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To help manage the ongoing supply disruptions, the health regulators have extended to 28 October 2022, serious shortage protocols (SSPs) for 12 of the 13 hormone replacement therapies (HRT). "The only HRT SSP set to expire on 29 July 2022 is for SSP021 Premique low dose 0.3mg/1.5mg modified-release tablets. After 29 July, there will be no need to restrict quantities of Premique tablets as its supply situation has now stabilised," said PSNC. In addition, the dose equivalence advice and endorsement guidance for SSP024 and SSP025 have been updated. SSP024 and SSP025 have been updated by DHSC to provide greater clarity to pharmacists on the dose equivalences to determine the appropriate quantity to supply. Pharmacists are asked to refer to the latest SSP versions and endorsement guidance published on NHSBSA's website.

In a recent meeting with the head of the government's HRT Taskforce, Madelaine McTernan, the National Pharmacy Association (NPA) board members gave a gist on the ongoing medicines supply issues in community pharmacy. The meeting, which explored possible solutions to end the nationwide shortage of some Hormone Replacement Therapies, took place on Friday (May 20). Independent contractors Reena Barai and Olivier Picard gave the so-called 'HRT tsar' an overview of the medicines supply issues in community pharmacy and discussed the new Serious Shortage Protocols (SSPs) which the government introduced in response to the on-going HRT disruption. Earlier this month, the NPA attended an HRT summit organised by the Department of Health and Social Care, alongside other pharmacy bodies, wholesalers and manufacturers. Health secretary Sajid Javid and pharmacy minister Maria Caulfield said they would be working collaboratively with manufacturers to meet demand and boost supply.

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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.

The PSNC on Friday said it has warned the DHSC about the "very serious impact" of the limited supply of certain antibiotics on pharmacies who are "having to chase stock, purchase without sight of any concession prices, and cope with increasing patient questions and abuse." With higher than usual number of cases of scarlet fever, caused by invasive Group A Streptococci (iGAS) infections, being reported in children across the country, supplies of antibiotics for Group A Strep treatment have seen a surge in demand, leading to limited supply at certain wholesalers and pharmacies. PSNC has urged the DHSC to adopt measures that could help to manage the current crisis, such as allowing pharmacists more freedom to change strengths or formulations without prescriber approval, outside of Serious Shortage Protocols. It has also raised concerns on the significant rise in wholesale prices of many oral antibiotics as a result of the surge in demand and the ongoing supply disruptions. PSNC also said they have received reports of some suppliers putting up their prices for any oral antibiotics they do have in stock.

The Department of Health and Social Care (DHSC) has allowed pharmacists to supply alternative penicillin to treat Strep A. It has issued Serious Shortage Protocols (SSPs) for three penicillin medicines. "The SSPs will help mitigate local supply issues of oral penicillin and allow pharmacists to supply alternative forms of the medicine if they do not have the specific formulation stated on the prescription," said DHSC. SSPs have been issued across the UK for 3 penicillin medicines on Thursday (December 15. "Issuing an SSP allows pharmacists to legally supply a specified alternative medicine, removing the need for the patient to return to the prescriber - which saves time in GP practices and inconvenience for patients." "Demand for penicillin has risen recently as it is used to treat strep A and scarlet fever, and the increased demand means that some pharmacists are experiencing temporary and localised supply issues and may not have the specific formulation listed on the prescription."

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 Department of Health and Social Care (DHSC) has issued a further five new Serious Shortage Protocols (SSPs) for Phenoxymethylpenicillin (Pen V) to enable the continued supply of antibiotics to patients. "The new SSPs, introduced with immediate effect, allow community pharmacists to consider different oral antibiotic preparations, to enable the continued supply of antibiotics to patients and mitigate the ongoing supply disruptions affecting Phenoxymethylpenicillin," said DHSC. On Friday (16 December) SSP043-SSP047 has been authorised by the Secretary of State to provide pharmacists with procedures to follow in providing suitable alternative oral antibiotics to substitute Phenoxymethylpenicillin. "For each SSP, DHSC has included specific patient counselling points which must be taken into account when deciding whether supply in accordance with an SSP is suitable for a patient."

