Friday, December 28, 2012

Michigan Board of Pharmacy Check Points - August 2012 (with April 2016 update)

Sample of Board of Pharmacy Inspection Points
(OK, this is a bunch of borrrrring text for those few readers used to lots and lots of cartoons...but sometimes, I need to do things that relate to my "chosen profession").  Please bear with me!

In August of 2012, while performing a pharmacy relief ritual in Michigan, I met a representative of the Pharmacy Board who inspected the site I was at and provided me with the following inspection items upon completion of his review, along with the board’s current interpretation of compliance with them.

April 2016 update: Refrigerator logs
Besides looking at daily signature logs and files of recalled products, the current trend in inspections is to check whether the refrigerator in your pharmacy (for drugs only, of course, NEVER for lunch or food) is within acceptable 1-5 degree C range and that the temperature is checked at least on a daily basis.  That means a simple log affixed to the refrigerator, with the temperature noted and an initial of the noter.  Just a head's up!  Of course, we don't know if the same inspections are done for extended delivery times within wholesaler trucks....but that's for another blog discussion!

Is the generic drug supplier noted on the label/receipt?
This is a no-brainer, provided your software is up to grade. Labels should be providing this automatically. I fill in at pharmacies that use SRS nearly exclusively, and they do a great job of keeping the labels filled with the most elaborate minutiae required by pharmacy boards and insurance companies. However, it should be noted that inpatient hospital pharmacies often make use of software that does not provide this information on the labels, labels generally created to fill discharge or employee prescriptions, a function that hospital software vendors may regard as ancillary at best–this may be a setting for procedural violations by the Michigan board.

Does the pharmacist hand initial all new prescriptions?
The initial needs to be on the back of new prescriptions, preferably on or across the software-generated label, with the date of the initial fill or profiling. Also, in the case of filling a prescription that has been previously profiled, the new software-generated prescription label needs to be affixed to the back of the prescription to indicate the date of filling.

Does the pharmacy have all necessary equipment and supplies/references?
The inspector wanted to know about the most current drug information available - specifically, which on-line service for this information does the pharmacy use. This particular pharmacy made use of Facts and Comparisons online, so that was covered. If printed references are used, they should be of the sort that are updated monthly, and the updates should be in place.

Does the pharmacy meet the minimum housing requirements?
This was an eyeball inspection. In essence, are there at least 200 square feet, is the roof secure, and are the rats kept outside.

Are the drugs obtained from legitimate sources, also quality and purity? Expired meds?
If your pharmacy is in the habit of placing ‘return to stock’ meds (ie, those not picked up after two weeks) on the shelf in the original vials, understand that the board interprets the ‘use by’ date on the label to be the expiration for that particular drug. Also, if the pharmacy pre-packs routinely used quantities - ie, Sertraline 100mg, 30ct - the vials need to have the company name, the lot number, and the expiration date. Theoretically, the inspector could also ask to see your repackaging log for these activities. The inspector also uses this item to ask about any files you have regarding drug recalls and whether the pharmacy has had any drugs returned due to recall, and if so, the documentation of that return.

Is the pharmacist using professional judgment when filling prescriptions?
This is geared for pharmacies near physicians who may have become rather casual about the quantities of controlled substances they order. If a physician is ordering 500 Methadone 10mg for a single patient monthly, and is doing that sort of thing for many patients, and the physician is not a world-recognized pain control expert, the inspector may consider routinely, unquestioningly filling such prescriptions to be an example of NOT using professional judgement.

Is the pharmacist counseling first time prescriptions?
Again, this is an eyeball view by the inspector during the visit. Insurance companies (Blue Cross, et al) like to throw this into some of their audits as well, I have noted, and I like to ask such auditors for some identification from the Michigan Board of Pharmacy.

Are there Policy and Procedures for designated tasks? Are they updated?
This is something that was interesting from an independent retail perspective. First of all, you need the policies about specific technician ‘can’ and ‘cannot’ do duties. Then you have to document that the technicians have read and understood these policies. Then you have to document that you have periodically reviewed these policies. Suddenly things felt like a JCAHO survey...

Are CII drugs locked or dispersed?
Well, yes they are.

Are CII invoices in a separate file?
The inspector wants to see the wholesaler files to verify that the controlled substances and the CIIs are all nice and separated.

Are controlled substances invoices dated and initialed?
And by that, they mean, by the pharmacist.

Do all controlled prescriptions indicate the quantity both written and numeric?
These are prescriptions from the physician, not phone orders. If a prescription falls into the pharmacy’s sphere with only the numeric quantity on it, the pharmacy had best be sure to fill in the written quantity, and then document that a call has been made to the physician to verify it.

