



Awareness Material
Awareness Material
Frequently Asked Questions(FAQs)
on Drug Safety
What is
?
It is a SAMI Drug Safety/Pharmacovigilance program for collection, detection, assessment, monitoring, and prevention of adverse event/s from SAMI medicinal products once they are authorized to be placed in the market for patient’s use.
This program of SAMI Drug Safety works to encourage safer medicinal use by encouraging reporting of suspected adverse event/s related to any of our products including all unwanted effects or unknown benefits one may get after taking any medicine of SAMI.
This program of SAMI will assist, via continuous monitoring of drug’s safety, in building trust on overall safety & efficacy of all SAMI products and ultimately encourage safer medicinal use of SAMI quality products, benefiting Public Health.
This program is your partner for safer use of our medicines. Your valuable inputs would enable us to ensure our patients wellbeing.

This program of SAMI Drug Safety works to encourage safer medicinal use by encouraging reporting of suspected adverse event/s related to any of our products including all unwanted effects or unknown benefits one may get after taking any medicine of SAMI.
This program of SAMI will assist, via continuous monitoring of drug’s safety, in building trust on overall safety & efficacy of all SAMI products and ultimately encourage safer medicinal use of SAMI quality products, benefiting Public Health.
This program is your partner for safer use of our medicines. Your valuable inputs would enable us to ensure our patients wellbeing.
What is Drug Safety or Pharmacovigilance?
What is Drug Safety or Pharmacovigilance?
It is based on the collection, detection, assessment, monitoring, and prevention of adverse event/s from medicinal products once they are in the market for patient's use. These effects include any response that is noxious and unintended, including lack of efficacy (i.e. no therapeutic effect) with those products. Medication errors such as overdose, misuse and abuse of a medicinal product, and information on exposure to the product during pregnancy and breastfeeding, are also collected.
Pharmacovigilance is an important pillar in regulatory processes for medicines, pre-clinical, clinical monitoring and post-marketing surveillance thus ensuring the safety of pharmaceutical medicines.
- Learning more about the safety profile and quality of a drug in general population.
- Ensuring safer use of medicines as a moral and professional obligation.
- Improving prescriber and patient confidence on products.
- Providing and updating information for prescriber for better use of medicines.
Your information will also enable SAMI Pharmaceuticals (Pvt.) Ltd. to fulfill our moral, ethical and legal responsibilities towards mankind and health authorities.
- Reporting to your doctor, pharmacist or nurse who can then notify to SAMI Pharmaceuticals (Pvt.) Ltd.
- Directly reporting to National Pharmacovigilance Center (NPC), Drug Regulatory Authority of Pakistan (DRAP)
- You may report to SAMI Pharmaceuticals (Pvt.) Ltd. by using below different methods:
- Online reporting on SAMI Drug Safety Form
- By downloading our SAMI Drug Safety Form. You can e-mail completed form to safety@samikhi.com
- By calling us on +92-(021)-34383400, or you may fax @ +92-(021)-34382012
Disclaimer: We receive suspected adverse events for our products only.
- Suspected drug (name of the SAMI product involved, its dose, duration of treatment, disease for which product was prescribed by doctor, is therapy ongoing or information about any other products you have taken around the same time and other relevant details)
- Description of adverse event (description of the suspected adverse event itself, such as the signs and symptoms experienced, date the suspected adverse event started and their results/effects)
- Reporting person identifiable details (contact information of the reporter like name, telephone number, email address, specifically of the person who is reporting the issue)
- Patient who experiences the possible adverse event (initials of the person and/or other identifiers, such as gender, date of birth etc.)
- Fatal i.e. results in death
- Life threatening
- Requires in-patient hospitalization or prolongation of existing hospitalization
- Results in persistent or significant disability / incapacity
- Leads to a congenital anomaly / birth defect
- Important medical events which may jeopardize patient or may require intervention to prevent one or the other outcomes.
- Pregnancy reports (Maternal pregnancy and partner pregnancy)
- Safety information of infants due to exposure via breastfeeding
- Inappropriate use of medicine (e.g. abuse, misuse, medication error, off-label use)
- Overdose
- Lack of effect
- Occupational exposure
- Drug interactions
- Medical device incident
- Unexpected benefits
- Counterfeit or falsified medicines
- Transmission of infectious agents via the product
SAMI Drug Safety Reporting Form
For safety reporting, you may download our drug safety reporting form and email or post us on given contact.
All personal information related to the reporting of adverse events is processed in accordance with the data protection legislation.
Please learn more using the FAQs on Drug Safety for making effective reporting of adverse event.
SAMI Drug Safety Reporting Form
For safety reporting, you may download our drug safety reporting form and email or post us on given contact.
All personal information related to the reporting of adverse events is processed in accordance with the data protection legislation.
Please learn more using the FAQs on Drug Safety for making effective reporting of adverse event.
Contact Us
Your valuable inputs would enable us to ensure our patients wellbeing!
To report possible adverse event/s related to any SAMI products, you may report on SAMI Drug Safety Reporting Form or alternatively you can email or call our Drug Safety Department on contact details provided below:
+92-(0)21-34383400 (Office hours and out of office hours)
+92-(0)3364393299 (24/7 Operations)
34-C, Block-6, P.E.C.H.S,
Karachi-75350 Pakistan
Contact Us
Your valuable inputs would enable us to ensure our patients wellbeing!
To report possible adverse event/s related to any SAMI products, you may report on SAMI Drug Safety Reporting Form or alternatively you can email or call our Drug Safety Department on contact details provided below:
+92-(0)21-34383400 (Office hours and out of office hours)
+92-(0)3364393299 (24/7 Operations)
34-C, Block-6, P.E.C.H.S,
Karachi-75350 Pakistan