Analyzing Colorado 2014 Prescription Drug Outlet Disciplinary Actions: Repeated Deficiencies

Baer Law recently completed an analysis of thirty-two (32) separate disciplinary actions against Colorado Prescription Drug Outlets (PDOs) by the Colorado State Board of Pharmacy (Board).

The Board registers and licenses pharmacy businesses, both in-state and out-of-state, including:

  • Prescription Drug Outlets;
  • Wholesale distributors of prescription drugs;
  • Manufacturers of prescription drugs;
  • Other outlets; and
  • Limited licenses.

The Board has jurisdictions over PDOs, or in-state pharmacies, pursuant to provisions of the Pharmacists, Pharmacy Businesses, and Pharmaceuticals Act at Title 12, Article 42.5, C.R.S (Article 42.5) and Board of Pharmacy Rules and Regulations (3 CCR 719-1).

PDOs failure to timely address repeated deficiencies and not promptly reporting changes in the status of a pharmacist-in-charge are of particular interest, not only because over fifty percent of the disciplinary cases analyzed involved one or both of these issues and resulted in fines ranging from $1000 to $10,000, but that, in most instances, the fines could have been avoided had the PDOs promptly addressed the prior documented deficiencies.

Issues addressing changes in the status of a pharmacist-in-charge will be discussed in the next Baer Law blog.

Baer Law identified three recent cases that resulted in probation and large fines simply because repeated deficiencies were never addressed or corrected. Again, it is important to note that had these deficiencies been promptly addressed each PDO could have avoided fines, probation and the burden of continued monitoring.

In the first case, during a routine inspection, the Board discovered six repeated deficiencies from previous Board inspections, including:

  1. Vaccine administration records not in compliance;
  2. Casual sales records that were not in compliance;
  3. Labeling on non-sterile compounded products made in anticipation of orders not in compliance with Board Rules;
  4. Return of stock records not in compliance;
  5. A compounded product was assigned a beyond use date that exceeded the expiration date of the individual component; and
  6. Compounding records did not accurately reflect the date a compounded product was prepared.

Additionally, the Board found five dispensing errors and discrepancies between what the prescriber’s directions for use were and what was placed on the patient’s prescription label. Ultimately, the Board placed the Pharmacy on five years probation with numerous strict stipulations on monitoring.

In the second case, the Board identified seven repeated deficiencies from previous inspections which included:

  1. Invoices not in compliance with Board rules;
  2. Notice of initial interpretation and final evaluation posting not in compliance with Board rules;
  3. Prescription files were not maintained in three (3) different prescription files: Schedule II, Schedule III-V, and non-controlled substance prescription orders;
  4. Beyond use dating for non-sterile compounded products were not in compliance with Board rules;
  5. The labeling non-sterile compounded products did not comply with Board rules; 
  6. The labeling of anabolic steroid prescriptions were not in compliance with Article 42.5 rules; and
  7. Four prescriptions orders were filled without valid DEA numbers on the orders.
As a result of these repeated deficiencies, the Pharmacy was fined $5000 and placed on probation with stipulations.

In the final case, a pharmacy was fined for nine repeated deficiencies including:

  1. Pharmacist manager immunization training documentation that could not be located;
  2. Prepack records for cassettes that did not include the name or initials of the pharmacist responsible for packaging;
  3. Vaccine records that did not include, among other things, the site of administration;
  4. Invoices for prescription drugs that were not dated upon receipt;
  5. Compounding records for non-sterile compounded products that did not contain appropriate beyond-use dating;
  6. A compounding record for a non-sterile aliquot preparation that did not include the date of preparation; 
  7. The policy and procedure manual for central processing could not be located;
  8. Electronic storage of controlled substance prescriptions is not allowed; and
  9. Transferred prescription orders did not include, among other things, the phone number of the transferring outlet, first fill date and last fill date.

For these repeated violations, the Board fined the Pharmacy $3000 and placed the Pharmacy on probation.

Colorado PDOs must take notice when the Board identifies a deficiency. PDOs must make a conscious effort to promptly address all documented Board deficiencies to avoid any future fines or disciplinary actions. Failure to do so, as documented in these three cases, could result in probation, significant fines and continued close monitoring by the Board.

In conclusion, by ignoring the Board’s recommendations, each PDO is placing the health, safety and welfare of the citizens of Colorado at risk, which is clearly unacceptable.