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Drug monitoring is all the rage in health care today, with the intense focus on patient safety and avoiding medication errors. But are pharmacists fully equipped and empowered to perform drug monitoring for their patients in the way that will bring about the greatest benefit?
John Wodtke, PharmD, MS, a member of the drug information team at Advanced Response Management, sees areas for improvement in the education and work environment of pharmacists before they can initiate those best efforts for patients.
"We have to start with how we define monitoring and the many facets of patient care that fall under that umbrella," Wodtke tells Drug Utilization Review. "Drug monitoring, to me, is the process by which we help ensure the intended outcomes of drug therapy are reached while minimizing the known side effects of the drug. This, of course, involves making sure the right drug in the right dose is given to the right patient at the right time.
"When we say the patient must get the right drug, it doesn’t mean simply making sure there’s not a mix-up so that something other than the intended drug is given," says Wodtke, who was a clinical hospital pharmacist earlier in his career and then assistant director of pharmacy for a large urban hospital. "This also means using our cognitive skills and checking the drug against the intended indication and the specific patient history and physical characteristics."
Saying the patient must get the right dose doesn’t simply mean checking the milligram strength on the capsule against that on the medication administration record (MAR), although it does include this step. It also means, Wodtke says, using pharmacokinetic fundamentals and applying them to specific patients to ensure that the strength of the drug ordered and written in the MAR is appropriate for this patient.
"When we say the patient must get the drug at the right time, this doesn’t refer simply to morning vs. evening," Wodtke adds. "We must also consider when the drug is given in coordination with food, when that’s important, and when it’s given in coordination with other drugs and vitamins with which it might bind and have undesirable effects. All of these steps are steps that we hear nearly from day one of pharmacy school. They are simple words, but absolutely necessary in helping achieve successful patient care. They are a part of the monitoring that must occur in order to help ensure the desired outcomes from drug therapy, but they are by no means all that is involved in monitoring."
Drug monitoring also involves evaluating drug levels in the patient’s body, checking for potential drug-drug interactions, watching the patient and the patient’s labs for signs of adverse events, and assessing patient compliance as well as patient understanding of the drug, Wodtke says.
"For drugs with a narrow therapeutic index such as phenytoin, digoxin, and aminoglycosides, it’s important to monitor the drug concentration in the patient," says Wodtke.
Where it’s not possible or convenient to measure the drug level directly, it’s important to measure surrogate markers, he says. "Pharmacists need to evaluate INR levels in patients on warfarin, and aPTT levels in patients on heparin."
For patients on antihypertensives, for example, the patient’s blood pressure should be monitored. In patients being treated for infections, patient temperature needs to be monitored.
"Checking for potential drug-drug interactions is important for every patient who is on more than one drug. Drugs that should be included in assessing for potential interactions include those that are available by prescription only, those available over-the-counter, and herbal or diet supplements," says Wodtke. Also, drugs that the patient may not receive continuously but that are included in the standing PRN orders should be evaluated for interactions.
"There’s a large gap for many pharmacists in their knowledge of herbal supplements," Wodtke notes. "The body of available knowledge itself is not well-defined and has gaps of its own, and many side effects and interactions remain unknown because those studies aren’t required for supplements. However, the information for herbal medication is growing rapidly. Drugs with a narrow therapeutic index do have some data with herbal supplements, and some key interactions have been found. But there remains a big gap in what pharmacists know about these interactions. These herbal products are not inert. The potential for interactions is very real. Pharmacists can help fill the knowledge gap by reporting any interactions observed between herbs and drugs.
"Adverse events form an important part of monitoring," Wodtke continues. "Any medication can result in an adverse drug event. However, some medications require special monitoring or dose titration to get the desired therapeutic effect while minimizing adverse events. Certain drugs can alert pharmacy staff to the occurrence of adverse events. For instance, a stat diphenhydramine or a one-time methylprednisolone or oral vancomycin dose can signal a potential adverse event. Many pharmacies print out these special orders and require pharmacist follow-up within 24 hours of drug administration."
Often adverse events are brought to the attention of pharmacists by the nursing staff. Pharmacy’s relationship with nursing is important for many reasons. Detecting and reporting adverse events is one of them, Wodtke adds.
At one institution described by Wodtke, the floor pharmacists hold monthly meetings with the floor nurses. In these meetings, pharmacists alert nurses to potential side effects of medications that patients on the floor are being given. For example, on an oncology floor where Compazine is given to combat nausea, the nurses are alerted to the potential of extraparamidal effects in their patients, and the adverse events are more likely to be reported.
"Pharmacists have to prioritize their work," notes Wodtke. "All serious adverse events have to be reported. Many events are reported internally and go to the P&T committee, but are never reported externally to the drug manufacturer or to MedWatch. It’s critical to Phase IV drug surveillance that serious adverse events be reported to drug manufacturers or to MedWatch. It’s the accumulation of reports of adverse events that can bring about a change in drug labeling or even initiate a drug recall.
Pharmacists end up having to use their judgment in reporting less serious events. For example, itching from morphine probably often goes unreported since it’s an expected side effect and most patients on morphine have standing PRN orders for diphenhydramine.
"Patient understanding of drugs is largely dependent on the counseling they receive from pharmacists," says Wodtke. "In counseling patients, pharmacists need to remember to ask open-ended questions. Minimize the opportunity for yes’ or no’ answers. By the end of a counseling session, the patient should be able to tell the pharmacist what each drug he or she is taking is and what it is for. The patient should be able to tell the pharmacist how he’ll take the drug, where and how it will be stored, if and when it can be refilled, and which side effects he should self-monitor for."
