UK Law Topics PDF

Law topics ○ UK legal system UK law Primary Legislation Definition: Primary legislation refers to laws made directly by Parliament through Acts of Parliament (also known as statutes). It forms the core legal framework in the UK. Key Features: 1....

Law topics ○ UK legal system UK law Primary Legislation Definition: Primary legislation refers to laws made directly by Parliament through Acts of Parliament (also known as statutes). It forms the core legal framework in the UK. Key Features: 1. Process: ○ A bill is proposed in Parliament. ○ It goes through multiple readings and stages in both the House of Commons and the House of Lords. ○ Once approved, it receives Royal Assent and becomes law, and difficult to change 2. Examples: ○ Poisons Act 1972 ○ Misuse of Drugs Act 1971 ○ Medicines Act 1968 3. Authority: ○ Primary legislation is the highest form of law and cannot be overridden by secondary legislation. Secondary (Delegated) Legislation Definition: Secondary legislation, also known as delegated legislation, is law made by an individual or body under powers given to them by an Act of Parliament (primary legislation). Types of Secondary Legislation: Statutory Instruments (SIs): ○ Most common form, used for detailed rules or administrative changes. ○ Example: Misuse of Drugs Regulations 2001 (issued under the Misuse of Drugs Act 1971). ○ Usually initiated by Delegated authority (e.g., ministers) ○ SI becomes law after laying on the table for 3 days Importance: Allows Parliament to focus on broader principles while delegating detailed or technical issues. Both the Act and SI together form the Stautary law Examples in pharmacy: ○ Changes in drug schedules under the Misuse of Drugs Regulations. ○ Updates to labeling rules under the Medicines Act. Parliamentary Oversight: Affirmative Procedure: Requires active approval by Parliament.  Negative Procedure: Becomes law unless Parliament objects within a set time. Judicial Precedent (Case Law) Definition: Judicial precedent, or case law, refers to decisions made by courts that set a legal standard or principle for future cases with similar facts. Key Principles: 1. Stare Decisis ("to stand by things decided"): ○ Courts must follow legal principles established by higher courts in previous cases. ○ Promotes consistency and fairness in the application of the law. 2. Hierarchy of Courts: ○ Decisions of higher courts bind lower courts. ○ Supreme Court (highest authority) decisions are binding on all lower courts. ○ Court of Appeal and High Court decisions are binding on courts below them. Types of Precedent: 1. Binding Precedent: ○ Must be followed if the facts and legal principles of the earlier case are similar. 2. Persuasive Precedent: ○ Not binding but may influence decisions (e.g., decisions from other jurisdictions or lower courts). Case Law in Pharmacy: Bolam v Friern Hospital Management Committee (1957): ○ Established the "Bolam test," which assesses professional negligence. Montgomery v Lanarkshire Health Board (2015): ○ Highlighted the duty of care to inform patients of risks. Criminal law: Relationship between an individual and the state and relates to the regulation of human behaviour. Civil law: Relationship between individuals and relates the conduct of human relationships European law: Primary law/ treaties > secondary legislation = regulation + directives (these are the SIs in the UK) + decisions Free movement: ○ Free Movement of Goods ○ Free Movement of Persons- Free movement of healthcare professionals eg pharmacists qualifying in the EU countries can work in the UK ○ Free Movement of Services ○ Free Movement of Capital ○ Intro to pharmacy law; POMs: Rx-ers, Rx's, POM records; legal classifications P & GSL; RP Public protection achieved in 2 ways 1. Restricting public access to poisons and potent drugs and medicines, thus preventing their use for criminal purposes, self medication and gratification of addiction  2. Ensuring the purity, potency and efficacy of medicines by controlling all stages of the manufacture, distribution and sale Pharmacy Law: Medicines Medicines Act 1968 ○ controls medicinal products at all stages ○ Veterinary Medicines Regulations 2013 ○ Human Medicines Regulations 2012 Misuse of Drugs Act 1971 ○ controls drugs and medicines which are addictive or misused Poisons Act 1972, as amended by Deregulation Act 2015 ○ controls poisons Health Act 2006 ○ Supervision and management of controlled drugs ○ Supervision → Responsible Pharmacist Health Act 1999 ○ Directs the General Pharmaceutical Council (GPhC) ○ Controls the pharmacy profession- Pharmacists & pharmacy technicians 1. Medicinal Product Any substance used to treat, prevent, or diagnose disease or modify physiological functions through pharmacological, immunological, or metabolic action. Can also be used for medical diagnosing. 2. Authorised Product A medicinal product with a valid marketing authorisation or approval (e.g., for safety, quality, and efficacy). If product has: ○ Marketing authorisation → medicines ○ Certificate of registration → homeopathics ○ Traditional herbal registration → herbal remedies 3. Relevant Medicinal Product A medicinal product regulated under HMR 2012, requiring a marketing authorisation and subject to pharmacovigilance rules. Not herbal or homeopathic. 4. Borderline Substances Definition: Products difficult to distinguish from medicines, such as cosmetics, food supplements, or herbal products. Criteria for Being Regarded as Medicinal: ○ Contains a pharmacologically active substance. ○ Makes medicinal claims, including: Treating or preventing disease. Affecting normal physiological functions in the human body. 5. Medicinal Purpose Includes treating, preventing, or diagnosing disease, contraception, anaesthesia, or altering physiological functions. 6. Administer  Giving or applying a medicinal product orally, by injection, or externally. 7. Medical Devices: Summary Definition: Instruments or products used for diagnosing, treating, preventing, or monitoring disease or injury, without acting pharmacologically. Examples: ○ Class I (Low Risk): Bandages, thermometers. ○ Class III (High Risk): Pacemakers, implantable devices. Regulation: ○ Governed by Medical Devices Regulations 2002. ○ UKCA marking replaces CE marking post-Brexit. Requirements: ○ Must meet safety and performance standards. ○ Labeling, certification, and adverse incident reporting to MHRA are mandatory. Key Difference from Medicines: Devices act physically or mechanically, not pharmacologically. Clinical Trial Authorisation (CTA): Phase 1: ○ Participants: 20–80 people. ○ Purpose: Evaluate safety, determine safe dosage, and identify side effects (S/E). Phase 2: ○ Participants: 100–300 people. ○ Purpose: Assess effectiveness and further evaluate safety. Phase 3: ○ Participants: 1,000–3,000 people. ○ Purpose: Confirm effectiveness, monitor S/E, compare to existing treatments, and gather data for safe use. Phase 4: ○ Post-Marketing Studies: Collect additional data on risks, benefits, and optimal use after the drug is marketed. Prescription-Only Medicines (POMs) Definition: Medicines that can only be sold or supplied with a valid prescription from an authorized prescriber. Medicinal products are usually designated as POM if: ○ Medical supervision is required in use to prevent (in)direct damage to human health ○ It is widely and frequently misused and presents a danger to health or ○ It is a new active substance or ○ It is for parenteral administration Authorized Prescribers (Rx-ers): Independent Prescribers Who: Doctors, dentists, pharmacist independent prescribers, nurse independent prescribers, some EEA health professionals, and others with restricted prescribing rights. Definition: Prescribing by practitioners responsible and accountable for assessing patients (diagnosed or undiagnosed) and managing their clinical care, including prescribing. Supplementary Prescribers Who: Pharmacists, midwives, nurses, chiropodists, podiatrists, paramedics, physiotherapists, radiographers, optometrists, and dietitians. Definition: Can prescribe within a patient-specific clinical management plan (CMP) for specific conditions. Works collaboratively with an independent prescriber (doctor or dentist) and with the patient’s agreement.  