Common Errors We See in Pharmacy Inspections and How to Avoid Them
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law and Carole C. Schriefer, R.N., J.D., The Health Law Firm
Pharmacies and pharmacists are subject to many types of inspections. These inspections are necessary to determine whether the business and its employees are complying with state and federal laws and regulations. Administrative agencies, such as the Drug Enforcement Administration (DEA), Food and Drug Administration (FDA) and the Department of Health (DOH), have the authority to inspect pharmacies.
Inspections may be routine and simply to confirm compliance with the law. Annual inspections by the Florida DOH are examples of these. However, inspections can also be triggered by a fear of imminent danger to the public health, safety, and welfare; a formal complaint; or the belief that a specific violation of law by the pharmacy or pharmacist has occurred or may occur.
Common Errors Found During Inspections.
With our experience working with pharmacists and pharmacies we’ve seen a number of different inspection deficiencies. These errors may result in a complaint being filed and the beginning of the administrative law process regarding investigations and hearings.
Here are some common deficiencies often found during pharmacy inspections:
1. Pharmacy technicians not properly identified with name tags and identified as
pharmacy technicians (as opposed to pharmacists);
2. Pharmacy technicians not supervised by pharmacist;
3. Medication on shelves not properly labeled (including exact number of pills remaining in bottle);
4. Controlled substances not accurately recorded on appropriate forms;
5. Not keeping schedule II inventory and dispensing records separate from schedule III-V records;
6. Failure to maintain a biennial inventory;
7. Controlled substance records (including invoices, inventories and logs) not properly maintained for required number of years;
8. Not having an accurate count for all controlled substances on hand;
9. Required DEA forms not maintained, accurate or complete;
10. Inadequate security measures (cameras, alarms, etc.);
11. Failure to control access to secured areas;
12. Proper pre-hire screenings not in place (background checks, references, etc.);
13. Proper computer security measures not in place;
14. Not properly identifying suspect controlled substance prescriptions;
15. No corrective measures in place to ensure legitimacy of a controlled substance
16. Not knowing the requirements for filling a legitimate controlled substance
17. Refrigerator not being maintained at the appropriate temperature; and
18. Food or other non medications (e.g., lab samples) being kept in refrigerator with medications.
Be Aware: All Pharmacies Are Subject to Inspections.
We are constantly writing blogs on pharmacies that, after inspections, get served with immediate suspension orders (ISO), emergency suspension orders (ESO), or have their controlled substance registrations revoked. This is not happening to just the smaller independent stores, but to the big chain pharmacies as well.
In a prior case, the DEA revoked the controlled substance licenses from two CVS pharmacies in Sanford, Florida. (Click here to read that blog.) This is why it is imperative for all pharmacies and pharmacists to know the state and federal laws and regulations.
Your Best Defense.
In our opinion, your best defenses are the following:
1. Know the laws and rules and be sure they are fully implemented and followed, always, by everyone in the store.2. Maintain good professional liability insurance that includes coverage for legal defense of administrative complaints and complaints against your pharmacy license and your pharmacist license. Cover should be at least $25,000 for legal defense expenses at the very minimum. Contact Lloyd’s of London or Healthcare Providers Service Organization (HPSO) if your agent can’t locate this insurance for you.
3. Contract with a good pharmacy consultant and have him/her make frequent visits and “mock investigations.”
Talk to an Experienced Attorney Before You Talk to an Investigator.
In Florida, you do not have any duty to cooperate with any investigator who is investigating you. This extends to DOH investigators, DEA special agents, police officers, sheriffs’ deputies or criminal investigators of any type. Our advice is to always contact an experienced health law attorney before making a statement to an investigator. Click here to read a previous blog on the best practice tips for dealing with investigators.
Never voluntary relinquish your DEA registration or your pharmacy license without speaking to an experienced health law attorney first. Click here to read a blog on why this is so important.
Contact Health Law Attorneys Experienced with Investigations of Pharmacies and Pharmacists.
The attorneys of The Health Law Firm provide legal representation to pharmacies, pharmacists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.
To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.
About the Authors: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.
Carole C. Schriefer is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.
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