Pharmacy Law Supplementary Materials

Private Healthcare Healthcare provided by businesses and individual practitioners, available to those who pay NHS Healthcare Healthcare provided by the government, available to all, funded by taxation Primary Care Basic healthcare provided by GPs, dentists, pharmacists, and optometrists Secondary Care Specialized healthcare provided in hospitals Tertiary Care Highly specialized healthcare in areas like neurosurgery and transplants NHS Act 1948 Established a comprehensive health service in the UK, free at the point of delivery Medicines Act 1968 Introduced to regulate medicines, replacing previous inadequate controls Thalidomide Drug causing birth defects, leading to stricter drug safety regulations Committee on Safety of Drugs Formed to ensure reasonable safety of new drugs, post-thalidomide tragedy Medicines Act 1968 Revocation Much of the original Medicines Act 1968 has been repealed or replaced Licensing Authority Either the Secretary of State or the Minister of Health, Social Services, and Public Safety General Pharmaceutical Council Regulatory body overseeing pharmacies and pharmacists in the UK BP & Other Standards Preparation and maintenance of British Pharmacopoeia and other quality standards GSL General Sale List - medicinal products available without a prescription P Medicinal product available only from a pharmacy, not requiring a prescription 1 / 18 Medicinal Product Substance preventing or treating disease in humans Medicinal Purpose Includes treating disease, contraception, inducing anesthesia Appropriate Practitioner Doctor, dentist, supplementary prescriber, nurse/pharmacist independent prescriber Community Practitioner Nurse Prescriber Exception for certain medications, see HMR 2012 Commission on Human Medicines Advises on safety, marketing authorizations, and risk management plans British Pharmacopoeia Commission Prepares British Pharmacopoeia standards for medicinal products Expert Advisory Groups Provide advice on medicinal products and quality standards Medical Device Product used for diagnosis, prevention, or treatment of illness Enforcement Regulatory oversight of licensing, safety, and compliance Register of Pharmacists List of registered pharmacists maintained by GPhC Marketing Authorisation Formerly known as PRODUCT LICENCE (PL). Required for every Medicinal Product before sale. Manufacturer's Licences Needed for Medicinal Products manufactured in the UK. Must be held by the production site. Wholesale Dealers Licences Required for companies selling, supplying, or procuring Medicinal Products to anyone other than end-users within the EU. Product development Process involving Clinical Trial Authorisation, Parallel Import Licences, and Manufacturer's Specials Licence. 2 / 18 Clinical Trial Authorisation Necessary for new Medicinal Products under development before testing on humans. Issued by MHRA. Parallel Import Licences Permitting import of Medicinal Products from other countries for sale in the UK. Manufacturer's Specials Licence Allows the production of unlicensed Medicinal Products for specific patient needs. Herbal Products Medicinal Products derived from plants or plant extracts. Homeopathic Products Medicinal Products based on the concept of treating like with like in highly diluted forms. Manufacturing and wholesale dealing Part III Regulations for manufacturing, importing, and wholesaling Medicinal Products, requiring licenses and setting assessment criteria. Responsible Persons Individuals designated to ensure compliance with regulations in Medicinal Product manufacturing and wholesale dealing. Qualified Persons Individuals responsible for certifying each batch of Medicinal Products meets quality standards before release. Set of standards detailing requirements EC Guide to Good Manufacturing Pracfor Medicinal Product manufacturing to tice ensure safety and quality. GSL Medicines Medicines classified as General Sales List, available for sale without a prescription. New Chemical Entity A novel compound not previously approved for therapeutic use. Phase I, II, III, IV Trials Successive stages of clinical trials to assess safety and efficacy of Medicinal Products. 