Long-Acting Injectable Antipsychotics Now Easier To Find Closer To Home

During their 2021 legislative sessions, both Maryland and North Carolina enacted bills to allow pharmacists to administer long-acting injectable antipsychotics (LAIA) and other injectable drugs to consumers with a doctor’s prescription. In Maryland, the new laws go into effect on September 1, 2021. In North Carolina, the new laws go into effect on October 1, 2021. LAIA are concentrated formulations of antipsychotic medications that release a dose of the medicine slowly over time (two to 12 weeks, depending on the medication)^3.

Maryland Senate Bill 84 authorizes a pharmacist to administer to consumers maintenance injectable medication, that are not biological products. The Maryland Board of Pharmacy is promulgating regulations to clarify and implement the provisions of this legislation.

North Carolina House Bill 96 allows pharmacists to administer injectable drugs to consumers with a prescription. Under state law, pharmacists can already administer vaccines, such as for influenza or coronavirus disease 2019 (COVID-19). On June 15, 2021, the North Carolina Board of Pharmacy issued temporary regulations. By April 2022, the Board of Pharmacy and the North Carolina Medical Board will develop rules for the types of medications pharmacists would be permitted to administer and record-keeping requirements.^1,2

“The general idea behind permitting pharmacists to administer LAIAs is that it will improve patient’s medication adherence. These medications are typically dispensed as a single unit-dose and administered in up to 90-day intervals. Providers typically prefer to administer these drugs in-office to reduce the possibility of medication-related adverse events,” said Kyle Robb, Pharm.D., State Policy and Advocacy Associate for the Bethesda, Maryland-based American Society for Health-System Pharmacists (ASHP). Kyle Robb also added that “nonadherence to [oral antipsychotics] is a known problem and is often estimated to be greater than 50% for certain patient populations. Pharmacy-based LAIA administration is intended to increase the number of options a patient has for locations they can receive their injection and eliminates the need for them to make and keep an office appointment just to receive an injection.”

These new laws in Maryland and North Carolina represent efforts from community pharmacists in the U.S. over the past 10 years to become more involved with administering medications, including LAIA, the way pharmacists can in England, Canada, and many other states in the United States.^4,5 This allows patients to receive injectable medications close to home rather than travelling to their doctor’s office for bi-monthly to monthly injections or taking daily oral medications. LAIA are typically given as an intramuscular injection, like receiving a vaccine. Depending on the pharmacy, the medication, and what the pharmacy has available in stock, a patient with a valid prescription could just walk in and receive the injection at their convenience rather than scheduling a specific appointment time. Many patients prefer the drop-in convenience of their local pharmacy over going to a provider’s office.   

Although LAIA are not right for all patients, for many, they can delay time to relapse that can be devastating for patients and their families.^{7, 8} Suicide is also a problem for people with schizophrenia. The lifetime risk of suicide in patients is about 5%, which is 20 times higher than that for the general population. New research published in the Journal of the American Medical Association in May 2021 said that patients who received LAIA had fewer suicide attempts and a 47% reduction in the risk of suicide mortality compared to patients who took oral antipsychotics.⁸ Relapses are also costly to the healthcare system as hospitalizations due to nonadherence to antipsychotics cost the system about $1.5 billion per year⁸.

Due to the high mortality rate, schizophrenia is often considered one of the most severe psychiatric disorders because people living with the disease have a life expectancy of 10 to 25 years shorter than individuals without schizophrenia⁸. Although there are many causes for the shorted life span, it is hoped that better adherence to antipsychotics will help patients live longer. There are some negatives to LAIA though. Some patients complain about pain at the site of the injection and perceive a lack of flexibility with their ability to adjust the dose. Some patients also report LAIA can cause slow dose titration and take longer to achieve ideal levels.⁹ Another issue is that there are fewer dosages of LAIA available compared to oral medications. Some LAIA also require refrigeration, which was often discussed this year regarding certain COVID-19 vaccines.

Over the past few decades, pharmacists have been taking a more active role in patient care. In the 1990s, for example, only a handful of pharmacists across the country were trained to administer vaccines. However, today nearly all community pharmacists have incorporated vaccines into their practices⁴. This was evident during 2021 as the first COVID-19 vaccines were rolled out into local pharmacies for distribution into the community. Proximity to local pharmacies is important as research shows approximately 90% of Americans live within two miles of a pharmacy, which is much better than community access to a primary care physician or a mental health provder.⁵

While pharmacists can administer vaccines in all 50 states and Washington, D.C., with some variability to patient age and types of vaccine, the legal landscape for administering LAIA and other injectable medications (such as drugs for arthritis, birth control, and opioid overdose) varies from state to state. “Some states explicitly authorize pharmacists to administer medications, some explicitly forbid it, and others are silent,” said Kyle Robb from ASHP.  

