Pharmacist Care for Mental Health

(MAP-AP Trial)

Overseen By Yazid Al Hamarneh, BSc (Pharm), PhD, CDM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Pregnancy, Substance abuse, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 months

94 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on patients who are starting new medications for depression or anxiety.

What data supports the effectiveness of this treatment for mental health?

Research shows that pharmacists can help improve how well people stick to their antidepressant medications, which can lead to better outcomes. Additionally, pharmacists' reviews of medications can reduce the use of inappropriate drugs, and their involvement in mental health care has been linked to improved patient satisfaction and resource use. ^{1 2 3 4 5}

Is pharmacist care for mental health generally safe for humans?

Research suggests that pharmacists can help improve medication safety and reduce inappropriate prescriptions for mental health conditions, indicating a generally safe role in patient care. ^{1 4 5 6 7}

How is the treatment 'Enhanced Pharmacist Care' for mental health different from other treatments?

Enhanced Pharmacist Care is unique because it involves pharmacists directly in mental health care, allowing them to assess and prescribe medications for conditions like depression and anxiety. This approach leverages pharmacists' expertise in medication management and provides a more accessible and potentially quicker way for patients to receive mental health care compared to traditional methods that primarily involve doctors. ^{4 8 9 10 11}

What is the purpose of this trial?

This is a clinical trial evaluating the experimental intervention of enhanced pharmacist care by pharmacists with additional prescribing authorization (APA) in Alberta, for patients newly diagnosed with Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD).

Research Team

Yazid Al Hamarneh, BSc (Pharm), PhD, CDM

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for adults over 18 in Alberta who've just been diagnosed with Major Depressive Disorder or Generalized Anxiety Disorder and are starting medication. It's not for those with a history of substance abuse, other mental health conditions like bipolar disorder, severe depression types, multiple suicide attempts, pregnant individuals, or non-residents.

Inclusion Criteria

I am an adult newly diagnosed with depression or anxiety and starting treatment.

Exclusion Criteria

History of and/or current substance abuse, intoxication, addiction or withdrawal

≥2 suicide attempts per year

I cannot commit to regular follow-up visits.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive enhanced pharmacist care with additional prescribing authorization, including monitoring, patient education, referral facilitation, and prescribing adjustments

6 months

In-person visits at enrollment, 1, 3, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Mental Health Assessment and Prescribing by Alberta Pharmacists

Trial Overview Pharmacists with special prescribing rights are testing an enhanced care approach for managing new cases of depression and anxiety. This includes assessing patients' mental health, adjusting medications if needed, providing counseling support, identifying drug side effects or interactions, and coordinating closely with physicians.

Participant Groups

Group I: Intervention Group (Standard Pharmacist Care + Pharmacist Interventions) Experimental Treatment 13 Interventions

Participants enrolled in the intervention group will receive pharmacist interventions, in addition to standard care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians), at enrollment (month 0) and at 1, 3, and 6 month in-person follow-up appointments

Group II: Control Group (Standard Pharmacist Care) Active Control 7 Interventions

Patients randomized to the usual care group will receive standard pharmacy care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians) and physician care, at enrollment (month 0) with no specific interventions for the duration of 6 months, until the 6 month in-person follow-up appointment

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Findings from Research

Incorporating a psychiatric pharmacist (PP) into primary care significantly improved access to depression treatment, reducing the average wait time for initial evaluation from 104.5 days in the behavioral health clinic to just 31.3 days in the primary care setting.

Patients treated by the PP showed a significant decrease in depression severity, with PHQ-9 scores dropping from 17.9 to 14.7, and reported high satisfaction with their care, indicating that this model is effective and well-received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficiencies and outcomes of depression treatment by a psychiatric pharmacist in a primary care clinic compared with treatment within a behavioral health clinic. Silvia, R., Plum, M., Dufresne, R.[2021]

The PharMIbridge trial aims to evaluate the effectiveness of a pharmacist-led support service for individuals with severe and persistent mental illness (SPMI), focusing on improving medication adherence and managing physical comorbidities over a 6-month period, involving 190 participants across 48 pharmacies.

Pharmacists in the intervention group will receive specialized training in mental health support and medication management, which is expected to enhance their ability to help patients compared to standard care, potentially leading to better health outcomes and quality of life for those with SPMI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the gap between physical and mental illness in community pharmacy (PharMIbridge): protocol for an Australian cluster randomised controlled trial. Wheeler, AJ., O'Reilly, CL., El-Den, S., et al.[2023]

Pharmacist interventions, particularly those combining patient education and drug monitoring, significantly improve patient adherence to antidepressant medications, with adherence rates increasing by 15% to 27%.

The review highlights that improved adherence is associated with better patient-reported outcomes and satisfaction, suggesting that pharmacist involvement can lead to enhanced treatment effectiveness for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of pharmacist interventions on patients' adherence to antidepressants and patient-reported outcomes: a systematic review. Al-Jumah, KA., Qureshi, NA.[2022]

Pharmacist-delivered community-based services can significantly improve adherence to antidepressant medications for patients starting treatment, as shown in three studies included in the review.