3 / 18 Discovery Phase Initial stage identifying potential drug candidates from thousands of molecules. Preclinical Testing Evaluating selected molecules for safety and efficacy before human trials. Registration Approval Final step where one molecule is approved for marketing after successful trials. MHRA Inspection Regular evaluation of manufacturing sites to ensure compliance with quality and safety standards. Phase 1 trials Tests on healthy individuals to study drug effects Phase 2 trials Evaluates drug effectiveness in a specific condition Phase 3 trials Assesses drug efficacy and safety in the general population GCP Ensures ethical and quality standards in clinical trials GMP Ensures quality manufacturing in clinical trials Marketing Authorisation (MA) Permission to sell, supply, or export a medicinal product POMs New medicines usually requiring prescription Pharmacovigilance Monitoring drug safety post-marketing Parallel Import Licence Allows sale of medicinal products across EU member states Investigational medicinal products Used in clinical trials to assess drug effects Herbal Medicines Products required to have Traditional Herbal Registration or Marketing Authorisation 4 / 18 General Sale List (GSL) Medicinal Products sold without pharmacist supervision Pharmacy Only (PO) medicines Licensed as GSL but available only through pharmacies Pharmacy (P) medicines Medicinal products requiring more control than GSL Control over the sale of medicines Regulations ensuring safe and appropriate use of medicinal products New Medicinal Products Recently developed pharmaceutical products Changes in Legal Classification Revisions to the legal categorization of medicinal products Additional restrictions imposed by MHRA Regulatory limitations beyond standard classification rules Safe use Ensuring proper and secure consumption of medicinal products Appropriate use Using medicinal products correctly for intended purposes Availability of advice Ensuring guidance is accessible for proper use of medicinal products General Sale List (GSL) medicines Medicinal products sold without pharmacist supervision Pharmacy Medicines Medicinal products requiring more control than GSL Retail Pack Sizes Limits on pack sizes for certain GSL products Pharmacy Only (PO)Medicinal Products GSL products available only through pharmacies Pharmacy Medicines P Medicinal products not POM or GSL, requiring pharmacy access Supervision Pharmacist oversight to intervene in transactions 5 / 18 Ethical Control over Sales of Medicines Regulations ensuring ethical practices in medicine sales Protocols for Sales of Medicines Guidelines specifying procedures for medicine sales Exemptions from prescription Control Exceptions based on dosage, strength, form, or packaging Products with >720mg pseudoephedrine Pseudoephedrine & Ephedrine Restricor 180mg ephedrine in a single transactions tion Exempted Controlled Drugs Controlled Drugs in specified form, dose, and strength New Medicinal Products Classification New MPs are POM for 5 years unless safety evidence exists POM to P to GSL Changes POM to P when safe without prescription, to GSL when safe without pharmacist GSL to P to POM Changes GSL to P if no longer safe without pharmacist, P to POM with new risks PGD Definition Written direction for POM supply/administration, signed by doctor, dentist, pharmacist Persons Under PGD Pharmacists, Registered Nurses, Registered Midwives PGD Permissible Circumstances Supply by authorized healthcare pros, assist NHS services Fate of Prescription Retain NHS prescriptions, endorse and return private ones Ibuprofen Tablets Legal Class P for headache relief Hydrocortisone Injection Legal Class POM for 100mg/ml dosage Paracetamol Tablets Legal Class GSL for 500mg tablets Chloramphenicol Eye Drops Legal Class POM or P based on formulation Water for Injection Legal Class POM for 10ml 6 / 18 Prescription Only Medicines (POMs) Medications obtainable only with a valid prescription Patient Group Direction (PGD) Allows specified healthcare professionals to supply and/or administer a medicine Emergency Supply Provision of medication at the request of a doctor or designated prescriber Human Medicines Regulations 2012 Legislation classifying medicinal products like POMs and GSL medicines Prescription Requirements for POM Specifications for a valid prescription including practitioner's signature and patient details Repeatable Prescription Prescription allowing multiple dispensing, with restrictions on number of repeats Forged Prescriptions Illegal prescriptions requiring verification before dispensing NHS Reimbursement Payment for drug costs incurred by the pharmacy POM Records Mandatory documentation for all POM supplies except specific cases POM Book Record book for all POM supplies, either physical or electronic Signed Orders Wholesale