Monday, May 27, 2013

Pharmacy Compounding And The Public

There's a very good reason why early 20th century laws, like the Pure Food and Drug Act, the Federal Food, Drug, and Cosmetic Act, and other FDA legislation were enacted.. because many innocent Americans died or suffered as a result of the unbridled quest of a few for greater profits.

When harmful consequences caused by those few begin to affect a significant portion the American public, our Federal political leaders need to act quickly and succinctly in order to protect the public and ensure that it doesn't happen again. IMO, that's not what's happening in pharmacy compounding.

For those unfamiliar with pharmacy compounding, let me explain how the process has worked over the years to give you a better understanding of the problem -

Traditionally, when a physician wants to provide a remedy for one of his/her patients, but such a remedy isn't commercially available (made by a pharmaceutical manufacturer), that physician would write a prescription for that patient, to be compounded (manufactured) by a neighborhood pharmacist.

This type of local manufacturing complies with the FDA rules and regulations for drug compounding because a physician writes a single prescription for a single individual patient, and because there is a direct relationship between the patient, the physician, and the pharmacist.

All three members of this relationship are directly involved in that one patient's care and can monitor whether that compounded prescription is effective or not. If an error was to occur anywhere in the process, only one patient would be harmed, and the source of that error could be easily traced and quickly corrected. This type of relationship has been working fine for decades.

But then, something changed along the way.

Recent medical technological advances made it possible for pharmacists to compound prescriptions in a more sterile environment. A niche was born, and some pharmacists sought to capitalize on it. Compounding pharmacists began to compound injectable prescription products outside of the hospital environment, similar to pharmaceutical manufacturers.

Over time, those pharmacists discovered that there weren't clear and concise laws regarding the compounding and sales of their products. There was an uncertain quasi-regulation of compounding pharmacies between both the State governments and the Federal government.

Somehow, compounding pharmacies were allowed to skirt the traditional rules of compounding and began compounding products without having that direct patient/physician/pharmacist relationship.

They began compounding injectable drugs without a written prescription from a physician, nor just for single individual patients. That niche progressed to the point where pharmacists started compounding injectable drugs in bulk, for local sale to hospitals, clinics, and doctors offices.

The compounding process further progressed to the point where pharmacists began shipping their compounded products interstate, throughout the United States. In essence, their pharmacies now became pharmaceutical manufacturing plants. But unfortunately, these pharmacies weren't being held to the same standards to ensure public safety that apply to pharmaceutical manufacturers.

Then, for various reasons, injectable drug shortages began to appear throughout the country. These compounding pharmacies began to grow and expand in providing replacements for those shortages.

But, no regulators seemed to be monitoring their activity. Compounders were left to self-regulate.

Because the important direct relationship between patient, physician, and pharmacist was missing, because no one outside of the profession was ensuring quality, and because these products were being shipped nationwide, it seemed only a matter of time before something tragic would happen.

A simple error could be "compounded" from only one patient being affected, to a large number of patients being affected, and it would become much harder to trace the source.

And that's exactly what happened. The multistate outbreak of fungal meningitis and other infections among patients who received contaminated steroid injections from just one compounding pharmacy has currently led to more than 740 innocent people being injured, with 55 deaths.

It's been over six months when we first learned of this tragedy, and yet compounding pharmacies are still being allowed to manufacture their potentially unsafe products, and are still allowed to continue shipping their products nationwide. No one in charge is seemingly attempting to stop it.

It's not like members of Congress are unaware of the unnecessary risks to the American public from allowing pharmacies to manufacture and sell injectable products without having to conform to the same sterility and manufacturing standards in which pharmaceutical manufacturers must comply.

Advocates in healthcare serving the interests of their patients as a whole have provided a simple solution to the problem. According to the Institute for Safe Medication Practices,
As we move forward and learn from the most recent outbreak, we call upon Congress to work with key stakeholders to address the need for additional laws on the federal level to fill in regulatory gaps. FDA oversight and regulations must be equal to what is required of pharmaceutical companies when compounding pharmacies dispense in mass quantities without individual patient prescriptions, manufacture sterile products from non-sterile active ingredients, or distribute across state lines.
Congress has also been told by the FDA that unclear laws make it difficult for them to enforce safety.

But yet, while there's reportedly a unconcerted effort on behalf of state and professional organizations in reaction to the problem, nothing is being done by Congress to simply correct the underlying cause.

House GOP members say that the laws don't need to be changed, and blame this tragedy on lack of FDA enforcement. They refuse to change the laws to clarify the regulatory gaps or work with Senate Democrats to quickly and succinctly rectify the situation. They're resolved to do nothing.

Meanwhile the Senate, acting like they are on the public's side, has taken the initiative to create a new regulatory class of drug manufacturers, confusingly called “compounding manufacturers,” that would be exempt from federal premarket approval and related labeling requirements, and thereby maintaining the status quo.

So I have to wonder, what the hell is wrong with all of these people? Don't they care?

To me, it seems as though no one in authority - not professional regulators, not State regulators, not Federal regulators, and neither political party wants to stop compounding pharmacies from behaving like pharmaceutical manufacturers, even when public safety is significantly at risk.

And that's the true tragedy behind this unfortunate incident.

Monday, May 20, 2013

Nothing Really Matters To Me

It's too late, my time has come. Nothing really matters to me about pharmacy anymore.

But, if there's anything I can share with new pharmacists just beginning their careers, it's DO NOT let your employer pressure you into working faster than you think is safely necessary.

Trust me on this. No matter which way the wind blows, you won't be able to live with yourself if you make a mistake and seriously hurt one of your patients.