Do all controlled prescriptions have a hand written signature?
This is still that gray area while e-prescribing and electronic signatures are becoming increasingly mandated at a federal level, but the states are still playing catch up with the technology. The prescriptions must have a hand written signature. If it looks like an electronic ‘stamped’ signature, it should be noted as having been verified by phone, and from whom the verification was obtained.
One further note - if the controlled substance is written by a PA or NP, the prescription MUST have BOTH the names and DEAs of the PA or NP *AND* the name and DEA of the 'overseeing physician.'
So the signature should look like:
Alexis H. Ceasar, NP DEA MC3232321, Dr. Dandy DO, DEA AD1234596
I am waiting word on how this is to play out with extended prescribing authority in Michigan for NPs who will be running their own, independent clinics.

Do faxed prescriptions display all required information - especially the name of receiving pharmacy
This is to protect from multiple pharmacies getting the same faxed prescription. If the pharmacy gets a cover letter to the faxed prescription, ATTACH IT to the prescription.

Do telephone prescriptions identify the sender/receiving individual?
On controlled substances especially, the signature on phoned prescriptions should read something like this: "Dr. Bonzo/Elaine RN/RPh initial." And that pharmacist initial had better be on the FRONT of the prescription - the initial on the back is only to acknowledge the first fill of the prescription.

Is the pharmacy reporting to MAPS
If the pharmacy isn’t doing this, it is presumed that the pharmacy is trying to hide some of its controlled substance dispensing activities. As the software becomes more sophisticated, more and more of the data is being used for tracking purposes of MANY activities. Google "Bob" Patel, Pharmacist, in Michigan to see the results of some of this tracking (and see this link of 1 Feb 2103 for final disposition of the results of the investigation: )
See end of this post for the pharmacies involved...
Is there compliance with the Code of Federal Regulations?
Not sure how the inspector determined this one, but the pharmacy got a pass on it.

Is the pharmacy filing its annual inventory?
This is especially for the controlled substances. Again, this data will eventually get tied to MAPS data to check for variances.

Is the professional license/limitations displayed?
And by displayed, that means so the unwashed, huddled masses at the cash register can see it.

Is the Consumer Information Notice (CIN) displayed?
Ditto above.

Are prescription drugs branded correctly?
That means, can the inspector go to a bag in the pickup bins, open it up, open the vial, and see that the drug brand in the bottle is the drug brand on the label and on the shelf. I guess this is to prevent someone from using any old generic fluoxetine for Serafem.

Well, that’s the world of pharmacy inspections in Michigan as of August 2012. Some of these items seem a bit odd in the 21st century - so many fussy fiddlings with little scraps of paper that are more reminiscent of the 1970s than in the age of the internet...but as I have said, if the Board of Pharmacy stipulates pharmacists wear paisley boxers, it’s time to visit the underwear counter at Sears!

The Patel pharmacies involved in the original indictment were (from : )

Detroit:Caring Pharmacy, 4000 W. Davison
Detroit Care Pharmacy and the Responsible Care Pharmacy, both at a similar address on Mack Avenue
• Four pharmacy store or business names all listed at 19460 Grand River Ave.: Grand River Pharmacy, Friendly Pharmacy, Levan Pharmacy and Kalika Corp.
Prestige Pharmacy on Dexter Road
Glendale Pharmacy on Glendale
Care For You Pharmacy on West McNichols Road

Best Care Pharmacy, 27101 Schoenherr Road
Highland Park Pharmacy, 28001 Schoenherr Road
Rapid Pharmacy, 11664 Martin Road

Bay City:
• Sapphire Apothecary on South Trumbell
• Tri-City Apothecary on Katalin Court
Other locations:
Rapid Drugs, later Noble Care Pharmacy, in Southfield
Independent Community Pharmacy, Dearborn
Taylor Apothecary, Taylor
Be Well Pharmacy, Berkley
Airport Apothecary, with addresses in Waterford Township and Bloomfield Hills
Rx Now Pharmacy, Livonia
Commerce Township Pharmacy, Union Lake, Commerce Township
Eastpointe Pharmacy, Roseville
Preferred Care Pharmacy, Pontiac
Preferred Pharmacy, Troy
Prestige Drugs, Hazel Park
Prestige Drugs Pharmacy, Oak Park
Davenport Pharmacy, Saginaw
Diamond Pharmacy, Kalamazoo

--And add to that, "Tri-Star" Pharmacy in Battle Creek