MSOP 1009 Introduction to Law Lectures with Legal Intro PDF

MSOP-1009 Introduction to Legislation and Practical Application for Pharmacists Mr Lea Learning Objectives: To be able to describe the processes involves in making legislation; from recognition of the need for change to making the change happen To know what each...

MSOP-1009 Introduction to Legislation and Practical Application for Pharmacists Mr Lea Learning Objectives: To be able to describe the processes involves in making legislation; from recognition of the need for change to making the change happen To know what each of the following are and what they represent: Green Paper; White paper; Bill; Act Primary legislation, secondary legislation, SI Policy Document Who is responsible for making laws in England? The Legal System: England and Wales Statute law – which has its origins in Parliament and includes criminal law, professional law and administrative law Civil law - about duties towards each other and includes common law and case law Statute Law Criminal law Enforced by the police and other statutory enforcement agencies including the GPhC Inspectorate Includes Medicines Act 1968, Misuse of Drugs Act 2001 Many of the Acts are enabling and require further subsidiary legislation such as regulations rules and statutory instruments to take effect Administrative Law NHS Act 1977 NHS Secretary of State ‘directions’ Professional Law Pharmacy Order 2010 Common Law Either An offence (if not abolished or codified by statute law) Or Tort – non contractual civil wrong Negligence Breach of confidentiality Defamation In relation to the practice of pharmacy we might be concerned with negligence – particularly when we are in a position that we owe a ‘Duty of Care’ to a patient – and issues of confidentiality in relation to the personal data to which the pharmacist and their staff may have access to Criminal vs Civil Law Criminal Case Law for the state/society Law for individuals Reasonableness Reasonable behaviour “Duty of Care” “Duty of Care” Liability not guilt Innocence/guilt Balance of probabilities Beyond reasonable doubt Not written Written by Parliament Judge made law Only Parliament can change Protects the individual Protects the state/society Sue Prosecute – eg CPS/GPhC Compensation Fines/imprisonment Insurable Not insurable Limitations Act applies Limitations do not apply Basic Structure of Courts Supreme Court (since 2009) in England and Wales Criminal Law Civil Law Court of Appeal Court of Appeal Criminal Civil Division Division High Court of Crown Court Justice Magistrates County Court Court In Summary Law Common Law Statute law Case law How are laws made? Policy into practice - elements Stimulus or reason for change Stakeholder engagement Option appraisal Impact assessment Consult on proposals Communications Legislation – primary and secondary Implementation – guidance and support Review Passage of Legislation Green Paper White Paper Bill Act How to Use and Reference Legislation Effectively: Acts Title Have both a long and a short title. The short title is sufficient for quoting and referencing e.g Medicines Act 1968 Numbering Each Act is given a number which denotes the numerical order in which Acts are passed in any calendar year. This number is called a Chapter number (c.) The Medicines Act 1968 c.67 indicates it was the 67th Act published in that year How are acts divided? Acts can be divided into common themes and these are titled Parts. These Parts may be subdivided into chapters (this is less important but helps navigation of the legislation) Sections Acts are subdivided into numbered enactments (topics) these are called Sections. Section 64 of the Medicines Act 1968 is a good example, this Section explains that it is illegal to supply medicines which are not of the nature and quality intended. How to Use and Reference Legislation Effectively: Regulations Each Section is subdivided into subsections Subsection 5 of Section 64 of the Medicines Act 1968 explains that the Section applies to dispensing errors Each subsection can be divided into Paragraphs (which are given a letter) Schedules Acts of Parliament may contain Schedules which are equivalent to appendices and usually explain the contents of a Section in more detail. How to Use and Reference Legislation Effectively: Regulations Regulations Regulations are secondary legislation and are used to implement the requirements of an Act of Parliament Numbering Regulations are Statutory Instruments and have an SI number e.g the Human Medicines Regulations 2012 are SI No. 1916 How are Regulations divided? Regulations can be divided into Parts and Chapters (similar to how Acts are divided) Each numbered