Friday, May 17, 2013

Vinchuca In The House | A Silent Killer

Chagas Disease is endemic throughout much of Mexico, Central America, and South America where an estimated > 8 to 11 million people are infected by the protozoan parasite Trypanosoma cruzi.

Infection occurs through vectorborne transmission via the feces of the triatomine insect (reduviid bug, kissing bug, assassin bug, and vincucha bug), which may be inadvertently inoculated into the skin or the mucosa of the eyes, nose, or mouth when the insect’s bite is scratched and rubbed.

The triatomine bug thrives under poor housing conditions (for example, mud walls, thatched roofs), so in endemic countries, people living in rural areas are at greatest risk for acquiring an infection. In rural Argentina, villagers speak of "muerte subita" or rapid death caused by Chagas.

But one Argentinian physician, Dr. Gustavo Farrugia, and his colleagues are trying to stop it.

Source: Al Jazeera: Witness

Thursday, May 16, 2013

The Inventor

According to the filmmaker, Benjamin Gibson, - earlier this year I proposed an idea to my 92 year-old neighbor and life-long inventor to shoot a short film documenting many of the inventions he's created throughout his life.

Nervous at the idea that many of his un-patented inventions may be compromised, Carl opened up to me in a much different way than I had originally intended, sharing his inspirations and the philosophy behind his life-long passion of creating - to help his fellow man.

The "Old School" generation, you've got to love them. They know what's important in life.

The Inventor from bzgibson on Vimeo.

Sole Survivor | A Documentary

When Galaxy Flight 203 was in its final seconds, George Lamson pulled his legs above his head, an arbitrary decision that helped save his life as he was thrown through the fuselage upon impact. Immediately after the crash, George’s sole survival was considered miraculous and newsworthy, making him a fixture in the media for a year.

Twenty-six years later, George lives a few blocks from the crash site and still struggles with the emotional weight of his survival. He doesn’t know if he was spared for a reason and if he was, what is that reason? In an effort to heal, he seeks to connect with the other thirteen sole survivors of commercial aviation disasters, including Cecelia Cichan, Bahia Bakari and Jim Polehinke – none of which have ever spoken publicly.

From award-winning filmmaker, Ky Dickens, Sole Survivor profiles the lives of these four people who were the only survivors of commercial plane crashes. Having suffered through the physical trauma of a deadly crash and the emotional impact of losing family members, these survivors are now sharing their stories. Here's the trailer -

Sunday, May 12, 2013

Common Sense Condom Use

Whatever happened to leaders in America using common sense in decision-making?

Currently, the police and courts of New York can use the fact that a person is just carrying condoms to help prove that they are engaging in prostitution-related offenses, or what people in that line of work prefer to call "transactional sex" (lol)

Although I'm personally against the exploitation of desperate people for selfish reasons, with all of the major political and corporate corruption destroying our nation, I would classify prostitution as a VERY low priority enforcement level. But, I'm also a BIG proponent for practicing safe sex.

Condom use has been proven to significantly reduce the transmission of STIs, and to reduce the incidence of unwanted pregnancies. So, while I can somewhat understand New York's zeal to battle prostitution, targeting condom use is absolutely the WRONG way to help prosecutors do their job.

Our goal is to encourage "transactional sex" workers to use condoms every time they "transact".

If we prosecute prostitutes for just carrying condoms, what do you think will happen next? They'll just say "fuck it, I'm not going to use condoms anymore. The risk of being prosecuted is too great." If that happens, STIs and unwanted pregnancies will skyrocket. Is that really what we want happening?

So, while I don't advocate for this group, what they're battling for is just the use of common sense.

Saturday, May 11, 2013

Find Your Mojo | Jujitsu-ing Reality

Writing a movie is difficult enough. Imagine writing it from a wheelchair without the ability to speak or move. That’s the unbelievable truth of what Scott Lew did for his new film, Sexy Evil Genius.

In 2004, Lew was diagnosed with Lou Gehrig’s disease (ALS), which has since left the writer a mute pentaplegic. (He can’t move his four limbs, neck or head) He’s forced to breathe with a ventilator and communicates with the help of an assistant, as well as an infrared dot on his forehead.

Despite living with ALS, screenwriter Scott Lew maintains his voice in the world through his scripts, giving added meaning to the expression "living to write.” Scott’s story is one of an indomitable spirit triumphing over tragedy.

Jujitsuing Reality from Chad Mann on Vimeo.

Thursday, May 9, 2013

Side Effected | A Short Film

An urgent meeting between the boss of a pharmaceutical company and one of his young employees is called in order to discuss a potentially groundbreaking new drug. Here's the trailer -

"SIDE EFFECTED" Teaser #1 from Lev Pakman on Vimeo and Facebook.

Thursday, May 2, 2013

Come Together Pharmacists

My heart tells me that I'm wasting my time, but my brain tells me that I need to say something.

So, let me tell you new pharmacy graduates that, as much as you're motivated to go out and show the world just how great you are, that you need to rein in your desires to prove yourself individually to those who can't wait to exploit you, and come together as one to assert your importance as a whole.

If you start competing against each other in order to prove that you're better than your colleagues, the powers that control the profession (chains, PBMs, insurers, and other large corporations) will use that competition to divide and conquer us.

Wednesday, May 1, 2013

The Opiate Effect

The documentary film, The Opiate Effect, tells the story of Will Gates, a UVM student who tragically died from a heroin overdose in 2009, and the effects of his death on his family as recounted primarily by his father, Skip Gates. Here's the trailer -