A strong pharmacovigilance and medication safety system is one of the key requirements for effective implementation of drug regulations. However, many developing countries even lack the most basic pharmacovigilance systems to ensure the safety of pharmaceuticals, and even in those that do, active support from regulators, healthcare professionals, and other relevant stakeholders is also missing. The registered medications in Pakistan are approximately between 76,000 and 88,000, out of which many possess minor therapeutic benefit over others, or are available in multiple different brands with varying prices and quality. To effectively combat the major problems of black-marketing and counterfeit medications, which lead to fictitious shortages in Pakistan, effective market vigilance is required. Although Pakistan has extensive regulations regarding the licensing of drug production facilities and registration of drugs, the implementation of these regulations is dubious resulting in poor quality assurance, increased drug expenditure, and irrational prescribing practices. Moreover, lack of baseline data, which can assist action on prioritized policy concerns, is also the missing link. Most of the pharmaceutical research focuses on rational prescribing whereas policy, supply side, and financing are largely unexplored fields. In order to establish a reliable and efficient healthcare system, effective pharmacovigilance programmes must be designed and placed into action to guarantee ongoing monitoring of the safety concerns of the marketed drugs.

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Pharmacovigilance in Pakistan: A Neglected Link

  • Madeeha Malik,
  • Azhar Hussain

摘要

A strong pharmacovigilance and medication safety system is one of the key requirements for effective implementation of drug regulations. However, many developing countries even lack the most basic pharmacovigilance systems to ensure the safety of pharmaceuticals, and even in those that do, active support from regulators, healthcare professionals, and other relevant stakeholders is also missing. The registered medications in Pakistan are approximately between 76,000 and 88,000, out of which many possess minor therapeutic benefit over others, or are available in multiple different brands with varying prices and quality. To effectively combat the major problems of black-marketing and counterfeit medications, which lead to fictitious shortages in Pakistan, effective market vigilance is required. Although Pakistan has extensive regulations regarding the licensing of drug production facilities and registration of drugs, the implementation of these regulations is dubious resulting in poor quality assurance, increased drug expenditure, and irrational prescribing practices. Moreover, lack of baseline data, which can assist action on prioritized policy concerns, is also the missing link. Most of the pharmaceutical research focuses on rational prescribing whereas policy, supply side, and financing are largely unexplored fields. In order to establish a reliable and efficient healthcare system, effective pharmacovigilance programmes must be designed and placed into action to guarantee ongoing monitoring of the safety concerns of the marketed drugs.