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Two steps forward and one step back for patient safety?

Two groups focus on improved outcomes, another on Rx "vending" machines



From the June 30, 2005
issue

As portrayed in a June 21, 2005, article in The Wall Street Journal, surgeons appear to be stepping up to the plate by adopting a focus on patient safety as modeled by anesthesiologists in an attempt to improve patient outcomes and reduce medical malpractice costs. We couldn't agree more that such efforts will pay off impressively in both human and financial terms. However, based on a seemingly unrelated article in the same edition of the newspaper, we are concerned that the profession of pharmacy might be taking a huge step backward in patient safety by embracing a new technology that allows dispensing of prescription medications from "vending" machines.

The first article (entitled "Anesthesiologists Now Offer Model of How to Improve Safety, Lower Premiums. Surgeons Are Following Suit" by Joseph T. Hallinan) offered irrefutable evidence on how anesthesiologists have largely shielded themselves from rising malpractice insurance costs by focusing on patient safety improvements rather than tort reform to protect them from lawsuits.

The 1999 Institute of Medicine report, To Err is Human, identified anesthesiologists as a rare exception to its sweeping criticisms about the lack of professional medical societies or groups that have demonstrated a visible commitment to reducing errors. And the high regard is well deserved. In 1985, the American Society of Anesthesiologists provided $100,000 to launch the Anesthesia Patient Safety Foundation (APSF). Despite some angst, the APSF decided to admit not just physician members, but also nurse anesthetists, insurers, and anesthesia equipment companies, bringing together a broad range of interdisciplinary stakeholders. The risk paid off.

Since then, the APSF has galvanized safety research and prompted significant changes in how anesthesia care is provided. From high-tech simulation mannequins that are used to help anesthesiologists recognize and respond to life-threatening conditions, to pulse oximetry, capnography, non-flammable anesthetics, and other safety features and practices that have been adopted as standards, the APSF has helped reduce anesthesia fatalities from 1 in 5,000 cases to 1 in 200,000-300,000 cases. As anticipated, better patient outcomes have also resulted in fewer lawsuits; anesthesiologists typically pay less for malpractice insurance today than 20 years ago.

Now, others-particularly surgeons-are praising anesthesiologists for choosing a different and more compelling response to the medical malpractice crisis. Based on the APSF success, the American College of Surgeons recently launched a study of malpractice cases modeled on the one that helped anesthesiologists first recognize many of their safety issues. It's clear that this is a huge step for patient safety, and we hope that others will follow suit, recognizing the enormous return on investment in both saving lives and money that will follow with such an undaunted focus on patient safety.

But now, for the potentially bad news. Another article in same issue of The Wall Street Journal (entitled "Pharmacies Test Kiosks That Dispense Refills: Some Regulators are Leery" by Rhonda L. Rundle) notes, "There's a new antidote for long lines at the pharmacy: machines that serve up your prescription refills like a can of Coke or a Snickers bar." These drug-dispensing machines (e.g., ScriptCenter, Automated Pharmacy Machine) are intended for prescription refills only. After a pharmacist fills and/or verifies the refill, it's placed in the machine so the consumer can pick it up at any time by logging on with a user name and password, swiping a debit or credit card, and removing the medication that has dropped into the bin.

Several state pharmacy boards have already cleared the use of machines that dispense refills, and they're being installed and tested in California and Virginia pharmacies. Of course, the benefits are easy to see: customer convenience, reduced waiting time for prescriptions, and potentially improved access to prescription refills for patients in rural settings, to name a few. Patient and drug accuracy can also be maintained with bar-coding and other advanced technologies. However, there are some significant potential downsides that must be considered.

Like many, we believe patient safety will be compromised if the new technology reduces the patient's interaction with pharmacists. Proponents of the technology believe it will allow pharmacists to spend more time with patients who have questions. Indeed, in several test sites for this technology, it appears that pharmacists are readily available to consult with patients who are picking up their prescriptions. However, many pharmacists feel that patients may be discouraged from asking questions about their medications when obtaining their refills from drug-dispensing machines. In fact, a pharmacist may not be available for questions if the pharmacy counter is closed when patients pick up refills. Detractors of the technology also worry that it will be a short and slippery ride before these kiosks dispense new prescriptions (as currently being explored in Hawaii) or before expanded technology allows physicians to directly send an electronic prescription to a "vending" machine stocked with medications, which in turn dispenses new prescriptions to patients.

The pharmacist's role in post-marketing surveillance of new medications may also be compromised with drug-dispensing machines. Currently, FDA and the Institute of Medicine's Drug Safety Committee are deliberating about ways to improve post-marketing surveillance of medications, perhaps in part through increased involvement of pharmacists. Even the new Medicare legislation acknowledges the value of pharmacist-patient interactions and allows reimbursement for enhanced pharmaceutical care (called Medication Therapy Management in the legislation). Yet, if drug-dispensing machines are used, opportunities to capitalize on these well-grounded initiatives could be missed. Pharmacists may not be able to interact with patients to the degree necessary to identify drug-related problems and offer enhanced pharmaceutical care. They may not be able to question patients about side effects upon refill, and thus will have limited opportunity to detect and report adverse drug reactions.

Proponents of the technology could argue that some community pharmacists currently spend negligible face-to-face time with patients anyway, especially for refills. They could also note that similar concerns have been voiced in response to mail service pharmacies, to no avail. However, it's difficult to shake our apprehension that this technology may be at odds with what we know is optimal for medication safety-ongoing interaction between patients and pharmacists.

Unquestionably, there are steps that can be taken or are currently being tested to increase and improve interaction between pharmacists and patients if drug-dispensing machines (and even mail order services) are employed. Pharmacist-staffed call lines, the consumer's ability to send questions to pharmacists and receive prompt answers by e-mail, the use of prompted questions programmed in dispensing machines about potential side effects that must be answered by patients before receipt of the refill, and many other forms of automated communication are all avenues worth exploring. Another option is to design work in ways that allow pharmacists to realistically increase the amount of face-to-face interaction with patients who do have questions about their medications, even requiring consultation for all new prescriptions and refills of certain identified high-alert medications.

But in the end, with reduced waiting time as the primary impetus for drug-dispensing machines, we still can't help but worry that we are once again sacrificing patient safety. Isn't sacrificing safety for other dimensions of quality and customer convenience what got us into this medical error mess to begin with?

While safe care does not guarantee quality care, it is an absolute prerequisite, and something that may not have been adequately considered with this new technology. To this end, researchers at the University of California San Diego Medical Center are planning to study this technology's impact on both patient care and pharmacy management. Perhaps we will be in a better position to evaluate its impact on patient safety once the research is completed and the findings are presented. Until then, we encourage pharmacists and other healthcare professionals who are testing this new technology to share your thoughts, concerns, and experiences with us so we can update the healthcare community periodically.

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