To help clarify the issues, a group called the Medication Administration Stakeholder Group formed in 2017 with members from the National Alliance of State Pharmacy Associations (NASPA) and the College of Psychiatric and Neurologic Pharmacists (CPNP). Together, they have been working with state legislators to clarify and expand the scope of practice for pharmacists. This year, 213 state provider status-related bills were introduced in 43 states. So far, 32 bills have passed in 18 states, including the two bills in Maryland and North Carolina.² This is an increase from 2019 when NASPA reported that 147 bills were introduced related to pharmacist provider status.⁵

Due in part to their efforts, 47 states now allow pharmacists to administer other prescribed medications with varying levels of restrictions, including the administration of LAIA with a prescription, a NASPA spokesperson said.¹² In 12 of those states, pharmacists need a collaborative practice agreement (CPA) to do so. A CPA is a formal practice relationship between pharmacists and other health care practitioners that allow for certain patient care functions, such as the administration of medications, to be delegated to the collaborating prescriber.^4,13

Also called “depot formulations” or “slow-release” medications, LAIA have been available in the United States since the 1960s. However, drug makers changed the technology by which medications are delivered or released into the blood stream in the 2000s, leading to what is called the second-generation of LAIA. These improved delivery techniques combined with a renewed interest from clinicians in LAIA has led to a slew of new research showing the benefits of injectables over keeping up with a regimen of daily oral medications.^11,12 Between the new research supporting LAIA and the increased access to receiving them through local pharmacies, patients and their providers should discuss whether an injectable may be a better option for certain illnesses, like schizophrenia.

References:

1. Maryland & North Carolina Implementing New Laws To Permit Pharmacists To Administer Long-Acting Injectable Antipsychotics. OPEN MINDS. (2021, June 30). https://openminds.com/market-intelligence/news/maryland-north-carolina-implementing-new-laws-to-permit-pharmacists-to-administer-long-acting-injectable-antipsychotics.
2. 2021 State Provider Status Mid-Year Legislative Update. NASPA. (2021, June 24). https://naspa.us/resource/2021-state-provider-status-mid-year-legislative-update/.
3. Zolezzi, M., Abouelhassan, R., Eltorki, Y., Haddad, P. M., & Noorizadeh, M. (2021). Long-Acting Injectable Antipsychotics: A Systematic Review of Their Non-Systemic Adverse Effect Profile. Neuropsychiatric disease and treatment, 17, 1917–1926. https://doi.org/10.2147/NDT.S309768
4. State Policy Recommendations for Pharmacists Administration of Medications. National Alliance of State Pharmacy Associations and the College of Psychiatric and Neurologic Pharmacists. (2017, March). https://naspa.us/wp-content/uploads/2017/04/Medication-Administration-Meeting-Report-FINAL.pdf.
5. Sachdev, G., Kliethermes, M. A., Vernon, V., Leal, S., & Crabtree, G. (2020). Current status of prescriptive authority by pharmacists in the United States. Journal of the American College of Clinical Pharmacy, 3(4), 807-817.
6. Barbui, C., Bertolini, F., Bartoli, F., Calandra, C., Callegari, C., Carrà, G., D’Agostino, A., Lucii, C., Martinotti, G., Mastromo, D., Moretti, D., Monzani, E., Porcellana, M., Prestia, D., Ostuzzi, G., & STAR Network Investigators (2020). Reasons for initiating long-acting antipsychotics in psychiatric practice: findings from the STAR Network Depot Study. Therapeutic advances in psychopharmacology, 10, 2045125320978102. https://doi.org/10.1177/2045125320978102
7. Correll, C. U., & Lauriello, J. (2020). Using Long-Acting Injectable Antipsychotics to Enhance the Potential for Recovery in Schizophrenia. The Journal of clinical psychiatry, 81(4), MS19053AH5C. https://doi.org/10.4088/JCP.MS19053AH5C
8. Huang C, Fang S, Shao YJ. Comparison of Long-Acting Injectable Antipsychotics With Oral Antipsychotics and Suicide and All-Cause Mortality in Patients With Newly Diagnosed Schizophrenia. JAMA Netw Open. 2021;4(5):e218810. doi:10.1001/jamanetworkopen.2021.8810
9. Shafrin, J., Forma, F., Scherer, E., Hatch, A., Vytlacil, E., & Lakdawalla, D. (2017). The cost of adherence mismeasurement in serious mental illness: a claims-based analysis. The American journal of managed care, 23(5), e156–e163.
10. Guzman, F. Long-Acting Injectable Antipsychotics: A Practical Guide for Prescribers. Psychopharmacology Institute. (19 June 2019). (https://psychopharmacologyinstitute.com/publication/long-acting-injectable-antipsychotics-a-practical-guide-for-prescribers-2201?canonical=%2Fpublication%2Flong-acting-injectable-antipsychotics-a-practical-guide-for-prescribers-2201#fn:1
11. Fact sheet: Long-acting injectable antipsychotics (LAIs). (2020) https://psychu.org/wp-content/uploads/2020/02/PsychU-LAI-Fact-Sheet-1.pdf.
12. Crocq M. A. (2015). A history of antipsychotic long-acting injections in the treatment of schizophrenia. L’Encephale, 41(1), 84–92. https://doi.org/10.1016/j.encep.2014.12.002
13. E-mail exchange with Allie Jo Shipman, Pharm.D., MBA, Director, State Policy, National Alliance of State Pharmacy Associations (NASPA) on July 9, 2021.