Thursday, January 16, 2014

Veterinary Medication Errors

Animal & Veterinary

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Veterinary Medication Errors

The FDA Center for Veterinary Medicine (CVM) works to prevent veterinary drug medication errors. A medication error, as defined by the National Coordinating Council for Medication Error Reporting and Prevention, is "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including: prescribing; order communication; product labeling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use."

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Veterinary Medication Error Causes and Public Health Consequences

CVM is responsible for monitoring and addressing issues that affect both animal and human health, including veterinary medication errors. When drug label information is misinterpreted or when one drug is mistaken for another, the treated animal’s health may be harmed. Medication errors involving animal drugs can also affect human health. For example, medication errors involving drugs used in food-producing animals could cause unsafe drug residues in human food. Also, there is a potential risk to people handling animal drugs if the drugs are handled or used improperly.
Some causes of medication errors include, but are not limited to:
  • drug names that look alike or sound alike,
  • drug labels that look alike,
  • drug labels that are unreadable due to font size or style, lack of background contrast, designs that hide information, or overcrowded information,
  • drug labels that have inadequate or inconsistent presentation of drug strength, dosage form (such as tablets or capsules), or active ingredients,
  • drug dosage devices (such as oral syringes) that are difficult to use because of poor design or inadequate directions for use,
  • use of error-prone abbreviations or symbols on written prescriptions,
  • illegible handwriting on written prescriptions, and
  • miscommunication while verbally prescribing orders.

CVM’s Role in Preventing Medication Errors

Within CVM’s Office of New Animal Drug Evaluation (ONADE), primary review divisions prospectively evaluate drug names, labeling, packaging, and product design prior to drug approval to help prevent medication errors. ONADE may also consult with CVM’s Office of Surveillance and Compliance in evaluating these aspects of the drug product. After a drug is approved and marketed, review divisions within CVM’s Office of Surveillance and Compliance monitor the post approval experience with the drug and overall safety profile, including review of adverse drug experience (ADE) reports, some of which may describe a medication error as a possible contributing factor to the ADE. Evaluation of these reports may lead to label/package design improvements and/or re-assessment of the drug name and other potential sources of error associated with the drug. In addition, CVM provides outreach about preventable veterinary medication errors to the public and veterinary professionals through various publications and presentations. Here are some of the things that CVM does to help prevent medication errors: 
  • Evaluation of Drug Names - A drug name is a critical “identifier” of every drug. Drug name confusion or misinterpretation of the drug name could lead to a medication error causing patient harm. For example, misinterpreting the drug name may cause the wrong drug to be given to the patient. When reviewing proposed drug names, CVM considers potential safety issues, such as look-alike or sound-alike names, that may result in name confusion and medication errors.
  • Review of Drug Labels and Packaging Design - The drug label is the primary way veterinarians and animal owners interact with a drug. The label communicates critical information about the drug, including:
    • proprietary (sometimes called Trade or Brand name)and established names,
      • Example: Amoxi-Tabs (amoxicillin). “Amoxi-Tabs” is the drug’s proprietary name and “amoxicillin” is its established name.
    • drug strength,
    • dosage form,
    • route of administration,
    • container quantity,
    • lot number, and
    • expiration date.
Before approval of an animal drug, CVM evaluates the drug’s labeling; from its container and carton labels, to its package insert and dosing device. We strive to identify potential problem areas, such as how the label displays and presents drug information. We may also assess the drug’s package design for user-friendliness, including instructions for use that are easily understood.
  • Review of Adverse Drug Event Reports and other sources of information - After CVM approves a drug, we continue evaluating it by reviewing available sources of information related to the post approval performance of the product including adverse drug event (ADE) reports. Some of these reports may describe medication errors as possible contributing factors to the ADEs. Based on our findings, we may ask the drug company to improve the drug’s package or label design, reassess the drug’s name, or take other actions intended to minimize potential for medication error.
  • Educational Outreach - CVM aims to increase awareness about veterinary medication errors and to educate veterinary professionals and the public about this important issue. Our outreach includes publications and presentations to the animal health industry, veterinary professional organizations, practicing veterinarians, veterinary colleges, and veterinary technicians.