division within a set of Regulations is called a Regulation e.g Regulation 214 of the Human Medicines Regulations 2012 requires prescriptions for the sale and supply of POM medicines Regulations are then subdivided into Paragraphs which are numbered and Subparagraphs which have a letter e.g. subparagraph 3a of regulation 214 says that a doctor is an Appropriate Practitioner. A summary of how legislation can be broken down is provided below to help you with reading legislation as you complete your studies Type of legislation Main division (1st level) Subdivision (2nd level) Subdivision (3rd level) Section Subsection Paragraph Act s. 1 s. 1(1) s. 1(1)(a) Article Paragraph Subparagraph Order in Council art. 1 art. 1(1) or para. 1 art. 1(1)(a) Order made by a Article Paragraph Subparagraph Secretary of State art. 1 art. 1(1) or para. 1 art. 1(1)(a) Rule Paragraph Subparagraph Rules rule 1 rule 1(1) rule 1(1)(a) Regulation Paragraph Subparagraph Regulations reg. 1 reg. 1(1) reg. 1(1)(a) The Human Medicines Regulations 2012 Mr A Lea Objectives for this lecture To build a legal knowledge base around the Human Medicines Regulations 2012 and its implications for pharmacists To develop your understanding of prescribing and supply of medicines both privately and within the National Health Service To review the responsibilities of the Pharmacist with regard to the sale of medicines To review the differences between the responsible pharmacist role and supervision. To review the impact of this legislation for pharmacists outside of dispensing and supply Legislation: What do you need to consider Human Medicines Regulations 2012 Medicines Act 1968 You will also need to know about The Medicines (Pharmacies)(Responsible Pharmacist) Regulations 2008 NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 NHS Terms of Service (CONTRACTUAL) Why is this important? Knowledge learnt in year 1 in this module will be essential in year 2 onwards and can be assessed by synoptic assessment We are going to cover the following information relatively briefly as you will be undertaking practical skills in this area in dispensing classes? Prescription forms Labelling Records Drug classification The Human Medicines Regulations 2012 Repeal nearly all of the Medicines Act 1968 (None of the below apply any more)! Sections 2A to 9. Section 89. Section 10(7). Section 91(1). Sections 92 to 103. Sections 11 to 14. Section 108(3) to (5) and (7). Section 15(1) and (2). Section 109(3). Sections 16 to 57. Section 110(3). Section 58(1A), (2) and (3). Section 111(3). Sections 59 to 61. Section 112(7). Sections 115 and 116. Sections 65 and 66. Section 126(4). Section 67(3A), (5) and (6). Section 130(2) to (8) and (10). Section 68. Section 132(2), (3) and (5). Sections 85 and 86. Schedules 1A and 2. In Schedule 3, paragraphs 5 to 7. Legal Classification of medicines Prescription Only Medicines (POM) The Prescription Only Medicines (Human Use) Order 1997 lists POM medication. Restrictions on sale and supply POM medicines can only be supplied to a patient on receipt of a valid prescription from an appropriate practitioner There a 3 LEGAL exceptions to this rule in the Human Medicines Regulations 2012 Exemption from POM status Medicines listed as POM under the 1997 order are exempt if they follow certain conditions Product is below a certain strength Product is in a specified form There is a specified route of administration The product is for specified conditions or limitations The product is sold in a specific quantity Alternatively Some medicines are exempt from POM status if they are sold in pack sizes not exceeding specified quantities. Pharmacy Medicines (P) Pharmacy medicines can be purchased without a prescription Pharmacy medicines can only be purchased from a registered pharmacy Can only be sold under the supervision of a pharmacist General Sales List (GSL) Classification: Restrictions for sale: Can be sold from any lockable premises Pharmacist does not need to be present for sales Must be sold in original packaging Quantities strictly controlled Interestingly GSL medicines can be sold from vending machines Pharmacy Only (PO) Pharmacy only medicines are legally GSL medicines under the Human Medicines Regulations 2012 There is no legally defined class of medicines called Pharmacy Only The medicines are available for self selection The MA or PL for the product stipulates they can only be sold in a pharmacy Supervision is not required Prescription requirements Who can write prescriptions? Prescriptions can only be written by an appropriate practitioner Originally this was limited to Medical Prescribers: Since 2008 his has included Swiss and EEA doctors and dentists. Non