This column draws primarily on US experience and includes, with permission, material from the ISMP Medication Safety Alert! biweekly bulletin, published by the Institute for Safe Medication Practices (ISMP), Huntingdon Valley, Pennsylvania, USA.

News

• On May 30, 2000, the National Aeronautics and Space Administration (NASA) and the department of Veteran Affairs (VA) in the US signed an agreement committing both agencies to create a voluntary patient safety reporting system for VA health-care facilities. The voluntary reporting system is based on the Aviation Safety Reporting System (ASRS) developed for the Federal Aviation Administration and operated by NASA. ISMP Canada is currently reviewing the merits of the Aviation Safety Reporting System, and comparing the system to that used by ISMP (in the US and Canada). ISMP Canada promotes voluntary medication error reporting systems which focus on learning from direct practitioners reporting. We encourage practitioners to report interesting medication events and their experiences dealing with actual or potential errors to ISMP Canada. Such reports and comments can be made on line in the ISMP Canada web site: www.ismp-canada.org. Reports can be submitted anonymously. However, the reporter's identity, when provided does allow ISMP Canada the opportunity to clarify and request additional information. Please be assured the reporter's identity and location of the events will be held in strict confidence.
• A number of hospitals in the Greater Toronto Area have established multidisciplinary "safe medication practice committees" or working groups which are under the auspices of either the P&T Committee or the Hospital's Quality and Risk Management Committee. These hospitals include University Health Network, Sunnybrook and Women's College Health Science Centre, The Scarborough Hospital, William Osler Health Care Corporation and the Centre for Addiction and Mental Health. The mandate and terms of references focus on prevention and development of strategies to reduce medication errors. Although other health care professionals have a major role to play and contribute to this important committee, pharmacists have taken the leadership to orchestrate its establishment. ISMP Canada has committed to provide support to this patient safety initiative and will facilitate the link and network communication among these groups and others who are planning for a similar venue. (Hospitals having established similar committees are encouraged to contact David U at davidu@ismp-canada.org to share strategies and related information)

Automatic Stop Order (ASO) Policies - A Time for Review

Although automatic stop order policies help safe guard patients against unnecessary and prolonged administration of medications, they can inadvertently add to the risk for drug-related problems. This is becoming more apparent as hospitals implement electronic systems with computerized MARs. Stop-dated drugs are sometimes discontinued by the system without being reviewed.A report recently received by ISMP Canada describes a hospitalized patient diagnosed with ongoing chest pain. The patient was awaiting cardiac surgery, and prescribed enoxaparin 100 mg sc q 12h. The hospital has a 7 day automatic stop order policy for all heparin orders including enoxaparin. The medication was not reordered prior to the stop date and all the usual "system-checks" failed to catch the discontinuation of enoxaparin for this patient. Some of the contributing factors mentioned in the report included: lack of knowledge about the policy; nursing and pharmacy workload; and a weekend stop date. Fortunately, there were no negative outcomes to the patient, and through follow-up checks in place, the medication was reordered 24 hours later.Recommendations:

• Incorporate, where possible, the duration of the drug treatments when developing diagnosis-specific treatment protocols and/or pre-printed treatment orders.

  Provide ongoing education to physicians to remind them of the value of specifying the duration and/or intent of medication orders at the time of writing the order. This can obviate the need for an ASO.

  Examine processes in place for ASO notification, the timing of the notification and the process for review.

  Educate patients about their medications and the review processes. Empower them to ask questions when a medication is suddenly stopped. Empower them to request ongoing information.

• Consider the possibility where pharmacists have hospital-endorsed authority to extend or remove automatic stop dates for specified indications. Documentation of such interventions in the Health Record would also provide ongoing education.

Communication between hospitals on patients being transferred

A 15 year-old female patient was transferred from one hospital to another hospital. The accompanying document listed current medications including anti-epileptic drugs Divalproex sodium and Lamotrigine 75 mg bid. During the initial interview with the patient, she was not aware that she was on lamotrigine. Further inquiry to the originating hospital revealed that the accompanying current medication document had lamotrigine included because the computer system recorded that the drug had been started in 1998. However more consultation with the pharmacy of the originating hospital confirmed that lamotrigine was not ordered nor given during her last admission.This is of particular concern because lamotrigine needs to be started very gradually. Too rapid a dose escalation can lead to a potentially fatal skin reaction. Since Divalproex sodium inhibits the metabolism of lamotrigine, the concomitant use of both drugs requires that lamotrigine be started at 25 mg every other day. Had the recipient hospital started the patient at 75 mg po bid, it would have put the patient at serious risk.

