Need Last Minute Deposition or Hearing Representation? Call The Health Law Firm

9 Indest-2008-6By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Our office often takes phone calls from pharmacies and pharmacists needing short-notice representation at a Board of Pharmacy hearing or at a deposition related to a health care matter.

In our experience, many other law firms refuse to represent clients at a hearings unless the firm is given plenty of advance notice. We always prefer to have sufficient time to obtain documents, review files, interview witnesses, conduct research and prepare, in order to provide the best possible representation to our client. However, we realize that in certain cases, the alternative is that the client either gets legal representation on little or no advance notice, or has to suffer the consequences of having no legal representation.

Be Aware that Administrative Proceedings Can be Complex.

In some cases individuals may be fooled into believing that they can effectively represent themselves. They later find out that they have gotten in over their heads. Laypersons (meaning, in this case, nonlawyers) who are not aware of such complex matters as the Administrative Procedure Act, the Rules of Civil Procedure, the Rules of Evidence, the Florida Administrative Code (F.A.C.) Rules which the Board of Pharmacy and the Department of Health (DOH) have enacted, may quickly be confused.

The inexperienced individual, or even the inexperienced attorney, in these matters can fall into a number of procedural traps that damage an effective defense. This can be advising the individual to talk to the DOH investigator, filing an unnecessary answer to an Administrative Complaint, forgetting or not knowing that the client’s right to be free of self-incrimination applies in this type of case and many, many others.

Procedural Mistakes Can Be Damaging To Your Defense.

Often you will find that merely having an experienced attorney to represent you at a hearing or Board meeting will assist you in avoiding mistakes that damage your case and assist you in preserving your rights for an appeal. In other cases it may even be possible to obtain a change in forum to obtain a better result. For example, many laypersons do not know that if you elect an informal hearing before the Board of Pharmacy, you have waived your right to prove you are innocent by contesting the facts alleged against you.

What few know or think of in the heat of the moment is that you can ask at the informal hearing before the Board of Pharmacy to contest the facts, to prove you are not guilty of the charges, and to have the hearing converted to a formal hearing. A formal hearing will be in front of a neutral Administrative Law Judge (ALJ), and you have a great many more procedural rights than you have at an informal hearing. However, we still recommend that you have an experienced health lawyer represent you at a formal hearing.

Professional Liability Insurance May Pay Legal Fees for Deposition Coverage.

If you are a pharmacist or pharmacy that has professional liability insurance, these often provide legal coverage for depositions. This is primarily because the outcome of the deposition may include having you named as a defendant in a professional liability or negligence lawsuit or having disciplinary charges filed against you.

One of the first things you should do if you receive a subpoena or a notice of a deposition is to contact your professional liability insurance carrier and see if it will pay for an attorney to represent you. For example, Healthcare Providers Service Organization (HPSO), CPH & Associates, Nurses Service Organization (NSO), Dentists Advantage and many other malpractice insurance companies provide excellent deposition coverage.

The second thing you should do is to call an experienced attorney and schedule a consultation. Even if you cannot afford to retain the services of the attorney for the actual deposition, a consultation may assist you in properly preparing.

Consult With A Health Law Attorney Experienced in the Representation of Pharmacists and Pharmacies.

We routinely provide deposition coverage to pharmacists, pharmacies and other health professionals being deposed in criminal cases, negligence cases, civil cases or disciplinary cases involving other health professionals.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants and other health professionals in investigations and at Board of Pharmacy hearings. Call now or visit our website www.TheHealthLawFirm.com.

Comments?

Have you ever had an informal or formal hearing before the Board of Pharmacy? What was the experience like? Please leave any thoughtful comments below.

About the Author: 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.

 

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

 

 

 

Florida Board of Pharmacy Approves Change to Destruction of Controlled Substances Rule

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm

At its meeting held in Orlando, Florida, on February 12, 2014, the Florida Board of Pharmacy approved final changes to Rule 64B16-28.303, Florida Administrative Code. This rule governs the destruction of controlled substances by Class II Institutional Pharmacies.

The focus of the new rule changes is to ensure that either the prescription department manager (PDM) or the consultant pharmacist of record signs off on all destruction of controlled substances. Further, the rule requires that a copy of the destruction documents be mailed to the Drug Enforcement Administration (DEA) within one business day of destruction.