Medical Prescribers have also been given the right to write prescriptions but their prescribing rights are limited to varying degrees based on their profession Legal requirements for prescriptions The following requirements apply to both Private and NHS prescriptions. Prescription must be written in ink or otherwise indelible. Prescription must be signed in ink by the practitioner with their own name The prescription must contain the following details: What information isn’t necessary under the Human Medicines Regulations 2012 The following are not required for prescriptions –Patient’s title: Mr, Mrs, Miss, Master –Patient’s postcode –Practitioner’s name in addition to the signature Please note that whilst the information listed above is useful it is not legally required Prescription content… Please note that it is impossible to dispense a prescription without this information NHS prescriptions also require additional information under NHS Regulations Prescription Requirements: In Summary Private NHS Patient Name As Private (not including repeatable, Patient Address Repeatable NHS prescriptions are a different service) Patient age (if under 12) Form Signed by practitioner Strength Practitioner details quantity Date Whether repeatable Indelible ink Labelling and record keeping Labelling medicines for dispensing Regulation 258 and Schedule 25 of the Human Medicines Regulations 2012 give the powers to set labelling requirements Regardless of the classification of the drug the label for an item dispensed by a pharmacy must legally contain... What a label should look like: Legal Losartan What a label should look like: Legal Losartan Take ONE tablet EACH day What a label should look like: Legal Losartan Take ONE tablet EACH day Warnings as necessary What a label should look like: Legal Losartan Take ONE tablet EACH day Warnings as necessary Mr Peter Brown What a label should look like: Legal Losartan Take ONE tablet EACH day Warnings as necessary Mr Peter Brown 05 October 2023 What a label should look like: Legal Losartan Take ONE tablet EACH day Warnings as necessary Mr Peter Brown 05 October 2023 Keep out of the reach of children What a label should look like: Legal Losartan Take ONE tablet EACH day Warnings as necessary Mr Peter Brown 05 October 2023 Keep out of the reach of children Medway School of Pharmacy Central Avenue Chatham Maritime What a label should look like 28 Losartan 50mg Tablets Take ONE tablet EACH day Warnings as necessary Mr Peter Brown 05 October 2023 Keep out of the reach of children Medway School of Pharmacy Central Avenue Chatham Maritime What a label should look like 28 Losartan 50mg Tablets Take ONE tablet EACH day Warnings as necessary Mr Peter Brown 05 October 2023 Keep out of the reach and sight of children Medway School of Pharmacy Central Avenue Chatham Maritime Tel 01634 883150 What your finished label should look like 28 Losartan 50mg Tablets Take ONE tablet EACH day Warnings as necessary Mr Peter Brown 05 October 2023 Keep out of the reach and sight of children Medway School of Pharmacy Central Avenue Chatham Maritime Tel 01634 883150 Labelling medicines for dispensing Pharmacists are legally allowed to add/amend information in certain restricted circumstances Changes limited to the following ONLY: Name of product Directions for use Precautions relating to use THIS DOES NOT MEAN YOU CAN ADD WHAT YOU LIKE This has nothing to do with PC / PNC (contractual) Prescription records and record keeping Private prescriptions must be kept for 2 years Regulations stipulate information required to record Regulations stipulate exemptions from record keeping Chronological order in your prescription book Time limit for keeping old records Prescription Register / Medicines Book Ensure there is sufficient space for the entry EXEMPLAR ENTRY A1/1 Mr Frederick Brown £ 19:98 01/02/23 23 Earls Avenue Medway ME4 4TR 4 Viagra 25mg tablets 1 prn Dr F Hartnell GMC 2345678 The Surgery 1 School Road Medway 17/02/2023 Prescription Register / Medicines Book Step 1 : Record the patients details EXEMPLAR ENTRY A1/1 Mr Frederick Brown £ 19:98 01/02/23 23 Earls Avenue Medway ME4 4TR 4 Viagra 25mg tablets 1 prn Dr F Hartnell GMC 2345678 The Surgery 1 School Road Medway 17/02/2023 Miss Robyn Porter 14 Drovers Way Medway, ME4 8AN Prescription Register / Medicines Book Step 2 : Record the prescription details EXEMPLAR ENTRY A1/1 Mr Frederick Brown £ 19:98 01/02/23 23 Earls Avenue Medway ME4 4TR 4 Viagra 25mg tablets 1 prn Dr F Hartnell GMC 2345678 The Surgery 1 School Road Medway 17/02/2023 Miss Robyn Porter 14 Drovers Way Medway, ME4 8AN 28 Citalopram 20mg tablets 1 OD Prescription Register / Medicines Book Step 3 : Record the