Medication safety during severe weather, power outages
IN THE drug (medicine) world, the quality of any medicine pretty much hinges on the acronym – SESA. What does this acronym represent? The letter S represents stability, the letter E represents efficacy, the Letter S represents safety and last, the letter A represents acceptability.
A drug product must meet all established specifications that are embodied within this acronym before it reaches the consumer. But most important, after the pharmacist has dispensed the medicine to the consumer or caregiver, it is expected that the drug product is handled, transported, stored and used in such a manner that the active ingredient contained in the product and the overall product remains safe, stable, acceptable and have the required potency to exert its biological effect (efficacy).
This article will be focusing on the stability and safety of medicines during severe weather conditions.
SEVERE WEATHER CONDITIONS AND MEDICATION MANAGEMENT
By knowing what actions to take before, during and after a hurricane or storm, you can increase your chance of survival. This, of course, includes proper medication management before, during and after a storm or hurricane has passed. Extra care in storage conditions is of particular importance, especially “if the power goes out.
A drug product (drug) must have both physical stability (retains its physical properties, including appearance, taste, uniformity) and chemical stability (chemical integrity and labelled potency within specified limits) to be of acceptable quality and deemed safe for use. Other areas of interest are: microbiological stability (sterility or resistance to microbial growth according to specified limits); therapeutic stability and toxicological stability (no significant increase in toxicity).
During severe weather conditions, the way medicines are stored is often compromised due to possible exposure to excessive heat (fire), moisture (water and humidity changes) and lack of refrigeration (power outages), all of which can speed up the rate at which a drug product breaks down.
YOUR DRUG SAFETY
The Center for Drug Evaluation and Research at the US Food and Drug Administration provides the following information on the use of drugs (medicines) that may be affected by fire, flooding or unsafe water, and on the use of the temperature-sensitive drugs when refrigeration is temporarily unavailable.
Drugs exposed to excessive
heat such as Fire: The effectiveness of drugs can be destroyed by high temperatures from fire. If you think your medicine 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, which may lead to serious health effects. If this occurs, then 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 and unsafe water: Drugs exposed to fire or unsafe water should be replaced as soon as possible once a replacement is available. 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 (made into
liquid): Drugs that have to be reconstituted (made into a liquid, using water) 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.
Temperature-sensitive drugs will lose potency if not refrigerated; therefore 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 labelled expiration date given on the packaging.
Insulin and other products in need of refrigeration (cold storage): After a disaster, patients in the affected area may not have access to refrigeration.
Ideal storage temperatures: According to the product labels from insulin manufacturers, it is recommended that insulin be stored in a refrigerator at approximately 36°F to 46°F (2 to 8°C). Unopened and stored in this manner, these products maintain potency until the expiration date on the package.
Insulin products contained in
vials or cartridges: Opened or unopened insulin may be left unrefrigerated at a temperature between 59°F and 86°F (15° to 30°C) for up to 28 days and continue to work.
ALL PRODUCTS IN NEED OF REFRIGERATION
It is recommended that you try to keep insulin and other medicines that require refrigeration as cool as possible. Cool means to store at temperature between 8°C and 15°C (46°F and 59°F) If you are using ice, avoid freezing the medication. DO NOT USE the medication, especially insulin, if it has been frozen. Keep these medicines away from direct heat and out of direct sunlight. Freezing may result in loss of medication strength or potency, or destructive alterations of product characteristics.
GENERAL MEDICATION STORAGE CONSIDERATIONS:
If you are concerned about the efficacy or safety of a particular product, contact your pharmacist, health-care provider or the manufacturer’s customer service department. Also, consult your drug product label (packaging insert) or the container, as well as the patient prescriptions labels that the pharmacist would place on the boxes or pill containers (jars and envelops) to see the recommended storage conditions for your medicines.
1. National Weather Service. Weather Safety. http://www.weather.gov/safety. Updated 2016. 2. US Food and Drug Administration. Hurricanes: Health and Safety. 2014. 3. Allen LVJ, Popovich NG, Ansel HC. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. 9th ed. Philadelphia: Lippincott Williams & Wilkins; 2011. 4. USP 33-NH 28. General notices and requirements. n.d. 5. Udesky L.: Storing your Medicine. Jan 20, 2016. https://consumer.healthday.com/e ncyclopedia/drug-center-16/miscdrugs-news-218/storing-yourmedicine-646535.html
TIECA HARRIS, MPHIL, RPH, BPHARM Registered Pharmacist and Lecturer Pharmaceutics Department School of Pharmacy, College of Health Sciences University of Technology, Jamaica