According to the Board’s statement, the purpose of the rule change is to make it “easier to properly dispose of [controlled] substances while ensuring that one of the persons signing for the destruction always is either the prescription department manager or the consultant pharmacist of record, and that a copy of the destruction is timely sent to the DEA.”

Who the Rule Applies To.

Although this rule applies to all permittees, pharmacists in Class II institutional pharmacies need to be aware that the Board’s clarifications were specifically aimed at those facilities. In case you are not sure whether you work in a Class II pharmacy, those facilities are defined as pharmacies which “employ the services of a registered pharmacist or pharmacists who, in practicing institutional pharmacy, [] provide dispensing and consulting services on the premises to patients of that institution, for use on the premises of that institution.” Section 465.019(b), Florida Statutes.

More Details of the Rule.

The new rule also states that destruction shall be conducted by at least two people. One will be the PDM or the consulting pharmacist of record and the other has to be one of the following: the medical director of the facility or his/her physician designee; the director of nursing or his/her licensed nurse designee, or a sworn law enforcement officer.

Finally, the rule retains the ability of the pharmacy to destroy the drugs by way of sending them to a reverse distributor in lieu of on-site destruction.

Check our blog regularly for updates on this and other recently adopted rules and changes.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of this rule change? Will the change affect your job or business? Please leave any thoughtful comments below.

About the Author: Lance O. Leider 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 Ave., Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 1996-2014 The Health Law Firm. All rights reserved.

Florida Department of Health (DOH) Shuts Down Boca Raton Compounding Pharmacy

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On October 26, 2012, the Florida Department of Health (DOH) issued an emergency suspension order (ESO) against a Boca Raton compounding pharmacy, according to a number of sources. The DOH in a press release called the conditions in the pharmacy so “deplorable” that nothing short of immediately shutting down the pharmacy would suffice.

Click here to read the press release from the DOH.

State Inspector Finds Feces, Bugs and Much More in Compounding Pharmacy.

On October 12, 2012, a state inspector arrived at the Boca Raton compounding pharmacy for an inspection. According to an article on Health News Florida, rodent feces, dead bugs and a sink full of dirty water were discovered. A film of powder covered surfaces in the drug-compounding area, where containers of drugs were open. Information on patients and prescriptions was missing, and drug labels were missing important information on the dose, lot number and prescribing physician.

Apparently the compounding pharmacy had been cited in past inspections for similar issues.

To read the Health News Florida article, click here.

Compounding Pharmacy Can Have a Hearing Before Action is Taken.

The compounding pharmacy can have a DOH hearing before final action is taken. The suspension is in effect until final disciplinary action, until the suspension is lifted or the case is appealed.

This inspection and ESO occurred in the wake of a nationwide outbreak of fungal meningitis linked to contaminated drugs made by a compounding pharmacy in Massachusetts. I previously wrote a blog on the Massachusetts compounding pharmacy shutting down. To read more click here.

It’s believed because of the meningitis outbreak, all compounding pharmacies are under the microscope.

Read About Another Florida Compounding Pharmacy Accused of Distributing Medications with Fungal Infection.

I previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog I wrote on this.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

Do you think the Boca Raton compounding pharmacy was unfairly served with an ESO due to the meningitis outbreak? Or do you think it is better for the Florida DOH to be safe rather than sorry? Please leave any thoughtful comments below.

Sources:

Gentry, Carol. “State Finds Pharmacy Conditions ‘Deplorable,’ Suspends License.” Health News Florida. (October 26, 2012). From: http://wusfnews.wusf.usf.edu/post/state-finds-pharmacy-conditions-deplorable-suspends-license

Florida Department of Health. “Department of Health Takes Action Against Florida Pharmacy.” DOH. (October 26, 2012). Press Release From: http://newsroom.doh.state.fl.us/wp-content/uploads/newsroom/2011/08/102612RejuviESO.pdf

About the Author: 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.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Pharmacies May be Liable for Filling Valid Prescriptions

Lance Leider headshotBy Lance O. Leider, J.D.

