In 2018, I was featured in the news for implementing an innovative model of care for our Mental Health Patients. I reflect upon the challenges of the pilot program and future outlooks. You can read the news article feature here.
Brief History of "Tranquiller, Ataratics, Neuroleptics and Antipsychotics"
If you recall from my previous post, we discussed a subtypes of Schizophrenia. As a refresher, Schizophrenics typically present POSITIVE and NEGATIVE symptoms theorized by fluctuations in the dopamine pathways of the brain. To name a few: hallucinations, delusions, flat effect, and disorganized speech and/or thoughts.
Prior to pharmaceutical treatment, modalities such as electroconvulsive therapy (ECT), lobotomies, insulin comas or sedation were typical. The mainstay pharmaceutical treatment in the 1950's for schizophrenia was opiates and barbiturate's. During this decade, scientists synthesized Chlorpromazine from a phenothiazine derivative. Originally indicated for nausea and other adrenolytic symptom's, chlorpromazine was first trialed on a manic patient. The manic patient was able to calm down and led to his release from an institutional locked setting. The results from this initial trial led to the development of "neuro-biological" drugs in psychiatry. "Ataractics" would be the termed first and is derived from the Greek word "atarakos" which means "not disturbed, not excited, w/o confusion, calm and steady". Ataraktein means to "keep calm" and is the verb form of "atarakos."
Haloperidol (Haldol) would be later developed in the tail end of the 50s by Paul Janssen. Janssen Laboratories is a huge company, that happens to be a subsidiary of Johnson and Johnson - at time of writing. Trifluperazine, thioridazine and fluphenazine would later be developed which constituted the "First Generation" Antipsychotics. From the 50s to the mid 90s, depending on the Physician or Group Organization, these medications were referred to as "Tranquilizers, Ataratics, and Neuroleptics". The National Institute of Mental Health (NIMH), which is a huge organization, later referred to these class of drugs as "Antipsychotics." There is still much debate over the semantics. Younger physicians will refer to them as "Antipsychotics" while the boomer generation of healthcare professionals may refer to them as "Neuroleptics." (It's quite funny when I speak to doctors over the phone about this because I can gauge their age quite quickly).
Secondary Generation antipsychotics would later be developed around the 90s. They were referred to as "novel" since they were different, new and distinguished themselves by the mechanism of action. For the average reader, just know that there are two different generations of antipsychotics that latch onto dopamine receptors, primarily. (This is a gross statement but it is much more incredibly nuanced than that). Lots of different receptors like 5-HT2 are H2 are affected as well (agonistically, partially or antagonistically). The Food Druga Administration tried to label these medications as "psychotropics." Unfortunately, "psychotropics" is a huge denominator which can represent antidepressants, anticonvulsants (to a degree), and antipsychotics.
With the birth of so many oral drugs for the treatment of Schizophrenia, it became evident that the pill formulation was difficult to swallow for many people. (Not literally). Many people diagnosed with Schizophrenia will be treated for the first time in an acute hospital setting and feel much better after. Routine compliance (or taking the medication on a daily basis) is quite difficult for most people, with extra emphasis on the mental health population.
We would see the development of "Long Acting Injections" for antipsychotics which can be given Intramuscularly or Subcutaneously. Risperdal Consta was the first injectable antipsychotic medication, in long acting form, to come onto market in 2003. It would be indicated for Schizophrenia Treatment and later Bipolar 1 Disorder. The oral tablet drug Risperdal (risperidone) would be developed in 1993, ten years prior to the release of its long acting injectable form. This medication would be administered on a bi-weekly basis.
The movie "One Flew Over the Cuckoo nest" starring Jack Nicholson did a great job highlighting the crude treatments towards Schizophrenia in the early ages before Antipsychotics were developed. Also Danny Devito is in this movie. I love Danny's role in It's Always Sunny in Philadelphia.
2003 to now, a lot of things have changed. We now have monthly to every three month injections to address Schizophrenia. There are a lot of tax benefits to this since it reduces hospitalization rates and increases compliance, reduces waste and improves overall outcomes. To name a few: Invega Sustenna, Invega Trinza, Aristada, Abilify Maintena, etc.
For the first time, we have the ability to replace an oral medication in lieu of a once-a-month injections. There are so many benefits to this, economically, socially, clinically and personally.
My entrepreneurial opportunity to Mental Health in Pharma
I have been involved in Pharmacy since I was a child. My father worked at Valley Medical with the numerous Psychiatrists that catered to the in-patient and out-patient community setting. He would later start his own Business which would pique my interest.
When I entered Pharmacy, I noticed that there was not much services readily available for Mental Health Patients. Every other "disease state" such as hypertension, hyperlipidemia, obesity have so much more resources. Why is that? Well, during the Nixon era, funding was slashed for Mental Health Services which forced the closure of many IMD's (Institutes for Mental Diseases) resulting in a marginalized population. I noticed that most of the innovative things to be offered were "Multi-Dose" pill packs. I used to operate three different robotic dispensing machines as my Pharmacy. Here is the result of one.
Amazon purchased Pill Pack sometime recently. I still think this is the dumbest purchase of all time, geared towards consumers and will explain the inner business workings of Pharma in a future post.
Multi-dose packs are great. The terminology isn't standardized across the profession but the general idea is that all the medications you take are sorted into an appropriate time. This saves the consumer time and also allows for safer outcomes for patients.
