1. Medicines Authority 203,Level 3, Rue D’Argens, Gzira,GZR 1368 Tel: (+356) 2343 9000 Fax: (+356) 2343 9161 postlicensing.medicinesauthority@g ov.mt Reporting side-effects and medication errors; What you need to know. “Our mission is to protect and enhance public health in Malta” ……. How You, your Healthcare professionals and the Medicines Authority can make medicines safer

2. This presentation will teach you important facts on reporting events related to your medicine(s).

3. Side-effects can be unexpected and troublesome Side effects = adverse drug reactions

4. If a medicine is used incorrectly, it may also cause troublesome and unexpected side-effects Medicine used incorrectly = medication error Medication errors happen when people in contact with medicines such as consumers or healthcare professionals, do not follow directions for taking or giving medications

5. Ways in which medications can be used incorrectly are: OVERUSE when too much or the wrong strength of a medication is taken, or taking a medication for longer than recommended. UNDERUSE when a medication is not taken when it should be. The Medicines Authority would like to know about problems with the use of medicines so we can learn from them and stop them from happening again to other people. Medication errors can occur because of several reasons; -mixing up medicine names or packaging - forgetfulness - lack of knowledge

6. To report side-effects and medication errors you need to know the following: Which medicines should you report on? What are the types of side effects and errors you should be reporting? Who should you inform about side effects? How do you report about a side effect and/or a medication error to the Medicines Authority? How does the Medicines Authority use reports about side effects and medication errors to help minimise risks?

7. Medicines to report on Prescription medicines…..need a prescription e.g. antibiotics, contraceptives, blood pressure and cholesterol medicines, insulin etc. Other examples: medicines to diagnose or treat diseases like cancer and vaccines

8. Medicines to report on Non-prescription medicines…over the counter e.g. antacids, laxatives, nicotine replacement products, some pain relievers, and cough and cold medicines, etc. Other examples are herbal products and vitamin supplements

9. Side effects vary Some side effects start soon Others take time to develop Side effects may occur Because of interaction with other medicines, foods or medical conditions Because the medicine is used incorrectly May not actually be a side effect at all

10. Which side-effects should you report? Serious side effects that result in Hospitalisation Malformation Disability Further treatment Life-threatening Death

11. Some side effects are known Talk to your doctor or pharmacist Read the patient information leaflet that comes with your medicine Contact the manufacturer Visit the Malta Medicines List www.maltamedicineslist.comwww.maltamedicineslist.com

12. Keeping track of side effects Note your observations - when a side effect started - how long the side effect lasted Note your medicines Use a notebook or computer file or a medicines card

13. Keeping track of side effects

14. How your notes help May alert health care professionals to a problem Can be a useful record for the future Can help you complete an adverse reaction report

15. A team effort You Your health care professionals The Medicines Authority

16. Concerned about a possible side effect? Inform your health care professional(s) Report to the Medicines Authority Report to the manufacturer of the medicine

17. Reporting suspected side effects and medication errors due to medicines marketed in Malta Identifiable patient Suspected medicine or health product Description of the side effect/reaction The reporter’s name and address

18. SECTION 1.1 Patient Details Identifier Age, gender, height, weight, ethnicity, area

19. SECTION 1.2 Suspected drug(s)/vaccines/blood products Name of the medicine and active ingredient (INN) List only the one(s) you suspect most Ingredients Dose and frequency Why it was prescribed (or why you took it) Date when medicine was started Date when medicine was stopped

20. SECTION 1.3 Suspected reactions Describe what happened Check off how serious each side-effect was in section 1.5 Check off the results of the side effect (ADR) in section 1.6

21. SECTION 3.0 Reporter Information Give your name, address and phone number You can report for someone else Health professional, patient? Reported to manufacturer?

22. More information about your side effect Other medicines you were taking For this event Additional relevant information Allergies, pregnancy, other illnesses Tests/Lab results Was the manufacturer notified? Is this a first report, or a follow-up report of a case

23. Medication Errors The Medicines Authority would like to know about mistakes with medicines so we can work to stop them from happening again to you and others. The information you can provide will help us do this.

24. The Medicines Authority will not keep: information that will identify you as a reporter of an error, or information that identifies healthcare staff involved in the error The form will only be used in order to see how medicines can be improved to be used in a safer way.

25. What should be reported? We're interested in learning about medication errors and near misses such as those involving; Medicine labels and packaging Names of medications The preparation and/or mixing of medicines Inadequate medication instructions

26. SECTION 2.1 Product(s) involved in medication error Medicine name ® Medicine ingredient Pharmaceutical Form e.g. tablet, suppository, injection Pharmaceutical strength e.g. 1ug, 500mg, 1g or 2000 i.u. Dose frequency, duration, route of administration e.g. 500mg three times daily, for 1 week by mouth Type of container e.g. blister pack, sachets, no container-loose strip

27. SECTION 2.2 Date medication error occurred Date medication error was discovered

28. SECTION 2.3 Describe the event, problem or medication error

29. SECTION 2.4 Where did the event occur? Nursing home Home Hospital inpatient Hospital outpatient Community pharmacy/ clinic Other ____________________

30. SECTIONS 2.5 and 2.6 Suspected cause of medication error Suspected contributing factors to the medication errors “ it could happen that your usual brand of blood-pressure medicines was changed to another brand medicine. The pharmacist verbally told you that you must take only ½ tablet of the new brand. You forget what the pharmacist said and take 1 tablet a day of this new brand for a few days which then makes you feel tired, dizzy and unwell. When you go to your doctor to find out what's wrong, he tells you that you’re blood pressure is low and realizes that a mistake has been done with the blood-pressure tablets”

31. SECTION 2.7 Was the medication error preventable?

32. SECTION 2.8, 2.9 Was any remedial action taken? Do you propose any remedial action?

33. SECTION 2.10 Did the medication error lead to an Adverse Drug Reaction (side-effect)? SECTION 3.0 name e-mail address -----------------------------------------  ------------------------------------

34. Contact us www.medicinesauthority.gov.mt/pub/adr Online reporting Paper-copy report form Contact details Post: 203, Level 3, Rue D’Argens, Gżira GŻR 1368 Phone: 23439178 Fax: 23439161 Email: info.medicinesauthority@gov.mt or knowyourmedicines.info@gov.mtinfo.medicinesauthority@gov.mtknowyourmedicines.info@gov.mt

35. Thank You