While the opioid epidemic continues, every provider in the drug supply chain has a duty to identify and report suspicious orders. Retail pharmacies in particular have been hit with a number of settlements in 2017 for failure to report suspicious prescribing. See Related Blog. Surprisingly, many pharmacies still do not have policies and procedures addressing dispensing of controlled substances. And that’s when licensing boards and the DEA stress the importance of such policies and training on identifying and reporting red flags.

During the increased audits and inspections the focus is on overprescribing and overfilling of controlled substances. Proper record-keeping helps identify red flags in dispensing and points to unusual patterns. A comprehensive record-keeping system helps pharmacies analyze ordering and dispensing data that may reveal spikes in drugs ordered and dispensed and deviations from the norm in scripts written by a particular physician.

If a pharmacy flags a physician who may be engaging in unauthorized prescribing, a further inquiry is needed (which must be documented). The caveat is that pharmacies need to be careful about such further inquiries. For example, a number of law suits had been filed against pharmacies by prescribers for defamation. Recently, CVS paid $1 million for discussing prescriber’s practices with patients (a dispensing pharmacist told patients that the prescribing physician operated a pill mill and was under investigations as a reason for his denial to fill the scripts). More information on CVS case. In this case, CVS had clear policies and procedures prohibiting pharmacists from discussing such information with patients but nevertheless the jury returned a verdict against the pharmacy. In light of this and similar cases, pharmacies should implement policies and procedures regarding communication with patients, describing what should not be discussed during a consultation.

             Tips from recent DEA audits:

The record-keeping must be absolutely the top priority when working with controls. Here are some of the issues that came up during the DEA audits this year:

  • Improperly performed inventories. It’s common for pharmacy inventory to omit the following regulatory requirements:

  • Time of the date the inventory was taken (beginning or end of the business day);

  • Finished form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);

  • Number of units or volume of each finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial)

  • Records of receipt and dispensing.

  • Dispensing records must state number of units dispensed, name and address of the person to whom it was dispensed, the date of dispensing, the name or initials of the individual who dispensed or administered the substance. Very often, pharmacy records omit patients’ addresses or/and the DEA number of the prescriber (or state incorrect number).

  • Invoices and ordering records (such as 222s) must be properly prepared and have the information on the supplier, date of receipt, number of containers.

  • Power of attorney. All ordering personnel must properly execute a power of attorney with the registrant. Often, the power of attorney is not dated, not coming from the registrant or missing altogether. And if a power of attorney is not properly executed, the controls were illegally ordered.

  • Physical controls. Schedule II must be locked and Schedules III-V do not have to be locked but assure that they are separated from the rest of the inventory in some high-visibility place (not at the back of the storage or by the bathroom or a locker room). The keys to the controls should be in the possession of the pharmacist at all times.

  • Employee screening. Per federal regulations, pharmacy shall not employ anyone who has access to controls, if such person has been convicted of a felony relating to controls or whose application with the DEA had been denied, revoked, or surrendered for cause. Pharmacy should run state, county, and federal background checks on all the employees with access to controls.

  • Reporting theft/loss. Pharmacy must report any theft or substantial loss of controls within one day of the discovery by filing Form-106. If not filed timely, the DEA may visit the pharmacy to investigate the delay. It is common to delay filing 106 while the investigation is pending. However, the DEA requires that the registrant files the form first and then performs the investigation. If it is determined that there was no loss, the report may be withdrawn or amended.

The DEA may impose substantial fines (which have increased this year) for every single record-keeping issue discovered during an audit.

Training staff on proper record-keeping, following every requirement  and regulation of Title 21 Code of Federal Regulations (starting with § 1300) and incorporating them into your policies and procedures are all parts of a solution to comply with state and federal regulations on dispensing and handling controls.