Adverse Drug Reactions (ADRs) and reporting to The Yellow Card Scheme

Yellow Card Scheme. Image result for yellow card scheme.

History. Drug safety testing. Commission on Human Medicines.

Related image. The Yellow Card Scheme. #PatientSafety.

Contributes to essential information required to assess risks and benefits in wider population.

Under-reporting. Animation2 MAINCOMP UK(1).

All serious reactions All suspected reactions to medicines under intensive monitoring Specific areas of interest: Children and over 65 Biological medicines Herbal/ complementary therapies Rare or delayed reactions, interactions Reactions not listed in SPC/ PIL.

Fatal. Life-threatening. Congenital abnormality. Involved or prolonged hospitalisation.

Online via the website https://yellowcard.mhra.gov.uk/.

Coronavirus Reporting Site. https://coronavirus-yellowcard.mhra.gov.uk/.

Reporter details. Patient details (initials, gender, age).

Use this crib sheet to help complete a Yellow Card if you suspect a Side Effect to a medicine Report it via a Yellow Card Side Effect suspected? Do you suspect an adverse drug reaction? Serious reaction? No Involves a black triangle medicine ( No Unlisted Involves a herbal NO Unsure To report Yes Yes Yes YOU CAN ALSO USE THE YELLOW CARO Repott a counterfeit product Report Report Report Report Report via Fake Portal The minimum information needed for completing a Yellow Card: Names otthe medicine(s) suspected to have caused the reaction For vaccines and biological medicines (including biosimilars) please include the brand name and batch number. suspected reaction(s) At least one patient identifier: ...e' Sex Age weight Initials Local identifier All Should be completed if available Reporter details Include your name and tull address *YellowCardCentreScotIand WMW. mhra. gov.ukfye Ilowcard use the Yellow Card Smartphone App Paper Yellow Cards available from: BNF. MHRAwebsite, your local pharmacy or free phone: 0800 731 6789 Additional information to supply (this information helps assess the Yellow Card): Details of the suspect medicine(s) if available. For example: Vdose v start and stop dates if known v route of administration (e.g. by mouth) v action taken with the drug - stopped, dose change. restarted, none etc. Details of the reactions if available: v a brief description of reaction v diagnosis if relevant and known v start and stop dates of reaction v seriousness (use tick boxes on Yellow Card) v treatment given if any v reaction outcome if known v details of medication error if appropriate Any additional information you have: V relevant medical history test results V other drugs taken in the last 3 months V If it is a suspected congenital abnormality, state all other drugs taken during pregnancy and date of last menstrual period if known If no futter information is available, please indicate this on the Yellow Card.

Certainty before reporting?. Image result for certainty.

The Scottish Government. CentreScotIand.

We aim to increase and improve the quality of adverse drug reactions (ADR) reporting in Scotland using the Yellow Card Scheme . Raise the profile of adverse drug reactions (ADRs) as an important safety and quality issue amongst both healthcare professionals and the public in Scotland through the delivery of training and promotional activities. Promote research that facilitates better understanding of the causes, effects and avoidance of ADRs We have freebies!!.

•YellowCard CentreScotIand Making medicines safer Home About Us Reporting Publications Drug Safety Training For Patients Links News Welcome to Yellow Card Centre Scotland This site will give you information about the personnel workjng in the Centre, as well as its main aim, which is to increase and improve the quality of adverse drug reactions (ADR) reporting in Scotland using the Yellow Card Scheme. Through its network of medicines information services throughout Scotland, YCC Scotland aims to provide local contact points to assist reporters when they are uncertain a±ut the correct steps to take in this prtxess. Complete a YellowCard Online Now! Latest News Yellow Card Reporting During the Coronavirus (COVID-1 9) Outbreak Support Yellow Card Nexplanon (etonogestrel) contraceptive implants Valproate (Epilim Y, Depakote Y) pregnancy prevention programme *Yellow Card Download the Yellow Card App Download on the App Store.

