According to the Centers for Disease Control and Prevention, opioid abuse had become a national epidemic, with more than 70,000 opioid overdose-related deaths in the United States in 2017. Meanwhile, the specialty pharmacist is strategically positioned to provide disease management services for opioids and other low-cost, high-risk drugs.

The field of specialty pharmacy began its rise to prominence in the 1980s by dispensing and monitoring the use of HIV and transplant drugs. This required hyper-vigilance and care to ensure successful organ transplants and the prevention of drug resistance. During this time, it became apparent that specialty pharmacies could provide extra value in improving outcomes with lifesaving drugs.

In a specialty pharmacy setting, the pharmacist can provide services and administer care that is beyond what’s available at a typical community pharmacy, in which time constraints and fewer resources would be inadequate for patients who require more involved disease management services and treatment.

That’s because specialty pharmacy provides high-cost, high-risk drugs with disease management services overseen by a pharmacist who is an expert in medications that are used to treat catastrophic diseases. The specialty pharmacist is also strategically positioned to provide disease management services for other high-risk drugs that are lower cost, but still have devastating impacts on society. Among these are high potency opioids and benzodiazepines.

Pharmacist-Patient Relationships Vital to Success
Specialty pharmacists are well positioned to manage the opioid epidemic because they are in regular contact with their patients who trust them. The pharmacist also has a good understanding of and the need for hyper-vigilance regarding the drugs’ adverse effects. Specialty pharmacists are cautious when dispensing controlled substances because addicted patients can become desperate and manipulative, resulting in elaborate schemes to obtain them. Most who have worked in community pharmacies can share stories about this behavior.

However, with specialized training, a pharmacist can manage these patients through boundary-setting, monitoring protocols, and regular communication with the prescriber. They also can learn weaning schedules that provide the foundation to safely step down a patient from opioids as needed, without fear of causing life-threatening withdrawal symptoms. 

Specialty Pharmacies Provide Program Support
In addition to providing disease management services, specialty pharmacies play key roles in supporting various programs geared toward reducing opioid abuse and treating addiction: 

Office of National Drug Control Policy established to reduce opioid Rx fills
Implemented in 1988, the principal advisory agency to the president on drug control activities, the White House Office of National Drug Control Policy (ONDCP), stresses education and awareness of the fatal results that can occur as a result of unnecessarily prescribing opioids. It was implemented to oversee 16 federal departments and agencies to reduce illicit drug use, manufacturing and trafficking, drug related crime and violence and drug-related health consequences.

In 2017, under the Trump administration, ONDCP set its sights on reducing opioid-related deaths with goals of reducing national opioid prescription fills by one-third, improving access to evidence-based addiction treatments and limiting the availability of illicit drugs in the United States. Reducing barriers to long-term replacement programs with opioid medication therapy (OMT) is a priority of the ONDCP. It’s also an opportunity for specialty pharmacists to provide white glove service to fragile patients susceptible to constant cravings of abandoning replacement therapy and reverting to dangerous alternatives, such as heroin or fentanyl. 

FDA approves Opioid Analgesic REMS program
On September 18, 2018, the FDA approved the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) program to reduce the risk of abuse, misuse, addiction, overdose, and deaths due to prescription opioid analgesics while maintaining access to pain medications. It plans to achieve this goal by educating health care providers involved in the treatment and monitoring of patients who experience pain.

The FDA believes that all health care providers involved in the management of patients with pain should be educated about the fundamentals of acute and chronic pain management, as well as the risks and safe use of opioids. This way, when they write or dispense a prescription for an opioid analgesic, or monitor patients receiving these medications, they can ensure that the proper product is chosen and used with appropriate clinical oversight.

Increased OMT success rates
A specialty pharmacist can provide necessary guidance and support to make a replacement program successful, and more convenient and accessible for patients who need access to a health care professional. Methadone has been proven effective at controlling opioid addiction and allows patients to lead productive lives. Methadone dispensing clinics require patients to arrive daily for individual doses, preventing them from overdosing.

Among the drawbacks to methadone for OMT is the inconvenience and impracticality of having to make daily clinic visits. Methadone also has a long half-life and cardiovascular toxicity issues that make it dangerous to use if not taken as ordered, once daily, and closely monitored. Also, dispensing more than a few methadone doses at a time could be lethal.

In Canada, where pharmacists provide methadone in community pharmacies, a National Clinical Guideline must be followed. Through regular communication with the prescribing provider, pharmacists have been able to provide methadone safely and more conveniently than the methadone clinic model in the United States.

