# data[].attributes.body
- Contribute to safety surveillance of health products

- Update the package inserts with relevant warnings

- Restrict the use of affected health products.

- Alerting healthcare professionals with advisories.

- Contributing data to WHO international drug monitoring programme.

# data[].attributes.body
1.1. A pharmacist shall consider and act in the best interest of the individual patient
2.5. A pharmacist shall not discuss the therapeutic efficacy of prescriptions or provide patient counselling in such a manner as to impair confidence in the prescriber or other healthcare professionals
4. A pharmacist shall strive to achieve and maintain high professional practice standards in the promotion and provision of health services and products

# data[].attributes.headline
How should AE (adverse events) reporting be handled?  

# data[].attributes.subject
How should AE (adverse events) reporting be handled?  

# data[].attributes.body
- Every manufacturer or supplier of a therapeutic product must report a serious adverse events immediately or no later than 15 days after adverse reaction has been discovered.

- must maintain records of adverse events and retain the record for 2 years after expiry date of therapeutic product.

- This report can be made by pharmaceutical companies and healthcare professionals for various health products like vaccines, cosmetics, drug and complementary health product, etc.

Submission of AE reports can be done by CMIS module, Hardcopy forms, emails, online form and mobile-friendly adverse event reporting form.

# data[].attributes.body
7.1. A pharmacist shall embrace continuous professional development as a form of personal responsibility to ensure knowledge and skills are kept up-to-date and relevant to the field of practice

# data[].attributes.body
9.3. A pharmacist shall refrain from publicly criticising his colleagues and other healthcare professionals

# data[].attributes.body
- TP has a non-critical defect that causes temporary or medically reversible adverse health consequences.
- Dear purchaser letter to be issued within 3 days
- Recall process to be completed within 3 weeks
Examples:
Minor labelling error

# data[].attributes.body
- Critical effect causing serious adverse health consequences or death
- Within 24 hours should a Dear Purchaser Letter be issued
- Process should be completed within a week unless justified otherwise

# data[].attributes.body
Initiate recall -> Notify stakeholders -> Issue press release to update public (If necessary) -> Filling in Product recall completion form.

# data[].attributes.body
reflects the severity of defect and the impact on person’s health

# data[].attributes.body
-Patients first
-Respect for all
-Legal compliance
-High practice standards
-Fitness to practice

# data[].attributes.body
-Collaboration with healthcare professionals
-Nurturing future & new pharmacists

# data[].attributes.body
-Honesty and integrity
-Professional competence
-Research ethics

# data[].attributes.headline
Different between Adverse events, Adverse drug reaction, side effects and allergies 

# data[].attributes.subject
Different between Adverse events, Adverse drug reaction, side effects and allergies 

# data[].attributes.body
Adverse events - medical occurrence temporally associated with the use of medicinal products but not necessarily causally related (may not be caused by the drug)

Adverse Drug Reaction - a Response to a drug which is unintended  or unexpected and it is caused by the drug.

Side effects - unintended but expected effect which is caused by the drug.

Allergies - an adverse drug reaction which caused by the immune response towards the drug, like rash, hives etc.

# data[].attributes.body
It is initiated by the HSA at either a
- Wholesale Level
- Retail Level
- Consumer Level

# data[].attributes.body
This Excludes Adverse events caused by accidental or deliberate overdose and medication errors.

# data[].attributes.body
-  Permanent removal of the affected products from the market OR a temporary removal for product correction, after which the corrected products may be returned to the market for sale.

# data[].attributes.body
A guide for pharmacists/pharmacy technicians to follow in order to maintain the expected standards.

# data[].attributes.body
Involves ALL REGISTERED PHARMACISTS

# data[].attributes.body
HSA does the product recall because of the defects it has in it.
Product registrants can also initiate a product recall by informing HSA within 24 hours of the intended recall

# data[].attributes.body
- Listed therapeutic products might be Hazardous for health
- Failure to conform any claims made by manufacturer or importer
- Fail to meet requirements of Health products act.

# data[].attributes.body
Any untoward medical occurrence that may present during a treatment with a health product (western drug, medical device, vaccine, cosmetics) but which does not necessarily have a causal relationship with this treatment.

# data[].attributes.body
A statutory board under Ministry of Health

# data[].attributes.headline
Team 2 / Problem 2: Should it be Reported?

# data[].attributes.subject
Team 2 / Problem 2: Should it be Reported?