Protect Against Opioid Lawsuits in the Pharmacy

Pharmacies and pharmacists are being held to higher standards than before when it comes to opioid liability. And with the convergence of the COVID-19 pandemic and the ongoing opioid crisis, patients are at more risk than ever of developing opioid dependency or relapsing.

In a virtual session presented during the National Community Pharmacists Association (NCPA) 2020 Annual Convention, which was held online October 18-20, Linda Clark, JD, Health Care Controversies Team Leader, Barclay Damon LLP and Joe Moose, PharmD, owner of Moose Pharmacies, discussed best practices for how pharmacists can help their patients while protecting themselves against potential lawsuits when it comes to dispensing opioid medications.

Already a national crisis prior to COVID-19, evidence suggests that the opioid epidemic has only worsened since the start of pandemic. According to Clark, over 20 million people in the US are reporting having a substance use disorder, many of whom are experiencing the additional stress of being locked down. Statistics have showed that drug overdoses climbed 18% within the first few months of the pandemic.

As opioid litigation against the drug supply chain continues to advance, pharmacies are under increased scrutiny when it comes to opioid dispensing. “We’re finding that more and more courts facing these issues are holding pharmacies to a very high standard indeed,” Clark said.

Pharmacies involved in lawsuits face allegations that include handling high volumes of opioid drugs without proper oversight, often with claims that defendants disregarded certain data and violated best practices. Clark also pointed to an uptick in prosecutors seeking to hold pharmacies and pharmacists criminally liable. For example, in 2017, a New Jersey pharmacist was convicted in federal court of distributing and illegally dispensing oxycodone. In some instances, the pharmacist would fill prescriptions for oxycodone even though the prescription had apparently been “washed” or “bleached” to remove the original physician’s writing.

“We’re seeing just now some major precedents coming down that will tell us what the best practices are for pharmacies and pharmacists dispensing opioids in the middle of this epidemic and this pandemic,” Clark said.

How Can Pharmacists Protect Themselves?

Incorporate Harm Reduction Strategies

With increasing susceptibility to liability in certain states, pharmacists should implement strategies for harm reduction for patients, especially amid the pandemic. Establishing thorough due diligence policies, which includes checking state prescription drug monitoring programs (PDMPs) and identifying potential red flags, is necessary. 

Some potential red flags can be identified by:

• Presentation of the prescription
• Patient behavior
• Medication taking and supply
• Illicit and illegal behaviors

In addition to ensuring each opioid prescription is valid, pharmacists have the responsibility of determining whether the prescription is in the patient’s best interest. Pharmacists should also assess whether the patient is a candidate for naloxone and provide follow-up with family members to educate about proper administration. Many states now allow prescribing of naloxone to a caregiver or family member.

Clark also recommended keeping an eye on state initiatives that are changing the landscape of pharmacist responsibility. For example, Florida recently passed House Bill 743 mandating health care professionals to inform patients of nonopioid alternatives prior to prescribing and ordering opioid drugs. The bill also requires informative pamphlets, a discussion with the patient, and documentation of nonopioid alternatives considered in the patient’s record.

Establish Standards of Care

Implementing internal policies for handling opioid prescriptions and standard of care for patients who are prescribed opioids is essential for the pharmacy’s practice. 

According to Moose, the cornerstone for this is, first and foremost, getting the process in place. Moose noted that pharmacists should be proactive in their approach and adopt an outlined process that is completed with each and every opioid prescription. For the process to be successful, it needs buy-in from the entire pharmacy staff, not just the lead pharmacist.

“Don’t expect to get this right on day one,” Moose cautioned. He suggested having frequent huddles and check-ins with staff to talk through different scenarios.

Since patients on opioids can consume a large amount of staff time and energy, utilizing an appointment-based model can help sync patients and increase efficiency, especially with patients who are taking chronic medications.

According to Moose, pharmacists should set expectations with patients by going over their pharmacy’s Policy & Procedures (P&P or Pledge) of dealing with opioids. The pharmacy’s Opioid Pledge should outline the commitment of the pharmacy and the patient for opioid medications. When patients know the pharmacy’s opioid P&P, they’ll cause less workflow disruption and will allow staff to focus on other services.

Moose noted that everyone on the pharmacy team should be on the same page when it comes to the Opioid Pledge and the pharmacy’s internal policies on opioid dispensing. Once the Pledge is developed, pharmacists should print copies and place at appropriate workstations, and make sure that all pharmacy staff members are educated on the workflow process and their individual roles.

Moose also recommended role play amongst pharmacist staff to practice discussing the Opioid Pledge. Begin providing patients with the pharmacy’s Pledge with the goal to provide it to all acute opioid patients at each time an acute opioid medication is received and to all chronic opioid patients, he said.

Ensure Documentation

Conscientious documentation and recordkeeping is at the forefront of protection against legal action, according to Clark. “We need to talk about what is the documented record that pharmacies and pharmacists can develop in order to show that they use due diligence in scrutinizing opioid prescriptions,” Clark said.

Pharmacies need to implement systems and processes for documenting everything that is done in the pharmacy to make sure that an opioid prescription is valid and appropriate. With courts now recognizing a pharmacy’s duty to maintain proper procedures, pharmacies should take extra care in ensuring their eCare plan and recordkeeping database meet applicable criteria.

Information that should be maintained includes:

1. Date
2. Identifying information, including that of the member documenting the patient contact
3. Patient presenting symptoms or concerns
4. Patient history summary and care plan if developed
5. Information provided to or received from other caregivers
6. Assessments, interventions, and recommendations where professional judgement was exercised along with the evidence on which recommendations are based
7. A follow-up plan that is sufficiently detailed to monitor the patient’s progress and ensure continuity of care by the pharmacist.

It is imperative to ensure that everything is carefully recorded in the eCare plan, which is vital for tracking the patient’s progress and utilizing all of the policies that have been put in place.

The eCare plan provides:

1. Proof the pharmacy did what the P&P states
2. Way of communicating what was told to the patient to other staff
3. Way of communicating what was told to the patient to the patient
4. Way of communicating to other medical providers
5. Tracking of progress toward tapering
6. Tracking of adjunct therapies

Maintaining detailed documentation is imperative for proof that the pharmacy is upholding best practices designed to keep their patients safe. “If somebody drags you into court of law, what are you going to do to show them? Where do we prove that we do that,” Moose said.

Although this step can be time consuming, Moose indicated that it will actually help pharmacists in the long run save time with patients who may be demanding of the pharmacy’s resources.

“It’s something that takes time on the front end, but it’s an investment in being able to care for the patient more efficiently, which I think will ultimately save you more time,” Moose said.

Reference:

1. Clark L, Moose J. How do I help my patients taking opioids and protect myself against potential lawsuits? Presented at: NCPA 2020 Annual Convention; October 18-19, 2020; virtual.