug Administration (FDA) has approved the Novartis drug, Cosentyx, (secukinumab) to treat moderate to severe hidradenitis suppurativa (HS)
in adults.
HS is a chronic, progressive and painful disease which affects one in 100 people worldwide, and has limited treatment options.
"Cosentyx is the only FDA-approved fully human biologic that directly inhibits interleukin-17A (IL-17A), a cytokine believed to be involved in the inflammation
of HS," said the Swiss company.
The FDA approval was based on robust Phase III data (SUNSHINE and SUNRISE studies) in which Cosentyx showed rapid relief from HS symptoms as early as Week 21.
The Royal Pharmaceutical Society (RPS) has confirmed that the recall of blood pressure drugs amlodipine and olmesartan by the Food and Drug Administration is
only for the US market and will not have any impact in the UK.
MHRA also clarified that the manufacturer of these drugs, Macleod Pharmaceuticals, does not supply amlodipine medicines in the UK.
It was published online in both the Daily Record and Daily Express on the morning of Monday, March 21, that the drugs had been recalled in the US by the FDA due to
deviations from standard manufacturing protocols by the manufacturer.
RPS intervened to ensure the articles were edited to make clear that this is not an issue in the UK after confirmation from the MHRA. Amlodipine tablets from Macleod
Pharmaceuticals aren't available for wholesale distribution in the UK.
When you visit a hospital, one of the last things that come to mind is worrying about legal aspects and what rights you might have - or lack. But these
issues and your understanding of them are more important than ever. Knowing exactly what hospitals can legally and cannot do to you is an essential part of
ensuring your protection as a patient when going in for care.
In this blog post, we'll break down the legal details behind being treated at a hospital so that you can feel more confident when making healthcare decisions.
Let's dive into the legal aspect of visiting a hospital, outline what hospitals can and cannot do to us, discover our rights as patients, and review any other
considerations worth keeping in mind!
OVERVIEW OF MEDICAL MALPRACTICE LAW AND HOW IT RELATES TO VISITING A HOSPITAL
When going to a hospital, concerned patients and their families should be aware of the legal risks posed in medical malpractice cases. These potential issues can
have life-altering consequences if misdiagnoses, wrong medication administration, or improper treatment occurs. Now, whether you seek damages for your injuries at
Staten Island University Hospital or in a different hospital in your hometown, it is important for visitors to understand that the law has set forth regulations
regarding acceptable standards of care expected by our nation's hospitals.
Those regulations can include procedures of qualified professionals that protect patients from financial exploitation and physical or emotional distress caused by
medical negligence. Understanding how this information applies to you will help you protect yourself legally if your rights are violated while visiting a hospital.
Pharmaceutical recalls are complicated and expensive, just like in any other business. Pharmaceutical recalls, however, pose a further risk because they might
change both short- and long-term health effects. To ensure smooth recalls with few negative effects on public health, it is crucial to understand the pharmaceutical
product recall procedure and the roles of each key player. Throughout the recall procedure, patient safety is crucially ensured by the FDA, pharmaceutical companies,
pharmacy technicians, and other healthcare professionals.
Learning about pharma recalls, procedures, and responsibilities is essential for guaranteeing patient safety for key actors like the Food and Drug Administration
(FDA), manufacturers, and other medical specialists.
RECALL CLASSIFICATIONS
Recalls can fall into one of three categories-class I, II, or III-with class I being the most serious and lethal. Products that have the potential to result in
serious, permanent complications or death are subject to Class I recalls.
Class II recalls are recommended for product flaws that have a low likelihood of harmful events or that can result in reversible side effects.
Last but not least, class III recalls typically arise from problems with packaging that do not pose a risk. Since they are frequently issued out of an abundance of
prudence rather than due to any negative impacts, many people may even describe this kind of recall as benign.
British pharmaceutical giant GSK said on Saturday (April 15) its oral antibiotic drug to treat uncomplicated urinary tract infections (uUTI) in female adults
and adolescents met the main goals in late-stage trials.
The drug, gepotidacin, in phase III trials, met its primary goals of being on a par or better than nitrofurantoin, the current standard of care for the treatment of
uUTIs, the company said.
GSK plans to submit results of the trials to the United States Food and Drug Administration for review later in the second quarter.
The drug, if approved, could become the first new type of antibiotic, which is critically important for countering drug-resistant infections, to treat uUTIs in 20
years, the company said.
"Gepotidacin, if approved, will offer a much-needed additional oral treatment option for patients at risk of treatment failure associated with resistance or
recurrence of uUTI," Chris Corsico, senior vice president of development at GSK, said.