Community Practitioner Nurse Prescribers Who: Nurses specializing in community care. Prescribing Rights: Limited to dressings, appliances, and licensed medicines listed in the Nurse Prescribers' Formulary (NPF). EEA Health Professional Who: A person in a European Economic Area (EEA) country or Switzerland who is: ○ Doctor of medicine ○ Nurse responsible for general care ○ Dental practitioner ○ Midwife ○ Pharmacist Registration: Must be registered to practice in an EEA country or Switzerland. Prescriptions by EEA Health Professionals Validity: Prescriptions issued in an EEA country (excluding the UK) or Switzerland are legally valid in the UK. Restrictions: Cannot prescribe Controlled Drugs (CDs) in Schedules 1–3. Guidance: Use professional judgment when dispensing. Prescriptions (Rx's) Types of prescription (Rx) 'Health Rx' = NHS ○ National Health Service ○ Rx charge - England only Private Rx ○ Patient pays full cost (drug & dispensing fee) ○ May get reimbursed if have private medical insurance Legal requirements for a valid prescription: Signature: ○ Must be signed in ink by the prescriber or authorized with an advanced electronic signature for electronic prescriptions. Prescriber’s Address: ○ Must include the prescriber’s address. Date: ○ Valid for 6 months from the appropriate date. 28 days for CDs Schedule 2,3 & 4 ○ For NHS prescriptions, the appropriate date is the later of: The signing date, or A specified date for dispensing. For private prescriptions, the appropriate date is the signing date. Particulars of Prescriber: ○ Must indicate the type of prescriber (e.g., doctor, dentist). Patient Information: ○ Name and address are required. ○ Age must be included if the patient is under 12 years Repeatable Prescriptions (Private Prescriptions Only) ○ A repeatable prescription allows medicines to be dispensed more than once. ○ The prescription must be dispensed for the first time within 6 months  ○ Repeat Instructions: Must explicitly state the number of times the medicine can be repeated (e.g., "repeat x3"). ○ If no number is specified: Non-controlled drugs can be repeated once (dispensed twice in total). Unless it is an oral conteaceptives which are repeatable 5 times (dispensed 6 times) within 6 months ○ Once a repeatable Rx has been dispensed once within a 6 month period, there is no time period in which Rx must be repeated (unless Rx-er specified otherwise) Where Rx is for CDs - 28 days ○ Controlled Drugs: Schedule 2 and 3 CDs cannot be repeated. Schedule 4 and 5 CDs can be repeated as per the prescriber’s instructions EEA/Swiss Rx written in a foreign language ○ Rx still valid ○ Provided pharmacist has enough information to enable safe supply and Rx compliant with legal requirements Dental Prescriptions Legal Basis: 1. Under the Medicines Act 1968 and HMR 2012, dentists can prescribe any POM. Recommendations: 1. General Dental Council (GDC): Dentists should prescribe only within their area of competence (dentistry-related drugs). NHS Dentists: 1. Restricted to drugs in the Dental Practitioners Formulary (DPF). Faxed Prescriptions Legality: ○ Not legally valid; lacks indelible ink and a signature from the prescriber. Usage: ○ Can confirm the existence of a valid prescription at the time of receipt. Legal Alternative: ○ Emergency Supply: Allowed at the request of the prescriber if all emergency supply conditions are met. Electronic Prescriptions (EPS) Definition: ○ Enables prescribers (e.g., GPs, practice nurses) to send prescriptions electronically to a dispenser (e.g., pharmacy). Validity: ○ Must be signed with an advanced electronic signature. ○ Since June 2015: Schedule 2 & 3 CDs can be sent electronically via EPS. Advanced Electronic Signature: ○ Uniquely linked to the prescriber. ○ Capable of identifying the prescriber. ○ Detects any subsequent changes to the prescription. POM Records Pharmacy records for sale/supply of POM A person lawfully conducting a retail pharmacy business must, in respect of every sale or supply of a prescription only medicine, make or cause to be made an entry. Except if:- ○ a) Rx is:  a 'health' (NHS) Rx or a Rx for oral contraceptive ○ b) a separate record is kept in the CD Register ○ c) sale is by way of wholesale dealing and order/ invoice (or copies) relating to sale is retained for 2 years Private Rx's & signed orders Record keeping of POM prescriptions Must be retained for 2 years ○ From date on which POM was supplied or sold ○ or in the case of a repeatable prescription, the date on which the last supply was made Exemptions: ○ 'health' (NHS) prescriptions → sent off for pricing ○ Private Rx for CD Schedule 2 & 3 → sent off ○ NB. Exemption does NOT apply to Rx for oral contraceptive Labelling Requirements and Practices for Dispensed Medicines Mandatory Labelling for Dispensed Medicines 1. Legal Requirements: ○ Patient’s name. ○ Supplying pharmacy’s name and address. ○ Date of dispensing. ○ Name of the medicine. ○ Directions for use. ○ Precautions (e.g., "For external use only"). 2. RPS Recommendations: ○ "Keep out of the reach and sight of children." ○ "Use this medicine only on your skin" (where applicable). ○ For secure environments: Include prisoner numbers as identifiers. Labelling Practices Label the actual container (e.g., inhaler, cream tube) rather than the outer container, per National Patient Safety Agency guidelines, to avoid loss of important information. Pharmacists can modify directions, medicine names, or precautions on labels if deemed inappropriate, without consulting the prescriber. This requires professional judgment and a clinical audit trail. Assembly and Pre-Packing Medicines Pre-packing for a different legal entity (e.g., NHS Trusts) requires an MHRA license: ○ Manufacturer’s/importer’s license (MIA). ○ Manufacturer’s ‘specials’ license (MS). Contact MHRA for specific guidance. Labelling for Medicines Broken Down from Bulk Containers When dispensing smaller quantities from bulk: ○ Include the medicine name, quantity, ingredients, storage instructions, expiry date, and batch reference number. ○ Upon dispensing, follow usual labelling requirements. POM Register A POM Register must include: ○ Date of supply.  ○ Name, quantity, formulation, and strength of the POM supplied. ○ Recipient’s name, address, trade, business, or profession. ○ Purpose of the supply. ○ Prescribers details Records must be kept for 2 years. Legal Classifications POM (Prescription-Only Medicines): Restricted to prescription. P (Pharmacy Medicines): Sold under pharmacist supervision. Without prescription GSL (General Sales List): Sold without pharmacist supervision in general stores. Drug Kardex- Hospital prescription POM supply in hospitals: ○ Patient Specific Direction (PSD) ○ POM may be supplied against a written direction (PSD) of a prescriber, instead of a prescription ○ The requirements specified for prescriptions are not required, but any 'written direction to supply' must be patient specific with their name (and hospital number for identification) ○ Given by appropriate practitioner ○ permits sale or supply against a patient's bed card (drug kardex/ chart) or patient notes directions to administer Administration of POM in hospital: ○ Directions do not need to be in writing- But good practice ○ Some hospitals formulate policies for administration of POM without written direction Emergency - requiring 2 nurses checking one another Routine administration of POMs (& P & GSL) Should be carefully considered and agreed Pharmacy (P) Medicines Not a POM or GSL they are covered by an authorisation which says it is only available from a pharmacy In order to sell P medicines ○ Premises = GPhC registered pharmacy ○ The medicines are kept behind the ocunter ○ Responsible Pharmacist must have taken responsibility for safe & effective running Person selling/ supplying needs to be: ○ a pharmacist, or ○ acting under supervision of pharmacist (pharmacist physically present, able to intervene & advise) Medicinal products that are to be available only from a pharmacy ○ Anthelmintics (worm medication) ○ Parenterals ○ Enemas ○ for use wholly or mainly for irrigation of: wounds, or bladder, vagina or rectum ○ Aloxiprin or aspirin for administration to children* Counter prescribed medicines ○ Pharmacist may be requested by a customer to 'make up' a medicinal product for treatment of a condition ○ Pharmacist uses own judgement as to treatment required ○ Person who requires the medicine is present in pharmacy ○ Such counter prescribed medicines are regarded as P medicines (even if contents are all GSL) ○ NB. POM cannot be counter prescribed Pharmacy medicines and dispensing ○ P medicines can be prescribed - private & NHS  ○ All Rx's for P medicines must be dispensed by, or under the supervision of, a pharmacist ○ In the dispensing context, all GSL are considered to be P medicines General Sales (GSL’s): A product that is not POM or P but is a product that is covered by a Marketing Authorisation which states the product is to be available on general sale GSL medicines are licensed products which can be sold/supplied with reasonable safety otherwise than by, or under the supervision of, a pharmacist A medicinal product may be included in more than one legal classification depending on certain conditions Reclassification procedure: ○ Legal status is part of its market authorisation = individual product ○ rather than by active substance listed in secondary legislation) All GSL products can be sold in ○ Retail pharmacies ○ Other retail shops ○ Automatic machines They have to be kept in a place that can be locked up so you cannot sell GSL’s in open fields etc. GSL - if sold from a retail pharmacy ○ Responsible pharmacist (RP) must be in charge of premises ○ RP does not need to be supervising or physically present Paracetamol & aspirin- (non-effervescent) tablets / capsules up to 500mg ○ Up to 16 tabs/caps - GSL ○ 17-32 tablets/caps - P ○ Not more than 100 tablets or capsules can be sold to a person at any one time Prescriptions can be written for GSL products ○ Unless blacklisted (NHS sign with cross on it) ○ All prescriptions require a legal and clinical check by a pharmacist ○ NHS prescriptions must be written in accordance with NHS regulations ○ Private prescriptions for GSL’s do not need to be signed or dated ○ If dispensed, labelling requirements for dispensed medicines apply Pharmacy Only medicines (PO): NOT a legal classification in the HMR 2012 PO is a product licensed as a GSL medicine, but restricted to sales through pharmacies only RP must be appointed ('signed on') The sale does not need to be supervised by a pharmacist PO medicines may be available by self-selection PO medicines are restricted by the terms of their licence or by the manufacturer Deregulation in Pharmacy Reclassification of Medicines: ○ Medicines may be moved from POM (Prescription-Only Medicine) to P (Pharmacy Medicine) or GSL (General Sales List) categories. ○ Aim: Increase accessibility for patients while maintaining safety. ○ Can go the other as well. Responsible pharmacist Every registered pharmacy must have a designated RP to ensure compliance with legal and professional standards. Responsibilities: ○ Display a notice showing the RP’s name and registration number. ○ Maintain the pharmacy record for legal and regulatory compliance. ○ Ensure safe and effective pharmacy operations.  The Health Act 2006 made changes to personal control and supervision requirements - as in Medicines Act (MA) Replaces 'personal control' with 'responsible pharmacist' Sets out statutory duty of responsible pharmacist (RP) ○ to secure the safe and effective running of the pharmacy - in relation to the sale & supply of all medicines Enables ministers to make regulations covering the ability of RP to be absent from the pharmacy Responsible pharmacist (RP) ○ Person in charge of particular registered pharmacy premises when it is open for business. ○ RP can be employed or locum pharmacist ○ One pharmacy- one RP ○ Absence from the Pharmacy Responsible Pharmacist may be absent from the pharmacy for a maximum of 2 hours (in 24 hours) In order to be absent, RP must: Remain contactable, be able to return with reasonable promptness, If this is not possible another pharmacist must be available to provide advice (does not have to be on pharmacy premises) ○ Display Notice: The RP’s name and registration number. Statement confirming their role as the RP ○ Responsible Pharmacist must record: Their name and registration number Date and time at which RP: became RP and ceased to be RP Can be electronic, in writing or both Pharmacy owner/ SI must keep record for 5 years Daily record, Continuous, e.g. sign in Mon am, sign off Fri / Sat pm Identify who has made alterations to either paper or electronic record ○ In relation to their absence from the pharmacy Date of absence Time at which absence commenced Time at which they returned (Reason* - not legally required, but may be good practice) Superintendent pharmacist (SP) ○ Person who has oversight responsibilities across whole of retail pharmacy business (no matter how many pharmacies owned ○ SP has responsibilities 24/7 ○ Role only exists for bodies corporates (not partnerships or sole traders) ○ New requirement that superintendent has to be senior manager who has authority to take decisions about certain matters relating to sale and supply of medicinal products ○ Restriction preventing SPs from being superintendent of more than one pharmacy business is removed, as is requirement to have a SI as member of board Pharmacy Procedures (SOPs) ○ Need to cover: ○ Arrangements to secure that medicines are ordered, stored, prepared, sold, supplied, delivered & disposed of in safe & effective manner ○ Giving advice on medicines by non-pharmacist staff ○ Identify pharmacy staff competent to undertake specific activities ○ Record keeping RP, supervising + physically present ○ Professional check (clinical & legal) of a Rx ○ Sale/supply of P medicines ○ Sale/supply of POM medicines Incl. handing over to pt, pt rep, delivery person ○ Supply of medicines under PGD ○ Emergency supply at request of patient or healthcare professional RP, supervising but not requiring physical presence ○ Assembly process (incl. MDS) Generating dispensing label Taking medicines off shelves  Assembly of item (incl. counting tablets) Labelling of containers with dispensing label Accuracy checking RP, but not requiring supervision ○ Sale of GSL meds ○ Processing waste stock medicines or patient returned meds (excl. CDs) RP not required ○ Ordering stock form pharmaceutical wholesaler's ○ Receiving stock (excl. CD) ○ Putting away onto shelves (excl. CD) ○ Date checking (excl. CDs) ○ Accessing the PMR ○ Receiving Rx's directly from patient or collecting from surgery ○ Delivery person conveying meds to patient ○ Regulation of medicines: marketing authorisations, manufacturers & wholesale licences, labelling RMP, advertising The main objectives of legislation are to ensure: A. Safety, quality and efficacy of medicinal products B. Withdrawal from use if any inherent danger comes to light Marketing Authorizations (MAs) Definition: An approval issued by the Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicines Agency (EMA) to market a drug in the UK. The liecense is initially granted for 5 years then has to be renewed. Required before a medicine can be legally sold or supplied. Specifies: ○ Drug indications, dosing, and formulation. ○ Storage conditions. ○ Licensing holder responsibilities. Product Names used in Marketing Authorisations (MAs) MHRA can reject any name → if it considers that the name: ○ Will cause confusion ○ Is misleading ○ Or is otherwise unsafe MA holder must keep records of: ○ Any adverse reports ○ All sales/ supplies ○ Sources of all materials ○ Documents that will facilitate withdrawal or recall ○ And produce a periodic safety update report (PSUR)  Unlicensed Medicines Definition: Medicines without a UK marketing authorisation (license). When Used: ○ No suitable licensed alternative exists. ○ Required for rare conditions or specific patient needs (e.g., specials). Off-Label Medicines Definition: Licensed medicines used outside their approved conditions (e.g., different dose, route, or indication). When Used: ○ No licensed treatment for the condition. ○ Evidence supports the alternative use. ○ Patient group or scenario (e.g., paediatrics) not covered by the license. Manufacturers and Wholesale Licenses Manufacturing License: Required for the production (make, assemble or import) of medicines. Wholesale Dealer’s License (WDA): Required for the distribution of medicines to pharmacies or other sellers. Both licenses are issued by MHRA and require compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). Manufacturing vs assembly ○ Manufacture - includes any process carried out in the course of making the product, but does not include dissolving or dispersing the product in, or diluting or mixing it with, a substance used as a vehicle for purpose of administering it ○ Assembly - various processes of dividing up, packaging and presentation of the product or substance ○ NB. Companies applying for a marketing