Tag: pharmacist license lawyer

For pharmacists: What you need to know about reporting a drug loss or theft

Posted on June 15, 2015 by - Licensure

Once you discover a drug loss or theft, time is short. The applicable Oregon Administrative Rule (OAR) requires that you report a “significant” drug loss or violation related to theft to the Board of Pharmacy within “one business day.” OAR 855-041-1030(2) & (3) (Reporting Drug Loss) provides as follows:

(2) The outlet shall notify the Board in the event of a significant drug loss or violation related to drug theft within one (1) business day.

(3) At the time a Report of Theft or Loss of Controlled Substances (D.E.A. Form 106) is sent to the Drug Enforcement Administration, a copy shall be sent to the Board.

To notify the Drug Enforcement Administration (DEA), go online and complete and submit a DEA Form 106. Print a copy and send it to the Oregon Board of Pharmacy, as required by OAR 855-041-1030(3), quoted immediately above. Never forget, however, that you are creating a public record. You are also reporting to the DEA and your licensing Board, both of which have significant enforcement powers. Consequently, you will be well served to have a competent attorney advise you throughout the reporting process. It is my preference to review, if not prepare, both reports.

A significant drug loss or theft will prompt an investigation by the Oregon Board of Pharmacy, and perhaps the DEA as well, depending upon the circumstances. The pharmacist(s), and especially the pharmacist in charge responsible for the pharmacy’s annual audits, perpetual inventories, and security of the pharmacy, will be exposed to additional scrutiny by the Oregon Board of Pharmacy and by the DEA. You will want competent legal counsel from the onset. If you proceed without competent legal counsel, you do so at your own peril.

What you should expect

If the cause of the drug loss or drug theft is not clear from the beginning, an investigation will certainly follow, and that investigation will continue until the cause of the drug loss or drug theft is fully known and understood by the Oregon Board of Pharmacy and, perhaps, the DEA as well. You will be interviewed. You should expect that one, or more, Board of Pharmacy inspectors will be involved until the case is resolved.

You should further expect that your pharmacy’s relevant annual audits and perpetual inventories will be requested and reviewed by pharmacy inspectors. Any shortcomings in your pharmacy’s inventory systems will prompt further review by the pharmacy inspectors. More will be required of the pharmacist in charge, as compared to a staff pharmacist, but all will need to be proactive in the investigation and resolution of any perceived lapse in pharmacy security. If the pharmacy’s inventory systems and procedures are legally inadequate, the responsible pharmacist(s), and especially the pharmacist in charge, will face additional scrutiny, and may face disciplinary proceedings.

If you are reporting a drug theft, and the theft was accomplished due to a security lapse, the Board of Pharmacy will pursue the security lapse until the cause of the security lapse is known. If the drug theft was accomplished after hours by someone other than a pharmacist, the pharmacy inspectors and the Board of Pharmacy will further want to know how, or why, a non-pharmacist had access to pharmacy keys and/or pass codes. OAR 855-041-1020 (Security of Prescription Area) requires the following:

(1) The area in a registered pharmacy where legend and/or controlled substances are stored, possessed, prepared, manufactured, compounded, or repackaged shall be restricted in access, in such a manner as to ensure the security of those drugs.

(2) The pharmacist-in-charge and each pharmacist while on duty shall be responsible for the security of the prescription area including provisions for adequate safeguards against theft or diversion of prescription drugs, and records for such drugs.

(3) When there is no pharmacist present, the pharmacy shall be secured to prevent entry. All entrances to the pharmacy shall be securely locked and any keys to the pharmacy shall remain in the possession of the pharmacist-in-charge and other employee pharmacists as authorized by the pharmacist-in-charge. When there is no pharmacist present, and it is necessary for non-pharmacist employees or owners to have access to the pharmacy, the prescription area shall be secured from entry as described in OAR 855-041-2100.

(4) Prescription drugs and devices and non-prescription Schedule V controlled substances shall be stored within the prescription area or a secured storage area.

(5) Any security system deviating from the requirements of this section, except as provided in OAR 855-041- 6310, shall be approved by the Board prior to implementation. Requests for such approval shall be in writing and provide a detailed description of the proposed system. A written description of such security system, as approved by the Board, shall be maintained in the pharmacy.

Finally, you should expect that the Board of Pharmacy investigation will continue until all discrepancies in inventory and systems have been understood and corrected. To the extent you are pro-active and take charge (if you don’t lead the investigation, a pharmacy inspector will), you will improve your chances of a positive and quick resolution. I would be remiss not to add that you will need legal counsel to guide you through the process.

For Pharmacists: Three medication errors could mean probation and loss of PIC

Posted on June 1, 2015 by - Licensure

It is well accepted that dispensing or medication errors occur with some regularity in the practice of pharmacy. While most dispensing errors are never reported to the Board of Pharmacy, once they are, there are consequences for the dispensing pharmacist. For a first and second reported dispensing error, the dispensing pharmacist is at risk of professional discipline by the Board of Pharmacy, most likely a reprimand, and a fine ranging from $1,000 to $5,000.

During one recent case, however, it was revealed to me that the Board of Pharmacy is of the view that for a third reported dispensing error, the presumptive sanction is a fine, plus five-years of probation, and loss of pharmacist-in-charge (PIC) privileges. This is true even when pharmacy workload is a factor, and the prescription involves a look-alike or sound-alike drug.

What you need to know

You need to know that the Board of Pharmacy is imposing discipline upon pharmacists for dispensing errors even though pharmacists know, and the literature establishes, that dispensing errors cannot be fully prevented. For example, according to one study cited by the Institute of Medicine’s 2007 report, 1.7 percent of new and refill prescriptions are dispensed in error:

This more recent, large-scale study of both new prescriptions and prescription refills found an error rate of 1.7 percent (Flynn, et al., 2003). This dispensing error rate translates to approximately 4 errors per 250 prescriptions per pharmacy per day, or an estimated 51.5 million errors during the filling of 3 billion prescriptions each year. One study of medication errors at Medco Health Solutions, Inc., a large mail order pharmacy, carried out by Medco employees, found a dispensing error rate of 0.075 percent—16 dispensing errors among 21,252 prescriptions (Teagarden, et al., 2005).

Preventing Medication Errors: Quality Chasm Series (2007). Retrieved from: http://books.nap.edu/openbook.php?record_id=11623&page=113.

Applying the above error rate of 1.7% to a pharmacy filling 1,500 prescriptions per week indicates that 25 dispensing errors occur each week in that pharmacy. Dispensing errors are not, however, fully preventable, due to what has been described by Stuart R. Levine, et al., as a “latent failure” in the practice of pharmacy:

“Medication errors rarely occur from the failure of a single element or because of mistakes from a single practitioner. Rather medication errors are the result of the combined effects of ‚Äòlatent failures’ in the system and ‚Äòactive failures’ by individuals. Latent failures are weaknesses in the structure of the organization, * * * . By themselves, latent failures are often subtle and may cause no problems. Their consequences are hidden, becoming apparent only when they occur in proper sequence and are combined with active failures of individuals to penetrate or bypass the system’s safety nets. Many of the latent and active failures that were at the root of medication errors are not apparent until a root cause analysis is performed. [Footnote omitted] For this reason, providing an optimal level medication safety requires both recognition and correction of latent failures in the system. * * * . It is unrealistic to expect absolute perfection or error free performance from any person. * * * .”

Stuart R. Levine, et al., Guidelines for Preventing Mediation Errors in Pediatrics, p. 427.