A Personalized Medicine Pharmacy ™

1. A Personalized Medicine Pharmacy™ Bringing personalized medicine to the community

2. Prepared by:Mr. Dipen Kalaria, B.Sc. PhmandMedical Director, Willem (Bill) Wassenaar, MDAugust 2006Pharmacy.ca311 Sherbourne St.Toronto, OntarioM5A 3Y11-800-727-5048Email: pharmacist@pharmacy.ca The authors would be glad to answer any inquiries you may have about this presentation’s content

3. What is Personalized Medicine? • The right drug; • At the right dose; • For the right person;

4. Discussion Points • Drug Development and Delivery Process • Evidence of Problems • How Patients Cope • Personalized Medicine • When to Seek Personalized Medicine Services

5. Drug Development Process • Efficacy is based on population statistics • Uniform study populations • Moderate to severe illness • Maximizes the probability of success • Medication tested in fixed strengths • Patient body size is not considered • But drugs work at specific concentrations

6. Drug Delivery Model • Emphasis is on the product not the patient • Only 1, 2 or 3 standardized strengths • Strength increments usually 100% • Prescribing focus • What is commercially available not what is the minimum actually required by a given patient

7. Is It A Problem? What is the evidence?

8. Adverse Drug Reactions • ADRs are the leading cause of hospitalizations* • 2.2 million serious cases • 100,000 deaths • 76% of ADR’s were dose dependent • Risk ratio of women to men of 1.5:1 • Other factors • Patient age • Number of drug exposures * Does not include errors in administration, non-compliance, over dosage, drug abuse & therapeutic failures Lazarou JAMA (1998) 279:1200-1205

9. The ‘Usual Dose’ Problem • Strength confused with dose • “I usually start with the 50 mg” • This could result in a dose of : • 1 mg per kilo for a 50 kg female • 0.55 mg per kilo in a 90 kg male • e.g. Cerivastatin (Baycol) • Strength range 4 fold (0.2 to 0.8 mg) • Dose range 7 fold (2 to 14 microgram/kilo)

10. Clinical Trial Exclusion Rates* • Up to 79 % of patients with a given condition are excluded from drug efficacy trials, based on the manufacturer’s exclusion criteria • Chief basis for exclusion • Illness severity too mild to show benefit over placebo • Significantly chronically ill patients * Zimmerman et al Am J Psychiatry 2005;162:1370-1372

11. Clinical Trial Drop Out Rates In patients meeting trial screening criteria: • Zyprexa: 15% discontinued treatment due to adverse events. • Paxil: 21% of patients in worldwide clinical trials discontinued treatment due to an adverse experience. • Zoloft: 15% discontinued treatment due to adverse events. CPS 36th edition

12. Major Drug Withdrawals • Cerivastatin (Baycol) • Terfenadine (Seldane) • Cisapride (Prepulsid) • Rofecoxib (Vioxx)

13. How Patients Cope • Patients suffering medication side effects typically do the following: • Try another drug in the same class • Try another drug in another class • Skip doses • Split pills in half to lower the dose • Suffer the side effects in silence • Stop therapy altogether

14. Personalized Medicine • What we do: • Provide custom strengths for individual patients • How we do it: • Unique patented technology • What we use: • Well known active ingredients • Ingredients are placed into capsules

15. Personalized Medicine Best possible benefit for the individual patient with the minimum of side effects • Side effects impact quality of life • Major problem of adherence to treatment • More humane treatment • Gently move up the dose to get the desired benefits • Minimizes the amount of drug taken

16. Personalized Medicine In Practice

17. Discontinuation Titrations Abruptly stopping some medications may cause patients to experience ‘side effects’. • May be mistaken for resurgence of illness. • Personalized Medicine provides a solution: • Paroxetine reduced by 10% per week. • Benzodiazepines reduced by 10% per month.

18. A Commercial Product’s Typical Strength Increments • Manufacturer’s medication available in strengths of 10, 20, 40, 80 mg • Each step up represents 100% increase • Is an intermediate strength adequate? • Titrate to effect: BP, Lipid profile • Minimize the amount of drug to be eliminated by liver and kidney

19. Impact of Taking A Little Less Than the Standard Strength

20. When To Seek Personalized Medicine • Family history of drug sensitivities • Personal history of medication intolerance • Lowest available strength is effective but the side effects are intolerable • Lowest strength not effective, next highest strength gives too many side effects • Taking many different medications

21. How To Use Our Service • Send us an email or call us about a particular patient and let us know what you would like to do • We will • Tell you about our experience with similar patients • Make recommendations for writing the prescription • Deal directly with the patient after you sign off

22. For More Information onPersonalized MedicinePharmacist: Mr. Dipen Kalaria, B.Sc. PhmMedical Director: Willem (Bill) Wassenaar, MDPharmacy.ca311 Sherbourne St.Toronto, OntarioM5A 3Y11-800-727-5048Email: pharmacist@pharmacy.ca Mr. Kalaria and Dr. Wassenaar are available for small group presentations to physicians, allied healthcare professionals and National/Provincial patient advocacy agencies.