transactions enabling professionals to obtain POMs for practice Emergency Supply Requestors Authorized professionals who can request emergency medication supplies Emergency Supply at Request of Doctor Prescriber must provide prescription within 72 hours Emergency Supply at Request of Patient Pharmacist ensures immediate need, previous prescription, appropriate dose POM Book Entry Includes date, medicine details, prescriber & patient info 7 / 18 Emergency Supply Label Contains date, medicine details, pharmacy info, 'Emergency Supply' PGD Details Includes clinical condition, treatment description, records required NHS PGDs Permissible for supply by authorized healthcare professionals Records in the Pharmacy Different record requirements for POMs, GSL, CDs, and private prescriptions Administering POMs Restrictions on parenteral administration without appropriate practitioner Medicines Act 1968 Legislation regulating the sale and supply of medicinal products Pharmacy Order 2010 Regulation governing the registration and renewal of pharmacies Health Act 1999 Legislation concerning the supervision and control of pharmacists General Pharmaceutical Council (GPhC) Regulatory body responsible for pharmacists, technicians, and pharmacy premises Responsible Pharmacist Individual overseeing supervision and control in a pharmacy Medicines (Pharmacies) (Responsible Regulations specifying responsibilities of Pharmacist) Regulations 2008 the responsible pharmacist Health Act 2006 Legislation related to the pharmaceutical profession HMR 2012 - Clause 220 Clause amended in 2020 due to Brexit, impacting pharmacy regulations Restricted Titles Titles prohibited for use unless the individual is a registered pharmacist Retail Pharmacy Business (RPB) Business involving the retail sale of non-general sale medicinal products Persons Lawfully Conducting a Retail Pharmacy Business (PLCRPB) Individuals or entities legally allowed to operate a retail pharmacy business 8 / 18 Superintendent Pharmacist Pharmacist responsible for managing the dispensing and supply of medicinal products in a business Body Corporate Legal entity that can operate a pharmacy business, requiring a superintendent pharmacist Pharmacy Department of a Hospital or Designated area within a medical facility Health-Center for pharmaceutical activities GPhC Standards for Retail Pharmacy Premises Guidelines ensuring proper identification and maintenance of pharmacy spaces Pharmacy Premises Accreditation Process of registering and describing spaces for preparing and dispensing medicinal products Space within a pharmacy for private disDesignated Area for Confidential Concussions between patients and pharmasultations cists Regulatory requirements for maintaining GPhC Standards for Registered Phara safe and effective pharmacy environmacies ment GPhC General Pharmaceutical Council: Regulates pharmacy professionals and premises Principle 1 Governance arrangements in registered pharmacies Pharmacist Registration Process of registering with GPhC after completing MPharm and pre-registration year Technician Registration Mandatory registration for pharmacy technicians with QCF(NVQ) level 3 RP Duties Ensuring safe pharmacy operations, delegation, and adherence to SOPs RP Absence Delegation Allowable tasks delegated during RP's absence, ensuring safe and effective pharmacy functioning 9 / 18 GPhC Functions Establishing standards, maintaining registers, and ensuring fitness to practice for pharmacy professionals Fitness to Practice GPhC's oversight on professional conduct, investigations, and restoration to register Professional Indemnity Mandatory insurance for pharmacy professionals Revalidation Standards Set by GPhC, includes CPDs, peer discussion, and reflective account Guidelines for person-centered care, Standards for Pharmacy Professionals communication, and professional behavior Protocol for Medicines Sale Written procedures for medicine supply and treatment advice in pharmacies Salbutamol Inhalers Contains salbutamol for asthma emergencies in schools HMR 2012 Human Medicines Regulations 2012 Prescriber Restrictions New prescribers in HMR 2012, e.g., Physiotherapist Independent Prescriber Auto-injectors Adrenaline auto-injectors for emergency use in schools Advertisement Promotes prescription, sale, or use of medicinal products SPC Sets boundaries for claims in adverts, varies for different types of products Regulations Controlled by MHRA, self-regulated, protect public health MHRA Medicines and Healthcare products