Microsoft word - copy of ismpcsb2009-1 - alert revatio _sildenafil_ medication incident.doc

The Institute for Safe Medication Practices Canada (ISMP Canada) is an analysis of medication error reports and ISMP Canada Safety Bulletin
ALERT: Revatio (sildenafil) Medication Incident
It is well-known to healthcare practitioners that use of nitroglycerin therapy is contraindicated in patients taking The urgency of the situation (i.e., patient with sildenafil (commonly known as Viagra). Many healthcare ischemic chest pain) and the lack of readily practitioners may be unaware that sildenafil is also
available drug references at the point of care led marketed under the brand name Revatio, for treatment
practitioners to omit the step of consulting drug of primary pulmonary hypertension or pulmonary references for pertinent information about Revatio. hypertension secondary to connective tissue disease.1 The following incident signals the need to heighten the awareness that Revatio is a brand name for sildenafil. Recommendations
A woman in her mid-50s presented to an emergency To minimize the potential occurrence of an incident department with chest pain. An electrocardiogram similar to the one described above, the following revealed some ST-T wave changes that were recommendations are suggested. (Some of these strategies strongly suggestive of cardiac ischemia. The may also be applicable to Emergency Medical Services where practitioners can administer nitroglycerin as part of a pulmonary hypertension, and her medications included Revatio. Although the patient’s home medication list was documented and reviewed, Facilities and Practitioners
nitroglycerin, among other medications, was ordered for the patient, initially for sublingual When documenting a patient’s list of home medications, include the generic name of every drug. administration, for her continuing chest pain and Consider including prompts in processes and tools elevated serum troponin T. Fortunately, the patient (e.g., emergency department cardiac assessment forms was also seen by an internist shortly thereafter; this and applicable order sets) to verify that the patient, physician recognized Revatio as a brand name for regardless of gender or age, has not recently used a immediately informed, and the nitroglycerin was Check drug references for unfamiliar drug products. discontinued. The patient experienced no adverse Readily available access to a pharmacist can assist with Recent therapy with any brand of sildenafil (Viagra, Revatio) is an absolute contraindication to initiation of any references available to healthcare providers at the point nitrate, in any form (e.g., oral, sublingual, transdermal, by of care. With thousands of medications on the market inhalation, or intravenous), because there is a risk of (and each drug entity having at least one brand name) potentially life-threatening hypotension.1 This contra- and many new drugs coming onto the market each indication is echoed in product monographs for other year, ready access to up-to-date drug information is selective phosphodiesterase-inhibiting drugs available essential for safe medication use. For example, in Canada, such as tadalafil (Cialis)2 and vardenafil electronic drug references are available for use with personal hand-held devices at the point of care. Assess opportunities for automated system-based alerts Contributing Factors
to warn practitioners about potentially lethal drug The following factors were identified as potentially combinations before medication administration. For o Facilities with automated dispensing cabinets or Exclusive use of the brand name Revatio on the patient’s medication list (without mentioning the computerized prescriber order entry systems could develop on-screen alerts requiring the practitioner to confirm, when considering use of a nitrate Practitioners, although knowledgeable about the medication, that the patient has not received or taken different indications for sildenafil, were not aware that ISMP Canada Safety Bulletin
one of the selective phosphodiesterase-inhibiting healthcare practitioners whenever they access healthcare Community Pharmacies, Physicians’ Offices, and
consumers is available from the manufacturer Outpatient Clinics