authorisation need to have a manufacturer licence first. ○ The manufacturer licence will be granted first, providing the product is in the process of being approved. The Licensing Authority must be satisfied before a licence is granted with:- ○ 1. What: Operations which will be carried out ○ 2. Where: Premises ○ 3. How: Equipment available ○ 4. Who: Qualifications of supervisory staff ○ 5. Records: Arrangements for safekeeping and maintenance of adequate records Manufacturer 'Specials' Licence ○ 'Specials' = specially manufactured or ordered products, including ○ cannabis-based products for medicinal use in humans (CBPMs) ○ Allows the holder to:- Manufacture unlicensed medicines 'specials' Import unlicensed medicinal products from outside the EEA ○ Medicinal product is supplied— to a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber; or for use under the supervision of a pharmacist in a registered pharmacy a hospital or a health centre No advertising Adequate supervision & procedure for manufacture to meet specified requirements Written records of manufacture or assembly kept available for inspection Wholesale Licenses  ○ Wholesale licenses are authorizations required for the distribution or sale of medicines to other businesses, such as pharmacies, hospitals, or healthcare providers, rather than directly to patients. ○ Allows the holder to sell and supply P, POM, GSL and traditional herbal medicines ○ Conditions for Wholesaler Licence Staff, premises, equipment and facilities must be adequate for the handling, storage and distribution of medicinal products so as to maintain their quality ○ Records of distribution must be kept for a minimum of five years so that products can be recalled from circulation if necessary ○ Wholesale Dealer's License (WDA): Key Requirements Application: Apply to the MHRA with details of premises, operations, and personnel. Good Distribution Practice (GDP): Ensure proper storage, transport, and handling to maintain medicine quality. Implement systems for recalls, complaints, and inventory management. Responsible Person (RP): Appoint a qualified RP to oversee GDP compliance and operations. Premises: Secure storage areas and equipment for monitoring conditions (e.g., temperature). Record-Keeping: Maintain transaction records (e.g., batch numbers, suppliers) for 5 years. Pharmacovigilance: Systems for reporting adverse events and defective medicines. Inspections: MHRA conducts regular inspections to verify compliance. Licensing Exemptions: Certain activities related to medicines are exempt from the requirement to hold a wholesale, manufacturer, or marketing authorization license under specific conditions. 1. Pharmacists in Registered Pharmacies (doctors, nurses, dentists, midwives): ○ Supplying medicines against prescriptions or in emergency situations. Splitting pack which is an example of assembly 2. Hospitals and Healthcare Institutions: ○ Supplying medicines directly to patients within their organization. 3. Specials: ○ Manufacture or supply of unlicensed medicines (specials) under a prescription for specific patient needs. 4. Named Patient Supplies/ counter prescribing: ○ Importing unlicensed medicines for an individual patient with no suitable licensed alternative. 5. Herbalist exemption: ○ The product is prepared or assembled on premises controlled by the herbal practitioner (which must be lockable to exclude public access). ○ The product is intended for administration to a person, and the person is present during the preparation. ○ The herbal practitioner exercises their professional judgment to determine the appropriate treatment. ○ The remedy does not contain specific prohibited substances. 6. Food and cosmetics: ○ Cosmetics: Products intended for external use, such as cleansing, deodorising, caring, or maintaining good condition. ○ Food: Includes beverages, confectionery, ingredients for food preparation, and dietary supplements containing vitamins (e.g., vitamins A, B, B2, B6, C, D, E). ○ Licensing Required: i. For oral administration as a food product, if there are no written dosage instructions. ii. If the recommended daily adult dose exceeds: 1. 2500 units of Vitamin A  2. 25 µg of Folic Acid 3. 250 units of Vitamin D 4. 5 µg of Cyanocobalamin (Vitamin B12) iii. Fortified foodstuffs with added vitamins exceeding these daily dosages also require licensing. Labelling and Risk Management Plans (RMP) Labelling Requirements: ○ Legible, indelible, comprehensible ○ English only or english and other languages, as well as in braille. ○ Drug common name, strength, and dosage form. ○ Instructions for use. ○ Expiry date and batch number. ○ Storage conditions and warnings. ○ P, POM, CD ○ NO promotional element ○ States “contains paracetamol” Risk Management Plans: ○ Identify risks associated with a medicine and how to minimize them. ○ Used for newly authorized medicines or medicines with specific safety concerns. Advertising Must comply with the Human Medicines Regulations 2012. Key rules: ○ POMs: Can only be advertised to healthcare professionals, not the public. ○ Information must be factual and not misleading. ○ Overstating therapeutic claims or omitting side effects is prohibited. ○ Herbals & homoeopathic Herbal Medicines: ○ Can be marketed as Traditional Herbal Medicines (THMs) with a Traditional Herbal Registration (THR) from MHRA. ○ Requires evidence of traditional use (30 years, including 15 years in the EU). ○ Label must state the product is based on traditional use, not proven efficacy. ○ Never adminitered through injection only externally orally or by inhalation. Homeopathic Medicines: ○ Can be registered under the MHRA with a Simplified Registration Scheme. ○ Does not require clinical efficacy evidence but must be safe and of high quality. ○ Labeling must avoid claims about specific diseases or conditions.  Labelling for traditional herbal medicines (THMP) 1. Statement that product is a traditional herbal medicinal product a. for use for specific purposes by reason of longstanding use 2. Statement that user should consult a. doctor or other health care practitioner if symptoms persist, or b. if adverse effects not mentioned on the package or package leaflet occur 3. Advertising: a. "Traditional herbal medicinal product for use in [specify one or more indications for the product consistent with the terms of the registration] exclusively based upon longstanding use as a traditional remedy" Possible adverse events or interactions Cranberry juice and warfarin Grapefruit juice - statins St John's wort - lots of interactions ○ Pharmacy regulation - GPhC: standards, revalidation Standards for Registered Pharmacies General Pharmaceutical Council (GPhC) oversees pharmacy practice and premises. Key standards: ○ Patient-centered care. ○ Safe and effective services. ○ Risk management and staff competency. ○ Transparent and ethical conduct. GPhC - Principal functions ○ to establish and maintain register of pharmacists, pharmacy technicians and premises at which retail pharmacy business is, or is to be, operated ○ to set and promote standards for the safe and effective practice of pharmacy at registered pharmacies ○ to set requirements by reference to which registrants must demonstrate that their fitness to practise is not impaired ○ to promote the safe and effective practice of pharmacy by registrants (including, for example, by reference to any code of conduct for, and ethics relating to, pharmacy) ○ to set standards and requirements in respect of the education, training, acquisition of experience and continuing professional development that it is necessary for pharmacists and pharmacy technicians to achieve in order to be entered in the Register or to receive an annotation in the Register and to maintain competence ○ to ensure the continued fitness to practise of registrants Renewal of Registration ○ Registration = 1 year from date of entry ○ Renew registration ever year, provided: Person's fitness to practise is not impaired standard of proficiency for the safe and effective practice of pharmacy AND additional requirements (if any) relating to continuing professional development (CPD) AND: Prescribed fee has been paid Indemnity arrangements ○ A registrant must have in force adequate and appropriate indemnity arrangements  ○ Provision for GPhC to ask for information on indemnity ○ Registrar can refuse to enter/ renew person on Register ○ GPhC professional indemnity requirements Insurance policy Employees: arrangement made by employer for purposes of indemnifying employee arrangement obtained through a professional body, trade union or defence organisation for the purposes of indemnifying a combination of these ○ GPhC now ask for this as part of annual declarations Revalidation ○ Requirement for pharmacy professionals to maintain registration. ○ Includes: ○ CPD (Continuing Professional Development): Document learning activities and their impact on practice. Atleast 2 have to be planned Planned learning Unplanned 1. What are you planning to learn? 