Saturday, March 04, 2017

Notes from The Cornered Druggist: Xerese, another useless FDA-approved drug

(While listening to public radio this morning, I was struck by its discourse on language and its various paths of evolution.   The combination of the letters “GM,” for example, can mean "genetically modified," "General Motors," or my first name when spoken in Alabama. But I digress...)

Yesterday, I received an order from a dentist's office for a product called Xerese, something we have never stocked, and a product that was listed as available from my wholesaler for the princely sum of $1085. This certainly warranted further exploration.

It turned out that this five (5) gram tube of an ointment contains a combination of 5% acyclovir and 1% hydrocortisone.

Acyclovir, a long-generic antiviral treatment for herpes, comes in capsules of 200mg for about 10 cents each, and hydrocortisone has also been available as an ever-the-counter product and can be found at a dollar store for, well, a dollar.

Five grams of Xerese contains a total of 250mg of acyclovir (a 5% concentration means 5 grams in 100 grams, so using the cross-multiplication process in algebra -- oh heavens, this note contains math! -- 250mg is in 5 grams, after the proper conversion of grams into milligrams -- oh my head, more math).

This means Valeant, the makers of Xerese, is taking raw materials that cost at most $1.10 and is charging $1085 for the product, wholesale.

So you may wonder why I just don't make this product by scratching together the ingredients,
investing about five minutes of mix and label time, and pass it on to the patient at a huge savings.

The answer is this - I am forbidden to do so by federal law. The FDA has given the license for this combination to Valeant of Canada, and for me to create the combination is to violate the directives of the FDA, and in so doing, would be dispensing a non-FDA approved product.

You may recognize the name Valeant, by the way, one of the recent collection of gouging pharmaceutical companies.

However, I can get a prescription for 8 acyclovir capsules from that dentist, see that the patient charge is no more than $5, then instruct the patient to get a one dollar tube of hydrocortisone ointment from my shelf, and then, by demonstration, show the patient how to mix the two products, how to put the combination into a one-ounce ointment jar, and then possess not just five grams, but thirty grams of homemade "Xeresel” with a wholesale value of over six thousand dollars.

To put it in context: Xerese costs $217/gram.   Gold (as of 3 March 2017) costs $39.70/gram.

Sadly, the WMU prescription benefit actually covers this product with a $40 copay to the patient. I will be aggressively petitioning them to correct this oversight.

Monday, January 16, 2017

Breakout Discussions at the October 2016 Heroin Summit Conference, Battle Creek, Michigan

Questions, notes, and discussion from the Opiate Summit - October 2016, Firekeeper’s Casino, Battle Creek MI
Breakout session - Jim Middleton, moderator
(the session ran 90 minutes - here are some of the notes I took during the discussion, covering nine of the dozen questions posed by the moderator (me), the panelists, or the audience.)

1. Akron, Ohio had a sudden emergence of carfentanil - how do we prepare for such an emergency in this area? - increased monitoring of nalaoxone use in treating overdoses - if it takes more than a few milligrams to resurrect the patient, chances are strong that the product in question contains carfentanil.  At present, fentanyl and carfentanil are not part of routine screening; current law enforcement personnel is able to focus on marihuana possession with greater interest because the product itself is so very visible.  Carfentanil can be lethal at a dose of 1mg.

2. When can we see improvements to the current MAPS program?  - the new server is set to roll out in January 2017, with clinicians being able to review their own MAPS usage data (to check for unauthorized use of their DEA information) in April 2017.  The internal flags within the MAPS program are set pretty high - reportedly, it takes the use of many multiple unique clinicians in a 30 day period to flag a patient as being suspicious, placing a lot of the interpretive burden for abuse at the level of the pharmacist.  Clinicians are still underutilizing the MAPS program, not helped by its “voluntary” participation.  (The Lieutenant Governor, during his opening remarks, openly acknowledged the challenge of the narcotic problem in Michigan, but seemed reluctant to increase any regulatory burden by Michigan upon the clinicians.)

