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.

Pharmacovigilance is the primary method used to identify hazards associated with medicinal products and with minimizing the risk of any harm that may come to patients.

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.

An adverse event is any unwanted medical occurrence in a patient who has been given a pharmaceutical product that may or may not have been caused by treatment with the product. This can be any unfavorable and unintended sign, symptom, or disease associated with the use of the product.

Any information relating to human health and/or wellbeing arising following exposure of humans to SAMI products come under Drug Safety Information. For further details, please see adverse event (AE).

We know that every drug is marketed after rigorous clinical research that outweighs its benefits over risks. But data about drug safety is still limited due to limited numbers of patients & population type studied in clinical trials. Overall safety of products is yet to establish once it comes in the market for use in large and diversified patient population. Continuous monitoring of drug safety allows to identify emergence of unknown or unexpected effects or sometime benefits of drugs. Therefore, it is vital to evaluate and monitor safety of medicines in clinical use to prevent and reduce harm to patients thereby contributing to public health.

By reporting adverse event/s for SAMI Pharmaceuticals (Pvt.) Ltd. product, you are giving us important feedback which will ultimately help us to take appropriate actions and to provide better instructions on how to use our products.

Your information will also enable SAMI Pharmaceuticals (Pvt.) Ltd. to fulfill our moral, ethical and legal responsibilities towards mankind and health authorities.

If you are concerned that you have had a suspected adverse event to a medicine, you may need to contact your healthcare professional who can advise on any treatment that may be needed. They can also report the issue to SAMI Pharmaceuticals (Pvt.) Ltd.

Anyone can report issues relating to the safety of SAMI Products to SAMI Pharmaceuticals (Pvt.) Ltd. This includes patients, care takers, other members of the public and healthcare professionals.

You can report a suspected adverse event in a number of ways:

• • 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.

To help us process your information quickly and effectively, please remember to report as much relevant information as possible of the following:

• 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.)

You need to report safety information immediately or within 24 hours of becoming aware of event.

You should report any adverse event that happens after taking a SAMI product, even if you have doubt about the medicine and event relationship. All serious and non-serious adverse events must be reported. These include but not limited to:

• 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