Heparin recall brings attention to policies

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Anticoagulation drugs have been in the spotlight already in the past year, primarily due to National Patient Safety Goal #3E, which targets the safe use of these drugs.

However, a new problem has emerged: Heparin bottles contaminated with oversulfated chondroitin were found at multiple facilities worldwide, from different suppliers.

This issue has brought an even higher level of attention to the handling and administering of heparin by staff members.

According to a recent statement by the FDA regarding this ubiquitous recall, the "working hypothesis is that this was intentional contamination, but this is not yet proven."

According to a memorandum from Dawn Benton, executive vice president/CEO of the California Society of Health System Pharmacists, the California Department of Public Health and Board of Pharmacy have agreed to conduct inspections of recalled heparin.

The following are items facilities nationwide should be able to present to inspectors:

  • Records of all medication recall notices
  • Compiled worksheets associated with the recall, including the lot numbers of the removed items, as well as the quantity of items quarantined to be returned to the manufacturer
  • Formal confirmation that all areas of the hospital have been examined (i.e., all departments, as well as emergency medication supplies)
  • The facility's policy and procedure for a recall
  • Any follow-up investigations for adverse drug reactions involving the recalled product during the period of time when said product was available to patients

Key standards involved

MM.4.70 is likely the most applicable standard when dealing with the heparin recall.
The standard states that medication administered by the hospital should be retrieved when a recall or discontinuation by the manufacturer or the FDA occurs for safety reasons and has three A elements of performance (EP):

EP 1: Medications, upon the hospital being informed that a medication has been recalled or discontinued, are to be retrieved and handled in accordance to hospital policy, as well as law or regulation

EP 2: The facility must notify everyone who orders, dispenses, or administers active medications of a recall or discontinuance from the FDA or the manufacturer

EP 3: Patients who are receiving the recalled or discontinued medication must be identified and informed of the recall or discontinuation

CMS' standard 482.25, pharmaceutical services, states that "the hospital must have pharmaceutical services that meet the needs of the patient and that [are] directed by a registered pharmacist to provide competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors."

Drug recalls are named under policies and procedures to minimize drug errors. Questions you should ask when addressing recall issues include:

Are there policies and procedures in place to minimize drug errors?

Do facility quality improvement activities pertain to pharmaceutical care?

Are policies and procedures reviewed and amended based on facility-generated reports of adverse drug events?

Does your facility evaluate external alerts and recommendations from national associations?

Does your facility evaluate new technologies or successful practices that have demonstrated enhanced medication safety in other organizations?

Are staff members familiar with these policies and procedures?

Are the policies and procedures periodically reviewed and evaluated to ensure that the actual implementation is occurring?

Additionally, refer to CMS standard 482.25(b), delivery of services, which states that "in order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with federal and state law."

The interpretive guidelines for this standard specify that medications dispensed by the facility should be retrieved after a recall or discontinuance.

Focus areas

The key issues surrounding recalls are as follows:

Accountability. You must have accountability within the pharmacy and other applicable departments.

Sources. Were you notified by mail, telephone, e-mail, or FDA announcement? Did it come from the manufacturer, the wholesaler, risk management, a trade publication, or the Internet? Did it come from a regulatory agency—the state pharmacy board or the department of health?

Drug locations. Identify which areas of the facility are involved, and whether any patient is currently receiving the recalled medication.

Response time. Response time must occur immediately upon notification.

Drug resources. Determine whether the product was received in your facility, and if so, how much is in-house.

In-house notification. All facilities must be informed and inspected to ensure that all recalled drugs were retrieved within a specified time frame—set a clock running to make sure this is handled properly.

Stock. Verify the stock numbers, and replace stock with a nonrecalled medication. (This is particularly relevant to the heparin recall, as there have been some concerns raised about a lack of supply following it.)

Leadership. Physicians and senior leadership may need to be involved in the event the recall is of a scale that prevents immediate replacement.

Patient identification. Notify risk management about any patient who has received the recalled drug.

Security. Make sure the recalled drug is secured and clearly segregated from other medications—this is especially important if the drug is being sent back to the manufacturer and will still be in-house until shipped.

Subsequent measures. Most recall sources will tell you what should be done with the faulty medication, such as whether you should destroy or return it.

Paperwork. All documentation involved in the recall should be kept on file for a time period specified by the facility. This is usually three to five years, but it will depend on your organizational policy.

Documentation. Document in the pharmacy and therapeutics committee (or equivalent) minutes any actions taken to deal with drug recalls, including who was notified, any patients affected, and any reports to the FDA.