Clinical Pharmacology & Therapeutics: topic
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Pharmacoecology Discussion
Katie Young
Wednesday, 27 February 2008 14:56 UTC
These questions relate pharmacoecology, which is the theme of March’s issue of Clinical Pharmacology & Therapeutics. Click here to see the articles!
1. What role do environmental factors, which affect pharmacokinetic and pharmacodynamic data, have in pharmacogenetic research?
2. Do scientists currently have the resources to determine key factors that affect treatment outcome or does an imbalance still exist among the importance of genetic and environmental factors?
3. Can concentration variability be minimized by avoiding concurrent medications and herbal supplements known to produce metabolic interactions for CYP450 substrates?
4. Should a physician prescribe a patient with a chronic condition such as HIV infection a less toxic, twice-daily medication such as IsentressTM, or a potentially more toxic once-daily drug such as Sustiva®?
5. Should there be consistent regulation of the efficacy claims of herbal medicines and natural health products?
6. Are current regulations adequate to ensure public safety and prevent deaths associated with supplements containing ephedrine?
7. Should an expert panel develop and oversee a system that categorizes the severity of drug interactions to help clinicians make better decisions?
8. Is the application of population-level evidence from trials to individual-level decisions too cumbersome?
9. Considering the trend toward globalization within the pharmaceutical market throughout the past decade, how has the FDA been challenged in their pursuit to ensure the safety and quality of available drugs?
10. Should drug manufacturers consider suppliers and intermediaries in addition to labeling and certification when confirming a drug’s safety?
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Replies
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1. It should depend on pharmacokinetic and pharmacodynamics properties of a certain drug. For example, a drug that is predominantly metabolized by a highly polymorphic CYP2A6, which is responsible for the metabolism of nicotine, should be affected by smoking behavior.
2. Currently, we still do not have appropriate database with enough information to predict clinical outcome or dose of a drug. We have to perform systematic and effective researches to find them. Biomarker researches have to be included.
3. If patients are treated with a drug solely metabolized by a specific CYP isoform, it is necessary to avoid the concurrent administration of drugs that are metabolized by the same isoform of CYP and also to minimize the use of herbal supplements that are considered to be contained components which are metabolized by the form of CYP or induce the CYP. For example, taking SUSTIVA with St. John’s wort (Hypericum perforatum) is not recommended as it may cause decreased levels of SUSTIVA, increased viral load, and possible resistance to SUSTIVA or cross-resistance to other anti-HIV drugs.
4. As described in the Pharmacoecology manuscript, it depends on the life style of a patient. Pharmacokinetic profiles are important to avoid the accumulation of the drugs for shift workers.
5. It may be very difficult, but need to be regulated consistently by rules to be established in the future.
6. In Japan, diet supplements are classified as foods. Therefore, the diet supplement should clear the product criteria established for foods by Ministry of Health, Labour and Welfare for approval. In general, components of therapeutic drugs such as ephedrine are not contained in the approved supplements. However, there is no criterion to check the contamination of dangerous drug components such as ephedrine and steroid.
7. It should be vary convenient for clinicians to make better decision for prescription.
8. The future population-level evidence from trial should be contained lines of information for personalized medicine including not only PK/PD/PGx but also a variety of other biomarkers.
9. It may be necessary to perform clinical trials including populations with various genetic back grounds and environment factors.
10. Drug manufacture should consider both of suppliers and intermediaries as well as labeling and certification.
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