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Does Your Disaster Plan Ensure Safe Medication Administration?
The number of natural disasters impacting nursing home operations in recent years has increased significantly. The Centers for Medicare & Medicaid Services (CMS) determined that the disaster plans of most nursing homes are inadequate, so they issued an emergency preparedness checklist designed to guide healthcare facility disaster planning. It requires the development of a continuity of operations plan using an all-hazards approach (e.g., hurricanes, floods, tornadoes, fire, bioterrorism, pandemic, etc.) that could potentially affect the facility directly and indirectly within the particular area of location. The checklist requires that the emergency plan ensure the safe provision of medications to residents, regardless of the type of disaster a facility may experience. (A link to information addressing additional disaster preparedness requirements effective November 2017 is provided at the end of this article.) To help facilities that experience service interruption from a natural disaster, the Center for Drug Evaluation and Research (CDER) at FDA offers the following information on the use of drugs that may be affected by fire, flooding or unsafe water, and on the use of temperature-sensitive drugs when refrigeration is temporarily unavailable due to a natural disaster. They caution that after a natural disaster, it is important to inspect all drugs. CDER provides the following guidance:
Drugs Exposed to Excessive Heat, Such as Fire - The effectiveness of drugs can be destroyed by high temperatures from a fire. If you think your medicines have been exposed to excessive heat, consider replacing them.
Drugs Exposed to Unsafe Water - Drugs exposed to flood or unsafe municipal water may become contaminated. This contamination may lead to serious health effects. We recommend that drugs-even those in their original containers with screw-top caps, snap lids, or droppers - should be discarded if they came into contact with flood or contaminated water. In addition, medicines placed in other storage containers should be discarded if the medicines came in contact with flood or contaminated water.
Lifesaving Drugs Exposed to Heat or Unsafe Water -
A drug may be needed to treat a life-threatening condition, but a replacement may not be readily available. Drugs exposed to fire or unsafe water should be replaced as soon as possible. If the drug looks unchanged - for example, pills in a wet container appear dry - the drugs can be used until a replacement is available. If the pills are wet, then they are contaminated and need to be discarded.
Drugs that Need to Be Reconstituted - Drugs that have to be reconstituted should be mixed only with purified or bottled water. Liquids other than purified or bottled water should not be used to reconstitute these products.
Drugs that Need Refrigeration - Some drugs require refrigeration (for example, insulin and certain liquid antibiotics). If electrical power has been off for a long time, the drug should be discarded and replaced. However, if the drug is absolutely necessary to sustain life (for example, insulin), it may be used until a new supply is available. Because temperature-sensitive drugs lose potency if not refrigerated, they should be replaced with a new supply as soon as possible. For example, insulin that is not refrigerated is effective for a shorter period of time than the labeled expiration date.
Insulin for Injection - Insulin from various manufacturers is often made available to patients in an emergency and may be different from a patient's usual insulin. After a disaster, patients in the affected area may not have access to refrigeration. According to the product labels from all three U.S. insulin manufacturers, it is recommended that insulin be stored in a refrigerator at approximately 36°F to 46°F. Unopened and stored in this manner, these products maintain potency until the expiration date on the package. Insulin products contained in vials or cartridges supplied by the manufacturers (opened or unopened) may be left unrefrigerated at a temperature between 59°F and 86°F for up to 28 days and continue to work. However, an insulin product that has been altered for the purpose of dilution or by removal from the manufacturer's original vial should be discarded within two weeks. Note: Insulin loses some effectiveness when exposed to extreme temperatures. The longer the exposure to extreme temperatures, the less effective the insulin becomes. This can result in loss of blood glucose control over time. Under emergency conditions, you might still need to use insulin that has been stored above 86°F. You should try to keep insulin as cool as possible. If you are using ice, avoid freezing the insulin. Do not use insulin that has been frozen. Keep insulin away from direct heat and out of direct sunlight. When properly stored insulin becomes available again, the insulin vials that have been exposed to these extreme conditions should be discarded and replaced as soon as possible.
CMS recommends maintaining at least a 7-day supply of all commonly used medications as part of your disaster planning. Your pharmacist is your best resource when developing the medication provision portion of your disaster preparedness response plan. He or she can assist with the creation of a comprehensive safe medication provision plan. When concerned about the efficacy or safety of a particular product during a natural disaster, contact your pharmacist who can provide guidance. Remember to educate your staff on the information they need to know in the event a natural disaster strikes, and periodically check to ensure all provisions of the plan remain disaster-ready.
To obtain the CMS disaster preparedness checklist and ensure your emergency planning is complete, visit
https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-12.pdf.
Obtain information on an updated CMS Final Rule addressing emergency preparedness by visiting
https://asprtracie.hhs.gov/documents/cms-ep-rule-resources-at-your-fingertip