Jeff Morrison Director, Government Relations and Public Affairs

1. Impact of Drug Shortages in Canada and the US International Summit on Medicines ShortageJune 20-21, 2013Toronto, Ontario, Canada Jeff Morrison Director, Government Relations and Public Affairs Canadian Pharmacists Association

2. Overview of Presentation • Review of CPhA survey data – December 2010 • Review of CPhA/Canadian Medical Association/Canadian Society of Hospital Pharmacists data – January 2013 • Snapshot of relevant US data • What has been done in Canada regarding shortages? • Questions?

3. Impact of Drug Shortages – CPhA Survey (December 2010) IMPACT ON PROVIDERS • During your last shift, did you have trouble locating a medication to fill a prescription (81% yes); Median number – 3. • In the last week, did you have trouble locating a medication (93% yes); Median number – 10. • During one shift how much time do you spend on shortages (average – 30 minutes, but included many hours). IMPACT ON PATIENTS • Do you think your patients’ health outcomes have been adversely affected? (70% yes). Reasons how: • Disruption in continuity of care • Alternative drugs are less effective, side effects, or no alternative available • Patients have stopped taking medications • Have your patients been inconvenienced in any way as a result of shortages? (91% yes) • More waiting, calling, physician visits • Frequent changes to medication, causing confusion • Increased cost, particularly when alternatives are not covered by drug plans or only brand available.

4. Top 10 Drugs in Short Supply (December 2010) Top 10 Drug Shortages 2010 - National: (n=825) • Amitriptyline (n=164) • Cephalexin (n=109) • Metoclopramide (n=54) • Clonidine (n=45) • Methotrimeprazine (n=43) • Diltiazem (n=32) • Tetracycline (n=30) • Amoxicillin + Clavulanate (n=28) • Hydralazine (n=26) • Metronidazole (n=19) Note: As for June 18, 2013, www.drugshortages.ca contained approximately 300 listings.

5. Impact of Drug Shortages – CPhA, CSHP, CMA Survey (January 2013) Impact on Patients CMA – 64% stated drug shortages had consequences for patients. CSHP – 78% agreed they are negatively impacting patients; 60% agreed patients had been inconvenienced; 59% agreed care to patients was compromised. CPhA – 91% agreed patients were inconvenienced; 51% agreed care had been compromised or patients suffered from adverse events. How? • Delays in treatment, or treatment stopped • Extra cost associated with alternative medication • Received a less effective medication or alternative • Extended hospital stays • Original condition worsened • Patient admitted to hospital

6. Impact on Practitioners – CPhA, CSHP, CMA Survey (January 2013) Impact on Practitioners • CMA – 67% stated shortages were having a negative impact on their practice • CSHP – 76% reported a “significant” impact on workload, while 20% stated shortages had “somewhat” of an impact. • CPhA – 75% reported shortages were having a “significant” impact on their practice, while 24% stated they were having “somewhat” of an impact. How? • Pharmacists and pharmacy technicians being reassigned to drug shortage-related activities, moving away from patient care. • Increases in time to research or consult with other health providers to source alternatives. • Increase in forms to complete (eg, insurance claims) • Increases in length of patient visits due to substitution concerns.

7. US Data on Impacts • Premier Healthcare Alliance estimates the cost to US hospitals of shortages at $416 million - $200 million to purchase more expensive generic drugs; $216 million in labour costs. • This does not include “grey market” pricing (thereby making real cost much higher). • “Incidences of shortage-related patients deaths have been reported in all healthcare practice settings in the past 15 months and at least 15 deaths have been attributed to shortages”. (Associated Press article, November 2011) • Similar patient outcomes as those found in Canada.

8. US Anecdotes – Institute for Safe Medication Practices – April 2012 • Unfamiliarity with brevital sodium (methohexital), used as a substitute for propofol, resulted in a serious dilution error during reconstitution of the powder. The patient ultimately received a massive overdose of the drug and died despite resuscitation efforts. • A cancer patient had progression of her disease, possibly hastening her death, because she could not complete treatment with doxorubicin due to a shortage. It was too late to switch to another protocol. • During a shortage of duanorubicin, children received induction treatment for ALL or AML (acute myeloid leukemia) with doxorubicin (typically not used in children) and experienced severe mucositis and gastrointestinal bleeding.

9. What Has Been Done / Is Being Done in Canada? • Creation of a national drug shortages reporting system – www.drugshortages.ca (Enhancements being planned, such as addition of therapeutic alternative information, better promotion). • Creation of a “Drug shortage response protocol” by federal/provincial stakeholder committee. • More wholesalers / end-users requiring multi-sourced product. • House of Commons motion and Parliamentary Committee report in June 2012 called for a series of recommendations (some are being implemented, others not). • Expansion in scope of practice for pharmacists across jurisdictions to better equip them to deal with shortages. • Industry is investing to increase manufacturing capacity. • This international conference!

10. Merci/Thank you! Jeff Morrison Director, Government Relations and Public Affairs jmorrison@pharmacists.ca (email) (613) 523-7877, x386 (phone) www.pharmacists.ca