3. How do you perceive the 25% reduction in opioid production affecting the current heroin crisis?  - the lack of access to legally prescribed and manufactured opioids will result in an increase in illicit use.  While the DEA is taking steps to reduce the total amount of opioid products available for use, with the tools they have at their disposal, the overall impact of this restriction is being regarded as misguided: pharmacies with the wherewithal will begin stockpiling product in anticipation of the shortage by year’s end, which will only further contribute to the shortage.

4. What responsibility do drug companies have in this opioid abuse problem?  - the concensus in the group was that it laid a lot of blame on the drug manufacturers, both for creating the problem and for apparent price gouging for the treatment - naloxone prices have escalated 400% in just the past few years.  LARA (Michigan’s Licensing and Regulatory Affairs) was also taken to task for their perceived lack of oversight, giving Michigan the reputation of being the “new Florida” (one peninsula switched to another) for “bad prescribers.”

5. Family medical providers are the most common over-prescribers.  Any studies on the causes of this or the actions being taken to reign in this practice?  - It takes 30 seconds to say yes, 30 minutes to say no.  Independent physicians have been placed in group practices in order to maintain reimbursement through their insurance contracts.  Blue Cross began cutting reimbursement by 25% to independent clinicians while linking reimbursement to community health improvement.  In January 2017, Blue Cross, through its pharmacy benefits provider (PBM) Express Scripts,  is also restricting controlled substance analgesics to a 30 day supply, along with a maximum daily “morphine equivalent” for pain therapy before triggering a prior authorization process.   Caremark, the nation’s other primary PBM is implementing similar restrictions in 2017.  Both PBMs are implementing these new controls in a rapid manner, often with only a few weeks’ (or days) notice.

6. What is “Pink”?  An Upjohn test drug with about 7 and ½ times the potency of morphine, it was not considered useful enough to go beyond initial studies, but was assigned an ID of U-47700.  The patent has apparently expired, and its manufacturing information has been circulating.  Pink, carfentanil, “bath salts” all seem to be originating from labs in China and are being distributed to the United States by way of Mexico.

7. What can hospital administrators do to help or support providers/clinicians?  Hospital emergency departments in Grand Rapids have created a network to identify and move opioid “frequent fliers” into rehabilitation programs, while strictly limiting outpatient prescriptions for controlled substance analgesics.  Cross-platform EMR databases also help to identify patients with similar health-risk behaviors.

8. Heroin addicts - criminals or victims?  - The original view that the overdosed heroin user was a victim was embraced by law enforcement in March of 2016.  However, by year’s end, the repeated revisits to overdosing are taking their toll on law enforcement attitudes.  One weekend, police rescued the same patient 6 times in a 48 hour period, and the patient refused further treatment.  Such rescues are becoming a challenge with pressures to work staffing more “efficiently” and with other police services still requiring attention.

8. What is the status of naloxone and pharmacy distribution in Michigan?  - still adrift in the Michigan legislature (October 2016), Kent and Kalamazoo counties have proactively partnered with Spartan-Nash stores and Dr. Sandra Dettman of Grand Rapids to provide naloxone kits with a prescription umbrella from Dr. Dettman.  The kits are 2-packs of naloxone in nasal spray format, with 4mg naloxone per dose.   The public is still completely misinformed about the effects of naloxone being a “cure” for the overdose - it is only effective for minutes before requiring re-administration, and carfentanil requires a substantial increase in dose for effectiveness (and is effective for an even-briefer period of time).

9. Has Adderall been a problem? - Adderall and other ADHD stimulants in the DEA C-II category are routinely abused or sold by students, prescribed with very brief physician interactions, and are coming under increased DEA scrutiny once it feels adequate processes are in place for opioid review.  “Helicopter” parents are pressing clinicians to prescribe stimulants, not for ADHD, but for performance enhancement in academics and athletics.  Stimulants used in such a manner may increase attentiveness and short-term memory retention, but may actually diminish long-term retention of information.

(cc) Jim Middleton, The Animating Apothecary

Wednesday, October 12, 2016

Tuesday, October 11, 2016

The Ranks are Thinning

http://www.wmich.edu/news/2016/09/35347

BY JEANNE BARON
SEPTEMBER 30, 2016 | WMU NEWS

Margaret Jane Watson

Margaret Jane Watson, a former Western Michigan University staff member, died Sept. 26 at Rose Arbor Hospice in Kalamazoo from complications due to cancer. She was 61.