"We need to fix the front door to our NHS by investing in community pharmacy," asserts Daisy Cooper as more and more pharmacies "worry about the future of their business." Reflecting on the challenges faced by pharmacists during the pandemic, she emphasised their pivotal role in launching vaccination schemes across communities and the larger role pharmacies play in complementing traditional NHS facilities. Cooper recalls her collaboration with local pharmacies in St. Albans, where she worked hand in glove with them to address challenges faced by pharmacists to obtain information from NHS England regarding protocols and procedures. She told Pharmacy Business reporter that she had to work out something "hand in glove to help them get those vaccinated schemes up and running, as pharmacies were desperate to take part in the vaccination scheme" in her constituency. Describing their unique selling point (USP), Cooper emphasised the convenience and immediacy of pharmacies located in high street areas and warned that pharmacy closures "should be a real wake up call for the government."

The Department of Health and Social Care (DHSC) has redetermined the December 2023 concessionary prices for four medicines following requests made by Community Pharmacy England (CPE) on behalf of community pharmacy owners. For Ezetimibe 10mg tablets (pack size 28), the price has been fixed at £17.78, up from £9.44. Other drugs included in the list are Aripiprazole 5mg (£8.52), Digoxin 125microgram (£3.70) and Digoxin 250micrgram (£3.70) tablets. Contractors would be reimbursed at the new prices only for prescriptions submitted for payment for the dispensing month of December 2023. CPE said they are still working with DHSC to agree price concessions for January. Check the final the December 2023 price concessionary here. Additionally, DHSC on Friday confirmed that there's now sufficient stock of Clarithromycin 125mg/5ml oral suspension to meet normal demand, and the Serious Shortage Protocol (SSP), SSP053 for the antibiotic expires on 12 January 2024.

WHAT IS PROTEINASE K MADE OF? Proteinase K is known enzyme belonging to the class of serine proteases that cleave adjacent to the carboxylic group peptide bonds of aromatic and aliphatic amino acids. It's also exhibited a very broad cleavage specificity. The enzyme was discovered in extracts of the fungus Engyodontium album. HOW DOES PROTEINASE K WORK? In molecular biology, main application of proteinase K is to digest proteins during nucleic acids purification in order to remove protein contaminants: - Proteinase K quickly inactivates nucleases (enzymes that digest nucleic acids) that degrade DNA or RNA molecules during the cleansing. - Proteinase K is activated by calcium. It does not affect the activity of the proteinase, but protects again autolysis, improves thermal stability, and regulates substrate binding capacity. To increase the stability of Proteinase K, thereby enhancing its action, Urea as well as SDS (sodium dodecyl sulfate) or elevated temperature at 37-60C is commonly used. Inactivation of Proteinase K is occurring at temperature above 65C. WHAT IS THE PURPOSE OF PROTEINASES? Proteinase K is used to break down proteins in cell lysates (tissues, cell culture cells) and to release nucleic acids due to its action described above. Proteinase K application purpose: DNA isolation from various tissues; Removal of DNAses and RNAses: Proteinase K and RNases can act together in the lysis buffer to degrades contaminating RNAs and proteins;

Northern Ireland will see changes in the regulatory landscape following the issuance of the Windsor Framework on 27th Feb 2023 and the corresponding EU Commission proposal. An agreement, in principle, has been reached by the UK and EU. The new path forward of the Windsor Framework marks a turning point in how both the UK and the EU will work together collaboratively and constructively to ensure that the same medicines are available in Northern Ireland at the same time as they are in the rest of the United Kingdom. Whilst this is a successful result for Northern Ireland patients, this is major change for companies that have made specific provisions in their supply chains for Northern Ireland. The supply chains of companies where provisions and changes were made such as introduction of GB specific pack may be impacted as a result. However, the burden on the UK Pharma supply chain will be eased. Prime Minister Rishi Sunak walks with European Commission chief Ursula von der Leyen in Windsor on February 27, 2023 Pharma companies will need to carefully consider making changes within their processes and supply chains pending the issuance of clear guidance from the MHRA on the regulation changes resulting from the Windsor Agreement and the corresponding EU Commission proposed regulatory changes associated with medicinal products within the Northern Ireland market. Smooth access to the EU market for Northern Ireland pharmaceutical and medical technology firms has been safeguarded within the constraints of the agreement. The pragmatic dual-regulatory system protects business, patients and healthcare services, and reflects that it is an essential state function to maintain and oversee the supply of medicines within the whole United Kingdom.