Prescription for error.

In pharmacies, the quest for profit can triumph over the concern for safety.

According to recent polls by The Gallup Organization, Americans consider pharmacists the nation's most trustworthy professionals.(1) Our experience has shown that patients who select their doctors carefully and often seek out a second opinion regarding a physician's diagnosis tend not to question the skill of a pharmacist or whether he or she has dispensed the appropriate medication.

Certainly, most patients would never consider the fact that their prescription may have been filled by someone who is not a licensed pharmacist. Unfortunately, the time limits imposed on pharmacists by high-volume sales and corporate pharmacies' emphasis on profits over safety have resulted in an alarming number of misfilled prescriptions.

Exact figures regarding the number of prescription medication errors that occur each year are not easy to find. Few states require pharmacies to report misfills, and most pharmacies will not reveal this information, even in the course of litigation. Studies indicate that as many as 12.5 percent of the prescriptions handled by outpatient pharmacies are misfilled.(2) If you consider that more than 1.5 billion outpatient prescriptions are dispensed every year, then 187.5 million prescription errors may occur annually.(3)

An understanding of how pharmacy errors occur begins with an understanding of the process a pharmacist is supposed to follow to fill each prescription. Most people think a pharmacist's only obligation is to read the doctor's prescription, count pills, and pour them into little brown bottles. While it is true that pharmacists' most basic duty is to inspect each prescription and confirm that the drug prescribed is the one dispensed, the proper procedures to follow for filling a prescription are more complicated.

When a prescription is handed to a pharmacist, he or she is supposed to confirm the patient's name, address, and phone number and that of the physician. The pharmacist must also be sure the prescription is legible. Any missing or illegible information is to be confirmed and handwritten on the doctor's prescription by the pharmacist or technician before the pharmacist can proceed.

Next, the pharmacist ensures that the prescription will provide the desired therapeutic effect. The pharmacist is often the one person who can prevent a serious medication-induced injury. A patient may have several physicians treating a number of different conditions, and these doctors may not coordinate their treatments. As a result, the pharmacist is often the only member of the health care team who knows all the medications that have been prescribed for a patient and is responsible for ensuring there will be no adverse effects.

To this end, the federal government and many states have imposed on pharmacists the duty to perform a drug utilization review (DUR).(4) The DUR provisions are intended to improve the quality of care provided, reduce the risk of injury, and optimize the effects of drug therapy. The pharmacist must conduct a review each time a new prescription is presented or an existing one is refilled.

The process begins with an evaluation of a patient's medical history, commonly referred to as the "patient profile." The pharmacist must make a reasonable effort to obtain, record, and update the following:

* the patient's name, address, and phone number; gender; and date of birth;

* medications the patient is taking--both prescribed and over-the-counter (OTC);

* medical devices the patient uses;

* allergies, illnesses, disabilities, and conditions the patient suffers from; and

* known reactions to drugs the patient has experienced.

The DUR process then moves to an evaluation of the following issues:

* potential drug therapy duplication;

* overuse and underuse of the medication prescribed;

* drug-disease contraindications;

* drug interactions, including those with nonprescription or over-the-counter medications;

* incorrect dosage;

* incorrect duration of treatment;

* drug-allergy interactions; and

* clinical abuse or misuse, such as taking too many narcotic medications.

If the DUR process reveals a problem, the pharmacist's best course of action is to contact the prescribing physician about the problem and follow his or her instructions as to whether the medication should be dispensed.

In addition to mandating the DUR process, many states require pharmacists to counsel patients as to the nature of the drug therapy prescribed.(5) The counseling function is important to the proper dispensing of prescription drugs and, ultimately, to the effective treatment of the disease or condition.

In the counseling session, the pharmacist should make sure the patient understands what the medication is, what condition it is intended to treat, and how to take the drug. The pharmacist should verify that the correct medication has been dispensed and properly labeled and ask the patient questions. This session is the pharmacist's last opportunity to prevent error. If the counseling requirement is ignored or treated as a mere formality, the pharmacist misses that chance.

Our firm's experience shows that most pharmacists believe counseling benefits patients but that time constraints preclude its being done effectively. As a result, the only major effect counseling regulations have had on consumers has been the "advisory" or "drug information sheet" handed to patients when they pick up their prescriptions.

It is common for a busy pharmacy to fill 300 to 500 prescriptions a day. If the pharmacists work 8- or 10-hour shifts with a standard 30-minute lunch break, in only a few minutes per prescription they must complete the drug utilization review, fill the prescription, and counsel the patient.(6) In addition, a significant part of a corporate pharmacist's income is determined by the number of prescriptions filled. All these factors add up to a system that places a premium on speed over caution.

Automation has helped pharmacists to some degree. A number of computer programs store patients' profiles and perform part of the DUR process by running information through a data bank that compares the drug requested to the patient profile and looks for known drug interactions, allergies, and dosage errors. If a problem is noted, the computer will alert the pharmacist and will not print the label until a proper response code--such as "dispensed with physician's consent" or "dispensed per the pharmacist's discretion"--is entered.

