If a Marketing Authorization Holder (MAH) nurtures a molecule and gives it a proper shape in form of a palatable dosage form with various types, i.e., in different strengths and route of administration(s), they also are required to keep a track-record of how the product is behaving in pharmacokinetic, pharmacodynamic and more so, pharmacogenetic pattern, once marketed.
Documenting and routing of all the product related inquiries can aid in analysis of product trend eventually with a span of its time spent in market. Simply adverse event monitoring is not a sufficient measure to comply to this dire need and the issues faced are to be addressed on a wider platform, also termed as Product information/inquiry evaluation and response.
MAHs look after their babies, whether it be medicinal or herbal medicinal products, medicated devices or vaccines etc., through the process of tracking which is popularly known as Medical inquiry or information, Call center, Product inquiry tracking and response etc.
Unless and until the product is administered across range of populations with different races and ethnicities, varied genetics, different age ranges, individual variations cannot be encountered and effectively dealt with in practice.
Similar to call centers of commodity service providers who have a developed system towards quality issues and complaints addressal and later respond/resolve those satisfactorily in a stipulated timeline, the main focus of a (medicinal) product inquiry process is to ensure the needful is performed in areas such as:
- Product quality complaints
- Questions related to product intake
- Inquiry on labeled information
- General query from the consumer
- Batch related problem(s)
- Beneficial effect not recognized before
- Drug-drug/drug-food/drug-herb interaction
- Accidental overdose
- Erroneous administration of medicinal product
- Safety concerns from Health care professionals
- Lack of efficacy information eg: probable emergence of a resistant strain to anti-microbial
- Allergic reaction of any nature
- Misuse/abuse of product
Broadly speaking, such medicinal product informational centers have been established in recent years so as to track the generation/source of inquiry and follow them to collect critical information or answer the arising concerns. After appropriate evaluation, it may undergo label variations or other alternative strategies to maintain the risk-benefit profile or simply the inquiry is recorded for track in future.
Though, the mechanism to capture has been defined (as above), the big challenge ahead is to ensure that the society in general, is aware of such a track process for medicinal product inquiries to maximize benefits of reporting and initiating appropriate actions, wherever necessary.
For further details, please view the Product inquiry trail and response
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