Watson joined the WMU staff in 1981 and retired in 2015 after more than 33 years of service to the University. The Kalamazoo resident began her WMU career as a clerk in University Libraries, where she had worked while a student at WMU.

She became supervisor of the Media Laboratory, a student-centered multimedia lab in the Division of Academic Services, in 1983 and classroom technology consultant in the Office of Information Technology in 2004.

MARGARET J. WATSON
In her technology consultant role, Watson's primary responsibility was to make sure that dozens of WMU's sophisticated technology carts were functioning properly for professors and instructors across all of the West Campus.

She monitored the carts from her office throughout her work day and was at the ready to trouble-shoot problems by phone or rush to classrooms when necessary. Just a few years into the job, some 700 faculty members were already incorporating the technology carts into their teaching.

As added services, Watson developed the original instruction manuals for each cart and provided one-on-one training for teachers at their convenience in the specific rooms where they would be using the carts.

She established strong relationships with faculty members during her time at the University and was an active volunteer. Notably, she served for several years on the Presidential Spirit Committee and was on the team that started Finals Finish, a longstanding multiday event that helped students weather final exam week.

Watson was born in East Jordan, Michigan, and worked as a librarian for Oneida High School in New York from 1977 to 1979.

She earned an associate degree in media technology from Ferris State University in 1975, a bachelor's degree in learning resource management from FSU in 1977 and a master's degree in library science from WMU in 1981.

REMEMBRANCES
No formal service is being held, per Watson's wishes. The family obituary and a personalized webpage where messages may be left is available through Penzien Funeral Homes at penzienfh.com.

Memorial gifts may be made to:

Hospice Care of Southwest Michigan
222 N. Kalamazoo Mall
Suite 100
Kalamazoo MI 49007-3882

Heroin Conference and "Next Steps" Summit - 14 October 2016

(With some pharmacy guy acting as a moderator during the break out sessions...)

Prescription Drugs and Heroin: The Next Steps Summit



Battle Creek, MI- Overdoses from heroin and prescription painkillers have killed an alarming number of Michigan citizens, destroying families and communities. To combat this issue, partners from Michigan State Police, Lakeshore Regional Entity and substance abuse prevention coalitions/councils from: Calhoun, Barry and Allegan counties partnered to plan a summit tackling this tough subject. It was the vision of this planning committee, to offer a venue where attendees can work together to create tangible next steps to synergistically address the epidemic that our communities are facing.    
“This epidemic does not discriminate; All across the state, it is taking good people and leading them down a trail that often ends in pain and sadness,” said Lt. Pazder.  More than just facts, this summit will have experts speaking on addiction and information to help participants know how to make an impact in their local community.
The speakers are Lt. Governor Brian Calley-Keynote, Bruce McColley -DEA-Assistant Special Agent in charge in Detroit, Abraham Azzam HIDTA Director and Deputy Director Craig Summers, and Dr. Weiner-board certified in Internal Medicine and Addiction Medicine-St. Joseph Mercy Hospital.   
The conference has over 350 individuals registered from west and southwest Michigan. The conference takes place Friday October 14th from 9:00-3:00pm at Firekeepers Resort and Conference Center in Battle Creek.  


(The actual count is 362! Woot Woot!)

See January 2017 post on some notes from the breakout session - it takes forever to get back to this blog, I swear!


Tuesday, May 10, 2016

Theodore Roosevelt on Liberty - 1916

Ah, politics and the strangeness of bedfellows. Republican Theodore Roosevelt made a speech 100 years ago about the abuse of industry upon hourly workers (the memory of the Triangle shirt factory fire was still fresh at that time) - and how we needed *more* government to protect the workers from the "liberty" demanded by these companies. Here's a 90 second excerpt from the 78rpm recording in my archives. Film from the Library of Congress was used for the background. I love history.

Let's see how this holds for a blog posting:


video