Improving patient safety is one of the most effective strategies to create additional value as the industry transitions to value-based reimbursement models. Not only does safer care improve health outcomes, it also reduces operating costs. One way drug manufacturers can parlay safer care into better clinical and business results is through electronic medication safety notifications.

Electronic medication safety notifications are alerts or warnings that are delivered to pharmacy management systems at the point of dispense: when a pharmacist starts the process of filling a prescription and is billing a patient’s insurer for the prescribed medication. Alerts and warnings are delivered on behalf of individual manufacturers to pharmacists within this workflow.

Common drug concerns that can lead to medication safety notifications

Drug manufacturers generate medication safety notifications for a variety of reasons, including an action by the FDA. For example, the FDA could:

    Using Electronic Medication Safety Notifications to Improve Patient Care Quote
  • Order a drug to be temporarily recalled from the market
  • Order a drug to be permanently withdrawn from the market
  • Order a drug to include a new safety warning for users

However, drug manufacturers don’t have to wait for the FDA to take action before generating a medication safety notification. Manufacturers understand their drug products better than anyone else, and they are more likely to learn about potential problems with their products before anyone else. They hear about potential medication safety issues through direct and indirect adverse event reporting.

Patients can report their concerns directly to drug manufacturers. Or, they can report problems to their pharmacists, who then contact the drug manufacturers. Reports can also come from physicians and other prescribers when they recognize their patient has had an adverse event.

Common concerns that often don’t rise to the level of a FDA-mandated action include:

  • Contraindications with other medications
  • Contraindications for use in a certain age, or gender
  • Look-alike and sound-alike drugs
  • Pharmacies dispensing the right dose strength but at the wrong frequency of use
  • Pharmacies dispensing the wrong strength or size of a single dose
  • Prescribers calculating medication doses incorrectly
  • Shortage or supply problems
  • Unanticipated or severe side effects
  • Formulation change
  • National Drug Code (NDC) change
Past methods of communicating drug concerns can exacerbate the problem

Prior to the advent of electronic medication safety notification capabilities, the way drug manufacturers communicated the common problems described above could best be described as haphazard. And surprisingly, some manufacturers still use the same inadequate methods today, creating important safety communications that may never get read because the delivery of the communications are not effectively reaching the target audience at the most timely moment.

Contacting a professional pharmacist or prescriber society that, in turn, would inform its members is certainly one way to communicate safety issues. “Dear Pharmacist” letters and “Dear Prescriber” letters may even be required by FDA. But, if a manufacturer wants to be sure its efforts meet the needs of the patient and not just the mandate of the FDA, then electronic medication safety notifications should be considered part of the overall communication plan.

The problems inherent in that traditional approach to medication safety notifications are obvious. Think of recall notices sent by automobile manufacturers to consumers. Most get thrown out immediately in the trash. The ones that aren’t thrown out immediately get filed away in a drawer, forgotten and rarely looked at again. The same is true of paper medication safety notifications sent to pharmacies and prescriber offices.

That creates business and clinical care disadvantages that ultimately may create a level of risk to patients. Manufacturers waste money and resources creating documents that go out to every pharmacy regardless of whether the pharmacy dispenses the medication. When notifications don’t reach the target audience, aren’t timely, or are ignored, patients may continue to receive a drug that is inappropriate, at the wrong dose, for the wrong indication or at the wrong interval. If a drug is under a shortage, then an in-workflow message can help direct the pharmacist to an appropriate alternative to discuss with the prescriber to avoid a treatment interruption. If a product’s formulation has changed, messaging can ensure that the pharmacist is aware and can properly counsel the patient on what is different about the drug product. By doing that, the patient understands any new use directions or potential new side effects. These issues, and more, can exacerbate patients’ health problems, raise questions about a drug’s effectiveness and damage the reputation of the manufacturer.

Using Electronic Medication Safety Notifications to Improve Patient CareHow an electronic medication safety notification system works

A better approach that avoids these pitfalls is creating a focused, streamlined communication to pharmacists at the point of dispense as part of their normal prescription-filling workflow. This is the electronic medication safety notification. Here’s how it works:

Step 1. The pharmacist receives a prescription, whether it’s e-prescribed or via hard copy.

