Personalized dosing: Tailor the medication to the patient

Joel ClaycombOne of the next big things in pharmacy over the next decade will be personalized dosing of medications. At the International Pharmaceutical Federation (FIP) conference in October, speakers at the session “Making medication unique through personalized dosing” outlined the benefits of this practice, particularly in connection with increased patient responses to therapy and the potential for reduction of harm.

Through genetic testing of individuals and the identification of specific cytochrome P450 enzyme metabolism types, pharmacists can modify the traditional “one-size-fits-all” model of practice. This revolution is likely to be aided with development of novel dosage forms and expanded use of 3-D printing.

See also: Pharmacogenomics: The right med, the right dose, every time

The role of the pharmacist

Hitoshi Sasaki from Nagasaki University Hospital, Japan, used some examples to describe the role of the pharmacist in personalized medicine. Citing reactions to nortryptilline, a commonly used tricyclic antidepressant with a wide range of potential side effects, he noted that from one patient to the next, a known CYP2D6 polymorphism can produce vastly different responses to the same dose, as well as variations in plasma concentrations. In addition, he said, with certain medications, an individual must specifically express a genetic trait in order for the medication to elicit a response, as is the case with the monoclonal antibody trastuzumab.

Sasaki emphasized the importance of healthcare pharmacists and pharmaceutical scientists educating themselves and developing appropriate communication skills to better embrace these new concepts in medicine. Because pharmacists have always been the best resource for drug information, it is essential that they be aware of these new developments and be able to identify the potential ethical, regulatory, and financial challenges that will ensue with increased use of genomics in the selection and dosage of medications.

See also: Pharmacogenomics could boost community pharmacy sales

The solid-dosage pen

Joerg Breitkreuz from Heinrich Heine University in Germany presented the concept of a solid-dosage form pen that enables the user to create an individualized dose of medication. Instead of a manufacturer producing a multitude of drug strengths, a solid-dosage pen would contain medication formulated into a “rod.” Using the solid-dosage pen, the patient would be able to slice off the appropriate dose. The rods are manufactured by a process similar to the formulation of standard tablets.

Medication rods would have expiration dating similar to that of more traditional products, although it is recommended that until further stability testing is done, the individual dose should be consumed immediately. The innovative design of the solid-dosage pen allows for flexible dosing, with less waste and mess.

3-D printing

Niklas Sandler from Abo Akademi University of Finland discussed the evolution of 3-D printing technologies and their potential for use in the manufacture of specific dosage forms for individuals. He noted that because 3-D printing will incorporate considerations such as differences in patient age, gender, ethnicity, lifestyle, and genetics, it will lead to dosing optimized beyond current norms.

With the FDA’s approval in August 2015 of the epilepsy medication Spritam, the first medication to be approved using 3-D printing technologies, the industry is much closer to the reality of personalizing medication by these means.

Implications

As pharmacogenomics gives rise to further improvements in identification of specific markers in individuals, the costs will continue to decrease and information databanks will grow exponentially. In the not-too-distant future, this will result in drug dosing based on more specific factors than a patient’s age and weight. Access to a large-scale database of genetic information for use in combination with emerging technologies will give providers the invaluable ability to select the most appropriate dose for optimal therapeutic results with minimal adverse events.

The future of pharmacy is now. While what we see developing at this moment is remarkable, it probably gives us only the slightest indication of what is yet to come.

A frequent contributor to Drug Topics, Joel Claycomb specializes in reports from far-flung locations. Contact him at jcclaycomb@gmail.com.