Case Examples of Medication Errors

The following examples are taken from FDA case reports. The examples involve actual medication errors or situations where medication errors could have occurred. The first example describes a medication error involving human drugs; the other examples involve veterinary drugs.
Examples Involving Drug Names
  • This is an example from the FDA Center for Drug Evaluation and Research where two look-alike and sound-alike human drug names led to medication errors.
The case report described an antiepileptic drug, Keppra (levetiracetam), and an antiretroviral drug, Kaletra (lopinavir/ritonavir). Medication errors occurred despite the drug products’ major differences: Keppra and Kaletra treat different conditions; Kaletra contains two active ingredients and Keppra contains only one. Although the dosage strengths do not overlap, both drugs are available as tablets or capsules, or as oral solutions. Both drugs also share an overlapping dosing quantity (5 ml) and twice-daily administration. The similarities between the names, routes of administration, dosage form, and dosing quantity, may further increase the risk of confusion between Keppra and Kaletra. More information and examples of Keppra and Kaletra drug confusion can be found at:
  • The second example is based on a CVM case report involving two veterinary brand-name drugs; however, we have changed the names in this particular description. The example shows how two drug names can look alike when handwritten.
A veterinary pharmacist noted that two brand name drugs, “Boncenia” and “Bevenia,” look alike on written orders. Both drugs are used in one species (e.g., dogs) and have similar doses but different indications. Both drugs also have name similarities, as shown below. They have the same beginning letter and ending letters. Look-alike letters can look similar when handwritten. In this case, the letter ‘o’ can potentially look like the letter ‘e’ and the letter ‘n’ can look like the letter ‘v’.
(Example: Boncenia and Bevenia)
These name similarities and overlapping characteristics about the products (e.g. both used in dogs, both injectable) may increase the risk of confusion. In this case, the veterinary pharmacist noted the similarities and corrected his error before dispensing the drug product.
Examples Involving Labels/Packaging
  • An injectable antibiotic drug for food-producing animals has silver writing on a white container label. It was reported that it was “…difficult to read the drug information outside or in the barn when treating the animals….”
  • An antibiotic labeled for intramammary infusion in dry dairy cows was mistakenly given to lactating dairy cows. The milk from the treated cows tested positive for antibiotic residues. The report stated, “…the drug container label for the lactating dairy cow is too similar to the drug for dry dairy cattle, so can get easily confused....”
  • A veterinarian reported that he almost gave the wrong drug to his client for his cattle. The veterinarian confused a drug used to cause luteolysis in beef and dairy cattle with a drug used to prevent and treat selenium-Vitamin E deficiency in weanling calves and breeding beef cattle. He stated the drug’s packaging looked too similar.

For Consumers: Suggestions for How to Avoid Medication Errors in Your Animals

Most medication errors are preventable. Communication is one of the keys to preventing medication errors. It's not much different from what you would do for you or for your child when your doctor prescribes a drug product. If you don’t understand why your veterinarian is ordering or prescribing a drug for your animal, ask. Other questions you can ask your veterinarian are:
  • What is the name of the drug? What is it supposed to do?
  • Could it interact with other drugs my animal is currently taking?
  • What are the possible side effects and what should I do to care for my animal?
  • How do I give it? Do liquids have to be shaken before use?
  • How many times a day should I give it?
  • How much do I give each time?
  • Should I give it before, during, or after meals?
  • What if I accidentally give too much?
  • What should I do if I forget to give a dose to my animal?
  • What should I do if my animal vomits or spits it out?
  • How should I store it?
  • Should I finish giving all the medication, even if my animal seems better?
Asking questions is important, but sometimes it’s not enough. Share information about your pet with your veterinarian, especially if you are getting a new prescription or visiting that veterinarian for the first time. Here are some suggestions that might help.
  • Keep a list of drugs that your animal is taking – including over-the-counter drugs, supplements, and prescription drugs. Bring it with you and show it to your veterinarian. Discuss any drug that your animal is allergic to or that have caused problems in the past.
  • Discuss any serious or chronic health conditions that your animal may have.
Here are some steps that could help you avoid medication errors at home:
  • Read labels and follow directions.
  • Store animal drugs away from human drugs to prevent mix-ups.
  • Store animal drugs out of reach of household pets. This is especially true of flavored chewable tablets which may lead to the pet seeking and consuming the flavored tablets, which may result in potentially serious accidental overdoses.
  • Keep your animal’s drugs in their original labeled containers.
  • Do not cut, crush, or break capsules or tablets unless your veterinarian tells you to do so. If your veterinarian tells you to cut the tablet in half, use a pill cutter (available at most drugstores) to get the most accurate dose possible.
  • Do not share one animal’s drug with another unless your veterinarian says it's OK to do so.

Report Veterinary Medication Errors

A medication error may cause a serious adverse event for the treated animal patient. If a veterinary professional or an animal owner reports a serious adverse event to the drug company, the drug company is obligated to comply with the regulations in 21 CFR 514.80 (b)(2) for reporting of all serious, unexpected adverse experiences to CVM.
In other cases, a medication error may not harm the patient. Perhaps someone caught the medication error before the drug was dispensed or given to a patient. Maybe a veterinarian or an animal owner recognized the potential for label or name confusion. Although drug manufactures are not required to send medication error reports to CVM, reporting of these events to CVM by veterinarians and animal owners is encouraged, regardless of the patient outcome. This will help us monitor for safety issues associated with the drug names, labels and packaging, and implement measures to increase safe use of the drug product. 

For Industry

CVM has a list of additional terms used internally to describe product problems; as such terms do not exist in VeDDRA. Examples include problems related to manufacturing and shipping, as well as terms used to describe medication errors. These terms are now available for use in Adverse Event Report (AER) submission to CVM, should you choose to use them.

Please see ‘Veterinary Adverse Event Reporting for Manufacturers’ for information concerning the voluntary use of CVM’s internal medication error terms. Specifically, please refer to the following documents under the Supporting Document section: ‘CVM GFI #188 Guidance for Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine’ (PDF); and ‘CVM Internal Terms for Use in Veterinary ADE Reporting’ (Excel).

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