Matthew

#RxSky #PharmSky #MedSky

#RxSky #Pharmsky #MedSky

VA/DoD Clinical Practice Guidelines recommendations:

There is insufficient evidence to recommend for or against ketamine infusions or esketamine to reduce the risk of suicide or suicide attempts. (Neither for nor against)

VA/DoD Clinical Practice Guidelines recommendations:

We suggest offering ketamine infusion as an adjunctive treatment for short-term reduction in suicidal ideation in patients with the presence of suicidal ideation and major depressive disorder. (Weak for)

VA/DoD Clinical Practice Guidelines recommendations:

For patients with MDD who have not responded to several adequate pharmacologic trials, we suggest ketamine or esketamine as an option for augmentation. (Weak for)

Systematic review of available literature found intravenous, intranasal, oral, and possibly intramuscular and subcutaneous maintenance ketamine treatment to be effective in sustaining antidepressant effect in treatment resistant depression

Serious renal and urinary problems seem uncommon

Despite low response rate and considerable out-of-pocket costs, almost half of real-world outpatients with TRD decided to continue with maintenance ketamine treatment due to perceived significant improvement

More than one third of patients displayed reduction in suicidality

Key risks of ketamine and esketamine:
Dry mouth, tachycardia, increased BP, and feelings of disassociation

Ketamine ulcerative cystitis

Risk of addiction?

Inconsistent evidence on long-term risks with ketamine infusion; Esketamine appears safe and effective for maintenance use up to one year

Both esketamine and ketamine require in office administration and require transportation to and from the appointment

#Ketamine and #Esketamine are both relatively effective for TRD but only Esketamine is #FDA approved for depression and suicidality

Ketamine is administered IV and cheaper but has less evidence for use

Esketamine is administered intranasally and is more expensive

rTMS is #FDA indicated for the treatment of major #depresison

Patients with TRD were three times as likely to achieve a response versus sham and were five times as likely to achieve remission

#Placebo effect plays a large role

Risks include irritation to stimulation site and headaches

Key risks to consider with #ECT:

- Short term memory loss
- General anesthesia risks

Symptom improvement is short-term and should be followed by maintenance treatment with antidepressants or repeated ECT treatments if antidepressants are not tolerated

Other considerations for ECT:
Catatonia
Psychotic depression
Severe suicidality
Hx of a good response to ECT
Need for rapid treatment response
The risks associated with other treatments are greater
Hx of a poor response to multiple antidepressants
Patient preference

When would you consider ECT?

Only “strong for” recommendation – even though evidence of low quality, meets GRADE 15 criteria as an intervention for treatment in a life-threatening situation in certain subpopulations

#ECT is more efficacious than sham ECT or pharmacotherapy but comes with risks

What options are there to treat DtD?

Electroconvulsive Therapy (ECT)
Repetitive transcranial magnetic stimulation (rTMS)
#Ketamine or #Esketamine

What are the goals and principals for managing DtD?

• Strive for optimal symptom control
• Reduce risks and impact of relapse
• Optimize psychosocial functioning

Treatment can be any modality and should normally be considered after at least two treatment trials

"Adequate" treatment includes evidence based #psychotherapy (EBP) and #pharmacotherapy

For pharmacotherapy, it means an adequate duration (4-6 weeks) and dose (half maximum dose or more)

Difficult to Treat Depression = #depression that continues to cause significant burden despite usual treatment efforts

This terminology is intended to be used in a clinical setting vs #research or regulatory settings

This terminology is more empathic and fosters a collaborative approach

Difficult-to-treat #Depression (DtD)

What is it and how is it different from treatment resistant depression (TRD)?

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#AAPP2025 #MentalHealth #Psychiatry #Pharmacy

How does the approval process look for DTx vs Drugs? This table laid it out great! #AAPP2025

De Novo = Provides a pathway to classify novel #medical devices for which there is no legally marketed predicate device

The verbiage for DTx is different compared to Drugs. DTx is "Authorized" where as drugs are "Approved"

What does @fda.gov approval for DTx look like?

After submission they can seek 501K clearance or De Novo authorization from the #FDA

510K clearance = a technological update that shows equivalency to a marketed device that already exists

5. Clinical trials - start full clinical trial to prove its value
6. Regulatory approval - seek approval from a regulatory body such as the @fda.gov

Fun Fact: there are >300,000 health related apps on the market and <1% are evaluated by the #FDA

How is DTx created?

1. Preclinical phase
2. Trial version - create a dry run trial for the software to work out kinks in patients
3. Pilot clinical study - test in a small group under controlled conditions
4. Full development - if successful, move into technical and commercial expansion

What's the deal with Digital Therapeutics (DTx)?

DTx are health #softwares intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has demonstrable positive therapeutic impact on a patients #health

#AAPP2025 #Pharmacy 🧵

Live posting during #AAPP2025 sessions

Stay tuned

#Psychiatry #Pharmacy #Medicine

Medical journals complain of 'harassment' from Department of Justice Multiple scientific publications have now received letters from the Trump administration questioning their editorial practices and standards.

At least three medical journals have received letters from U.S. Department of Justice that questioned their editorial practices and standards, prompting several journals to push back and assert their independence.

A JAMA study found that at current state-level vaccination rates, measles may become endemic again; increasing vaccine coverage would prevent this.

Read the full Original Investigation covered by the @washingtonpost.com. @nathanlo.bsky.social jamanetwork.com/journals/jam...

Her husband was mistakenly deported. Now she’s caught in a political frenzy. Jennifer Vasquez Sura has fought to bring her husband, Kilmar Abrego García, home from a Salvadoran prison while caring for their children, two of whom have autism.

Jennifer Vasquez Sura has fought to bring her husband, Kilmar Abrego García, home to Maryland from a Salvadoran prison while caring for their kids, two of whom are disabled.

“I just want my husband back, my best friend back, my kids’ father back,” Vasquez Sura said. “I want our life back.”

@sanders.senate.gov and @aoc.bsky.social did something that no California Dems likely could: turn out 26,000 people for a weeknight rally in a Republican House district and chart a way forward for an enfeebled Democratic Party, writes political writer Joe Garofoli.

📷: @stephenlamphoto.bsky.social