1. Describe an unplanned event or activity that enabled you to learn 2. How are you planning to learn it? something new or refresh your knowledge or skills 3. Give an example of how this learning has benefited the people using your 2. Give an example of how this learning services benefited the people using your service ○ Peer discussion: Reflect with a colleague to improve performance. ○ Reflective account: Discuss how GPhC standards apply to your practice. Reflective account - record/ form Tell briefly about your area of work (the setting of your practice and your main roles) Tell briefly who the typical users of your service(s) are. Tell how you meet the standards for pharmacy professionals GPhC have selected Give a real examples) taken from your practice to illustrate how you meet the standards we have selected ○ Misuse of Drugs Act & Regs, CD supply, possession, Rx, midwife SO, requisition, instalments, records, safe custody, destruction Misuse of Drugs Act & Regulations The Misuse of Drugs Act 1971 provides the framework for controlling dangerous or harmful drugs (Controlled Drugs - CDs) to prevent misuse. Misuse of Drugs Regulations 2001 outlines how CDs can be lawfully possessed, supplied, prescribed, and stored. 2. Controlled Drug Supply CDs are classified into schedules 1–5 based on therapeutic use and risk of misuse: ○ Schedule 1: No medicinal use (e.g., LSD, ecstasy) – possession requires a Home Office license. Exemptions for possession by pharmacists are limited to for purpose of destruction handing over to a police officer ○ Schedule 2: Medicinal use but high misuse potential (e.g., morphine, methadone). ○ Schedule 3: Moderate misuse potential (e.g., buprenorphine, tramadol). Not exempt, i.e. safe custody requirements apply Diethylpropion Buprenorphine Flunitrazepam Temazepam ○ Schedule 4: Lower misuse potential (e.g., diazepam). ○ Schedule 5: Very low risk (e.g., codeine in small doses). 3. Possession Authorized persons: Doctors, pharmacists, and patients with a valid prescription. Unlawful possession is a criminal offense unless authorized under specific regulations. Possession or supply is not lawful unless the person concerned is acting in his capacity as a member of his class, or in accordance with the terms of his/her licence Doctors, dentists and pharmacists (when acting in their capacity as such) are amongst those who have general authority to possess, supply and procure all CDs (except Schedule 1) Certain other persons, incl. wholesalers, importers and exporters, must obtain licences from the Secretary of State Travelling with Controlled Drugs (CDs): ○ A personal licence from the Home Office is not required if carrying less than a three-month supply of CDs. ○ Patient advice: ○ Obtain a covering letter from the prescriber, including: Patient's name Travel details Prescribed CD name Total quantities Dosage ○ Check import/export regulations with the embassies or high commissions of transit and destination countries. ○ Verify any additional requirements from the travel operator. 4. Prescriptions (Rx) Requirements for a CD prescription (Schedules 2 and 3): ○ Patient's full name, address, and DOB. ○ Prescriber's full name, address, and registration number. ○ Drug name, form, strength, and total quantity (in both words and figures). ○ Dose and specific directions (e.g., "as directed" is insufficient). ○ Date: Valid for 28 days from the date on the prescription.  ○ Private prescriptions need to be on a standardised form ○ Prescriber can only have a UK address Electronic prescriptions for CDs are permitted for Schedules 2–5, but must comply with legal standards. Supply of CD (Schedule 2 & 3): ○ Cannot be supplied later than 28 days after appropriate date on Rx includes Schedule 4 CDs ○ Owings of dispensed Rx's for Schedule 2, 3 or 4 CDs cannot be supplied more than 28 days after appropriate date ○ In case of instalment Rx (FP10MDA*), unless first instalment is dispensed within 28 days of appropriate date ○ No repeatable Rx's allowed for Sch 2 & 3 CDs ○ Instalment prescriptions are not REPEATS ○ Schedule 4 CDs - repeatable Rx's allowed First dispensing within 28 days No specified timeframe for repeats ○ Schedule 5 CDs - repeatable Rx's allowed First dispensing within 6 months No specified timeframe for repeats 5. Midwife Supply Orders (SO) Midwives can obtain and administer certain CDs (e.g., pethidine, morphine, dimorphine) under a Midwife Supply Order. The SO must include: ○ Midwife's name and profession. ○ The pregnant womans name ○ Purpose of the CD. ○ Amount required. ○ Signed by an appropriate medical officer (e.g., supervisor of midwives). This must be retained in the pharmacy for 2 years Any left overs cannot be destroyed by the midwife but rather surrendered to the medical officer. 6. Requisition Forms Used to request CDs for professional use (e.g., hospitals, GP practices). Only prescribers can order Must include: ○ Recipient’s name, address, and profession. ○ Name, form, and strength of the CD. ○ Quantity required. ○ Signature of the requester. ○ Dated For Schedule 2 and 3 CDs, requisitions must be submitted to the supplier before delivery. ○ In an emergency it can be supplied but need the form in 24hrs Written authorisation for the messenger who will be collectting the CD’s on the purchasers behave.This authorisation needs to be retained for 2 years. 7. Instalments For CDs prescribed as instalments (e.g., methadone for addiction treatment): ○ The prescription must state the instalment amounts and the intervals. ○ Example: "Dispense 14mg daily; provide 7 days’ supply in two instalments of 3 days and 4 days." ○ Pharmacists must adhere strictly to the prescription details. ○ Maximum of 14 days of treatment can be prescribed for schedule 2 drugs Instalment direction combines two pieces of information: ○ Amount of medicine per instalment and ○ Interval between each time medicine can be supplied ○ Both dose and instalment amount must be specified separately on Rx  ○ If a starting date is specified, this must be complied with ○ All instructions on Rx must be complied with, e.g. specified instalments at stated time intervals Exceptions: ○ Please dispense instalments due on pharmacy closed days on a prior suitable day. ○ If an instalment's collection day has been missed, please still dispense the amount due for any remaining day(s) of that instalment. ○ Consult the prescriber if 3 or more consecutive days of a prescription have been missed. ○ Supervise consumption on collection days. ○ Dispense daily doses in separate containers. Prescribing cocaine, diamorphone and dipianone for the treatment of addiction can only be done by doctors specially authorised by the secretary of state. 8. Records Schedule 2 CDs: Detailed records must be kept in a Controlled Drugs Register (CDR), including: ○ Date of supply. ○ Name and address of the person supplied. ○ If it is a HCP you need their name, address and request their ID ○ If a representative come they need a letter and and ID ○ Should ask for ID ○ Prescriber details. ○ Amount supplied. ○ Running balance of stock. CDR entries must be made on the day of supply or the following day. This record must be kept for 2 years 9. Safe Custody CDs in Schedules 2 and 3 (except certain exemptions like phenobarbital) must be stored in a secure, locked cabinet or safe. Access is limited to authorized personnel. A record of who has access may be required for audits. 