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Report CopyRight/DMCA Form For : Preparing Unlicensed Medicines V28 Final
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 medicines The audit. should form part of the evidence which provides assurance and demonstrates. that the pharmacy continues to be safe and appropriate to carry out this. While this is not a full list of issues that need to be taken into account the. audit should look at the, premises including temperature light and moisture controls and where. applicable for example in aseptic preparation air quality and other. environmental requirements,equipment and facilities. quality controls the preparation process, hygiene issues including avoiding cross contamination and microbial. contamination,staff training and skills, records including the method of preparation traceability of ingredients. used labelling applied and how the records themselves are kept. Also any incidents and complaints should be reviewed and reported if this is. appropriate,1 3 Reactive review, A review should take place when any of the following happens. changes in key staff those who have specialist training knowledge and. experience and are involved in preparing medicines. the introduction of new staff,a change in the equipment. a change in the form or source of ingredients,any incidents. the environment or facilities available are no longer fit for the task. concerns or feedback received, a review of near misses and error logs indicates concerns about this. This reactive review should say when a new risk assessment is needed It can. form part of that new risk assessment when one needs to be carried out. Concerns feedback near misses and errors should be documented taken into. account and should be acted on to improve safety,1 4 Recall procedures. As well as having policies and systems for handling complaints under the. standards you must raise concerns when you suspect that medicines are not fit. for purpose You should have systems in place so that you can demonstrate. that you can effectively manage an appropriate response and take action. where there may be a problem with an unlicensed medicine you have. If there is a problem with an unlicensed medicine that you have prepared you. should have systems in place to be able to contact members of the public and. recall unlicensed medicines that you have made for them. These procedures should include who is responsible for taking action and how. that is to be carried out It should also include details of the other bodies or. authorities that need to be told about the product s recall. Any problems that may have occurred during the preparation of the product. may only become apparent later Or there may be a problem with one of the. ingredients or starting materials used obtained from a supplier and this may. only be discovered later,1 5 Accountability personnel. Under the standards you must make sure that there are clear lines of. accountability for staff providing pharmacy services. It should be clear which pharmacist is accountable for the preparation of an. unlicensed medicine Records that show which pharmacist is accountable for. supervising the preparation of each medicine or batch of medicines should be. made and kept for an appropriate time, It should also be clear which pharmacy technician and which other personnel. are involved in preparing an unlicensed medicine Records that show which. pharmacy technicians or other members of staff were involved in the. preparation of each medicine or batch of medicines should be made and kept. for an appropriate time,1 6 Record keeping, You should keep detailed records of the preparation of the medicine to. safeguard patients Records should contain enough detail to make sure that if. there is a recall or an incident affecting a patient s safety the method of. preparation can be clearly reconstructed You should keep records for as long. as you consider and can demonstrate to be appropriate Ask the pharmacy s. professional indemnity insurance provider for advice about how long records. should be kept for, The records should include information on the following. The process Description of the key preparation steps used. Calculations working shown and double checked,The name of the supervising pharmacist. The name of the pharmacy technician involved if,applicable. The names of other personnel involved if applicable. The quality assurance or testing process used,Environmental factors For example temperature and. moisture conditions,The formula The complete formula. The source of the formula pharmacopeia formula or other. validation, The ingredients The source manufacturer brand and the wholesaler or. For each ingredient or,starting material used,distributor. Certificate of conformity if applicable,Certificate of analysis if applicable. Batch number,Expiry date, Quantity used and details of the person measuring and. person double checking quantities, TSE guidance13 should be followed if applicable that is. where an ingredient is of animal origin, Description of the container and closure used For example. whether they were glass or plastic,The product Date prepared. A reference number or identification,Expiry date give reasons. Date supplied to the patient or customer,The patient or The patient or customer s name. customer The patient or customer s address, The patient or customer s contact details for example. phone number email address, Also if supplied The patient s doctor name address and phone number. against a The patient s age if it is on the prescription. prescription Other prescription details date and type. A sample of the label that has been put on the medicine. The TSE guidance is the MHRA guidance Minimising the Risk of Transmission of Transmissible Spongiform. Encephalopathies via Unlicensed Medicines for Human Use See the Other sources of information section at.
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