prescribers details EXEMPLAR ENTRY A1/1 Mr Frederick Brown £ 19:98 01/02/23 23 Earls Avenue Medway ME4 4TR 4 Viagra 25mg tablets 1 prn Dr F Hartnell GMC 2345678 The Surgery 1 School Road Medway 17/02/2023 Miss Robyn Porter 14 Drovers Way Medway, ME4 8AN 28 Citalopram 20mg tablets 1 OD Dr E Foster GMC 1234567 Central Surgery, 24 Bredgar Close Medway Kent Prescription Register / Medicines Book Step 4 : Record the date on the prescription (even pharmacists forget to do this!) EXEMPLAR ENTRY A1/1 Mr Frederick Brown £ 19:98 01/02/23 23 Earls Avenue Medway ME4 4TR 4 Viagra 25mg tablets 1 prn Dr F Hartnell GMC 2345678 The Surgery 1 School Road Medway 17/02/2023 Miss Robyn Porter 14 Drovers Way Medway, ME4 8AN 28 Citalopram 20mg tablets 1 OD Dr E Foster GMC 1234567 Central Surgery, 24 Bredgar Close Medway Kent 26/09/2023 Prescription Register / Medicines Book Step 5 : Record the date prescription supplied to the patient (don’t make entries early!) EXEMPLAR ENTRY A1/1 Mr Frederick Brown £ 19:98 01/02/23 23 Earls Avenue Medway ME4 4TR 4 Viagra 25mg tablets 1 prn Dr F Hartnell GMC 2345678 The Surgery 1 School Road Medway 17/02/2023 Miss Robyn Porter 02/10/2023 14 Drovers Way Medway, ME4 8AN 28 Citalopram 20mg tablets 1 OD Dr E Foster GMC 1234567 Central Surgery, 24 Bredgar Close Medway Kent 26/09/2023 Prescription Register / Medicines Book Step 6 : Create an entry number for audit purposes (record on RX and label too!) EXEMPLAR ENTRY A1/1 Mr Frederick Brown £ 19:98 01/02/23 23 Earls Avenue Medway ME4 4TR 4 Viagra 25mg tablets 1 prn Dr F Hartnell GMC 2345678 The Surgery 1 School Road Medway 17/02/2023 A1/2 Miss Robyn Porter 02/10/2023 14 Drovers Way Medway, ME4 8AN 28 Citalopram 20mg tablets 1 OD Dr E Foster GMC 1234567 Central Surgery, 24 Bredgar Close Medway Kent 26/09/2023 Prescription Register / Medicines Book Finally: Record the price charged for the prescription. (It MUST NOT be excessive!) EXEMPLAR ENTRY A1/1 Mr Frederick Brown £ 19:98 01/02/23 23 Earls Avenue Medway ME4 4TR 4 Viagra 25mg tablets 1 prn Dr F Hartnell GMC 2345678 The Surgery 1 School Road Medway 17/02/2023 A1/2 Miss Robyn Porter £ 3.60 02/10/2023 14 Drovers Way Medway, ME4 8AN 28 Citalopram 20mg tablets 1 OD Dr E Foster GMC 1234567 Central Surgery, 24 Bredgar Close Medway Kent 26/09/2023 Licensing, manufacturing and quality assurance Human Medicines Regulations 2012 Manufacturers must Manufacture their medicines using methods that comply with the marketing authorisation Maintain and demonstrate quality standards Label their products to a specified standard Provide patient information leaflets with their products What sort of license is necessary? Marketing Authorisation Manufacturers Licence Product licence (parallel importing) Wholesale dealing licence Marketing Authorisation (MA) Marketing Authorisations were previously called Product Licences The MHRA must consider a number of factors prior to issuing an MA Safety Efficacy Quality Manufacturer’s/importer’s licence (MIA) Manufacture or package medicinal products Trade licenced medicinal products imported from non EEA countries by wholesale When issuing licences the following are considered Premises, equipment and processes Equipment Skills and qualifications of those involved in manufacture Storage conditions Parallel Import licences (PI) Those wishing to import medicines to the UK from within the EU require a parallel Import Licence The product must have a Marketing Authorisation in another EU state Divided into three categories Simple Standard Complex Manufacturer 'specials' licence (MS) License allows the holder to manufacture unlicensed medicinal products These are more commonly known as 'specials’ Examples include Martindale and BCM Licence also allows the import of unlicensed medicinal products from outside the EEA Examples include Clinigen Wholesale dealing licences (WL /WDL) Holders of Wholesale Dealers Licence (WL) may buy and sell by wholesale Pharmacy Medicines (P) Prescription Only Medicines (POM) General Sale List (GSL) Medicines and Some herbal medicines Holders of a Wholesale dealer (GSL) licence (WDL) may buy and sell by wholesale General Sale List (GSL) medicines only Wholesale dealing licences (WL /WDL) Holders of Wholesale Dealers Licence (WL) may buy and sell by wholesale Pharmacy Medicines (P) Prescription Only Medicines (POM) General Sale List (GSL) Medicines and Some herbal medicines Holders of a Wholesale dealer (GSL) licence (WDL) may buy and sell by wholesale General Sale List (GSL) medicines only Quality assurance The Human Medicines Regulations 2012 requires manufacturers to maintain the quality of the medicinal products it produces. Maintaining staff, premises and equipment effectively