Steps to Implementing Pharmacogenomics (PGx) in Your Practice

1. Evaluate PGx potential
   Survey potential local market
   Consider PGx knowledge base of the healthcare community
   Consider incidence of treatment failures and toxicities
2. Acquire PGx education
   Pharmacists and staff
   Healthcare practitioners
3. Evaluate facility
   Patient database (complexity, security, etc.)
   Private conference/consulting area
   Communication options
4. Determine drugs/lab tests to be covered
   FDA labeling testing requirements/suggestions
   Initial list
   Expansion list
5. Select a laboratory
   In-house or outsourced
   Locating a PGx laboratory
6. Obtain and secure specimen
   Obtain and properly handle specimen securely
   Confidentiality requirements
   Communication of results to physicians
7. Consider economics (personnel, charges, etc.)
   Cost analysis
   Reimbursement
8. Promotion/Marketing
   Professional, Face-to-face
   Website

• PGx testing can be conducted before treatment begins, decreasing the trial and error approach for certain drugs.
• Many drugs have a high rate of toxicity or a narrow therapeutic range and the prevalence of variant alleles of relevant genes is sufficiently high to warrant the use of genetic information.
• There is sufficient evidence for a relationship between genetic factors and response or patient outcomes.
• Pharmacists and physicians can interpret results and use the information for the patient.
• Communicate the usefulness of PGx testing to physicians involved in direct patient care.
• Discuss the possibility of offering this service to physicians.

2. Education

• Get educated concerning PGx via online courses and educational seminars to establish baseline knowledge and demonstrate competencies in providing PGx consults.
• Determine level of comfort of physicians concerning PGx. If low, offer access to online courses, seminars, etc. where they can become educated.
• Communication between pharmacists and physicians is important.

3. Survey facility

• Evaluate space requirements/availability in your facility, including a private conference/consulting area, office space, and laboratory facility (if samples are obtained onsite).
• Address the electronic medical record and the computer systems utilized in the pharmacy and any modifications required to handle PGx consultations. This can involve:
      o  creating test names andcreating test names and
      o  written consultation templates
  for the electronic medical record system for each of the genes to be measured. Appropriately designed, these templates will facilitate patient specific written consultations by pharmacists for each PGx test result.
• If in a hospital, sometimes one can integrate with an already established clinical pharmacokinetics (PKs) service. This helps to resolve space issues but may require electronic medical record modification.

4. Determine drugs and tests to be covered

• In recent years, the FDA has approved the incorporation of genetic information to guide dosing in product labeling for specific drugs including mercaptopurine, irinotecan, cetuximab, trastuzumab, abacavir, clopidogrel, and warfarin. Additional FDA drug label information can be obtained at:
  (https://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/
  Pharmacogenetics/ucm083378.htm).
• Based upon medical practices in the community, one can identify drugs metabolized by polymorphic enzymes with commercially available genotyping tests.
• It is common to begin testing with a limited number of drugs and then expand the list generally to include test for the CYP2D6 gene which is involved in the transformation of up to 25% of clinically useful drugs including codeine, tamoxifen, antiarrhythmics, neuroleptics, and tricyclic antidepressants.

5. Select a laboratory

• Evaluate and select a reference laboratory, preferably one certified by CLIA, that has facilitated the transition of PGx from a research endeavor to clinical practice.

6. Procedure

• Tests require the patient's blood or other sample which is sent overnight to the selected testing laboratory.
• Results are then transmitted to the pharmacy, the pharmacy performs the consult, and then transmits the recommendation and results to the physician.
• Patient confidentiality must be maintained throughout the procedure.

7. Economics

• Conduct a cost analysis to determine the feasibility of conducting a PGx service and for each selected test.
• Determine the availability of any reimbursement.
• If in a hospital with a clinical PKs laboratory, it may be possible to include PKs with PGx testing as a function of that laboratory.

8. Promotion/Marketing

• Personal meetings with physicians utilizing well-designed PGx information and the emphasis on patient care may assist in helping treat problematic or nonresponsive patients or those that exhibit toxicities.
• Emphasize the "problem-solving" aspect of your pharmacy, both PGx and compounding.
• Place information about the availability of tests and pharmacist services on your Internet site as well as informing physicians and local hospital staffs.

Next week: PGx Basics

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

FDA-approved Pediatric Oral Formulations Cost Excessively
As the FDA approves a brand-name liquid formulation of a generic drug for use in children, costs soar. As an example, the wholesale cost of a 10-mL dose of Qbrelis (lisinopril for pediatric heart conditions) solution was 775 times more than a 10-mg lisinopril tablet. This is an extreme example, but authors of a study documented five other examples of drugs where the liquid-to-tablet cost ratio was especially high, including:

Pillbox "Reminder Gadgets" Ineffective
Three low-cost reminder gadgets do not encourage patients to stick to their medication schedules, according to a recent study in JAMA Internal Medicine. A study on this topic suggests that other interventions are needed to improve adherence, and an editorial recommended multi-component, patient-oriented adherence interventions. The study included a pill bottle strip with toggles, a digital timer cap, a standard pillbox, or a control of no device at all. A medication possession ratio greater than 80% was achieved by 15.5% of the patients in the standard pillbox group, 15.1% of the digital timer cap group, 16.3% of the pill bottle strip with toggles cohort, and 15.1% of the control group.
http://www.medpagetoday.com/primarycare/generalprimarycare/63429

Maryland State Board of Pharmacy Approves PCAB
PCAB Accreditation was approved by the Maryland State Board of Pharmacy as a means of fulfilling non-resident licensure requirements for compounding pharmacies who want to ship into the state. Additionally, Maryland approved ACHC Inspection Services (AIS). Maryland joins Oklahoma, Ohio, Florida, and Texas in approving AIS to conduct required inspections.
http://achc.org/pdf/ACHC_Maryland_AIS.pdf

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Did You Know ...

�that now is the time to get changes made for pharmacy compounding in pushback to the FDA?

Tip of the Week

It looks like now is the time to round up the forces and work towards pushback on the FDA. Their "overreach" in implementation of the DQSA related to compounding is causing untold problems in meeting patient's needs. Also, as it appears many activities will be moving back towards the states, it is time for state boards of pharmacy to be in control of their states and establish their own professional practice standards for compounding (nonsterile and sterile) as well as for a realistic and reasonable set of requirements for handling hazardous drugs.

Looking Back

Lawyers, doctors, druggists, bakers,
Mountaineers and undertakers,
Make their bristly beards behave,
By using brushless
     Burma Shave