Preparing Unlicensed Medicines V28 Final-Books Pdf

Preparing unlicensed medicines v28 final
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The General Pharmaceutical Council is the,regulator for pharmacists pharmacy. technicians and registered pharmacies in,England Scotland and Wales. About this guidance, This guidance should be read alongside the standards for registered. pharmacies1, The standards for registered pharmacies aim to create and maintain the right. environment both organisational and physical for the safe and effective. practice of pharmacy The standards are grouped under five principles. This document gives guidance under each principle which should be followed. when an unlicensed medicine is prepared in a registered pharmacy By. following this guidance the pharmacy will,demonstrate that it meets our standards and.
provide assurances that the health safety and wellbeing of patients and. the public are safeguarded, Responsibility for ensuring this guidance is followed lies with the pharmacy. owner If the registered pharmacy is owned by a body corporate for example. a company or NHS organisation the superintendent pharmacist also has. responsibility Everyone responsible needs to take into account the nature of. the pharmacy and the services provided and most importantly the needs of. patients and members of the public, As well as meeting our standards the pharmacy owner and superintendent. pharmacist must make sure they keep to all legal requirements including. medicines legislation and health and safety data protection and equalities. legislation, Pharmacy owners and superintendent pharmacists should make sure that all. staff members including non pharmacists involved in preparing unlicensed. medicines are familiar with this guidance and appropriately trained in all areas. that are relevant to their duties, Pharmacists and pharmacy technicians involved in preparing unlicensed. medicines must maintain the quality of their practice keep their knowledge. Standards for registered pharmacies, and skills up to date and work within their professional competence as.
required by the standards of conduct ethics and performance2. We expect this guidance to be followed however we recognise that there are. a number of ways to meet our standards and achieve the same outcomes for. patients of providing safe treatment care and services If you do not follow. this guidance and provide and manage services in a different way to that. described in this guidance you should be able to show how your alternative. ways of working safeguard patients identify and manage any risks and meet. our standards, In this document when we use the term you this means. a pharmacist who owns a pharmacy as a sole trader and. a pharmacist who owns a pharmacy as a partner in a partnership and. a pharmacist who is the appointed superintendent pharmacist for a. body corporate and,the body corporate itself,Standards of conduct ethics and performance. The scope of this guidance, This guidance applies to the process of preparing an unlicensed medicine by. or under the supervision of a pharmacist in a registered pharmacy in Great. This guidance applies to registered pharmacies preparing unlicensed. medicines whether this happens rarely occasionally or is part of the core. business of the registered pharmacy The circumstances under which. unlicensed medicines may be prepared are covered by specific laws. If the activity is not covered by the exemptions set out in legislation you will. need a Manufacturing Specials MS licence from the Medicines and. Healthcare products Regulatory Agency MHRA If the activity is part of the. core business of the pharmacy you should get advice from the pharmacy s. legal advisers or insurers or the MHRA on whether the service model you use. needs an MHRA licence,This guidance applies to all the following. the one off preparation of an unlicensed medicine in accordance with a. prescription for an individual patient, the preparation of a stock3 of unlicensed medicines which will later be.
supplied from the pharmacy by you against a prescription for an. individual patient, the preparation of methadone4 for supply in accordance with a. prescription either for immediate supply in accordance with a. prescription or initially as stock3 to be supplied from the pharmacy by. you in accordance with a prescription at a later time. the preparation of an unlicensed medicine based upon the pharmacist s. the preparation of an unlicensed medicine by a pharmacist based on the. specification of the patient, Preparation for stock at a pharmacy is acceptable as long as it is subsequently supplied by that pharmacy or. another pharmacy which is part of the same legal entity. The preparation of an unlicensed medicine including unlicensed methadone is also commonly referred to as. extemporaneous preparation, Throughout this document we use the terms preparing and preparation. which refer to making a medicine from ingredients These terms are not. intended to include the process of simply diluting or dissolving a product in a. vehicle designed for that purpose as part of its marketing authorisation for. example adding a set amount of water to reconstitute an antibiotic powder. Introduction, The law5 sets out the restrictions on how medicines are licensed. manufactured advertised administered sold and supplied. The vast majority of medicines supplied from registered pharmacies are. licensed medicines By licensed medicines we mean those that have a valid. Marketing Authorisation MA in the UK Throughout this document when we. talk about licensed or unlicensed medicines we are referring to medicines. which either have an MA that is they are licensed or do not that is they are. unlicensed, Licensed medicines are manufactured by authorised licensed pharmaceutical.
manufacturers and are covered by a rigorous approval process which is. overseen by the MHRA, The manufacturers who make these medicines are also regulated and licensed. by the MHRA For more information about the approval and inspection of. manufacturers please see the MHRA s website6, Having all these arrangements in place makes sure that. medicines that are licensed are assured to a certain level of efficacy. when used in line with their licence quality and safety. products are only available if they are effective when used in line with. their licence and, those that manufacture licensed medicines are doing so to a high. standard that is consistent throughout the industry. This means that the public and patients can have a high degree of confidence. that licensed medicines when prescribed in line with their licence are. effective and safe for them to take and that they have been made in a way. which meets a certain standard, In general when a prescriber issues a prescription they will prescribe a. medicine that is licensed and indicated for the condition to be treated And as. Medicines Act 1968 and the Human Medicines Regulations 2012. www mhra gov uk, a rule UK and European law says that only authorised licensed medicines.