10. Destruction ○ Expired or unwanted CDs (Schedule 2) must be destroyed in the presence of an authorized witness (e.g., a GPhC inspector). ○ The destruction process must be recorded in the CDR. ○ Schedule 3-5 CDs: Destruction can occur without a witness, but good practice involves documenting the process. ○ ○ Signed orders Definition: A signed order is a written request from an authorized professional (e.g., a dentist or veterinarian) to obtain Prescription-Only Medicines (POMs) or other specified medicines for use in their practice or for a specific patient. Key Features:  ○ Purpose: ○ For stock supply to a professional (e.g., a dentist ordering fluoride varnish for patient use). ○ Not intended for individual patient prescriptions. ○ Information Required: A valid signed order must include: ○ Name, address, and profession of the requester. ○ Description of the medicine (name, form, strength, and quantity). ○ Purpose for which the medicine is required. ○ Signature of the requester. ○ Date of the order. ○ Record-Keeping: ○ Pharmacists must keep a record of the signed order in their POM register (if applicable). ○ Retain the signed order for 2 years for audit purposes. ○ Exemptions: ○ Signed orders for certain medicines (e.g., CDs) require additional compliance based on their schedule. ○ POM emergency supply, incl. CD Definition: The Emergency Supply of POMs allows pharmacists to supply medicines without a prescription in situations where it is impractical for the patient to obtain one in time. Two Scenarios: 1. At the Request of a Prescriber: ○ A doctor, dentist, or other authorized prescriber can request the supply of a POM by phone, fax, or other communication. ○ Written prescription must be provided within 72 hours. ○ Applies to most medicines, including some CDs (Schedules 4 and 5, but not Schedule 2 except phenobarbital for epilepsy). 2. At the Request of a Patient: ○ Pharmacists can supply a POM directly to a patient in urgent situations, provided: The patient has previously been prescribed the medicine by an authorized prescriber. The pharmacist is satisfied it is an emergency and there is an immediate need. Information Required for Patient Requests: Patient Details: Name and address. Medicine Details: Name, strength, form, and quantity (limited to what is clinically necessary, usually up to 30 days’ supply). Circumstances: Why the emergency supply is necessary and why a prescription cannot be obtained. Exceptions for Emergency Supply: Controlled Drugs (CDs): ○ Schedule 2 CDs cannot be supplied, except phenobarbital for epilepsy. ○ Schedule 3 CDs cannot be supplied (e.g., buprenorphine, tramadol). ○ Schedules 4 and 5 CDs can be supplied, subject to normal rules. Record-Keeping: Pharmacists must record: ○ Date of supply. ○ Patient details. ○ Prescriber’s name (if applicable).  ○ Medicine details. ○ Emergency circumstances. Labeling: Must include standard prescription labeling requirements and indicate the supply was made as an emergency. Clinical topics Prescribing skills: ○ Documentation and history taking - process Comprehensive History Components ○ Introduction and Patient Details ○ Build rapport ○ Confirm patient information ○ Presenting Complaint (PC) and History of Presenting Complaint (HPC) ○ Use the Golden Minute technique ○ Ask open-ended questions ○ Practice active listening ○ Medical History Exploration ○ Past Medical History (PMH) ○ Past Surgical History (PSH) ○ Use MiTJTHREADS mnemonic for a comprehensive review ○ ○ Medication and Allergy Assessment ○ Detailed drug history ○ Comprehensive allergy screening ○ Family and Social History ○ Genetic predispositions ○ Lifestyle factors ○ Use SAFEHELPHAT framework ○ ○ Systems Enquiry ○ Comprehensive body system review ○ Detailed symptom investigation ○ Summary and Closure  ○ Summarise understanding ○ Safety netting ○ Address patient concerns ○ Clinical decision-making - theories Consultation History Taking (CHT) Tools 1. WWHAM ○ Who is it for? ○ What are symptoms? ○ How long? ○ Action taken? ○ Medication context 2. ASMETHOD ○ Age/Appearance ○ Self or others ○ Medication details ○ Timing ○ History ○ Other symptoms ○ Danger signals 3. SOCRATES (Pain Assessment) ○ Site ○ Onset ○ Character ○ Radiation ○ Associated symptoms ○ Time course ○ Exacerbating/Relieving factors ○ Severity ○ Using resources - BNF/BNFC/SPC/pregnancy resources ○ Using resources - interactions Clinical management of: ○ Lower GI - constipation, diarrhoea, irritable bowel syndrome (IBS) Constipation Symptoms: Infrequent bowel movements, hard/lumpy stools, straining. Treatment: ○ First-line: Bulk-forming laxatives (e.g., Ispaghula husk). ○ Second-line: Osmotic laxatives (e.g., Lactulose). ○ Lifestyle: Increase dietary fiber, hydration, and regular exercise. Linked Resource: Constipation Management PowerPoint Diarrhoea Symptoms: Frequent loose stools, abdominal cramps. Treatment: ○ First-line: Oral rehydration salts (ORS).  ○ Second-line: Loperamide (Imodium) for adults. ○ Lifestyle: Stay hydrated, avoid fatty foods. Linked Resource: Diarrhoea Management PowerPoint Irritable Bowel Syndrome (IBS) Symptoms: Abdominal pain, bloating, changes in bowel habits. Treatment: ○ First-line: Antispasmodics (e.g., Hyoscine). ○ Second-line: Low FODMAP diet, probiotics. ○ Lifestyle: Stress management, regular meals. ○ Upper Gl - GORD, functional dyspepsia, peptic ulcer Gastro-Oesophageal Reflux Disease (GORD) Symptoms: Heartburn, regurgitation, chronic cough. Treatment: ○ First-line: Alginates (e.g., Gaviscon Advance). ○ Second-line: Proton pump inhibitors (e.g., Omeprazole). ○ Lifestyle: Avoid triggers, elevate head of the bed. Functional Dyspepsia Symptoms: Epigastric pain, bloating, early satiety. Treatment: ○ First-line: Antacids. ○ Second-line: H2 receptor antagonists (e.g., Ranitidine). ○ Lifestyle: Smaller meals, reduce fatty/spicy foods. Peptic Ulcer Disease Symptoms: Epigastric pain, nausea, possible bleeding. Treatment: ○ First-line: Proton pump inhibitors. ○ Second-line: Treat H. pylori infection if present. ○ Lifestyle: Avoid NSAIDs, alcohol, and smoking. ○ Nutrition - vitamins and minerals, nutritional support Vitamins and Minerals Key Deficiencies: ○ Vitamin D: Bone health. ○ Iron: Anemia. ○ B12/Folic Acid: Neuropathy, anemia. Supplementation: Based on individual needs and deficiencies. Nutritional Support ○ Oral Nutrition: High-protein/calorie supplements. ○ Enteral Nutrition: Feeding tubes. ○ Parenteral Nutrition: IV nutrition for non-functioning GI tract.  ○ Bowel cancer Symptoms: Rectal bleeding, changes in bowel habits, weight loss. Management: Screening: FIT tests, colonoscopy. Treatment: Surgery, chemotherapy, radiotherapy. Prevention: High-fiber diet, regular screening. ○ Renal dysfunction - assessment of renal function, basic renal function tests, acute kidney injury (AKI) and chronic kidney disease (CKD) basics Assessment of Renal Function Key Tests: ○ Serum creatinine, eGFR, urea. ○ Urinalysis for protein, blood. Acute Kidney Injury (AKI) Causes: Dehydration, sepsis, nephrotoxins. Management: Hydration, treat underlying cause. Chronic Kidney Disease (CKD) ○ Stages: Based on eGFR. ○ Management: Blood pressure control, manage comorbidities, dialysis for end-stage disease. ○ Liver dysfunction - assessment of liver function, liver blood tests, management of common complications of liver disease (pharmacological and non-pharmacological), management of alcohol withdrawal Assessment of Liver Function Tests: ALT, AST, bilirubin, albumin, INR. Complications of Liver Disease Portal Hypertension: Beta-blockers, avoid alcohol. Ascites: Diuretics (e.g., Spironolactone). Hepatic Encephalopathy: Lactulose. Alcohol Withdrawal ○ Symptoms: Tremors, agitation, seizures. ○ Management: Benzodiazepines, thiamine. ○ GI infections - Helicobacter pylori, C Diff Helicobacter pylori Symptoms: Dyspepsia, nausea, bloating. Treatment: Triple therapy (PPI + 2 antibiotics). Clostridium difficile Symptoms: Watery diarrhea, abdominal cramps. Treatment: Oral vancomycin or fidaxomicin. ○ Immune disease - inflammatory bowel disease Inflammatory Bowel Disease (IBD): Crohn's disease and ulcerative colitis ○ Crohn's Disease: Affects any GI segment, patchy inflammation. ○ Ulcerative Colitis: Limited to colon, continuous inflammation. ○ Management: Corticosteroids, immunomodulators, biologics. ○ Skin conditions - psoriasis, eczema, acne Psoriasis.Treatment: Topical steroids, vitamin D analogs. Eczema Treatment: Emollients, hydrocortisone cream. Acne Treatment: Benzoyl peroxide, retinoids. ○ Asthma Asthma Management: ○ Short-acting beta-agonists (SABA). ○ Inhaled corticosteroids (ICS). ○ Chronic obstructive pulmonary disease (COPD) Chronic Obstructive Pulmonary Disease (COPD) ○ Management: Smoking cessation, bronchodilators, corticosteroids.  ○ Respiratory infections Respiratory Infections ○ Common Pathogens: Streptococcus pneumoniae, influenza. ○ Treatment: Antibiotics if bacterial, antivirals for influenza. ○ Lung cancer Lung Cancer ○ Symptoms: Persistent cough, hemoptysis, weight loss. ○ Management: Surgery, chemotherapy, radiotherapy. Prescribing skills: ○ Principles of physical assessment - basic consent Infection Control and Professionalism: Adherence to a strict dress code, including being "bare below the elbows," securing long hair, wearing discreet jewelry, and displaying student identification badges. Compliance with infection control procedures, notably proper hand hygiene. Person-Centered Approach: Employing "The C's" approach to clinical skills, which includes: ○ Consent: Obtaining patient permission before proceeding. ○ Communication: Clearly explaining procedures to the patient. ○ Comfort: Ensuring the patient's physical and emotional comfort. ○ Confidentiality: Maintaining patient privacy throughout the assessment. ○ Consideration: Being mindful of the patient's needs and concerns. Structured Assessment Techniques: Introduction to the PIPPA acronym for physical assessment: ○ Preparation and Positioning: Ensure the patient is in the correct position for the clinical skill. Ask the patient to remove clothing if needed, maintaining dignity. Position yourself appropriately to perform the examination. ○ Inspection: Observe the area being assessed for appearance or abnormalities. Example: In a respiratory exam, inspect the chest wall for symmetry and abnormalities like scarring. ○ Palpation: Use hands to gently feel or press the area being examined. Example: In a cardiovascular exam, palpate the carotid pulse in the neck. ○ Percussion: Tap the area gently with fingers to assess underlying structures. Example: In a respiratory exam, percuss the chest wall to identify resonance or dullness.  ○ Auscultation: Listen to the area with a stethoscope for sounds such as crackles or murmurs. Example: In a respiratory exam, auscultate the chest wall for breath sounds or abnormalities like crepitations. ○ Initial and Closing Steps in Assessments: ○ Emphasis on the importance of proper introductions, obtaining consent, and ensuring patient comfort at the beginning of an assessment. ○ Proper closure of the assessment, including summarizing findings, addressing patient questions, and documenting the encounter. ○ Introduction to Basic Observations Blood Pressure (BP): ○ Definition: The force exerted by circulating blood on the walls of blood vessels. ○ Measurement: Recorded in millimeters of mercury (mmHg) as two values: ○ Systolic Pressure: Pressure during heartbeats. ○ Diastolic Pressure: Pressure between heartbeats. ○ Normal Range: ○ Ideal: 90/60 mmHg to 120/80 mmHg. ○ High BP (Hypertension): 140/90 mmHg or higher. ○ Low BP (Hypotension): 90/60 mmHg or lower. Pulse (Heart Rate): ○ Definition: The number of heartbeats per minute. ○ Normal Range: 60 to 100 beats per minute (bpm) at rest. ○ Tachycardia: Over 100 bpm at rest. ○ Bradycardia: Below 60 bpm at rest; can be normal in athletes or individuals on certain medications. ○ Rhythm Assessment: Evaluate for regularity; irregular rhythms may indicate conditions like atrial fibrillation. Respiration Rate: ○ Definition: The number of breaths taken per minute. ○ Normal Range: 12 to 20 breaths per minute at rest. ○ Abnormal Rates: Below 12 or above 25 breaths per minute at rest. ○ Influencing Factors: Conditions such as asthma, anxiety, pneumonia, heart failure, lung diseases, and narcotic use can alter respiration rates. Temperature: ○ Definition: The body's internal heat level. ○ Normal Range: 36.5°C to 37.2°C (97.8°F to 99°F). ○ Variations: Affected by factors like gender, activity, food and fluid intake, time of day, and menstrual cycle stages in women. Oxygen Saturation (SpO₂): ○ Definition: The percentage of hemoglobin saturated with oxygen. ○ Normal Range: 95% to 100%. ○ Hypoxemia: Below 90% indicates low oxygen levels, requiring prompt attention. Recognizing Abnormal Readings: Deviation from Normal Ranges: Values outside the normal ranges may indicate underlying health issues. Patient Baseline: Consider individual variations; some patients may have baseline readings differing from standard norms. Clinical Context: Assess abnormal readings in conjunction with other clinical findings and patient history. Responding to Abnormal Readings: Immediate Action: Significantly abnormal vital signs may require urgent intervention. Consultation: Report findings to a supervising clinician or healthcare provider promptly. Documentation: Accurately record all observations, noting any interventions taken. NEWS2 (National Early Warning Score 2): ○ Purpose: A standardized tool used in the UK to assess and respond to acute illness severity in adults. ○ Components: Scores based on six physiological parameters: respiration rate, oxygen saturation, systolic BP, pulse rate, level of consciousness, and temperature. ○ Application: Aids in early detection of clinical deterioration, guiding timely interventions. ○ Using resources and basic management planning ○ Basic observations Vital Signs Monitoring: Temperature: Techniques for axillary, oral, and tympanic measurements. Pulse Rate: Measuring heartbeats per minute, identifying tachycardia or bradycardia. Respiration Rate: Counting breaths per minute and recognizing abnormalities. Blood Pressure: Measuring systolic and diastolic pressure with appropriate tools. Oxygen Saturation (SpO₂): Using pulse oximetry to determine blood oxygen levels and act on low readings. Assessment of Alertness and Consciousness: Neurological Observations: ○ Use of tools such as the Glasgow Coma Scale (GCS) to assess levels of alertness and consciousness. ○ GCS evaluates: 1. Eye Opening: Spontaneous, to voice, to pain, or none. 2. Verbal Response: Oriented, confused, inappropriate, incomprehensible, or none. 3. Motor Response: Obeys commands, localizes pain, withdraws, or none. AVPU Scale: ○ A – Alert: Fully awake and responsive. ○ V – Verbal: Responds to voice but not fully alert. ○ P – Pain: Responds to painful stimuli only. ○ U – Unresponsive: No response to stimuli. Additional Clinical Assessments: Blood glucose testing for diabetes management. Urinalysis to detect health issues such as infections or kidney problems. Infection Control and Consent: Emphasis on hand hygiene to prevent cross-contamination. Gaining patient consent and maintaining confidentiality during examinations. Documentation and Reporting: Recording observations accurately. Acting on abnormal findings, such as low GCS scores or unresponsiveness. Use of Standardized Tools: ○ NEWS2 (National Early Warning Score 2): ○ Incorporates observations like respiration, SpO₂, BP, pulse, temperature, and consciousness to detect early signs of deterioration. ○ Peak expiratory flow rate (PEFR) Consent and Confidentiality: Informed Consent: Before conducting any examination or procedure, obtain informed consent by clearly explaining the process, purpose, and addressing any patient questions. Ensure the patient's agreement is voluntary and can be withdrawn at any time. Confidentiality: Maintain strict confidentiality of all patient information obtained during the procedure, adhering to professional and legal standards. Procedure Overview: ○ Preparation: ○ Explain the procedure to the patient and obtain informed consent. ○ Ensure the peak flow meter is clean and functioning properly. ○ Have the patient assume a comfortable, upright position. ○ Measurement (continued): ○ Instruct the patient to seal their lips tightly around the mouthpiece of the peak flow meter. ○ Ask the patient to blow out as hard and fast as possible into the device. ○ Record the value shown on the meter. ○ Repeat the procedure three times to ensure accuracy, noting the highest value as the PEFR reading. ○ Interpretation: ○ Compare the recorded PEFR with normal values for the patient’s age, sex, and height. ○ Identify any significant deviations that may indicate conditions such as asthma or chronic obstructive pulmonary disease (COPD). ○ Post-Procedure: ○ Provide the patient with feedback on the results. ○ Clean and disinfect the peak flow meter according to infection control guidelines. ○ Document the findings accurately in the patient's records. Clinical Applications of PEFR:  ○ Asthma Management: Helps monitor airflow limitation and assess the severity of an asthma attack. ○ Treatment Response: Evaluate improvement after the administration of bronchodilators. ○ Baseline Monitoring: Track chronic respiratory conditions over time. Body Mass Index (BMI): ○ While PEFR measures respiratory health, BMI is often assessed