Florida pharmacies have had their potential liability significantly expanded by the Fifth District Court of Appeal. In its recent decision, Oleckna v. Daytona Discount Pharmacy, the appellate court held that a pharmacy owes a duty to its patients that go beyond following the prescribing physician’s directions and properly dispensing the medication.

The court defined the pharmacy’s duty to use due care in filling a prescription to mean more than what it called “robotic compliance” with the instructions of the prescribing physician.

From the court’s decision and some others from around the state it would seem that Florida pharmacists are now under an obligation to question the quantity, frequency, dosage, combination, and possibly even the purpose of a valid prescription. Florida pharmacies are no longer simply a conduit for validly prescribed prescription medications. They are now an integral part of the health care system where trained professionals are expected to act as a check and balance on physicians and other prescribers.

This decision is in keeping with recent Florida Board of Pharmacy cases dealing with narcotic pain medications. The Board has interpreted Section 465.003(6), Florida Statutes, and Rule 64B16-27.820, Florida Administrative Code, to place a duty on a pharmacist to use his or her skill and experience to evaluate the propriety of every prescription presented on a global level.

While courts and the Board are more than willing to expand the scope of a pharmacist’s duty to his or her patients, unfortunately, neither have provided any prospective guidance on how to fulfill the duty.

Suggestions for Compliance.

Below are some suggestions for ensuring your pharmacy is fulfilling its obligation to its patients. This list is by no means exhaustive and is only intended to offer some basic guidance.

1. Know the physician and verify the credentials of an unfamiliar one;
2. Check the Prescription Drug Monitoring Program (PDMP);
3. Do not fill prescriptions that are more than 30 days old without verifying them with the prescribing physician;
4. Question higher than normal dosages and more frequent administration instructions;
5. Do not provide early refills without verifiable documentation and contact the physician when the patient is seeking an early refill on a medication with a high potential for abuse (the physician is usually in the best position to recognize drug seeking behaviors);
6. Flag concerning prescriptions for mandatory counseling prior to dispensing to give you an opportunity to discuss the risks with the patient;
7. Check the patient’s profile for interactions and discuss them with the patient and, if necessary, the prescribing physician;
8. Periodically check with the prescribing physician on long term medications;
9. Document everything done to verify the propriety of a prescription in the patient’s record; and
10. Most importantly, don’t be afraid to refuse a fill.

In addition to these steps, you should also be conducting regular staff meetings and routine reviews of your processes to ensure that they remain functional and able to be followed.

Comments?

Do you think a pharmacy or pharmacist should be held liable for filling valid prescriptions? How do you verify you or your employees are in compliance? Please leave any thoughtful comments below.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm, please call (407) 331-6620 and visit our website at www.TheHealthLawFirm.com.

About the Author: Lance O. Leider 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 Ave., Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2015 The Health Law Firm. All rights reserved.

Phony Pharmacist Gets Prison Time for Working at Pharmacies in Central Florida

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On November 2, 2012, a former Altamonte Springs resident was sentenced to three and a half years in federal prison for fraudulently working as a Central Florida pharmacist from 2000 to 2009, according to the Department of Justice (DOJ).

Click here to read the press release from the DOJ.

I previously blogged about this story when the fake pharmacist pleaded guilty. Click here to read that blog.

Man Allegedly Worked at a CVS and Walgreens in Central Florida.

According to an article in the Orlando Sentinel, the man worked at pharmacies throughout Central Florida, including a CVS and a Walgreens. While working at one of the pharmacies, he allegedly gave a customer the incorrect medication, causing that person to suffer a stroke.

Fake Pharmacist Has to Change His Name.

Allegedly, the man fraudulently obtained a pharmacy license in September of 2000
from the Florida Department of Health (DOH) by using the name, date of birth, Social Security number and pharmacy education information of a licensed pharmacist in Arizona. In 2004 the man actually changed his legal name by fraud to the name of the licensed pharmacist.

Along with his prison sentence, the fake pharmacist was ordered to change his name back to his legal name.

Excuse My Alliteration.

Excuse my alliteration, but I just love all of those “F” sounds like I used in the title for this blog. For comparison, see my blog on Franck’s Pharmacy fungus case.

More Stories on Phony and Fraudulent Professionals to Come.
In the near future on this blog we will include additional articles on fake doctors and health professionals, some old, some new.

