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Package inserts: Are they present to guide our patients?


1 Department of Pharmacology, Indian Armed Forces Medical Services, Lucknow, Uttar Pradesh, India
2 Medical Officer, Armed Forces Medical Stores Depot, Lucknow, Uttar Pradesh, India
3 Medical Officer, Command Hospital, Lucknow, Uttar Pradesh, India

Correspondence Address:
Tejus Anantharamu,
Armed Forces Medical Stores Depot, Lucknow - 226 002, Uttar Pradesh
India
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/mjdrdypu.mjdrdypu_366_21

Background: The information regarding the prescribed medication has to be given to the patients who consume the same. Most medicines now need a valid prescription for dispensing by a registered pharmacist. This chain of medicine distribution takes away the decision-making rights of the consumers, thereby greatly increasing the responsibility of the prescribers and dispensers. The availability of Package Inserts (PIs) has been made mandatory by most agencies globally. Materials and Methods: Each saleable unit of all the available medicines in the medical stores were analyzed for the availability of the PIs. The medicines for which PIs were available were classified into those manufactured within India and outside. All the PIs were assessed for their completeness. Results: Only a minor fraction (20.9%) of the saleable units of the available medicines carried PIs. All PIs carried information on therapeutic indications including posology and method of administration. The main difference between the imported and indigenous medication PIs was with regard to information on antidotes for overdosings, list of excipients, incompatibilities, shelf life, and specific instructions for use/handling.Conclusion: The availability and quality of PIs must be checked regularly by the concerned regulators and suitable punishment clauses must be introduced through legislations to ensure all manufacturers to adhere the same. The ultimate goal of good PIs must not only be to provide information to health care professionals but also to enhance the knowledge of the healthcare consumers to make informed decision-making and thereby enhancing the quality of healthcare.


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    -  Anantharamu T
    -  Narain NS
    -  Mathur AG
    -  Roy P
    -  Gupta A
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