The theory behind these programs is that the pharmacist cannot print or apply a label until he or she has seen the "alert" message, exercised professional judgment, and taken measures to protect the patient from harm. But even with the help of computers, the average pharmacist is hardpressed to keep up with the daily volume of prescriptions.

In the past, most state regulations required pharmacists to personally count and pour medication and apply labels to prescriptions before they were dispensed. The demand for speed has led to expansion of the role of pharmacy technicians. Although pharmacists must complete a five-year program to earn a degree, most technicians are required to have only a high school diploma or its equivalent and a brief training course on how to read prescriptions, input data into pharmacy computers, and count medication.

The high volume of prescription sales and pressure from large corporate pharmacies have led some states to change the regulations that govern tasks technicians can perform. Many now permit technicians to count and pour medication and apply labels "under a pharmacist's supervision." Most state regulations still do not permit technicians to perform drug utilization review or counsel a patient.(7)

It is ultimately the pharmacist's duty to ensure that the prescription is filled as written, confirm that it is therapeutic and not harmful, and counsel the patient on how the drug should be taken. Safeguards ensure medication cannot reach a patient until a licensed pharmacist has handled the prescription.

This fail-safe in the system breaks down if state regulations are ignored and pharmacies rely on technicians to respond to alerts. Litigation has revealed that many pharmacies have developed shortcuts to keep up with the sales volume. Some corporate pharmacies train technicians to bypass DUR alerts by entering one of the override codes. That way, technicians can generate a label and fill prescriptions. They are then supposed to set those bottles of medication aside for a pharmacist to review before they are dispensed.

Other companies allow technicians to phone doctors' offices to discuss prescriptions. The technician usually speaks to a nurse, and neither the pharmacist nor the prescribing physician are ever made aware of the DUR alert. Unfortunately, these shortcuts allow potentially dangerous prescriptions to reach patients. When technicians can override DUR alerts with a keystroke, errors can occur.

Evaluating error

Analysis of a possible pharmacy error should track the DUR process. You should begin by evaluating the condition of the patient, including physical limitations, diseases, and allergies, and by obtaining a complete understanding of his or her medical history. Request a copy of your client's profile from the pharmacy and collect his or her records. If your client used more than one pharmacy, request copies of the patient profile from all of them.

Review the information requested by each pharmacist as well as the information provided by your client. You probably will not be able to hold a pharmacist responsible for an injury that resulted from your client's failure to inform the pharmacist of a potential drug allergy or complicating physical condition. You may be able to establish a pharmacist's negligence for failing to inquire about this information.

From these records, you should be able to determine the physical condition of your client at the time of the pharmacy error and list all medications he or she took during the relevant time period. Look at the medical records from all the physicians and other health care providers who have treated your client. Also, have your client list all medications and over-the-counter drugs he or she has taken, including herbs or other natural supplements. If your client is not able to provide the information, have a family member, close friend, or care provider do so. Be sure these lists include a description of how the medication or OTC drug was taken and in what dosages.

Once you have this information, research each medication. References like the Physician's Desk Reference outline conditions a drug treats; its proper dosage; and any physical, mental, or emotional factors that are contraindications for using the drug.(8) Most references also list potential adverse reactions, side effects, and drug interactions. From this information, you should be able to determine whether any of the symptoms or injuries your client suffered are related to the medication prescribed or dispensed.

You cannot rely solely on the written records to determine if a prescription error has occurred. While drug allergies or adverse drug interactions may be evident from the documents, written records will not reveal whether the proper medication was in the bottle or whether the appropriate instructions were on the label. To be thorough in this review, inspect the bottles. If the bottle is empty, you probably cannot prove the prescription was misfilled. Although a lab test or toxicology report may support a finding of a misfill, in most cases your job will be easier if some medication is still in the bottle.

Request a copy of the prescription the pharmacist used. Get a copy of both sides, as many pharmacists and technicians make notes on the front and back of the document while processing the prescription. Often, this is where the person responding to a DUR alert will note what action was taken, for example, "Dr. Jones advised OK to dispense." Finding out whose handwriting appears on the prescription can help establish who actually filled it.

If you believe a misfill has occurred, you need to determine how it happened. Remember that a pharmacist may not have been involved in all stages of the dispensing process, and, in some cases, the pharmacist may not have seen the prescription at all. Find out how many prescriptions were filled by the pharmacy the day the errant prescription was dispensed, how many hours the pharmacist had worked in the days leading up to that day, and who the technicians on duty were when the prescription was filled. Look for evidence that the prescription was filled by a technician, not a pharmacist.

Common defenses

As you evaluate a case, consider these defenses that may be raised.

Blame the patient. This is the first line of defense for the pharmacist. Often a misfilled prescription is an obvious error. It is common for a pharmacist to place the prescription label on a prepackaged container that also bears the manufacturer's label. If the prescription has been misfilled, the manufacturer's label will show the bottle contains a different medication than the one prescribed. The defense will say the patient should have noticed the discrepancy.

Do not let the pharmacist blame the patient. He or she is trained to recognize the proper medication. In this age of "generic substitution," when prescriptions for brand-name drugs are often filled with less expensive generic equivalents, the patient cannot be responsible for failing to recognize that the drug dispensed is different from the drug prescribed.