Regulatory Agency, oversees advertising compliance Licence Holder Ultimately responsible for advertising compliance 10 / 18 PAGB Administers OTC code of practice for pharmaceutical industry ASA Ensures adverts are legal, decent, and honest in all media Qualified Signatories Delegated responsibility for advertising compliance Complaints MHRA keeps copies for 7 years, companies for 3 years Public Health MHRA's key function is to protect public health through safe medicine use Vetting MHRA checks advertising compliance before publication Advertiser Responsibility Responsible for advert content and compliance Publisher Responsibility Has responsibility for published adverts Breaches Offense for any person to breach advertising regulations MHRA Role Checks, monitors, and enforces advertising compliance Letter to Advertiser MHRA sends potential breach notifications to advertisers Regulation Enforcement MHRA enforces regulations when advertising does not comply Advertising Regulations Rules governing the promotion of medicines to the public Civil sanctions Non-criminal penalties imposed for breaching regulations Psychomotor effects Effects on mental processes and physical movement PIL Patient Information Leaflet Comparative claims Statements comparing a product to others in the market 11 / 18 OTC Over-the-counter POM Prescription-only medicine HC professionals Healthcare professionals ADR Adverse Drug Reaction INN International Nonproprietary Name ABPI Association of the British Pharmaceutical Industry SPC indications Approved uses of a medicine as per its Summary of Product Characteristics EMC Electronic Medicines Compendium Homeopathic medicines Medicines based on the concept of treating like with like Blue Guide Guide to advertising and promoting medicines Controlled Drugs (CDs) Medications regulated under the Misuse of Drugs Act Misuse of Drugs Act (MDA) Legislation banning possession, supply, and import of CDs Misuse of Drugs Regulations (MDR) Rules permitting possession and supply of certain CDs Schedule 1 (CD Lic POM) Class of CDs needing a license for legal handling Schedule 2 (CD POM) CDs pharmacists can possess, supply, and procure Schedule 3 (CD No Register POM) CDs less likely to be misused than Schedule 2 Schedule 4 (Part I and Part II) Split into benzodiazepines and anabolic steroids Schedule 5 (CD Inv POM or P) Preparations of CDs exempt from full control Medicinal cannabis Cannabis-based products for medicinal use 12 / 18 Home Office licence Permit for lawful possession of certain CDs Pharmacist independent prescriber Authorized to prescribe and administer CDs Import and export of CDs Requires a license for certain schedule CDs Travelling with CDs Patients carrying CDs abroad may need a license Administration of CDs Authorized personnel can administer CDs based on schedules Lawful possession of CDs Various mechanisms including Home Office license Controlled Drugs (CDs) Medications regulated under specific laws for possession, supply, and administration Safe Custody Requirements ensuring secure storage of certain scheduled CDs Misuse of Drugs Regulations 1973 Legislation dictating secure storage of schedule 2 and 3 CDs Direct Personal Supervision Pharmacist oversight required when certain CDs are dispensed Denaturing Process rendering CDs irretrievable before disposal Exemption Certificate Permission to use alternative storage for CDs, granted by the police Witnessed Destruction Required for certain CDs to adjust stock levels accurately Accountable Officer Individual authorizing senior staff to witness CD destruction Incineration Method of destroying CDs after denaturing to prevent environmental harm CD Denaturing Kits Recommended tools for rendering CDs irretrievable before disposal 13 / 18 Solid Dosage Forms CD forms like tablets that should be crushed or added to denaturing kits Liquids Denaturing Process of rendering liquid CDs irretrievable using denaturing kits Home Secretary Official authorizing witnesses for destruction of certain CDs Pharmacy Stock Destruction Process of destroying pharmacy CDs witnessed for accuracy Schedule 1 Drugs Controlled substances like cannabis resin requiring safe custody Schedule 2 Drugs Controlled substances like morphine needing secure storage Schedule 3 Drugs Controlled substances like buprenorphine requiring safe custody measures CQC Regulatory body possibly requiring organizational security policies for CDs MEP Core reading material for understanding CD handling regulations Sold Secure Silver Standard