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Related Concept Videos

Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

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Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
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Drug Classes and Categories01:25

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Drugs can be classified according to their chemical composition or their intended therapeutic application. For instance, anti-infective agents that possess the ability to eliminate pathogens or suppress their growth and reproduction can be grouped based on the organisms they target or their chemical structure. Furthermore, drugs can be divided into prescription, nonprescription, or controlled substances. Prescription medications, such as antibiotics, require oversight from a licensed healthcare...
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Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

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Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
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Sedatives and Hypnotics Drugs: Miscellaneous Agents01:17

Sedatives and Hypnotics Drugs: Miscellaneous Agents

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Sedatives and hypnotics encompass a wide range of substances, each with its unique mechanism of action, uses, and potential adverse effects.
Melatonin congeners like ramelteon (Rozerem) and tasimelteon (Hetlioz) selectively bind to melatonin receptors (MT1 and MT2) and thus mimic the actions of melatonin, a hormone that regulates sleep-wake cycles. Tasimelteon is primarily used for non-24-hour sleep-wake disorder, common in blind patients. They are also used to treat conditions like insomnia...
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Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

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As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
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Unlicensed medicines.

Richard Griffith1

  • 1Senior Lecturer in Health Law at Swansea University.

British Journal of Nursing (Mark Allen Publishing)
|September 27, 2019
PubMed
Summary

This discussion covers legal aspects of providing unlicensed medicines for patients with special needs. It explores the regulatory framework governing the supply and administration of these treatments.

Area of Science:

  • Health Law
  • Medical Ethics
  • Pharmaceutical Regulation

Background:

  • The use of unlicensed medicines presents unique legal and ethical challenges.
  • Existing regulatory frameworks may not adequately address the special needs of certain patients.
  • Ensuring patient safety while facilitating access to potentially life-saving treatments is a key concern.

Purpose of the Study:

  • To analyze the current legal landscape surrounding the supply and administration of unlicensed medicines.
  • To identify legal considerations for healthcare professionals and institutions.
  • To explore potential legal pathways for meeting special patient needs with unlicensed medications.

Main Methods:

  • Legal analysis of relevant statutes, case law, and regulatory guidance.

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  • Review of ethical principles in medical practice.
  • Discussion of comparative legal approaches.

    • Main Results:

    • The supply and administration of unlicensed medicines are subject to complex legal requirements.
    • Key legal principles include patient consent, professional responsibility, and regulatory oversight.
    • Deviations from standard licensing procedures require careful justification and risk management.

    Conclusions:

    • A robust legal framework is essential for the safe and ethical use of unlicensed medicines.
    • Healthcare providers must navigate a nuanced legal terrain to meet special patient needs.
    • Further clarification and potential legislative updates may be beneficial to address evolving challenges.