Medication reviews conducted by pharmacists can help reduce the prescription of potentially inappropriate medications for high-risk patients, indicating their valuable role in optimizing mental health medication management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community pharmacy services to optimise the use of medications for mental illness: a systematic review. Bell, S., McLachlan, AJ., Aslani, P., et al.[2022]

A systematic review of 35 publications from 1972-2003 found that clinical pharmacists positively impact mental health care, with 16 studies showing improvements in patient outcomes, prescribing practices, and satisfaction.

Despite the positive results, most studies were small and had design limitations, indicating a need for larger, multicenter trials to better evaluate the effectiveness and cost-effectiveness of pharmacists in mental health settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the impact of pharmacists in mental health: a systematic review. Finley, PR., Crismon, ML., Rush, AJ.[2022]

In a pilot project involving 144 patients, the inclusion of pharmacists in primary care behavioral health teams significantly improved medication safety, with an 18% increase in patients up-to-date on monitoring for psychotropic medications after 3 months.

The risk of drug interactions decreased by 20%, indicating that pharmacist-led medication reviews can effectively enhance patient safety in managing psychotropic medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacist medication reviews to improve safety monitoring in primary care patients. Gallimore, CE., Sokhal, D., Zeidler Schreiter, E., et al.[2018]

Community pharmacists are viewed as accessible drug experts who can significantly enhance the safety and tolerability of antidepressant drug treatments (ADT) by monitoring adherence and efficacy.

Healthcare leaders expressed a strong desire for increased collaboration between pharmacists and healthcare teams, highlighting the need for regulatory changes to support pharmacists' expanded roles in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contributions of community pharmacists to patients on antidepressants-a qualitative study among key informants. Guillaumie, L., Moisan, J., Grégoire, JP., et al.[2022]

A pharmacist-psychiatrist collaborative clinic for adult ADHD was successfully implemented, involving 58 patients and 774 encounters over three years, demonstrating the potential for effective interdisciplinary care in mental health.

The model allowed pharmacists to engage in various roles, including psychiatric evaluation and medication management, although challenges such as limited time and reimbursement issues were noted, highlighting areas for improvement in collaborative mental health practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an innovative adult attention-deficit hyperactivity disorder clinic. Lee, KC., Kim, E., Kim, J., et al.[2020]

In a study of 217 patients with depression and/or anxiety, no significant difference was found in the improvement of PHQ-9 and GAD scores between those receiving care from a provider alone and those receiving care from both a provider and a clinical pharmacist.

However, patients who worked with clinical pharmacists reported higher medication adherence, indicating that pharmacists can play a valuable role in supporting patients, even if overall symptom improvement was not statistically different.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Evaluating Clinical Pharmacy Services in an Ambulatory Psychiatry Setting. Lindell, VA., Stencel, NL., Ives, RC., et al.[2019]

Pharmacists can play a crucial role in mental health care by participating in multidisciplinary teams, supporting early detection of mental illnesses, and improving medication management, which can enhance patient outcomes.

Barriers to implementing pharmacist-led mental health services include stigma, pharmacists' attitudes, and collaboration challenges with physicians, but addressing these issues can facilitate better integration of pharmacists into mental health care teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New roles for pharmacists in community mental health care: a narrative review. Rubio-Valera, M., Chen, TF., O'Reilly, CL.[2023]

Community pharmacies have the potential to play a significant role in mental health services, as they regularly interact with mental health consumers and their carers, which can enhance support and medication management.

The review identified various international studies and systematic reviews that suggest professional service interventions in community pharmacies could be adapted to improve mental health care in Australia, drawing on existing models for chronic physical health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring an increased role for Australian community pharmacy in mental health professional service delivery: evaluation of the literature. Hattingh, HL., Scahill, S., Fowler, JL., et al.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficiencies and outcomes of depression treatment by a psychiatric pharmacist in a primary care clinic compared with treatment within a behavioral health clinic. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Bridging the gap between physical and mental illness in community pharmacy (PharMIbridge): protocol for an Australian cluster randomised controlled trial. [2023]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Impact of pharmacist interventions on patients' adherence to antidepressants and patient-reported outcomes: a systematic review. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Community pharmacy services to optimise the use of medications for mental illness: a systematic review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluating the impact of pharmacists in mental health: a systematic review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Pharmacist medication reviews to improve safety monitoring in primary care patients. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Contributions of community pharmacists to patients on antidepressants-a qualitative study among key informants. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Development of an innovative adult attention-deficit hyperactivity disorder clinic. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

A Pilot Evaluating Clinical Pharmacy Services in an Ambulatory Psychiatry Setting. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

New roles for pharmacists in community mental health care: a narrative review. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Exploring an increased role for Australian community pharmacy in mental health professional service delivery: evaluation of the literature. [2017]