Pharmacovigilance at Paramount Therapeutics Ltd

Paramount Therapeutics Ltd (PTL) has a vibrant and very functional Pharmacovigilance Department (PV) with well-established structures for detecting, assessing, understanding and preventing adverse drug reactions (ADR) and/or possible drug related problems. The PV department brings the available services to your consulting rooms, pharmacies and other areas for convenience and personal comfort. Regular visits to prescribers and users of medicines provide our PV experts the real time experience and information to assist in the management of ADRs. Most importantly, our PV activities connect with the Ghana Food and Drugs Authority and the world pharmacovigilance centre in Uppsala, Sweden to collate, analyze and address all ADRs. Please note the following is committed to providing quality pharmaceutical products and improving the safety of health products in Ghana. Through our comprehensive pharmacovigilance system, we are able to collect data on adverse events and carry out risk evaluations, which helps to minimize these adverse events as well as communicate effectively on them.

The World Health Organization (WHO) in 2002, defined pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.
Our pharmacovigilance system helps to prevent harm from adverse events, promotes the safe and effective use of medicinal products, ensures public confidence and contributes to patient/customer safety.

What To Report

We continue in our efforts to improve the quality of our products as well as ensure the safety of all customers. We therefore entreat all customers to report all issues related to adverse events/reactions and product quality.

• ADRs resulting from prescription medicines and over the counter medicines

• Drug abuse, drug overdose, drug interaction.

• Quality defects of medicinal product

• Suspected counterfeit

• Therapeutic ineffectiveness

Adverse Event (AE)

An adverse event is another name for an adverse drug reaction or an adverse effect of a drug. This can be described as any unexpected or dangerous reaction to a drug or any unwanted effect caused by the administration/use of a drug. The start of the adverse event/ reaction may be sudden or develop over time and must be reported immediately.

Some examples of such events/reactions are:

• Skin rash

• Loss of weight

• Shortness of breath

• Dizziness

• Headache

• Nausea

• Back pain

• Blurred vision

• Hair loss

• Allergic reactions etc.

Product Quality Complaints (PQCS)

At PARAMOUNT THERAPEUTICS (PTL), quality is our priority! Our mission to provide quality and affordable medicine demonstrates our level of commitment to quality. This commitment to quality extends to all products we import, market or distribute. We therefore attach great importance to product quality complaints.

With our robust quality assurance system, which covers all aspects our operations, we are able to minimize issues of product quality to a great extent. However, product quality issues may occur during the manufacturing, packaging, release testing, stability of the product, storage or distribution of the product.

Product Quality Complaints (PQCs) are any possible failure of a drug to meet any of its specifications. Some examples of PQCs are: packaging errors such as broken cap, broken bottle, missing batch/lot number, missing expiration date, change in colour, volume or clarity of the product (such as small particles found in an originally clear product), suspected counterfeit or malfunctioning of a device etc. All the above product quality issues together with other product quality issues must be reported immediately.

What information is needed to report

In the unfortunate instance of adverse events/reactions or product quality complaints, below is the information the reporter must provide to PARAMOUNT THERAPEUTICS LTD (PTL):

• The name of the product/any PTL distributed product/any product purchased from PTL

• The Complaint (Nature of the complaint/details of complaint)

• Contact details of the patient

• Contact details of the reporter

Do not hesitate to contact any member of our Quality Assurance team on the contacts above or visit our office to lodge all complaints.

We take all complaints seriously and follow up on all complaints to guarantee customer satisfaction.

Kindly pick a PV FORM from any of our branches or any of our Pharmacists, sales or marketing representatives

• You can also download a copy from our website www.paramountghana.com

• Fill the form appropriately

• Call our PV LINE: +233 504615240/ +233 593330849 for the necessary assistance

• Submit filled form via WhatsApp to our PV line or by email to our address: admin@paramountghana.com

• You can also download the Ghana FDA mobile app MedSafety to aid in your adverse drug reporting

• Alternatively send the fiIled form directly to our PV / Quality Assurance team at Paramount Therapeutics Ltd, 61-westloop street, Tesano, Accra to lodge all complaints.

We take all complaints seriously and follow up on all complaints to guarantee customer satisfaction.