Ensure that all medication information available to patients and shared with other practitioners includes the The individual practitioner who reported this incident was the physician who prescribed the nitroglycerin. The report eloquently conveyed the concern that, unlike Viagra and consider reviewing how the generic name is other selective phosphodiesterase-inhibiting medications, presented on labels for medications dispensed, in Revatio is not a well-known brand name. Although other drug information documents provided to patients, generic medications may be marketed under different brand and on medication profiles that may be provided to names for different indications by one manufacturer, the patients or shared with other institutions or potential severity of the drug interaction between nitroglycerin, a commonly used medication for the treatment of chest pain,5,6 and Revatio (sildenafil), makes Engage patients in the medication use process by this a particularly high-risk situation. educating them about the medications they are taking, assisting them to maintain an up-to-date list of ISMP Canada has notified Pfizer, the manufacturer of medications with both generic and brand names for each both Viagra and Revatio, of this incident. In addition, drug, and encouraging them to provide the list to ISMP Canada has alerted Health Canada about this report. Acknowledgements
ISMP Canada gratefully acknowledges expert review of this bulletin by (in alphabetical order): Patti Cornish, RPh, BScPhm, Patient Safety Service, Sunnybrook Health Sciences Centre; Mary Dimeo, RN(EC), MN, Adult Nurse Practitioner,
Emergency Department, St. Michael's Hospital, Toronto; Dan Perri, BScPhm, MD, St. Joseph's Healthcare, Hamilton, Assistant Professor of
Medicine, McMaster University, Divisions of General Internal Medicine, Clinical Pharmacology, and Critical Care Medicine; John W. Senders, PhD,
Professor Emeritus, University of Toronto; Jason Volling, BScPhm, ACPR, Pharmacist, Emergency and Pharmacy Departments, Toronto Western
Hospital, University Health Network.
Revatio, sildenafil citrate tablets [product monograph]. Kirkland: Pfizer Canada Inc.; 2008 Sep 9 [cited 2008 Dec 16]. Available from: Cialis (tadalafil tablets) [product monograph]. Toronto: Eli Lilly Canada; 2008 Apr 15 [cited 2008 Dec 18]. Available from: Levitra (vardenafil hydrochloride tablets) [product monograph]. Toronto: Bayer Inc.; 2008 Apr 15 [cited 2008 Dec 18]. Available from: Revatio, sildenafil citrate tablets. Part III: Consumer information [product monograph]. Kirkland: Pfizer Canada Inc.; 2008 Sep 9 [cited 2008 Dec 16]: 40-42. Available from: American College of Cardiology / American Heart Association 2007 guidelines for the management of patients with unstable angina/non ST-elevation myocardial infarction: a report of the American College of Cardiology/ American Heart Association task force on practice management of patients with unstable angina/ non ST-elevation myocardial infraction. J Am Coll Cardiol. 2007[cited 2008 Dec 18];50(7):e31-e157. Available from: Task Force for Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes of European Society of Cardiology, Bassand JP, Hamm CW, Ardissino D, Boersma E, Budaj A, Fernandez-Aviles F, et. al. Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes. Eur Heart J. 2007[cited 2008 Dec 18];28:1598-1660. Available from: 2009 Institute for Safe Medication Practices Canada. Permission is granted to subscribers to use material from the ISMP Canada Safety
Bulletin for in-house newsletters or other internal communications only. Reproduction by any other process is prohibited without permission from
ISMP Canada in writing.
ISMP Canada is a national voluntary medication incident and ‘near miss’ reporting program founded for the purpose of sharing the learning
experiences from medication errors. Implementation of preventative strategies and system safeguards to decrease the risk for error-induced injury
and thereby promote medication safety in healthcare is our collaborative goal.
Medication Incidents (including near misses) can be reported to ISMP Canada:
(i) through the website: or (ii) by phone: 416-733-3131 or toll free: 1-866-544-7672.
ISMP Canada can also be contacted by e-mail: ISMP Canada guarantees confidentiality and security of information
received, and respects the wishes of the reporter as to the level of detail to be included in publications.

A Key Partner in the Canadian Medication Incident Reporting and Prevention System


Microsoft word - ketocam tabs_pil_eng trans_rus.doc

INSTRUCTION For medical application of the preparation KETOCAM® Registration number: Commercial name of the preparation: Ketocam® Medicinal form: film coated tablets Composition : Each film coated tablet contains: Active substance: Ketorolac tromethamine 10.00 mg. Auxiliary substances: Microcrystallic cellulose 150.50mg, Maize starch (dry) 56.00mg, Magnesium stearate

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