To see a recent blog on a fake dentist in Miami, click here. You can also read the story of a fake plastic surgeon in New York by clicking here.

Contact Health Law Attorneys Experienced with Representing Pharmacists and Pharmacies.

The attorneys of The Health Law Firm provide legal representation to pharmacists and pharmacies in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI 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.

Comments?

What do you think of all the fake health provider stories? Please leave any thoughtful comments below.

Sources:

FBI.gov. “Pharmacist Impersonator Sentenced to Prison and Ordered to Change His Name.” FBI, Tampa Division. (November 1, 2012). From Press Release: http://www.fbi.gov/tampa/press-releases/2012/pharmacist-impersonator-sentenced-to-prison-and-ordered-to-change-his-name

Pavuk, Amy. “Fake Pharmacist Sentenced to Federal Prison.” Orlando Sentinel. (November 1, 2012). From: http://www.orlandosentinel.com/news/local/breakingnews/os-fake-pharmacist-prison-20121101,0,4565731.story

About the Author: 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.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

 

The 25 Biggest Mistakes Pharmacists Make After Being Notified of a Department of Health Complaint

1 Indest-2008-1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The investigation of a complaint which could lead to the revocation of a pharmacist’s license to practice and the assessment of tens of thousands of dollars in fines, usually starts with a simple letter from the Department of Health (DOH). This is a very serious legal matter and it should be treated as such by the pharmacist who receives it. Yet, in many cases, attorneys are consulted by pharmacists after the entire investigation is over, and they have attempted to represent themselves throughout the case. Often, the mistakes that have been made severely compromise an attorney’s ability to achieve a favorable result for the pharmacist.

These are the 25 biggest mistakes we see in the pharmacy cases we are called upon to defend after a DOH investigation has been initiated:

1.  Failing to keep a current, valid address on file with the DOH (as required by law), which may seriously delay the receipt of the Uniform Complaint (notice of investigation), letters, and other important correspondence related to the investigation.

2.  Contacting the DOH investigator and providing him/her an oral statement or oral interview. (Note: There is no legal requirement to do this.)

3.  Making a written statement in response to the “invitation” extended by the DOH investigator to do so. (Note: There is no legal requirement to do this.)

4.  Failing to carefully review the complaint to make sure it has been sent to the correct pharmacist. (Note: Check name and license number).

5.  Failing to ascertain whether or not the investigation is on the “Fast Track” which may then result in an emergency suspension order (ESO) suspending the pharmacist’s license until all proceedings are concluded. (Note: This will usually be the case if there are allegations regarding drug abuse, alcohol abuse, sexual contact with a patient, mental health issues, or failure to comply with PRN instructions.)

6.  Providing a copy of the pharmacist’s curriculum vitae (CV) or resume to the investigator because the investigator requested them to do so. (Note: There is no legal requirement to do this.)

7.Believing that if they “just explain it,” the investigation will be closed and the case dropped.

8.  Failing to submit a timely objection to a DOH subpoena when there are valid grounds to do so.

9.  Failing to forward a complete copy of the patient medical record when subpoenaed by the DOH investigator as part of the investigation, when no objection is going to be filed.

10.  Delegating the task of providing a complete copy of the patient medical record to office staff, resulting in an incomplete or partial copy being provided.

11.  Failing to keep an exact copy of any medical records, documents, letters or statements provided to the investigator.

12.  Believing that the investigator has knowledge or experience in medical procedures or health care matters or procedures being investigated.

13.  Believing that the investigator is merely attempting to ascertain the truth of the matter and this will result in the matter being dismissed.

14.  Failing to check to see if their medical malpractice insurance carrier will pay the legal fees to defend them in this investigation.

15.  Talking to DOH investigators, staff or attorneys, in the mistaken belief that they are capable of doing so without providing information that can and will be used against them.

16.  Believing that because they haven’t heard anything for six months or more the matter has “gone away.” The matter does not ever just go away.

17.  Failing to submit a written request to the investigator at the beginning of the investigation for a copy of the complete investigation report and file and then following up with additional requests until it is received.