Security standard mentioned in MEP for CD storage PSI 45/2010 Ministry of Justice guidance for integrated drug treatment systems Key Log Documented access to CDs for audit purposes Environment Agency Regulatory body overseeing CD disposal licenses Controlled Drugs (CDs) Medications with strict regulations for supply and management Dispensary Stock Management Proper handling and organization of medication inventory Safe Custody Requirements Rules ensuring secure storage of medications to prevent misuse 14 / 18 Patient Returns Process of patients bringing back unused medications Obsolete Stock Medications that are expired or no longer in use Destruction of CDs Disposal process for controlled drugs to prevent misuse Requisition Official request for the supply of medications Prescription Written order for the dispensing of medications CD Registers Records documenting the supply and use of controlled drugs Schedule 1 CDs Controlled drugs with specific regulations for possession Practice Advice to Pharmacists Guidelines on handling patient confidentiality and controlled drug possession Requisition Requirements Legal criteria for requesting schedule 2 and 3 controlled drugs Approved Forms Official documents required for requisitioning certain medications Emergency Supply Provision of medication without requisition in urgent situations Indelible Marking Permanent labeling on requisitions for tracking and auditing MDA Requirements Additional criteria for prescribing certain controlled drugs Prescription Validity Duration for which a prescription is legally acceptable Prescriber's Address Mandatory inclusion of prescriber's location on prescriptions Formulation Specification of the drug's physical form on prescriptions 15 / 18 Strength Potency indication for medications with multiple variants Total Quantity Complete amount of medication prescribed in both words and figures Instalment Directions Instructions for dispensing medication in multiple parts Dental Prescriptions Specific requirements for prescriptions related to dental treatment Prescriber Identification Number Unique identifier for prescribers on prescription forms Private Prescriptions Non-NHS prescriptions issued outside of healthcare institutions Controlled Drugs Register Used to account for Schedule 1 and Schedule 2 drugs received and supplied by a pharmacy. Sativex A Schedule 4 part I drug for which a CD register is recommended by the Home Office. CD Register Law Specifies class, form, and strength at the top of each page; if paper-based, it must be a bound book. Separate Sections Different classes of drugs must be in distinct parts of the CD register. Prison CD Registers Prisons have one compliant CD register, but different areas have their record books. CD Register Storage Each register must be kept at the applicable premises for at least two years. Electronic CD Registers Allowed by law, entries must be attributable, auditable, and compliant with best practice. CD Receipt Record Includes date received, supplier details, and quantity; good practice to note invoice number. 16 / 18 CD Supply Record Includes date supplied, recipient details, authority to possess, and quantity supplied. CD Register Corrections Errors must be noted with dated corrections by authorized personnel. Running Balances Help detect discrepancies; SOP should cover balance checks and discrepancy handling. Liquids Check Visual checks, periodic volume measurements, and end-bottle balance checks are recommended. Pharmacist Accountability Pharmacists are legally accountable for CDs and responsible for maintaining balances. Delegating Tasks Pharmacists can delegate tasks but remain legally accountable for CD management. POM Book Entries For private prescriptions of Schedule 2 CDs, a CD register entry suffices, but best practice includes POM book entry. Invoices Retention Invoices for scheduled 3 and 5 CDs must be kept for two years; NICE advises six years for tax checks. Technical Errors Minor typographical errors on prescriptions must be clear, indelible, and attributed to the pharmacist. Controlled Drugs Schedules Classified into 5 schedules with varying levels of control on possession, supply, and procurement. Storage Requirements Schedule 2 and 3 drugs need to be stored in a controlled drugs cupboard meeting legal standards. MDR Requirements Additional requisition and prescription demands for Schedule 2 and 3 CDs. 17 / 18 Further Reading NICE guideline NG46 and BNF provide additional guidance on controlled drugs. 18 / 18