Medicims A Healthcze Regulata•y Agerx:y *Yellow Card Centre Scotland Do you suspect an adverse reaction to medication has happened? To get further information on a topic please click on the information icon within the Would you like to.....? The Scottish Government Leam about the Yellow Card Scheme and how to report Find learning, training or promotional resources What is the Yellow Card Scheme? What is the Yellow Card Centre Scotland (YCCS)? What is an Adverse Drug Reaction (ADR)? Who can report and what should be reported? What details go into a report? How to submit a report? Patients, Carers and Parents Websites Vldeos & interactive materials Posters, leaflets & information cards Face-to-face training Healthcare Professionals Websites Online learning Videos & interactive materials Posters, leaflets & information cards Face-to-face training Frequently Asked Questions and Contact Details Keep up to date- Apps, News & Twitter.

Key reporting trends April 2020 – March 2021. CentreScotIand.

1203 reports 22 reports per 100,000 population Yellow Card Reports (Scotland) 16% decrease.

10,948 reports 200 reports per 100,000 population COVID-19 Vaccine Reports (Scotland).

*Other = dentist, healthcare assistant, optometrist, medical student, radiographer, chiropodist, midwife, pre-registration pharmacist, pharmacy assistant.

Reporter trends 2016/17 to 2020/21. 2016/17 Patient Groups Pharmacy (Hospital) Pharmacy (Community) Pharmacy (Other) Doctor (GP) Doctor (Hospital) Nursing (Hospital) Nursing (Other) Other Healthcare Professional 398 183 95 44 157 280 121 119 66 2017/18 Patient Groups Pharmacy (Hospital) Pharmacy (Community) Pharmacy (Other) Doctor (GP) Doctor (Hospital) Nursing (Hospital) Nursing (Other) Other Healthcare Professional 443 170 71 55 174 255 104 87 51 2018/19 Patient Groups Pharmacy (Hospital) Pharmacy (Community) Pharmacy (Other) Doctor (GP) Doctor (Hospital) Nursing (Hospital) Nursing (Other) Other Healthcare Professional 477 136 59 91 166 241 121 84 54 2019/20 Patient Groups Pharmacy (Hospital) Pharmacy (Community) Pharmacy (Other) Doctor (GP) Doctor (Hospital) Nursing (Hospital) Nursing (Other) Other Healthcare Professional 504 164 62 87 143 195 131 76 70 2020/21 Patient Groups Pharmacy (Hospital) Pharmacy (Community) Pharmacy (Other) Doctor (GP) Doctor (Hospital) Nursing (Hospital) Nursing (Other) Other Healthcare Professional 508 161 25 70 85 158 88 63 45.

Top Reported Medicines (excluding Covid-19 vaccines) EDOXABAN INFLUENZA VACCINE =ROTAVIRUS VACCINE =SERTRALINE IVACAFTOR/TEZACAFTOR/ELEXACAFTOR.

KEEPING UP TO DATE.

SIGN UP!. MHRA Latest advice for medicines users Drug Safety Update The monthly newsletter from the Medicines and Healthcare Regulatory Agency and its independent advisor the Commission on Human Medicines Volume 15 Issue 5 December 2021 Contents Haloperidol (Haldol): reminder of risks when used in elderly patients page 2 for the acute treatment of delirium Venetoclax (Venclyxto V ): updated on tumour page 6 lysis syndrome (TLS) Dapagliflozin (Forxiga): no longer authorised for treatment of type 1 diabetes mellitus COVID-19 vaccines and medicines: updates for December 2021 Letters and medicine recalls sent to healthcare professionals in November 2021 page 10 page 13 page 15.

Screenshot Image. Yellow Card App. Screenshot Image.

Drug Analysis Profiles ( iDAPs ). Complete list of all suspected ADRs reported via YC scheme – use with caution Access via https://yellowcard.mhra.gov.uk/idap Inclusion of a particular reaction only implies causality Should not be used for determining incidence Reporting rates are influenced by seriousness of ADR, ease of recognition, extent of use.

European Database of suspected ADR reports ( EudraVigilance ).

In conclusion..... YellowCard. Stay VIGILANT. REPORT side-effects.

Questions.