If you think medication safety means showing up in the supply room with a clipboard to count narcotics and flag outdated drugs every now and again, think again. Here are 10 tips that go above and beyond routine inspections, counts and expiration dates.
1. Intermingling. When I'm reviewing a facility for medication safety, one practice or bad habit that always sends up a red flag is the intermingling of medications. Casually stocking different drugs in the same bin, compartment or tray is the root of many avoidable errors. Those who stock drug supply areas, including PACU storage, anesthesia carts and especially code carts, should segregate drugs.
2. Tagging the bag. I've seen nurses write identifying information directly onto the surfaces of flexible IV bags with "Sharpie"-brand pens or other permanent markers. But I would strongly advise against this. Not only have there been reports that chemicals in the ink can leach through the plastic into the IV fluid, but I'd also have concerns about the legibility and potential smudging of the markings. The best practice is to use conventional, pre-marked labels to indicate the patient's name, any additives, the time the IV was started and other information.
3. Patient's own. I'm often asked if patients should be allowed to bring their own personal medications into a surgical facility and use them there. My answer is "yes," provided the meds meet all the following ground rules:
- they're items that the facility doesn't stock;
- there's a logical need for their use during the perioperative stay;
- they're FDA-approved drugs;
- there's a valid, signed order from an authorized prescriber in the medical record;
- they have reasonable integrity, such as in-date status, and are properly labeled; and
- they're entered into the medical record, as you would enter any other prescribed or administered medication.
4. Recall vigilance. Drug recalls go straight to the heart of our safety and legal responsibilities. We must be able to insulate our patients and all stakeholders from potentially defective products and to do so promptly. Here's a framework for an effective recall management policy. Designate a binder or folder for recall announcements and log your receipt of, and any action taken on, each recall. An empty folder means that your system is flawed. Most vendors and distributors will send you their recall policies. Keep these in your recall binder. One wholesaler even provides a written commitment that you'll be promptly advised of recalls affecting your facility. Seek such commitments from all of your suppliers.
If you receive a recall notice and don't have the affected product on hand, note this information on the announcement. Initial it, date it and file it. If you do, however, hold supplies of the recalled product, sweep the facility and all of your drug storage areas promptly and note the action taken on the announcement.
The FDA's "Recalls, Market Withdrawals and Safety Alerts" Web site (www.fda.gov/opacom/7alerts.HTML) is a comprehensive source for all recalls, while its MedWatch recalls page (www.fda.gov/medwatch/safety.htm) focuses specifically on human medical products. The MedWatch program (www.fda.gov/medwatch) is also a go-to site in the event that your staff ever finds a drug or device is defective or carries unanticipated adverse effects. Behind many national recalls are local facilities with sharp-eyed staffs. Your pharmacy consultant should be able to help you coordinate and file a report to the program's overseers.
5. When drugs are missing. Unaccounted-for drugs represent a potentially serious breach of security and safety for your facility. In the event that you discover a loss of controlled substances at your facility, take these seven steps:
- Invoke the "60-minute rule." Unless you're dealing with an obvious break-in, you should first review your paper documentation for about an hour to determine whether it's just a miscount. A "loss" is almost always a paper error rather than an intentional act.
- Nursing leadership should go up the chain. Inform your leadership, including the medical director, the administrator, your corporate leadership (if applicable) and the person whose name is on your facility's DEA license. Also call your pharmacist or pharmacy consultant.
- Don't play detective. Let the authorities orchestrate the investigation. Don't discuss the situation with your staff unless the authorities direct you to.
- Keep a detailed log of all actions taken, including each of the steps listed above, all communications and all phone calls.
- When you contact local, state and federal authorities for guidance, document the names of the personnel to whom you spoke, when you spoke to them and the directives they assigned you.
- File the required forms as directed by state and federal agents.
6. Discarding doses. Here's an easy way to render partial doses, such as an unused portion of fentanyl or a midazolam ampoule, non-recoverable in the OR. Put some cotton or a piece of gauze into a paper cup. Place the cup on the anesthesia cart at the beginning of the day or before a case begins. Have the clinician squirt any discards into the cup and dispose of the cotton or gauze into a red sharps container. Some sharps containers even include a layer of absorbent material, allowing discards to be injected directly into them.
7. Allergy alerts. List a patient's drug or other allergies prominently in his medical record. Many facilities place labels alerting providers to patient allergies on the front cover (some states require this, though others don't), while other facilities choose not to. If allergies are listed outside, and if the record contains multiple admissions, it is critical to note them in a chronological fashion, date the information and update the status of the allergies upon each subsequent admission. Some facilities use a different label each time.
If a patient has no allergies, recent reviews by accrediting bodies point to a preference for the notation NKA ("no known allergies") over NKDA ("no known drug allergies") so as to recognize latex, soybean and other non-drug reactions. Above all, you should aim for and surveyors are looking for a system that equips providers with meaningful, legible and easily accessible information as the patient's drug therapy is developed.
8. Latex cautions. The incidence of latex sensitivity is about 3 percent to 6 percent in the general population, although certain conditions such as spina bifida can raise the likelihood of sensitivity to more than 70 percent. As a group, healthcare workers experience about a 17 percent sensitivity rate. Here are some strategies for reducing latex exposure during drug administration.
- Use IV tubing without ports, cover the ports with tape (label the tape, "Do not inject drugs or withdraw using this port") or try using stopcocks rather than latex ports.
- Use ampoules whenever possible. If they're not available, draw meds directly from opened multiple dose vials after the stoppers have been removed.
- Only draw the meds immediately before the case begins. The contact with the rubber plunger can cause problems, and that is time-dependent.
- If possible, use glass or latex-free syringes.
- Don't shake multiple-dose vials.
9. Stay cool. Some medications must be refrigerated at a temperature of 36 ? F to 46 ? F in order to ensure their stability, their efficacy and your patients' safety. Surveyors will expect you to have the ability to know if refrigeration has failed, especially if that failure took place when the facility was unoccupied.
While you're on the premises, keep a daily log monitoring the refrigeration temperature with a traditional thermometer. While you're away, a battery-driven audible alarm (at a cost of about $50) or a continuous temperature monitoring device (about $250) can keep tabs on the temps. The latter option is a passive system that requires no daily documentation by the staff.
If you have a freezer for drugs, vaccines or compounded products, you'll need a separate record and monitoring device. The Centers for Disease Control and Prevention recommend that you use continuous certified and calibrated chart recorders for vaccine storage monitoring. Here's a neat trick: Freeze a cup full of water and place a penny on top of the ice. If the penny falls to the bottom, you'll know your freezer has failed.
10. Departure due diligence. Not a month goes by that I don't see a facility's leadership in transition. If you're a departing administrator, medical director, director of nursing, PACU manager or clinical nurse responsible for controlled drugs, or are the DEA and state registrant for your facility's drugs, perform a documented exit inventory on your final day. You simply can't afford to be notified later that the inventory was incorrect when you walked out the door. For peace of mind and for closure to your duties, complete a "change of responsibility and controlled drug inventory validation form." Your pharmacist can help you draw this up. It should include your facility's name and address, the registrant's name and DEA number, the date, the signature and printed name(s) of the personnel performing the inventory, and a chart listing the drugs and amounts on hand. The facility should keep a copy for its files, as should the departing staff member.