Going back to my time in Pharmacy. I quickly noticed that the amount of resources for Mental Health were next to nothing. We had a lot of different Long Acting Injections ("LAIs") but very little usage of it. I quickly discovered, most providers were not comfortable in administering LAIs. It is an incredibly complicated business process and requires a lot of high-touch services that go along with it.
I realized this was an opportunity that was too good to pass up.
Challenges in LAI clinics
LAI's are usually underpaid by most providers. It is a specialty drug and most specialty drugs for retail Pharmacies are note adequately reimbursed. Unlike flu shots, no administration fee is given, on the pharma side for billing, for LAIs. Ultimately, getting into this niche would require the Pharmacy to operate at a loss.
LAI's are a huge legal exposure. You will have varying ages in Mental Health. If you recall from my first blog post, Schizophrenia typically occurs in the 20s for most people. There will be adolescents, under 18, a non-consentable age, that may benefit from LAIs instead of daily oral medications.
LAI's require patient monitoring. This patient monitoring can be up to 30 minutes to 3 hours at times. It is expensive to have an employee sit around and watch over someone. Remember, the dynamics of this program isn't a recognizable reimbursable service.
LAI's require documentation of process and outcomes. If you're going to try and attempt a LAI clinic, you need to measure the simple fact: are your patients doing better? We look at hospitalization rates quite heavily when someone becomes a patient of our LAI clinic.
LAI's require specialty training. LAIs are different from flu shots. They are heavily lipophilic. We will need to ensure appropriate Z-track administration technique.
LAIs are expensive and require an enormous back-end for Prior Authorizations and Treatment Authorization requests. Health payors do see this as a beneficial outcome but there is so much yellow tape and paperwork to fill out. Pharmacists aren't directly paid to do these requests and is usually provided as a complimentary service for your business.
LAIs require a high-touch component. If you look at most Medical Practices, they take two approaches: Client-Dependent or Physician-Dependent. In a Client-Dependent Model, we are making the reliance on our patients to make choices for their health and coordinate services with various Providers. This will be most solo Provider practices. In a Client-Dependent Model, the Doctor/Physician is in charge of making choices and navigating through the medical process for their patients. LAIs require a different approach. I termed this as "Pharmacy-Dependent" business model.
LAIs have different pharmacokinetics. It is important to be well versed with initiation and maintenance dosing along with oral medication supplementation. Depending if you are in the hospital setting, you will want to reach a Concentration Max (CMax) and Time Max (TMax) as fast as possible to stabilizing your patient. Certain LAIs may be more advantageous than others because of its pharmacokinetics profile.
The Pharmacy-Dependent model requires the Pharmacy to coordinate appointment dates, appointment reminders, possibly reliable transportation, follow-ups, monitoring, and coordinating insurance approval. That is a lot of work! You might be skeptical as the reader, saying, why do we need to give transportation or give constant reminders? The Schizophrenia population is quite fragmented. Case Workers are typically understaffed with heavy loads. Most of our patient population do not have a vehicle or car; if you did not know this, Schizophrenia is typically associated with a lower-socioeconomic status. Additionally, many schizophrenics have a hard time keeping with a regular schedule. With LAI's, you're asking the patient to commit to a date in the future, which may or may not be forgettable.
I have seen Pharmacies try to replicate this model, with absolute failure. There is a lot of back-end processes that need to develop. This is where I can help you as a Pharmacy Owner or Business Developer carve out. One competitor tried to replicate this model and administered a once-a-month injection to a patient, THREE TIMES in one month.
A lot of these challenges are difficult and require a lot of planning with experience. I knew that tackling this challenge would allow us to cater to a larger mental health population. And I was definitely right. The annual sales of the business would confirm this for me. We would later receive proposals from various counties and non-profits for our services.
Schizophrenia Taboo
I have seen many adolescents be diagnosed with Schizophrenia for the first time. They may be hospitalized for a week or so and leave feeling fine. Parents typically dismiss the schizophrenia episode as a one time thing. Societal norms and mental health as a shunned topic lead to misunderstandings of how critical it is to treat schizophrenia immediately and routinely. The hospital may be able to stabilize the patient and the patient may not show symptoms for a month or so. However, a few months later, positive and negative symptoms may become more pronounced.
Those diagnosed with schizophrenia will discover their illness by having an "episode". This may present as mania or positive symptoms such as auditory hallucinations. Every time a patient has an episode, it has been shown that their baseline cognitive function decreases each time. This baseline regresses and worsens if schizophrenia is not treated seriously. The best time to treat schizophrenia is at the first episode, if you want to have the best outcomes.
Future Outlook
We will see different formulations of medications in the future that may replace traditional oral medications- particularly useful in the mental health population. This is a huge revenue stream for Pharmacies that are wishing to break into a niche market and obtain a larger customer base. It is quite easy to be short-sighted with the capitol loss in venturing in a niche but if you have an investment thesis or business proposal, it is possible that it can be wildly successful. "Nothing ventured, nothing gained."
Here's what I can do for you
I understand the in and outs of Pharma and can help you develop pilot programs or explore other revenue streams for your business. I have the experience, the curiosity and the persistence to see the light of success. I am able to think outside the norm and develop innovative models for your business and projects. Understanding payor relationships and contracts are absolutely necessary to be successful. This is where I shine.
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