There are few places where our grandparents, parents and children are known as intimately as at our neighborhood pharmacy. Since the day we entered the world, the local pharmacist has protected our secrets and counseled us on our personal health care, no matter how sensitive or embarrassing our medical needs.
In recent years, independent pharmacies have struggled to compete against chain stores that have opened directly across the street. The independent pharmacies that have managed to survive continue to provide personal customer attention to us now that are grandparents and many of our parents are gone. Unfortunately, many independent pharmacies have not been able to keep up with the increasing and frequently shifting industry regulations. Refilling a prescription prior to the due date or allowing family members to pick up our prescriptions and discuss our health care with the pharmacist has long been a benefit for loyal customers. Pharmacies that eliminate those accommodations without sufficient communication and education risk alienating existing customers. At the same time, many of the old practices intended to provide personal care for familiar customers significantly increase the risk of regulatory and law enforcement scrutiny. Some of the greatest vulnerabilities in the industry relate to procedures for securing and dispensing controlled substances and protecting customers’ privacy rights.
Drug Enforcement Administration (DEA) investigations of drug diversion continue to increase. Drug diversion, or the redirection of prescription drugs for illegitimate purposes, takes a portion of Medicare and Medicaid funds away from legitimate care. Patients who misuse prescription drugs create additional costs for federal health programs. Drug diversion can involve drug users who obtain prescriptions from multiple doctors. The DEA also investigates pharmacies that bill Medicare for prescriptions that were dispensed for controlled medications without proper verification of the customer, prescription or health care provider. Drug diversion can be extremely lucrative. According to the DEA, a bottle of 30 mg Oxycodone tablets sells on the street for as much as $2,400 per bottle.
Additionally, the DEA investigates pharmacies involved in drug diversion. Some of these pharmacies have filled hundreds of unlawful, medically unnecessary prescriptions that were then billed to Medicare. In a recent Florida investigation, a doctor wrote illegal prescriptions that were ultimately filled by a pharmacy. The doctor, the pharmacy and its owner were prosecuted. The DEA has also investigated pharmacies that stocked or re-labeled expired and counterfeit medications, sold them as legitimate prescriptions to unsuspecting patients and billed Medicare or Medicaid for the drugs. Amber DeRigo, a former DEA Diversion Task Force officer, warned that “pharmacists cannot just defer to the prescribing practitioner when deciding if a prescription for a controlled substance is valid. They must use their own judgment when ascertaining whether or not a prescription was issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.”
Drug Diversion Prevention Measures
- Require valid identification from every customer obtaining a new prescription for a controlled medication
- Conduct an initial check of all patients with controlled substance prescriptions in the local prescription monitoring program (PMP) and make a notation in each patient’s store record
- Re-check the patient in PMP if a pattern or concerns arise
- Require every customer, when picking up a prescription, to sign a signature log with a label affixed to the log indicating the prescription number, date, time and name of the patient
- Create a policy that no prescriptions for controlled medications will be filled for out-of-state customers or for customers outside of a certain radius of the store (one or two counties away)
- Establish a verification system for checking and verifying DEA numbers, doctors’ names and doctors’ addresses to ensure prescriptions are valid
- Regularly analyze drug utilization reviews (DURs) in order to check for suspicious patterns of physicians and customers, verify DEA numbers and compare cash receipts and percentages of controlled medications dispensed against national averages
- Establish a policy against waiving co-payments to avoid violating anti-kickback and false claims act statutes
Because pharmacies handle protected health information (PHI) from their customers, they must abide by all regulations in the Health Insurance Portability and Accountability Act (HIPAA). When employees are dealing with PHI, the employees must ensure that the person whom they are speaking with has authorized access to PHI. HIPAA requires that all new employees complete training and that all employees obtain additional training if a new or revised policy or procedure is written. HIPAA also requires documentation of the follow-up training regarding those policies and procedures.
In addition to federal HIPAA privacy and security violations, pharmacies must adhere to state privacy laws. In California, for instance, a health care provider may have to pay $4 million or more for violating the state’s medical privacy laws by posting patient names and medical diagnoses on a public website.
Here are some measures pharmacies should consider implementing:
- Designate and train a privacy officer who is able to understand his/her responsibilities and effectively answer employee and patient questions and requests regarding HIPAA
- Provide every new customer with a HIPAA information pamphlet and have customers acknowledge in writing that they have received notification of their privacy rights
- Create a private counseling area where PHI can be discussed
- Require every customer to identify any individual authorized to pick up prescriptions on their behalf and keep the information on file
- Require identification from anyone picking up a controlled medication on behalf of a patient
- Maintain a breach log and standards for reporting a breach
Here are some of the “red flags” the DEA looks for with doctors and pharmacies:
- Prescription patterns – prescriptions for the same drugs and the same quantities coming from the same doctor
- The “Cocktail” – Prescribing combinations or “cocktails” of frequently abused controlled substances, usually involving a CII and a benzodiazapine (CIV) such as Oxycodone and Xanax
- Geographic concerns – a patient drives a great distance in order to get his prescription filled/issued at a particular pharmacy/physician’s office when there were several closer options
- Shared addresses by customers presenting prescriptions on the same day
- Groups of people coming in with the same prescriptions from the same clinic/doctor
- The prescribing of controlled substances in general
- Quantity and strength
- Paying cash
- Customers with the same diagnosis code from the same doctor
- Prescriptions written by doctors for infirmaries not consistent with their area of specialty
- Fraudulent prescriptions
Because there will be no reduction in enforcement activity to curtail the misuse of controlled medications and to protect the privacy rights of consumers, it is imperative that independent pharmacies establish and diligently monitor their compliance practices while continuing to fight faithfully to provide exceptional service to their local communities. As Ben Franklin said, “an ounce of prevention is worth a pound of cure.”