"All that glitters is not gold" ~ William Shakespeare
"All that is gold does not glitter" ~ J.R.R. Tolkien
The internet has transformed our world, with seemingly endless information at our fingertips. Unfortunately, not all information is reliable. Useful resources may remain hidden unless you know where to look. Here are some tips on finding Internet resources aimed at improving drug safety.
A patient suspects that a prescribed drug may have caused an adverse reaction. What do you say?
Honesty and transparency are fundamental, both ethically and legally, in modern healthcare. The first Canadian Guidelines on disclosure, published in 2008, recognise the patient's right to be informed when harm may have occurred during treatment. If a patient suspects that a prescribed drug may have caused an adverse reaction, what do you say to the patient initially? The guidelines state that the initial interaction should include "an expression of regret for what happened, the avoidance of blame and speculation, and the provision of emotional and practical support for the patient".1
In 2006 the Apology Act was passed in British Columbia, the first provincial legislation that specifically prevents liability arising from an apology.2,3 Legislation may differ in other provinces. The Canadian Disclosure Guidelines are available at the Canadian Patient Safety Institute website, under "Tools and Resources".
How can you keep up to date with techniques to avoid medication errors?
Subscribe to ISMP Canada's Safety Bulletins. These newsletters are free, in electronic form, to healthcare workers. They describe real-life medication errors that have occurred in Canada, with a thoughtful analysis of why they might have happened, and recommendations of how to avoid similar errors in the future. A recent bulletin described several cases in which a diluent had been administered without any active drug. One of the products was glucagon. Failure to administer the active drug would have serious consequences in a patient experiencing a hypoglycaemic reaction.
The Institute for Safe Medication Practice Canada (ISMP Canada) is a national, non-profit organization that focuses on drug-related safety problems, from anticoagulant safety to bar coding. It offers several other newsletters for a modest cost, as well as "nearly free" products. For a reasonable cost, they provide a community pharmacy medication error reporting program, a medication safety self-assessment program, and medication reconciliation kits. ISMP in the US (ismp.org) has free resources including an error-prone abbreviation list and a list of high-alert medications, and minimal-cost educational posters.
Where can you report a medication error so that others can learn from it?
In Canada, the national reporting organization for medication errors is ISMP Canada. Healthcare professionals can report online and anonymously, although providing contact information allows ISMP to follow up.
Can patients report medication errors and adverse drug reactions?
There are new Internet sites created to make it easier for patients to report adverse drug reactions and medication errors.
ISMP Canada has a new reporting service for patients at the website www.safemedicationuse.ca. In simplified language, patients are encouraged to report their own concerns about errors such as the wrong medication or a confusing label, without the involvement of a healthcare provider. This can be done anonymously, but providing as many details as possible, including contact information, increases the value of the report. They also offer a free subscription to patient-friendly newsletters.
To report an instance in which harm has occurred, Health Canada now provides a simplified form for patients to use. The "Consumer Side Effect Reporting Form" can be found at www.medeffect.ca, and either printed out and mailed in with a postage-paid envelope, or completed online. Adverse reactions due to a medication error can be reported here.
How can you keep up to date on regulatory advisories and drug withdrawals?
Most pharmacists are aware that Health Canada has a free email subscription service which simultaneously informs all subscribers about new drug safety advisories. Simply go to www.medeffect.ca and subscribe to email notices or RSS feeds to stay informed.
Where can you quickly find the current contraindications for a drug in Canada?
Contraindications help keep the patient safe, but they can change over time and vary between countries. In Canada, the best place to find the current contraindications for a specific drug is an up-to-date Canadian drug product monograph. Most of you will have access to the e-CPS, which has drug product monographs and CPhA group monographs as well as links to new Health Canada advisories. This resource provides the most up-to-date contraindication information. However, it is not free. Be careful when accessing free drug information on the internet, even from authoritative sites.
Beware of different contraindications in the U.S. compared to Canada. For example, the drug Rosiglitazone is contraindicated in patients with any level of heart failure in Canada, but only contraindicated in patients with NYHA Grade III or IV heart failure in the U.S.4,5
Beware of outdated product monographs. Health Canada's Drug Product Database now contains numerous product monographs that are freely accessible. Unfortunately, this resource is not updated as frequently as the e-CPS. For example, a recent warning concerning Saquinavir and QT prolongation was available on e-CPS and Lexi-Drugs Online within a few days, although the Product Monograph available through the DPD had not changed.
The free monographs available through the DPD can be very useful, but sometimes confusing. For example, recent evidence suggests that there may be an increase risk of myopathy in patients who take Simvastatin if they are Chinese and also take lipid-modifying does of niacin.6 To find out the details, try googling "DPD Canada", find the Simvastatin product monographs, then search for "Chinese". The information differs in different Canadian Simvastatin product monographs accessed through the DPD. Look for the latest and safest information.
How can you keep informed of drug warnings from other countries?
With our proximity to the United States, it is useful to know about safety warnings from the FDA. Often a Canadian warning or drug removal will soon follow. Anyone can subscribe to drug safety warnings from the FDA by subscribing to Medwatch Safety Alerts, which will provide information by email, text message, RSS feed and a twitter site. The UK also has a free subscription service (MHRA emails alerts).
Written by Barbara Cadario, B.Sc.(Hon), B.Sc.Phm., M.Sc., BC Drug and Poison Information Centre
References:
- Disclosure Working Group. Canadian Disclosure Guidelines. Edmonton, AB: Canadian Patient Safety Institute. 2008.
- BC Ministry of Attorney General. Apology Act Enacted. Available from: URL:http://www.ag.gov.bc.caljustice-reform-initiatives/civil-project/apology-act.htm. Accessed November 5, 2010.
- BILL 16 - APOLOGY ACT. 2006. Available from URL:http://www.leg.bc.ca/38th2nd/3rd_read/gov16-3.htm. Accessed November 5, 2010.
- Health Canada. Status of Rosiglitazone Drugs in Canada (Avandia®, Avandamet® and AvandarylTM). July 8, 2010. Available from URL:http//www.hc-sc.gc.ca/ahc-asc/media/advisories-avis_2010/2010_116-eng.php. Accessed November 8, 2010.
- FDA Drug Safety Communication: Ongoing review of Avandia (rosiglitazone) and cardiovascular safety. 2/22/2010. Available from: URL:http://www.fda.gov/Drugs/DrugSafety?PostmarketDrugSafetyinformationforPatientsandProviders/ucm201418.htm. Accessed November 8, 2010.
- FDA Drug Safety Communication: Ongoing safety review of high-dose Zocor (simvastatin). March 19, 2010. Available from: URL:http://www.fda.gov/Drugs/DrugSafety?PostmarketDrugSafetyinformationforPatientsandProviders/ucm201418.htm#AdditionalInformationforHealthcareProfessionals2. Accessed November 16, 2010.
©2011 B.C. Drug and Poison Information Centre
A version of this document was published in BCPhA's The Tablet. 2011; 19(6):22-23.