Ensuring handling, storage and distribution safety Quality control and qualified persons undertaking qualitative and quantitative analysis of substances and products Must comply with the Good Manufacturing Practice directive Labelling medicines All medicinal products (EXCEPT DISPENSED MEDICINES) must have the following information on their label. Product name Formulation Quantity of product Strength Any active excipients Route of administration Keep out of reach of children Labelling medicines Handling conditions Storage conditions Expiry date Warnings required by the marketing authorisation How to dispose of safely Name and address of licence holder (PL or MA) MA or PL number Batch number Instructions on how to take if self medicating Labelling medicines Blister packed medicines In addition to the information on the package the container must contain the: Product name Name of the holder of the Marketing Authorisation Expiry date Batch number Labelling medicines Small containers such as eye drop bottles If a container is too small to include all the required labelling information an abbreviated label may be used which must include Product name Method of administration Quantity of product Batch number Expiry date The outer package must contain the full labelling requirements Patient information leaflets The Human Medicines Regulations 2012 sets regulations regarding leaflets. Patient information leaflets (PIL) significantly differ between manufacturers, but should contain Identification of the medicinal product Therapeutic indications Any necessary instructions for use Side effects What to do in an emergency Reference to the expiry date Date of last revision Other issues to consider What is supervision? Human Medicines Regulations 2012 The sale or supply of POM and P medicines must be supervised by a pharmacist The definition of supervision depends on the task undertaken Examples of Case law include, Roberts v Littlewoods (1943) ,RPSGB v Boots (1953) Reclassification of medicines POM - P Medicine is not likely to present a danger to human health if used correctly Medicine is not likely to present a danger to human health if used incorrectly Has been used as a POM medicine safely without unusual side effects requiring investigation by the MHRA or EMEA Medicine is not an injection www.MHRA.org.uk Switching from POM to P: What is involved? Manufacturer wishing to market a POM as a P medicine submits all data held by them to the MHRA MHRA assesses the proposed product against a range of standards Consultation time to determine whether the product is desirable or necessary MHRA grants licence if information provided is satisfactory License states strict conditions to allow product to be sold as a P medicine. POM to P switches why are they important First POM to P switch was Ibuprofen in 1983 POM to P switches give pharmacists the opportunity to supply genuinely effective treatments over the counter POM to P switches also require pharmacists to remain competent and up to date POM to P switches create a significant amount of press attention, errors by pharmacists and their staff are amplified Key POM – P switches 1983 Ibuprofen tablets 1987 Hydrocortisone 1% topical 1991 Nicotine gum 2mg 1992 Antifungal products 1993 Non drowsy antihistamines 1994 H2 antagonists 2000 Domperidone 2001 Levonorgestrel 2005 Chloramphenicol eye drops 2008 Azithromycin 2017 Atorvaquone (Antimalarial) 2018 Sildenafil (Viagra) www.pagb.org.uk Switching from P to GSL Before a P medicine is reclassified as a GSL medicine the Minister for health under guidance from the MHRA must be satisfied The medicine does not pose a risk to the public and Can be sold safely without the need of pharmacist supervision and advice Good example Aciclovir POM → P 1993 P → GSL 2004 Offences under the Human Medicines Regulations 2012 and the Medicines Act 1968 Improper use of restricted titles Failure to correctly label a medicine* Sell or supply any medicinal product not of the nature or quality demanded Failure to provide an appropriate patient information leaflet ‘Loaning’ POM medication Purchasing medicines from unlicensed wholesalers Sale and supply of certain unlicensed medicines Adulteration of medicines Failure to identify the responsible pharmacist Repeat Prescribing, Repeat Dispensing, Supplies without a prescription Repeat Prescribing Private NHS Prescriber can specify how many times the Repeat prescribing request form prescription can be repeated Attached to patients Rx Has to be dispensed once within 6 months Patient ticks off which items needed Repeats can be collected as required Given to doctor or pharmacy provided still clinically relevant New prescription produced