18.  Failing to wisely use the time while the investigation is proceeding to interview witnesses, obtain witness statements, conduct research, obtain experts, and perform other tasks that may assist defending the case.

19.  Failing to exercise the right of submitting documents, statements, and expert opinions to rebut the findings made in the investigation report before the case is submitted to the Probable Cause Panel of your licensing board for a decision.

20.  Taking legal advice from their colleagues regarding what they should do (or not do) in defending themselves in the investigation.

21.  Retaining “consultants” or other non-lawyer personnel to represent them.

22.  Believing that the case is indefensible so there is no reason to even try to have it dismissed by the Probable Cause Panel.

23.  Attempting to defend themselves.

24.  Believing that because they know someone with the Department of Health or a state legislator, that influence can be exerted to have the case dismissed.

25.  Failing to immediately retain the services of a health care attorney who is experienced in such matters to represent them, to communicate with the DOH investigator for them, and to prepare and submit materials to the Probable Cause Panel.

Bonus Point: 26. Communicating with the Department of Health about the pending case.

Not every case will require submission of materials to the Probable Cause Panel after the investigation is received and reviewed. There will be a few where the allegations made are not “legally sufficient” and do not constitute an offense for which the pharmacist may be disciplined.

In other cases, an experienced health care attorney may be successful in obtaining a commitment from the DOH attorney to recommend a dismissal to the Probable Cause Panel. In other cases (usually the most serious ones), for tactical reasons, the experienced health care attorney may recommend that you waive your right to have the case submitted to the Probable Cause Panel and that you proceed directly to an administrative hearing. The key to a successful outcome in all of these cases is to obtain the assistance of a health care lawyer who is experienced in appearing before the Board of Pharmacy in such cases and does so on a regular basis.

Contact Health Law Attorneys Experienced with Department of Health Investigations of Pharmacists.

The attorneys of The Health Law Firm provide legal representation to pharmacists and pharmacies in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI 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 Author: 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.

Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

 

Terrible Things That Can Happen after Discipline on Your Pharmacist License or Resignation of a Pharmacist License after Notice of Investigation

5 Indest-2008-2By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Do you have a pharmacist license in several different states? Do you have a license in more than one health profession? Have you been notified that an investigation has been opened against you? Are you thinking about resigning your pharmacist license or voluntarily relinquishing such a license? Then you must be aware of the following.

First, you should never voluntarily relinquish or resign your license after you know that an investigation has been opened or that disciplinary action has been taken against you. Such a resignation is considered to be a “disciplinary relinquishment” and is treated the same as if your license had been revoked on disciplinary grounds.

Second, this will be reported out to other states, agencies, to the National Practitioner Data Bank (NPDB), to any certifying bodies for certifications you have and to other reporting agencies (such as the National Association of Boards of Pharmacy). Other states and other professional boards will most likely initiate disciplinary action based upon the first one.

Protect Your Pharmacist License.

The following is a list of some of the adverse actions that you can expect to be taken against you after discipline on your license or after you resign your pharmacist license after receiving notice of investigation:

1. A mandatory report to the National Practitioner Data Base (NPDB) which remains there for 50 years. Note: The Healthcare Integrity and Protection Data Bank or HIPDB recently merged into the NPDB.

2. Must be reported to and included in the Department of Health (DOH) profile that is available to the public online (for those having one), and remains for at least ten years.

3. Any other states or jurisdictions in which the pharmacist has a license will also initiate investigation and possible disciplinary action against him or her in that jurisdiction. (Note: I have had two clients who had licenses in seven other states and all, even ones that were inactive or not renewed years ago, initiated action).

4. The Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) will take action to exclude the provider from the Medicare Program. If this occurs (and most of these offenses require mandatory exclusion) the provider will be placed on the List of Excluded Individuals and Entities (LEIE) maintained by the HHS OIG.

a. If this happens, you are prohibited by law from working in any position in any capacity for any individual or business, including hospitals, nursing homes, home health agencies, physicians, medical groups, insurance companies, etc., that contract with or bill Medicare or Medicaid. This means, for example, you are prohibited from working as a janitor in a nursing home that accepts Medicare or Medicaid, even as an independent contractor.

b. If this happens, you are also automatically “debarred” or prohibited from participating in any capacity in any federal contracting, and you are placed on the U.S. General Services Administration’s (GSA) debarment list. This means you are prohibited by law from working in any capacity for any government contractor or anyone who takes government funding. This applies, for example, to prevent you from being a real estate agent involved in selling property financed by a government backed loan, prohibited from working for an electrical company that bids on contracts for government housing projects, working as a school teacher in a public school, etc.

c. If this happens, your state Medicaid Program is required to terminate you “for cause” from the state Medicaid Program. In many states, this is also grounds for revocation of your pharmacist license.