concurrently to evaluate overall health and its potential impact on lung function. ○ BMI Calculation: Weight (kg) ÷ [Height (m)]². ○ Implications: Obesity or underweight status can influence PEFR, as excess weight may restrict lung expansion. ○ Body mass index (BMI) ○ Importance of Measurements: ○ Recognize that weight is crucial for dosing medications, while height is essential for calculating BMI and Body Surface Area (BSA), which can influence drug dosing accuracy. ○ Be aware of patients' preferences for imperial units (stones/pounds and feet/inches) and the necessity to convert these measurements to metric units (kilograms and meters) for clinical use. ○ Hand and Equipment Hygiene: ○ Prioritize hand hygiene before and after patient interactions and equipment handling. ○ Use alcohol-based hand sanitizers or soap and water if hands are visibly soiled. ○ Sanitize equipment surfaces, such as scales, before and after each use to prevent cross-contamination. ○ Patient Interaction: ○ Introduce yourself and confirm the patient's identity. ○ Ensure patient comfort and obtain informed consent for the procedure. ○ Explain the purpose and process of the measurements in patient-friendly language. ○ Measuring Height: ○ Instruct the patient to remove shoes and stand straight with feet flat and together, arms at their sides, and shoulders level. ○ Ensure the headpiece of the stadiometer firmly touches the crown of the head. ○ Record the height in meters, as this is standard for BMI calculations. ○ Measuring Weight: ○ Ask the patient to remove heavy clothing and stand on the scale without leaning. ○ Place the scale on a firm, flat surface and ensure it is zeroed before use. ○ Record the weight in kilograms, which is standard for BMI calculations. ○ Calculating BMI: ○ Use the formula: BMI = weight (kg) / [height (m)]². ○ Interpret BMI values to assess underweight, normal weight, overweight, or obesity status. ○ Recording and Interpretation: ○ Document measurements accurately in the patient's records. ○ Use BMI values to identify potential health risks and inform clinical decisions. Additional Considerations: ○ Be mindful of patients' comfort and privacy during measurements. ○ Ensure equipment is calibrated and functioning correctly to obtain accurate readings. ○ Understand the limitations of BMI, as it does not differentiate between muscle and fat mass  ○ Prescription writing - asthma Introductory steps 1. Introduces self to the patient including name and role 2. Confirms the patient's name and date of birth and records in charts/notes 3. Briefly explains the purpose of the consultation 4. Gains consent from the patient to proceed with the consultation Information gathering (if applicable to SLE) 1. Confirms the patient's medication history 2. Confirms the patient's allergy status 3. Confirms the patient's past medical history 4. Explores the patient's ideas, concerns and expectations (ICE) in relation to the consultation 5. Explores the patient's perspective of the medication use and what they already know about the medication Providing medicine related information 1. Identifies the therapeutic indication for the patient 2. Describe how the medication will manage the condition 3. Advises the patient how to use the medication including the dose 4. Discusses the possible side effects of the medication and, where applicable, management or safety nets related to these side effects 5. Discusses any interactions, considering both drug-drug and drug-food (if applicable to SLE) 6. Explains how the medication with be monitored (where applicable to include efficacy, safety and any specific recommendations by manufacturer) Concluding Steps 1. Confirms the patient's understanding of the medication 2. Summarises the information discussed in the consultation appropriately 3. Discusses plans for follow-up (where applicable) 4. Discusses safety net 5. Check if the patient has any final questions 6. Thank the patient for their time 7. Record consultation accurately in notes Prescription writing Writes a legal prescription which is clinically appropriate including all of the following: 1. Patient's name and address 2. Patient's date of birth and/or age 3. Name of the medication 4. Strength and formulation of the medication 5. Dose of the medication (which is clinically appropriate) 6. Quantity of the medication/duration of prescription (which is clinically appropriate) 7. Draws a "Z" underneath the last prescription item to indicate no more items OR writes 'no more items' under the last prescription item 8. Signature 9. Date 10. Prescribing designation (Pharmacist Independent Prescriber), registration (University ID number) 11. Prescriber address and contact details Documentation - record findings accurately in notes 1. Date and time (24 hour format)  2. Name and role 3. Main notes entry documentation as per requirements of SLE 4. Signature 5. Full name, role, registration (University ID number) 6. Contact details (if applicable) Common condition topics ○ Safely manage the following conditions over the counter: ○ GASTRO - dyspepsia, GORD, diarrhoea, constipation, threadworm, IBS, haemorrhoids ○ INFLAMMATORY SKIN - eczema, contact dermatitis, acne vulgaris, bites and stings ○ INFECTED SKIN - fungal skin infections, scabies, impetigo, herpes simplex/shingles ○ RESPIRATORY - cough, cold, hay fever GASTROINTESTINAL CONDITIONS 1. Dyspepsia Symptoms: Upper abdominal discomfort, bloating, nausea, heartburn. Red Flags: Blood in vomit/stools, difficulty swallowing, unexpected weight loss, over 40 years with first presentation, pain radiating down the arm. Referral Time: 5–7 days; immediate if cardiac suspicion​. Treatment: ○ First-line: Gaviscon Advance (5–10ml after meals and at bedtime, 12+ years)​. ○ Second-line: Nexium Control (esomeprazole 20mg daily for 14 days, 18+ years)​. Lifestyle Advice: Avoid trigger foods (spicy/fatty), eat smaller meals, elevate the head of the bed, and reduce caffeine/alcohol. 2. GORD (Gastro-Oesophageal Reflux Disease) Symptoms: Heartburn, regurgitation, chronic cough, throat irritation. Red Flags: Same as dyspepsia​. Referral Time: 5–7 days​. Treatment: Same as dyspepsia. Lifestyle Advice: Similar to dyspepsia. 3. Constipation Symptoms: Infrequent bowel movements, hard stools, straining. Red Flags: Blood in stools, nausea/vomiting, abdominal pain, changes in bowel habits >2 weeks​. Referral Time: 2–3 days with OTC product; 2 weeks with dietary advice​. Treatment: ○ First-line: Bulk-forming laxative (Ispaghula sachets, over 6 years, 1 sachet morning/evening)​. ○ Second-line: Lactulose solution (up to 30ml daily, all ages)​. Lifestyle Advice: Increase dietary fiber and water intake, and regular exercise. 4. Diarrhoea Symptoms: Frequent loose stools, abdominal cramps. Red Flags: Blood/mucus in stools, severe pain, duration >3 days adults, >2 days children 1 day in infants 3 weeks​. Referral Time: 3 weeks if symptoms persist​. Treatment: ○ First-line: Simple linctus (5ml up to 4 times daily, 12+ years)​. ○ Second-line: Pholcodine linctus for dry cough (10ml up to 6 times daily, 12+ years)​. Lifestyle Advice: Stay hydrated, avoid smoking, and use humidifiers. 2. Cold Symptoms: Runny nose, sneezing, mild fever, congestion. Red Flags: Pain on inspiration, worsening symptoms in vulnerable groups​. Referral Time: 2 weeks​. Treatment: ○ First-line: Paracetamol or ibuprofen for symptomatic relief​. ○ Second-line: Decongestants like pseudoephedrine (16+ years)​. Lifestyle Advice: Rest, drink fluids, and inhale steam. 3. Hay Fever Symptoms: Sneezing, itchy eyes, nasal congestion. Red Flags: Difficulty breathing, systemic symptoms​. Referral Time: 2 weeks if uncontrolled​. Treatment: ○ First-line: Oral antihistamines (loratadine 10mg daily, 6+ years)​. ○ Second-line: Intranasal corticosteroids (Pirinase, 2 sprays daily, 18+ years)​. Lifestyle Advice: Keep windows closed, shower after outdoor exposure, use sunglasses. Red Flags Critical Warning Signs Respiratory Red Flags: Breathlessness Unusual cough Hemoptysis Unexpected weight loss Gastrointestinal Red Flags: Unexplained weight changes Appetite modifications Rectal bleeding Persistent abdominal pain Skin Red Flags: Broken skin Infection signs Unexpected bleeding Meningitis Warning Signs Symptoms Across Age Groups Adult Indicators: High temperature Confusion Rapid breathing Muscle/joint pain Headache Light sensitivity Infant Specific Signs: ○ Refusal to feed ○ High-pitched cry ○ Bulging soft spot ○ Unresponsiveness