1. To differentiate between side effects and adverse events. 2. To describe some symptoms occurring as drugs’ side effects or adverse events. 3. To familiarize with giving general advice and strong warnings.
KHOA Y DƯỢC – ĐẠI HỌC ĐÀ NẴNG KHÓA: 2020 – 2025 HỌC PHẦN: ANH VĂN CHUYÊN NGÀNH Lesson : Drug safety and regulatory affairs Objectives To differentiate between side effects and adverse events To describe some symptoms occurring as drugs’ side effects or adverse events To farmiliarize with giving general advice and strong warnings Drug safety & Regulatory affairs Drug safety (Pharmacovigilance) Regulatory affairs Collecting information and preventing of adverse effects Improving the safety Controlling the safety and efficacy of drugs After used Before used Which department is responsible for each of the following tasks Drug safety Reporting an adverse drug reaction Regulatory affairs ✓ to health authorities Submitting documents needed to ✓ obtain marketing approval for a drug Monitoring and evaluating ✓ suspected side effect Responding to a physician’s report Compiling dossiers for submission ✓ ✓ to authorities Writing the drug information for the patient ✓ Taking drugs: additional effects (beside desired effects) • An unintended reaction caused by a drug or medical treatment • Generally used by public, however, avoided by medical authorities Side effect Adverse event (adverse experience) Serious adverse event • An unwanted medical occurrence which a patient experiences during treatment • May or may not be a side effect of a drug • An adverse event that threatens life, requires or prolongs hospitalization, or results in death Match each phonetic spelling to one of the words /ˈædvɜːs/ or /ədˈvɜːs/ /ˈreɡjələtəri/ /ɔːˈθɒrəti/ /ˈmɒnɪtə(r)/ /ɪˈvæljueɪt/ /əˈpruːvl/ /səˈspektɪd/ /kəmˈpaɪl/ /ˈdɒsieɪ/ 10 /ˌhɒspɪtəlaɪˈzeɪʃn/ a evaluate b regulatory c authority d monitor e compile f approval g dossier h adverse i suspected 10 j hospitalization Put one of the vocabulary items from the box into the sentences below evaluate – hospitalization – suspected – dossiers – authorities – approval approval Is there a(n) …………………… for Molnupiravir from FDA as an effective treatment for SARS-CoV-2? dossiers Lots of ……………………… need to be submitted by the end of the day, so you'd better hurry up! evaluate Clinical trials will …………………… the effectiveness of different vaccines Put one of the vocabulary items from the box into the sentences below evaluate – hospitalization – suspected – dossiers – authorities – approval Thalidomide was immediately under investigation after its serious adverse events authorities were reported to health ……………………… suspected If you’re concerned that you have had a …………………… adverse reaction to a medicine, you may need to contact your healthcare professional hospitalization Study’s results illustrated that the number of patients requiring ………………………… was significantly lower in the fully vaccinated group Read the following doctor’s report Answer the following questions What were the patient’s symptoms before she was admitted to hospital? She fainted and had a skin rash, and inflammation; small, red, itching spots all over her body; a racing heart, a headache, and insomnia How was she treated by her physician? The physicain/doctor gave her a strong sedative and took her off the medication What was her condition when she was discharged from the hospital? She only had a mild skin irritation Were the clinical trials successful? How did the clinical trials go? ……………………………………………………………………………………………………………………… The facts neither prove nor disprove this The evidence is inconclusive ……………………………………………………………………………………………………………………… How will this affect other products which are not yet on the market? What does it mean for the products in the pipeline? ……………………………………………………………………………………………………………………… This product may or may not have caused the reaction A reaction to the product cannot be ruled out ……………………………………………………………………………………………………………………… Match the following sections with their descriptions Administrative Data biological, chemical and pharmaceutical _ documentation with manufacture, quality control and testing data Common Technical Document overview of quality, clinical and non _ clinical data Summaries Quality documentation about clinical trials and _ post-marketing information Non-clinical Study Reports general information, such as the _ marketing authorization application form, as well as product characteristics and labelling Clinical Study Reports _ study reports, pharmacology, pharmacokinetics, toxicology and references PIL – Patient information leaflet Important information for any person taking a drug can be found in the “PIL” or patient information leaflet Such information is also called the patient leaflet, patient packet or patient insert In the US, it is also referred to as a patient information sheet (PIS) or medication guide Note: In order not to be confused with “pill”, you should say each letter when you talk about PIL Read the email from the Head of Regulatory Affairs Answer the following questions What are the strong points in this department’s documentation? The strong points are its completeness and technical details How could it improve its documentation? They could improve readability and differentiate when describing frequent and rare risks by being more or less direct in language What effect could a change in the style of language have on patients? Better style could increase patient compliance Listen to the dialogue between Wendy, the senior medical writer in the Regulatory Affairs department, and Mark, a junior staff member about writing patient information leaflets (3) Before you take this product (7) Further information (6) How to store (4) How to take/use (1) Read this leaflet carefully because it contains information you need to know (5) Possible side effects (2) What the product is, and what it is used for Add the headings in the box to the PIL for MensamintTM Match the following sentence halves to complete the information from the PIL of PogoloxTM PogoloxTM may cause are allergic to any antibiotics _ Tell your doctor right away if _ your temperature continues to rise You must not operate machinery while taking this _ drug Do not take PogoloxTM if you this medicine can cause diarrhoea _ Stop use of PogoloxTM serious liver damage _ immediately Like all antibiotics, if you experience any chest pain _ General advice (GA) & Strong warnings (SW): sentences often used Giving GA Giving SW …(Drug)/this medicine may cause …(symptoms) Do not use/take …(drug)/this medicine if … You should not use/take … (drug)/this medicine if you have a history of … …(Drug)/this medicine can interact with other medicines Stop use and ask a doctor if … Like all drugs, …(drug)/this medicine can cause side effects Keep out of reach of children Use …(drug)/this medicine with caution while … Tell your doctor immediately/right away if … It is posible that you may receive …(drug)/this medicine, or an alternative may be used You must not … while taking …(drug)/this medicine Give examples of general advice and strong warnings Read the article about different classes of drugs in different countries Answer the following questions In your opinion, how high is the risk of counterfeit prescription drugs? Who should try to stop such criminal activity? The industry? The government? Should online pharmacies be banned, or more tightly regulated? ... Regulatory affairs Drug safety (Pharmacovigilance) Regulatory affairs Collecting information and preventing of adverse effects Improving the safety Controlling the safety and efficacy of drugs After... patient, the physician … … (Drug) is/is not believed to be related to the event After taking … (drug) , the patient experienced … An interaction between … (drug 1) and … (drug 2) was suspected At the... (GA) & Strong warnings (SW): sentences often used Giving GA Giving SW … (Drug) /this medicine may cause …(symptoms) Do not use/take … (drug) /this medicine if … You should not use/take … (drug) /this