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Steps to Implementing Pharmacogenomics (PGx) in Your Practice
THE BASICS
From nucleated cells to functional proteins, the following graphic summarizes the general steps for NORMAL and for ALTERED proteins.
Part A is the process resulting in a "normal" protein; Part B results in an "altered" protein. The variant genotype, or allele, produces the altered protein.
The functions of these proteins (normal or altered) include:
- transporters,
- enzymes, and
- drug targets (receptors)
When the variant is present, the effect depends upon the type of variant and whether or not it was the same from each (homozygous) or different (heterozygous) parents.
The proteins of interest can (produce):
- normal function,
- enhance function,
- eliminate function, and
- reduce function
The function can be related to absorption, distribution, metabolism, and excretion (ADME) processes (Pharmacokinetics), as well as to the drug receptors (Pharmacodynamics). In other words, the alleles can alter proteins responsible for drug:
- Absorption (influx and efflux transporters),
- Distribution (influx and efflux transporters),
- Metabolism (metabolic enzymes, etc.),
- Excretion (influx and efflux transporters), and
- affinity of the receptor for the drug (drug target)
The total picture of these processes is involved in a patient's response to a drug which can be no effect, altered effect, toxicity, and even death.
Next week, we will look at definitions, nomenclature, and designations.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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News
160-mg Solid-dose Pediatric Tylenol
J&J/McNeil is transitioning to a single strength of 160 mg in the U.S., phasing out 80-mg chewables. This transition taking place throughout the year is in response to a 2011 FDA advisory committee recommendation that the FDA consider a single strength for solid pediatric products. Each manufacturer and retailer is to decide whether and when to make the transition.
http://www.pharmacist.com/article/solid-dose-pediatric-tylenol-transitioning-single-160-mg-strength
Ohio Bill May Allow Pharmacists to Substitute for High-priced Epinephrine
Responding to a national outcry about the soaring cost of EpiPen, an Ohio state legislator has introduced a bill that would facilitate competition by granting pharmacists the authority to substitute epinephrine autoinjectors without requiring a new prescription. HB 101, the Epinephrine Accessibility Act, would allow pharmacists to recommend an epinephrine product other than the one prescribed—whether from a cost, ease-of-use, or effectiveness standpoint—as long as it still meets a patient's needs. The purpose of the bill is to give patients more access to affordable options.
http://www.pharmacist.com/article/ohio-bill-would-allow-pharmacists-substitute-high-priced-epinephrine-prescriptions
FDA Warning Letter to Hospira Plant Bought by Pfizer for not Learning from Earlier Mistakes
At the time Pfizer purchased Hospira in a $15 billion deal in 2015, executives said they were well aware of Hospira's history of regulatory issues but thought the company was resolving its problems. However, the FDA obviously does not agree and sent CEO Ian Read a scathing warning letter. The agency said that Pfizer should have recognized long ago there were issues that needed addressing because the agency had cited five other Hospira plants for similar problems in four warning letters issued in 2010, 2013, 2014, and 2015.
http://www.fiercepharma.com/manufacturing/pfizer-plant-slapped-fda-warning-letter-for-not-learning-from-earlier-mistakes
Deadly Infection Risks from Hospital Floors and Sinks
Hospital floors and sinks may be contaminated by bacteria like methicillin-resistant Staphylococcus aureus (MRSA) or Clostridium difficile, according to a new study published in the American Journal of Infection Control. The research team swabbed a number of surfaces, including the floors, clothing, call-buttons, and other high-touch items, in 159 rooms at five Cleveland hospitals. The researchers also found that in 41% of these rooms, at least one high-touch object came in contact with the floor.
http://www.fiercehealthcare.com/healthcare/studies-hospital-floors-sinks-pose-infection-risk
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