should be supplied placed on the market UK and European law governs the. circumstances under which prescribers can prescribe and request an. unlicensed medicine to be supplied You can find more information on the. prescribing of an unlicensed medicine on the General Medical Council s. GMC s website7, However there are exemptions in the legislation which allow unlicensed. medicines to be prescribed and supplied to individual patients. The law says that an unlicensed medicine may be prescribed to fulfil the. special needs of a patient when there is no suitable licensed product available. For example a lactose intolerant patient may need a lactose free preparation. or a child may need a preparation in liquid form, The law also allows unlicensed medicines to be manufactured by the holders of. MS specials licences These manufacturers are regulated by the MHRA and. comply with strict licensing requirements, The law also recognises that a pharmacist in a registered pharmacy should. have the pharmaceutical skill and knowledge to safely prepare and supply a. medicine without the need to be licensed as a manufacturer. In general legislation8 requires the medicine itself be licensed9 However the. law allows a pharmacist to prepare medicines in a registered pharmacy. without the need for the product to be licensed, A patient has every right to expect that when an unlicensed medicine is. prepared by a pharmacy professional in a registered pharmacy it is of an. equivalent quality as the licensed medicine they will receive such as those. produced by a regulated and licensed manufacturer As certain high profile. past cases10 11 have shown preparing an unlicensed medicine in a pharmacy is. an activity that can pose a risk to patients and have potentially serious. consequences when risks and process are not managed properly. www gmc uk org, Section 10 of the Medicines Act 1968 Regulation 4 of the Human Medicines Regulations 2012.
Regulations 17 and 46 of the Human Medicines Regulations 2012. Peppermint water case BBC coverage,Meningitis outbreak BBC coverage. When a patient is supplied with a medicine it is of vital importance that the. medicine is safe and fit for purpose Pharmacists making supplies must also. consider their individual professional standards and responsibilities to the. patient There is also a legal duty that medicines supplied to patients are of the. nature and quality requested or prescribed, If you choose to prepare unlicensed medicines under this legislation you. should follow the guidance set out in this document. The owner and the superintendent pharmacist are responsible for making sure. that there are systems in place to safeguard the health safety and wellbeing of. patients and the public who use their services This guidance covers the areas. we believe may present an increased risk when medicines are prepared in a. registered pharmacy It will help the owner and superintendent pharmacist to. meet our standards for registered pharmacies, Guidance for registered pharmacies preparing unlicensed medicines. The guidance takes each of the five main principles from the standards for. registered pharmacies and then under each principle highlights areas that. need further consideration in relation to preparing medicines. Principle 1 The governance arrangements safeguard the health safety and. wellbeing of patients and the public, The following areas relate to this principle in the standards for registered. pharmacies Each area is expanded on below and contains the relevant. 1 1 Risk assessment,1 2 Regular audit,1 3 Reactive review.
1 4 Recall procedures,1 5 Accountability personnel. 1 6 Record keeping,1 1 Risk assessment, A risk assessment is a careful and thorough look at what in your work could. cause harm to patients and what you need to do to prevent this The. preparation of medicines is a pharmacy service which could potentially cause. harm and therefore you should carry out a risk assessment to ensure safe. outcomes for patients, Risk assessments should be specific to the individual pharmacy the staff. working in it and to each medicine to be prepared, You should consider the risks before deciding whether your pharmacy should. prepare medicines or whether you might consider other options for supplying. a particular medicine For example you may, thoroughly investigate whether a licensed product exists and is.
available and obtain that or, buy an unlicensed medicine from a reputable source such as an. authorised manufacturer or importer, You should carry out the necessary checks to satisfy yourself that any. arrangements you have in place to manage the risks involved meet the. requirements of principle 1 If you intend to prepare medicines you will need. to be able to produce evidence for the arrangements you have in place to. manage the risks identified for example in the form of a risk assessment. The risk assessment should be reviewed regularly see section 1 2 Regular. audit and should also be reviewed when circumstances change see section. 1 3 Reactive review, You can find more information on managing risk in the GPhC Inspection. Decision Making Framework12 This gives indicators of outcomes in relation to. the standards for registered pharmacies, The risk assessment should state what the risks are and may include finding. out whether an equivalent relevant licensed product exists and is available It. should also include, a formula from a recognised source for example from an official.
pharmacopeia,a method validation,a calculation verification. the use of specialist equipment,consideration of contamination. hygiene measures,product specific risks, assurances around ingredients and starting materials. the suitability of premises,relevant staff skills,training and competence. the circumstances that would trigger a new risk assessment. This is not a complete list of all issues that need to be taken into account. GPhC Inspection Decision Making Framework,1 2 Regular audit.
You should have robust systems in place so that you can demonstrate that. your pharmacy continues to be a safe place in which to prepare. unlicensed medicines for patients and, you can produce medicines which are safe effective and of a suitable. You should carry out a regular audit at an interval that you can demonstrate to. be appropriate on the process of preparing unlicensed. preparing unlicensed medicines January 2014 2 The General Pharmaceutical Council is the regulator for pharmacists pharmacy technicians and registered pharmacies in England Scotland and Wales 3 About this guidance This guidance should be read alongside the standards for registered pharmacies 1 The standards for registered pharmacies aim to create and maintain the right environment both

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