By way of introduction to patient safety, we will look closely into 2 distinct areas of specializations that patient safety is at the core of their practice. Pharmacovigilance and Pharmacoepidemiology. Here are their definitions.
Definition #1: According to World Health Organization (WHO), Pharmacovigilance or commonly abbreviated as PV, has universally been defined as, the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
Definition #2: Pharmacoepidemiology, commonly abbreviated as PE, is defined by WHO, as the study of the use and effects/side-effects of drugs in large numbers of people with the purpose of supporting the rational and cost-effective use of drugs in the population thereby improving health outcomes.
To give a better understanding of the two specialties in day to day practice within the Pharma Industry, we will start with an activity that is expected to be performed frequently; Adverse Event, AE or Adverse Drug Reaction, ADR reporting.
Definition #3: What is an AE? An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Definition #4: What is an ADR? adverse drug reaction (ADR) is an injury caused by taking a medication.
Simply put, while PV dictates every day reporting of adverse events/reactions experienced after one takes a medicinal product, PE dictates for studies/publications, commonly known as drug utilization studies, to be made in correlation to the effects of these cumulated events in a defined population. in an effort to enhance patient safety.
Why is patient safety important to you?
Over the recent past, the Healthcare industry has been evolving by enhancing patient-centricity, meaning, more and more, the industry is rightly putting the patient’s needs at the center of every day practices. This new age of practice has been a game changer with huge improvements from the earlier practices, where the patient was the bottom of the line end user of the healthcare innovations.
More and more, the Health Authorities are churning out newer and modern regulations that are enforcing safe and quality innovations or products for its citizenry. In addition to reviewing the latest drug studies, your healthcare professionals are demanding for easier and more treatment options for you and as a result of your AE reporting, we are seeing the Pharma industry coming up with more and more innovative, new age products that are safer and patient friendly.
Additionally, we are noting the policy makers are now encompassing specialists and experts in their panels to ensure that the policies being formulated cover an all rounded patient safety aspect. And day by day, we are noting a new space being created for patient advocacy or association groups that are demanding for sound representation of different disease areas or patient aspects.
And finally, the academia has provided everyone with tools for formal training in patient-centric ways of practice and specializations.
As a result, you are now more knowledgeable in understanding your treatment options based on the immense information readily available. You as a patient, are also more empowered to use every available platform available to you, to seek better care.
What do you need to do next?
You, the patient
| Continue engaging your Healthcare professional by reporting any Adverse Event you come across from the treatment options available. |
The Pharma company
| It is a regulatory requirement for the Pharmaceutical companies to collect and report safety reports to the Health Authorities, for the products that are used in the market. Therefore, to the Pharma industry embrace quality management systems and invest in scaling up your innovations towards better collection and submission of your product safety reports. |
The Healthcare professional
| To the Healthcare professionals, do not shy away from reporting an adverse event presented to you by your patient. Adverse Event reporting does not equate to sabotaging or undermining your practice. Adverse events experienced by your patients are not your fault. Documenting and reporting of these events is the only sure way we can perform drug utilization studies for our population. |
To the Health Authorities
| To the Health Authorities, in addition to churning out regulations, also ensure that these regulations are fully and fairly implemented to your citizens. |
By way of enhancing patient-centricity in the East Africa (EA) region, PVCC Consulting is a company that was founded to offer a wide range of patient safety services that are holistic, quality, cost-effective and innovative for pharmaceutical, generic and biotechnology companies. Our founder has an unrivalled reputation in the EA Pharma sector in leading Pharmacovigilance, Pharmacoepidemiology and Regulatory aspects.
We support your company in Keeping patIents Safe and Sound.
