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Related Concept Videos

Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

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...
Dosage Regimen: Individualization01:24

Dosage Regimen: Individualization

Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
Drug Distribution: Tissue Binding01:21

Drug Distribution: Tissue Binding

Upon entering the systemic circulation, drugs can distribute into the interstitial and intracellular fluid of various tissue cells. This distribution is facilitated by the binding of drugs to different cellular components within tissues, which may lead to drug accumulation in specific areas. Drugs bound to tissue components serve as reservoirs that release free drugs back into the system, prolonging the drug's overall action. However, this accumulation can also result in local toxicity.
For...
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...

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Related Experiment Videos

[Tablet splitting: do discount contracts influence prescribing quality?].

Renate Quinzler1, Thilo Bertsche, Joachim Szecsenyi

  • 1Abteilung Innere Medizin VI, Klinische Pharmakologie und Pharmakoepidemiologie, Universitätsklinikum Heidelberg, Heidelberg, Germany.

Medizinische Klinik (Munich, Germany : 1983)
|September 23, 2008
PubMed
Summary
This summary is machine-generated.

German generic drug substitution laws may compromise tablet splitting. Discount contracts can lead to unscored tablets, impacting patient medication adherence and safety.

Related Experiment Videos

Area of Science:

  • Pharmaceutical policy
  • Drug utilization research
  • Patient safety

Background:

  • In Germany, approximately 25% of tablets are split for administration.
  • Mandatory generic substitution via discount contracts aims to reduce drug costs.
  • Potential differences in tablet splitting properties between original and generic drugs are a concern.

Purpose of the Study:

  • To investigate the impact of generic substitution under discount contracts on tablet splitting quality.
  • To assess the risk of substituting scored tablets with unscored forms or capsules.

Main Methods:

  • Analysis of prescription data from 425 ambulatory patients with polymedication.
  • Simulated drug switching based on current German discount contracts.
  • Evaluation of tablet splitting properties before and after substitution.

Main Results:

  • 24% of all prescribed tablets were intended for splitting.
  • Generic substitution was mandated for 54% of these split tablets.
  • Approximately 10% of substitutions involved replacing a scored tablet with an unscored tablet or capsule, posing splitting challenges.

Conclusions:

  • Current legislation prioritizing cost reduction may inadvertently affect medication effectiveness and patient handling.
  • Policy should balance cost-saving measures with the need for appropriate drug formulations for administration.
  • Further research is needed to ensure patient safety and adherence when generic substitution affects tablet splitting.