Safe Medication Practices include confirmation of the status of high alert medications when patients are being transferred. In this case the hospital to which the patient was being transferred went a great length to find out exactly what the patient was on during her last visit to the other hospital. Practitioners when generating the up-to-date medication data from the computer system should take extra caution to retrieve data for current medications only. Last and not least, educating patients through patient discharge/transfer counseling on their current medications will empower the patient to ask questions. In this case, the patient's knowledge did help to prevent a potential serious drug related problem from occurring.

(The special feature described below is taken directly from ISMP Medication Safety Alert! Volume 5, Issue 7, April 5, 2000.)

Pain, paralysis, and knowledge of impending death marks intrathecal vincristine

PROBLEM: We received a newspaper report last week about a former police chief with Burkitt's lymphoma who received vincristine (ONCOVIN and others) intrathecally instead of methotrexate. As a result, he suffered paralysis, agonizing pain, and awareness of his own impending death, which occurred on Christmas day, 10 weeks after a neurologist administered the drug. The vincristine was intended for IV use. The potential for this tragic mix-up is well known. Warnings appear in the product labeling, drug monographs, and numerous articles in this newsletter and professional journals. Why do such needless tragedies continue to happen when they are so readily preventable?

While we have no specific information other than news reports about the above-cited error, most often, errors result when medication syringes are mixed up during the injection process. USP requires specific cautionary labeling when dispensing vincristine. A label that states, "FATAL IF GIVEN INTRATHECALLY. FOR IV USE ONLY. DO NOT REMOVE COVERING UNTIL MOMENT OF INJECTION," must be applied to all syringes by dispensers. Each syringe must be placed into an overwrap which also must have this labeling. However, some may not be aware of the labeling standard or may not know that each drug carton contains the cautionary labels and overwrap. These may be missed if staff is not specifically looking for them. Even if vincristine is properly labeled and packaged, clinical personnel may dangerously remove the drug from its overwrap in advance of IV injection. If vincristine is near an intrathecal medication during the drug administration process, the physician, focused on performing a lumbar puncture, maintaining sterility, and preventing patient movement, may overlook the syringe label and accidentally pick up the intrathecal medication. A neurologist, who may not be familiar with cancer drugs or protocols, may administer the drug. If both syringes are present, the neurologist may erroneously believe that each is to be given intrathecally.

SAFE PRACTICE RECOMMENDATION: ISMP and FDA will be increasing efforts to alert the healthcare industry about this problem and suggest solutions. We both urge you to take the following steps today to prevent accidental intrathecal administration of IV medications: 

• Never dispense an IV medication in a way that allows its entry into the physical location where an intrathecal medication is being administered. Consider administering intrathecal medications in a designated location (e.g., a treatment room) at a standard time (e.g., early morning or late evening). The pharmacy can prepare intrathecal medications immediately before they are needed and deliver the drugs to a specific location that is different from the delivery time and location of the patient's remaining therapy. 

• The list of intrathecal drugs that are administered for any disease is very small. Cytarabine, methotrexate, thiotepa, gentamicin, vancomycin, and hydrocortisone are among those used for cancer patients. Establish a list of drugs that can be administered intrathecally (or epidurally) and ban all other injectable drugs from rooms where lumbar punctures are performed.

• Require at least two health professionals to independently verify and document the accuracy of all intrathecal doses before administration. In some cases, a family member might help in the checking process.

• Wrap intrathecal drugs within a sterile bag which is then wrapped again in a sterile towel or another bag labeled for intrathecal use. Do not unwrap the package until immediately prior to injection.

• Accrediting and regulatory bodies should provide oversight to assure that facilities where chemotherapy is given have policies and procedures in place that are being followed to prevent accidental intrathecal injection of IV drugs.

David U is the Pharmacy Manager, Centre for Addiction and Mental Health, Queen's St. Site, Toronto. David can be reached at davidu@ismp-canada.org.