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Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
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Pharmacodynamic methods provide insights into a drug's effects on physiological processes over time and play a crucial role in understanding bioavailability and therapeutic efficacy. These methods can be broadly classified into acute pharmacological and therapeutic response approaches, each with distinct mechanisms and applications.The acute pharmacological response method directly correlates a drug's physiological effects, such as ECG or pupil diameter changes, to its time course in the body.
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Drug shortages: clinical implications and burdens - a trinational multiple-methods study including key stakeholders.

Olaf Rose1,2, Kreshnik Hoti3, Blete Isufi3

  • 1Institute of Pharmacy, Pharmaceutical Biology and Clinical Pharmacy, Paracelsus Medical University Salzburg, Salzburg, Austria.

Journal of Pharmaceutical Policy and Practice
|September 26, 2025
PubMed
Summary

Drug shortages significantly disrupt patient care across Austria, Germany, and Kosovo, impacting pharmacists and physicians. Political and economic factors, alongside regulatory hurdles, drive this crisis, necessitating coordinated solutions for drug availability.

Keywords:
Drug shortageEuropeclinical implicationsmanufacturerpatientpharmaceutical policypharmacistphysician

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Area of Science:

  • Pharmacology
  • Health Services Research
  • Public Health

Background:

  • Escalating prevalence of drug shortages in recent years.
  • Significant differences in healthcare systems across Austria, Germany, and Kosovo.
  • Need to investigate clinical implications and burdens of drug shortages in diverse healthcare settings.

Purpose of the Study:

  • To investigate the clinical implications and burdens of drug shortages.
  • To compare these impacts across three countries with differing healthcare systems.
  • To identify the root causes and contributing factors to drug shortages.

Main Methods:

  • Trinational, multiple-methods study design.
  • Utilized questionnaires and in-depth interviews with patients, physicians, pharmacists, and manufacturers.
  • Employed descriptive statistics for quantitative data and Mayring's qualitative content analysis for qualitative data.

Main Results:

  • Manufacturers face pricing pressure and inflation; mitigation strategies may increase costs.
  • Pharmacists and physicians report significant practice disruptions, with up to 50% of patient encounters affected.
  • Patients experienced moderate therapy interruptions; political factors identified as primary root causes.

Conclusions:

  • Drug shortages profoundly disrupt clinical practice and patient care in the studied nations.
  • Economic pressures, political factors, and regulatory obstacles exacerbate the drug shortage crisis.
  • Coordinated mitigation strategies are essential to address the identified causes and improve drug availability.