The pharmacist may also blame the patient for missing information in the patient profile. The pharmacist must make a reasonable effort to obtain, record, and update profile information. The profile is a key part of the data from which the pharmacist will conduct a drug utilization review.

Examine the questions asked in the profile to be sure the proper information was requested and to learn about the pharmacy's policy for updating or revising the profile. If your client has not fully revealed all requisite information, the pharmacist cannot be expected to recognize a potential danger. But your client cannot be blamed for failing to give information the pharmacist never requested.

Challenge causation. Often the liability facts presented by a pharmacy error are not subject to dispute. In these cases, the most common defense is to challenge the causative link between the misfill and the resulting injury. The case will proceed much as any medical malpractice or products liability case.

Be prepared to present competent expert testimony to establish the cause-and-effect relationship between the misfilled drug and the injury. You must distinguish between the underlying illness or infirmity and the damage caused by the improper medication. In addition to pointing to your client's preexisting condition, the pharmacist may argue that the dosage or duration during which your client took the medication was insufficient to cause the injuries.

The defense may also claim your client had an aberrant or unforeseeable reaction to the improperly prescribed medication. Then, you must present medical data to support the relationship between the injuries and the drug. Peer-reviewed medical articles, FDA filings such as research supporting approval of the drug and adverse reaction reports, and your client's medical records may provide the evidence you need.

Unlike most attorneys who handle medical malpractice actions, those involved in misfilled prescription cases are likely to find an ally in the client's prescribing doctor or subsequent treating physicians. These physicians are often willing to provide testimony that establishes the nature and extent of the damage as well as the causative link between the medication and the injuries.

A word of warning: You must consider the facts of the case carefully and be sure the prescribing physician is not a potential defendant before you place responsibility for establishing causation in his or her hands.

Blame the doctor. The pharmacist's third line of defense may be to blame the doctor in cases where dangerous combinations of medication were prescribed, a known potential for an allergic reaction is demonstrated, dosages were incorrect, or overuse or underuse issues are presented. The pharmacist will likely argue that pharmacists cannot prescribe medicine or interfere with treatment.

Although these cases may include physician negligence, the pharmacist cannot escape liability by hiding behind the doctor's flawed prescription. The purpose of the drug utilization review is, after all, for the pharmacist to catch and report errors.

It is the pharmacist's duty to make sure that the drug dispensed is the drug prescribed and that the drug prescribed is not unreasonably dangerous. It would be difficult to hold a pharmacist liable if he or she recognized a potential adverse consequence, spoke to the prescribing physician about this, and dispensed the medication only on orders from the doctor. It could be argued that the pharmacist met the standard of care by consulting the physician?

Pharmacists' actions are more subject to question when they rely on their own judgment to dispense medication in spite of the potential adverse effect, warn patients of the risk but dispense drugs anyway, or deny patients the medication that was ordered.(10)

Again, it is important to recognize that pharmacists cannot delegate to technicians their responsibility to dispense safe and effective medication. Where a prescription should have triggered an alert during the DUR process, it is critical to learn exactly who conducted the review and who decided the drug should be dispensed.

When pharmacists place volume and profits over caution and quality, a prescription for error results. Litigation cannot reverse the injuries clients suffer, but it can put pharmacies on alert and heighten their concern for safety.

Notes

(1.) Leslie McAneny & Lydia Saad, Honesty & Ethics Poll: Pharmacists Strengthen Their Position as the Most Highly Rated Occupation, Gallup Organization (Dec. 13, 1997), available at http://www. gallup.com/poll/releases/pr971213.asp.

(2.) Una A. Kistner et al., Accuracy of Dispensing in a High-Volume, Hospital-Based Outpatient Pharmacy, 51 AM. J. HOSP. PHARMACY 2793, 2793 (1994).

(3.) Id.

(4.) Omnibus Budget Reconciliation Act of 1990, Pub. L. No. 101-508, 104 Stat. 1388, 4401 (Nov. 5, 1990). Technically, the act applies only to outpatient dispensing for Medicaid patients. However, more than 40 states have enacted similar regulations that apply to most, if not all, pharmacists who dispense prescription medication to outpatients.

(5.) Id.

(6.) This assumes an average of two pharmacists per shift who are not also responsible for any of the administrative tasks required to run a pharmacy.

(7.) See, e.g., 22 TEX. ADMIN. CODE [sections] 291.31-.32 (West 1998).

(8.) You may access the Physician's Desk Reference on the Internet at http://www.pdr.net.

(9.) See generally Pysz v. Henry's Drug Store, 457 So. 2d 561 (Fla. Dist. Ct. App. 1984).

(10.) See generally Walker v. Jack Eckerd Corp., 434 S.E.2d 63 (Ga. Ct. App.), cert. denied, 1993 Ga. LEXIS 1033 (Ga. Oct. 29,1993); Hook's SuperRx, Inc. v. McLaughlin, 642 N.E.2d 514 (Ind. 1994).

S. Craig Smith is a shareholder with Demarest, Smith, Jones, Giunta & Moore in Dallas. Thomas William Arbon is an associate with the firm.