Pharmacists should be provided time to perform discharge counseling with patients, Wodtke says. One institution he describes has a warfarin counseling program for which the pharmacy department created a standard warfarin information sheet. Pharmacists then counseled patients discharged on warfarin. Warfarin is the primary topic of discussion, but the pharmacists hold the patient’s entire drug list in hand and discuss every part of the drug regimen. The pharmacists then are sure to document the discharge counseling activity in the patient chart. The pharmacy department follows up one week after discharge and asks specific questions about the warfarin therapy — such as the dose to be taken, and side effects — to assess patient understanding and retention.
"This hospital chose warfarin, but one or more of the other drugs with a narrow therapeutic index can be targeted in order to benefit patients and help document and prove the important role pharmacists play in effective drug therapy and patient safety," Wodtke says.
The recent recall of alosetron (Lotronex) serves as a good example of the need for effective patient counseling, self-monitoring, and reporting of adverse events.
"It’s impossible to know the exact number of side effect occurrences, ischemic colitis or otherwise, associated with alosetron . . . or any drug for that matter," Wodtke says. "But had more patients been counseled completely to the point of full understanding of their drug with alosetron, it may well be that adverse events would have been reported earlier and the eventual recall of alosetron would have come sooner."
Is alosetron’s fate a call to action?
|The recent recall of alosetron (Lotronex) by Glaxo has spurred the American Pharmaceutical Association (APhA) to say it should be a call to action for consumers, pharmacists, and other health care professionals to consider and use medications more carefully. According to APhA, alosetron represents the third prescription medication to be recalled this year, and the sixth drug withdrawn from the market in the past two years due to adverse side effects. APhA states that written patient information alone, while helpful, is not sufficient to fully educate patients. Patient counseling that comes directly from a trained pharmacist is more effective in educating patients about their drugs.|
As pharmacists counsel patients about their drugs, they should also encourage patients to report any adverse events to their physicians or pharmacists, according to Wodtke. He also points out that patients can report their own adverse events directly to drug manufacturers or to MedWatch.
"Tracking susceptible organisms within an institution also falls under the umbrella of monitoring," Wodtke says. "For example, a pharmacist may be caring for a patient with Pseudomonas infection. The pharmacist gets involved typically because the physician writes an order for an aminoglycoside. The pharmacist may think this will be a simple case of aminoglycoside monitoring and kinetics. The reality is that the pharmacist also needs to monitor continued cultures and sensitivities, then evaluate whether or not the specific aminoglycoside is the one this patient should receive.
Pharmacists, along with their infectious disease committees, must follow organisms within their institutions over time due to the inevitable development of resistance. Protocols and antibiotics of choice have to change on occasion due to institution-specific resistance trends."
Making it possible for hospital pharmacists to fit monitoring into their already full schedules is a long-standing problem with no easy solution.
"Pharmacists try to increase time spent in patient care, yet we’re also still trying to convince payers to reimburse us for cognitive services, and that effort alone takes huge amounts of our time just in documentation," Wodtke says. "However, there are some efforts that we can make now to allow pharmacists more time to spend on patient care and safety. Minimizing the distributive role of the pharmacist by using technology to its fullest is one step. Pyxis stations and robotics, for example, can reduce the demand on the pharmacist for distribution. Giving technicians more training and responsibility can also help. While we’re spending time with documentation and talking to payers about reimbursement, we can also dovetail on those efforts by working on convincing the same payers that we have a significant role in patient care and safety. Pharmacists want to be reimbursed not just for cognitive services, but also because we can contribute significantly to patient safety. Therefore, document, document, document!
"There are several ways that institutions target drugs or patients to be monitored," says Wodtke. "Some make that decision based on which unit a patient is in. What I have seen a lot is that, because of the current shortage of pharmacists, institutions perform drug monitoring based on specific target drug therapies. Drugs that have potential serious side effects, drugs with a narrow therapeutic index, and drugs that are expensive usually top the list of those that are monitored."
According to Wodtke, there are several steps pharmacy directors can take to better enable pharmacists to perform monitoring.
1. Time. "More time is paramount, of course, but things that might be a little easier to provide include decentralized, bedside access to patient charts and lab data. Electronic patient charts that include long-term patient history from previous admissions and/or doctor visits may be expensive, but they are very effective in smooth patient care.
2. CE. "Continuing education is a must. Pharmacists must know precisely what they’re doing. Experience and repetition are invaluable, but pharmacists must continue to educate themselves and not become complacent. The ability and access to use computers to their fullest extent will help. Even a simple calculator is a great tool in drug monitoring," Wodtke says.
3. Peer support. "We should never overlook our peers. The old adage that two heads are better than one’ certainly applies in pharmacy. It goes both ways, too. We should feel free to ask a colleague for his/her opinion or to double-check our calculations, but we should also be willing to do the same for others when asked.
"There are unlimited opportunities for pharmacists to provide effective intervention on behalf of patients by monitoring. Time, however, is not unlimited. Pharmacy directors can work together with their pharmacy teams to determine the methods that can be implemented in their institutions to give pharmacists more time to spend in patient care and effective monitoring. The goal is patient safety. Proactive steps toward that goal by everyone at all levels of pharmacy will be required to get closer to achieving the goal."
[Editor’s note: Results from a survey by the American Society of Health-System Pharmacists (ASHP), the 2000 ASHP National Survey of Pharmacy Practice in Acute Care, cover pharmacists’ role in patient wellness activities, including monitoring. The survey can be found in the Dec. 1, 2000, issue of the American Journal of Health-System Pharmacy. A summary report containing graphs and charts of the survey data may be obtained from Eli Lilly by calling (800) 874-2778.]
• John Wodtke, PharmD, MS, Advanced Response Management, 8717 W. 110th St., Suite 240, Overland Park, KS 66210. E-mail: firstname.lastname@example.org.