by doctor Wording determines how many times Patient collects Rx from doctor or pharmacist something can be dispensed So how does that work in practice? Repeat dispensing An essential service of the pharmacy contract You are required to offer it Available in electronic and paper format (electronic most popular) Pharmacy Staff must: dispense repeat dispensing prescriptions received ensure that each repeat supply is required and appropriately timed seek to ascertain that it is safe for the patient to take Repeat Dispensing Suitable for Not suitable for Regular medication Changing medication Stable condition Patients with dose changes Regular patients Certain controlled drugs Patients who don’t use a regular pharmacy How long is the prescription valid for? Valid for 12 months provided dispensed for first time within 6 months No limit of the number of batches that can be supplied Majority of supplies are for 6 months More than 12 batches can be issued if the dispensing interval is less than monthly. What do you need to consider when dispensing? If using paper, the patient must bring you the RA and the RD forms Must be kept safe, best kept in pharmacy For paper and electronic Batch forms should be dispensed in order Patient should be advised when to return for next supply Patient should be advised when medicine is due to run out. Emergency Supplies Emergency supplies: Relevant legislation Emergency supplies are allowed to be made by a registered Pharmacist from registered premises under the Human Medicines Regulations 2012 The regulations set out The types of practitioner who are entitled to order an emergency supply The conditions in which a patient may legally be supplied with a medicine at their own request Record keeping requirements that are expected for such an emergency supply Emergency Supplies Can be requested by a patient Can be requested by the following practitioners Doctor, supplementary prescriber, community practitioner nurse prescriber (CN), nurse independent prescriber, optometrist independent prescriber or pharmacist independent prescriber, Dentist Doctors and Dentists from EEA or Switzerland Patients whose Doctor or Dentist practises in an EEA country or Switzerland can request emergency supplies Emergency Supplies (Practitioner) Pharmacist must be satisfied that the practitioner is unable to supply a prescription immediately. The practitioner has agreed to supply a prescription within 72 hours The product is supplied in accordance with the directions of the practitioner Emergency Supplies (Practitioner): Record keeping The pharmacist making the supply must record in the prescription register: Date of supply Prescription details Name and address of practitioner Name and address of patient The date on the prescription The date the prescription was received Emergency Supplies (Patient) The pharmacist must be satisfied that: There is an immediate need to supply The medicine has been supplied before on a prescription by a qualified practitioner That the dose and instructions are appropriate to the condition The pharmacist is also restricted to giving a maximum of: (with some exemptions) –30 days supply for POM –5 days for phenobarbitone for epilepsy and Schedule 4 and 5 controlled drugs The pharmacist is also required to make records of any such supply Emergency supplies (Patient): Record keeping Labelling Date of supply Date of supply Details of medicine supplied Details of medicine supplied Name and address of person requesting the Name of person requesting supply medicine Name and address of the pharmacy The nature of the emergency The words ‘emergency supply’ The words ‘keep out of reach of children’ (or other similar wording) What happens during a pandemic? What Happens During a Pandemic? Under the Human Medicines Regulations 2012 the sale or supply of medicines can be relaxed in the anticipation of or in the event of a pandemic This includes Legal requirements for sale and supply of POM, P and GSL medicines Pharmacists supplying medicines against a protocol issued by government ministers or specified government agencies Pharmacists supplying emergency supplies without interviewing the patient  Emergency Supply: Ethical dilemma You are the pharmacist in charge of a busy high street pharmacy. It is a busy Thursday morning at about 10:00. A patient comes in and asks for an emergency supply of a ‘ventolin’® MDI inhaler. They are not wheezing or in distress, they show you a repeat slip to prove that they use the inhaler. The repeat slip indicates that they haven’t requested the inhaler for 4 months and are due a review with the asthma nurse. The patient is willing to pay, They have before! (£4.10) What do you do?