Step 2. The pharmacist enters all the patient information and prescription information into the pharmacy management system and clicks ‘submit’ or ‘enter’ to generate a claim to the patient’s prescription insurance plan.

Step 3. A central network claims adjudicator reviews the claim for the parameters the manufacturer specifies, such as reviewing whether the age of the patient is appropriate for the drug and/or dose. If there’s no reason to generate a medication safety notification based on the parameters of the claim submitted, then the adjudicator allows the claim to move forward to the patient’s health plan for coverage determination.

Step 4. If the parameters of the prescription indicate there is a need for a medication safety notification, the claim is redirected back to the pharmacy before being sent to the health plan.

Step 5. The medication safety notification informs the pharmacist of the potential issue regarding the prescription medication and prompts the pharmacist to address it before resubmitting the claim. Sometimes, the “issue” is a request by the manufacturer that the pharmacist ensures the patient is thoroughly counseled on how to use the drug if taking it for the first time when he or she arrives to pick it up.

Step 6. Once the pharmacist resubmits the claim, it will go on to the health plan who will respond with coverage information.

All of the above electronic communications occur seamlessly in seconds within the pharmacy workflow. Pharmacists no longer have to remember those paper notifications they have filed away. They don’t have to log in to an external manufacturer website or log into an email system to retrieve a manufacturer’s notice buried in weeks or months of other unrelated emails. Those are workflow interruptions that truly cost them money and distract them from their other important work.

Benefits of using an electronic medication safety notification system

In addition to sidestepping the pitfalls of a paper notification system, an electronic medication safety notification system generates a number of clinical and business benefits for manufacturers and retail pharmacies. Electronic medication safety notifications can:

  • Improve medication safety at the point of dispense
  • Decrease the risk of future adverse drug events
  • Provide efficient and scalable drug safety messaging across multiple dispensing sites
  • Improve customer and patient satisfaction
  • Increase customer and patient loyalty
  • Provide drug product updates to pharmacies
  • Serve as a vehicle to deliver additional patient education information
  • Build stronger relationships between pharmacies and prescribers
Maximizing the benefits of electronic medication safety notifications

The key to maximizing the benefits of electronic medication safety notifications for retail pharmacies is not only in incorporating the notification process into the pharmacist’s normal workflow, but defining parameters that can further streamline the timeliness and appropriateness of the notification. For most known safety issues, reminders to pharmacists can be set to occur only on the original fill and first refill. Perhaps the medication’s safety issue only applies to females of reproductive age. If so, if the patient’s gender is submitted on the claim and indicates ‘male,’ no notification will result. There are many parameters that can be used to limit workflow interruption while ensuring the timeliness of a notification.

Further, retail pharmacies dispensing the medication can provide a consistent level of patient care. Consistency means pharmacists are providing the same level of care to each customer regardless of site. Independent of which retail pharmacy the patient gets their prescription medication from, when an electronic safety notification is delivered, pharmacists are receiving consistent information at consistently the right time they need it.

Given the industry’s shift to value-based payment models, providing the safest possible care to patients is a non-negotiable condition for doing business. Drug manufacturers can do their part by adopting an electronic medication safety notification system to make drug use by customers as safe as possible.

Related: Learn more about McKesson’s medication safety messaging services for drug manufacturers

Patricia daCosta

About the author

Dr. Patricia daCosta is a senior product manager at RelayHealth Pharmacy Solutions. She has been with RelayHealth for nine years using her clinical knowledge to effectively manage NotifyRx™, RxSafety Advisor™ and REMS, which are SaaS-based prescription safety solutions. She earned her Doctor of Pharmacy degree from Mercer University and has 18 years of experience as a pharmacist in retail pharmacy settings as well as clinical patient care settings, including many specialty roles in support of HIV/AIDS patient management, MTM and Chronic Care Improvement Programs, and anticoagulation management services.