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12 Challenges to Implementing Pharmacogenomics in Your Practice
Individualization of drug therapy is the primary focus of pharmaceutical compounding as well as pharmacogenomics (PGx) testing. Over the past months (with some interruptions due to critical issues that have arisen), we have covered the basics, provided case examples, and listed a number of references and resources that can be used. One further topic needs to be briefly discussed and that involves the challenges to implementing PGx in your practice, including professional, ethical, legal, and social.
Below, we list 12 examples of the challenges to implementing PGx that we are facing today.
- Baseline knowledge of healthcare practitioners: The knowledge base of physicians, practitioners, and nurses regarding PGx is not up to par, partly because this relatively new field is just recently being taught at the universities and many practitioners have never taken the time to be adequately trained in this field.
- Setting standards: Standards should be developed for integrating PGx services into routine medication therapy management (MTM) services. Acceptable and profession-adopted standards may also alleviate some liability.
- Reimbursement: Even though MTM reimbursement is still hit-and-miss, reimbursement for PGx must be achieved, as there are additional costs involved.
- Ownership of information: Who owns the PGx data? It is on record at the laboratory, physician's office, maybe even the pharmacy, and with the patient. How can one confirm that ownership means complete control of the data and other storage sites first use and then delete the data?
- Privacy and confidentiality: Data can be stored and easily disseminated either on purpose or by accident. The relative ease of obtaining data is problematic and poses a big risk for loss of privacy.
- Information control/integrity: Information must be collected, organized, protected, and utilized in such a manner that its integrity cannot be questioned.
- Race, ethnicity, and vulnerable population testing: This may occur when an individual with a known genetic disorder or genetic polymorphism is treated differently by an employer or insurance company. It may also involve denial, limiting, or cancelling of health insurance.
- Information technology: PGx test information needs to be a part of the patient's clinical record. Pharmacists involved in PGx testing must have access to the patient's record to be most effective.
- Timing of and access to PGx testing: PGx testing should be done prior to prescribing a therapeutic regimen as appropriate. Clinicians doing PGx testing regularly should have little difficulty, but clinicians rarely doing PGx testing may find it slow to get started initially. This is where pharmacists can serve numerous physicians to speed the process along.
- Testing availability: A potential barrier to testing has been availability, however this appears to be in the process of being addressed. It is important to establish a relationship with a good laboratory.
- Extended MTM sessions: If a regular MTM session takes about 30 minutes, a session involving PGx may double the time commitment required. This would also mean an increase in what is charged for the session.
- Training and Personnel: It is important for PGx training to be provided in the pharmacy curriculum for students entering the profession and in continuing education programs for pharmacists in the profession considering getting involved with offering this service.
Summary: Are the challenges easily overcome? Not necessarily, but they can be overcome with effort and planning.
NOTE: Many thanks to the following that spent a lot of time and effort in trying to clarify the sterile filters for human use issue:
| Michael Akers, PhD | Lisa D. Ashworth, BS, RPh |
| Melanie A. Jordan, PhD | Willis C. Triplett, PharmD |
Don't forget, you can download all the documentation received from various companies at: www.CompoundingToday.com and follow the suggestions in the newsletter of June 16, 2017.
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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Tip of the Week
Knowledge (data) is power.
Data is "factual information used as a basis for reason, discussion, or calculation." Moving from a cash-based practice to a third-party pay practice is problematic, as it requires moving data from under your control to the third party's control�a loss of "power," as third parties use it for a multitude of purposes, whether we like it or not. They now have the power!
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