Introduction to English Law and Ethical Principles

What was thalidomide originally prescribed for? Nausea from morning sickness How did the effect of thalidomide on pregnancy go unnoticed? The drug was not tested on pregnant women What were the effects of thalidomide on adults? Nerve damage Limb difference, sight loss, hearing loss, What were the effects of thalidomide on facial paralysis, and impact to internal foetuses? organs. What changes were made as a result of Changes were made to the way drugs the thalidomide scandal? were marketed, tested and approved Name a change that was made due to Drugs for humans could no longer be the thalidomide scandal. (prompt: animal approved based only on animal testing. testing) Name a change that was made due to the thalidomide scandal. (prompt: pregnancy) Drugs marketed for use of pregnant women needed proof of safety. Which law passed as a result of the thalidomide scandal? The medicines act 1968 What is the medicines act 1968? Made distinctions between POM, P and GSL medicines. For doctors to share previously unknown What was the yellow card scheme origiside effects of medications they prenally used for? scribed. What is the yellow card scheme used for Anybody can now report a side effect now? through forms or online. A treatment for leprosy, Some AIDS-reWhat is thalidomide used to treat today? lated conditions and symptoms of cancers i.e. multiple myeloma. What does ADR stand for? adverse drug reaction To control the safety, quality and efficacy What was the purpose of the Medicines of medicinal products through use of a Act 1968? system of licences and certificates. 1/4 Which part of the medicines creation process does the medicines act 1968 regulate? The entire process from the first clinical trials of a medicine through to the manufacture and supply of the medicine to the patient. Which piece of legislation did the medicines act become superseded by and after how long? It was effective for 40 years until it became superseded by the human medicines regulations 2012 after 40 years. What is the CHM and its purpose? The Commission on Human Medicines provides advice to ministers on the safety, efficacy and quality of medicines What is the EMA and its purpose? The European Medicines Agency provides advice to ministers on the safety, efficacy and quality of medicines Controls on veterinary medicines, includVeterinary Medicines Regulations 2013? ing their manufacture, advertising, marketing, supply and administration. Misuse of Drugs Act 1971? Imposes a complete ban on the possession, supply, manufacture, import and export of controlled drugs except as allowed by regulations or by licence from the Secretary of State. Misuse of Drugs Regulations 2001? Allows for the lawful possession and supply of controlled drugs for legitimate purposes; covering prescribing, administering, safe custody, dispensing, record keeping, destruction and disposal of controlled drugs. The Misuse of Drugs (Safe Custody) Regulations 1973 ? Controlled Drugs (Supervision of Man- Requires controlled drugs to be kept eiagement and Use) Regulations 2013? ther in a lockable place. Health & Care Act 2022? Makes it easier for health and care organisations to deliver joined-up care for people who rely on multiple different services. 2/4 Health Act 2006? Requires that all enclosed public places and workplaces will become smoke-free in England and Wales. Data Protection Act 2018 ? Allows you to have the right to find out what information the government and other organisations store about you. Equality Act 2010? A law introduced to give all social groups protection against discrimination. Pharmacy Order 2010? Established the General Pharmaceutical Council (GPhC), the new regulator for pharmacists, pharmacy technicians and registered pharmacy premises. Health and Safety at Work Act 1974? Law making sure that employees have safe working conditions and methods. The main laws passed by legislative bodWhat is primary legislation? *and a phar- ies i.e. the UK parliament. Example : macy related example Medicines Act 1968, Misuse of Drugs Act 1971. What is secondary legislation? A law made by ministers, who have been granted this authority by an Act of Parliament, rather than made by parliament. What is green paper in terms of law? A consultation document which is the first step in changing or creating a new law. Anyone can comment on it through the department's website. What is white paper in terms of Law? The next step. The government's prefered future policy on a subject before introducing legislation allowing the government to test public opinion and get feedback before presenting to parliament. What is the role of the parliament? (in terms of new laws) To examine and approve new laws Who can new laws be introduced by? The government, Members of Parliament or the house of lords 3/4 What is a drug tariff? The amount of money paid monthly to pharmacies for their service. What is criminal law? 4/4