In addition, methadone replacement therapy has better outcomes than buprenorphine/naloxone combinations, which have lower retention rates.1

However, when compared with methadone:
 
  • OMT with upper dose thresholds of buprenorphine/naloxone is safer and can be dispensed 1 month at a time.
  • Buprenorphine/naloxone combinations are more popular options for addictionologists to prescribe. 
  • Due to patient dissatisfaction, buprenorphine/naloxone regimens are not as effective at maintaining OMT adherence. 

Specialty Pharmacies: Controlling Dispensing with High-Tech Devices
For patients who fail on buprenorphine/naloxone, methadone is a good, cost-effective alternative if it’s made available in a safe environment with oversight from a specialty pharmacy, which mimics the methadone clinic setting without the inconvenience of daily visits. In lieu of daily clinic visits, high-tech devices supply the drugs in a controlled unit that a specialty pharmacist could manage effectively for opioid patients who are at risk of potential overdose. 

Examples of such devices include MedacubeLiviathome, and Herohealth, which tracks use to improve adherence. However, they also can be used to prevent overutilization. Their anti-tampering features provide safe storage for medications with high abuse potential. The technology tracks when doses are taken or missed. Data are then transmitted to a service offered and closely monitored by a specialty pharmacy.

Benzodiazepine Prescriptions Pose Challenges
Benzodiazepines are in another drug class for which abuse is a concern. Although the combination of opioids and anti-anxiety medications is not recommended, it occurs frequently since anxiety and pain often go hand in hand.

The risk of overdose toxicity is potentiated by the combination of these 2 respiratory depressants. The risk is highest when more doses are taken at 1 time rather than spacing doses as prescribed. A medication-dispensing device—in combination with oversight from a specialty pharmacy—could offer a safer, necessary solution when co-prescribing these agents.

Meanwhile, patients who miss a benzodiazepine dose can experience dangerous withdrawal symptoms. Missed doses occur because initial doses are taken too frequently, then the patient runs out of medication before it’s time to have the prescription refilled. A pharmacist who dispenses benzodiazepine prescriptions can be challenging. If filled early, there likely is a chance that misuse will continue because more than the prescribed amount will be taken at more frequent dosing intervals.

Meanwhile, if the pharmacist doesn’t refill the prescription the patient is at risk for withdrawal symptoms, which can be lethal. A patient experiencing withdrawal symptoms can be sent to a hospital for detox or to a specialist who may be able to detox in an outpatient setting. But this scenario will require the pharmacist to fill a new benzodiazepines prescription, perhaps in smaller quantities and in a daily supply.

In this circumstance, the medacube device could be helpful, as it provides only one dose at a designated time and allows patients to safely be weaned off the drugs at a schedule that prevents withdrawal symptoms.

Conclusion
Specialty pharmacists are well positioned to combat the opioid epidemic through training and collaborations between opioid prescribers and patients they treat. This team approach can be successful in ensuring that patients have the treatment they need and are being supervised, managed, and appropriately monitored. Meanwhile, a dispensing device and specialty pharmacist offer a safe alternative to methadone clinic settings that can be effective, yet inconvenient and impractical for patients.

For patients who fail on buprenorphine/naloxone, methadone is a good, cost-effective alternative if it’s made available in a safe environment with oversight from a specialty pharmacy, which mimics the methadone clinic setting without the inconvenience of daily visits.  The Canadian health care system is an example of how to successfully utilize pharmacists to safely dispense methadone for OMT and is a good example of how pharmacists could be utilized to close the gap that exists in the United States.

Reference
  1. Whelan Paul J, Remski Kimberly. Buprenorphine vs methadone treatment: A review of evidence in both developed and developing worlds, Journal of Neurosciences in Rural Practices, 2012 Jan-Apr; 3(1): 45–50.

About the Author
Nivedita Kohli earned her Bachelor of Pharmacy degree from the Bouvé College of Health Sciences at Northeastern University and is currently enrolled in the Master of Pharmacy Business Administration (MPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in pharmacy business. She spent the past 20 years developing and implementing drug safety initiatives for a health plan and pharmacy benefit management provider serving Western New York. Over the past decade, she spearheaded educational programs for healthcare practitioners around appropriate opioid prescribing in addition to supporting the Erie County Opioid Epidemic Task Force with multi-faceted programs to improve the outcomes and reduce the impact of the opioid epidemic in Western New York. More recently, she is focusing on opportunities to provide high quality, sustainable healthcare in the current US market, employing her skillset in managed care and business.