5. Any profile or reporting system maintained by a national organization or federation will include the adverse action in it, generally available to the public.

6. If you are a pharmacist or other professional with clinical privileges at a hospital, nursing home, HMO or clinic, action will be taken to revoke or suspend the clinical privileges and staff membership if you have such. This may be in a hospital, ambulatory surgical center, skilled nursing facility, staff model HMO or clinic. This will usually be for clinical pharmacists.

7. Third party payors (health insurance companies, HMOs, etc.) will terminate the professional’s contract or panel membership with that organization.

8. The U.S. Drug Enforcement Administration (DEA) will act to revoke the professional’s DEA registration if he or she has one.

9. Many employers will not hire you or will terminate your employment if they discover your license has been disciplined in another state.

What You Should Do.

– Don’t take the easy way out by immediately relinquishing your license if you are notified you are under investigation.

– Don’t hide your head in the sand by thinking the case will just go away on its own.

– Don’t take the easy way out. If you are innocent of the charges, request a formal hearing and contest the charges; defend yourself.

– Do not request an informal hearing or a settlement agreement in which you admit the facts alleged against you are all true. If you do this, you are “pleading guilty.”

– Do immediately seek the advice of an attorney who has experience in such professional licensing matters and administrative hearings. They are out there, but you may have to search for one. Do this as soon as you get notice of any investigation and especially before you have talked to or made any statement (including a written one) to any investigator.

– Do purchase professional liability insurance that includes legal defense coverage for any professional license investigation against you, whether it is related to a malpractice claim or not. This insurance is cheap and will provide needed legal assistance at the time when you may be out of a job and not have money to hire an attorney. Beware of the insurance policy that only covers professional license defense if it is related to a malpractice claim.

Get Your Own Professional Liability Insurance.

We strongly encourage all licensed health professionals and facilities to purchase their own, independent insurance coverage. Make sure it covers professional license defense under all circumstances. Make sure you have enough coverage to actually get you through a hearing. $25,000 coverage for just professional licensure defense is the absolute minimum you should purchase; $50,000 may be adequate but $75,000 or $100,000 may be what you really need in such a situation. For a few dollars more (and I do mean only a few) you can usually purchase the higher limits.

Also, I will repeat, make sure it covers your legal defense in an administrative disciplinary proceeding against your license, even if there is no malpractice claim filed against you or likely to be filed against you.

We also recommend that you purchase coverage through an insurance company that allows you to select your own attorney and does not make you use one that the insurance company picks for you.

Companies we have encountered in the past who provide an inexpensive top quality insurance product for professional license defense costs include: CPH & Associates Insurance, Healthcare Providers Organization (HPSO) Insurance and Lloyd’s of London Insurance.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

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 Author: 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.

 

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

New Permit Law for Florida Pharmacies that Compound Sterile Products

LOL Blog Label 2Lance O. Leider, J.D., The Health Law Firm and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Florida Board of Pharmacy announced a new law which will be required for pharmacies that compound sterile products. Effective September 23, 2013, Rule 64B16-28.100(8), Florida Administrative Code (F.A.C.), requires most pharmacies that engage in the preparation of sterile compounded products in Florida to obtain a Special Sterile Compounding Permit. Pharmacies compounding sterile products under their current pharmacy permit may continue to do so, but must obtain the new Special Sterile Compounding Permit on or before March 21, 2014.

Click here to read the notice from the Florida Board of Pharmacy.

We believe the updated requirements are a result of the recent recalls of tainted compounded medications that have spread across the country and infected thousands of patients. These new standards will make it easier for authorities to quickly spot where tainted batches of medications were produced.

Special Sterile Compounding Permit Exceptions.

All permitees that are currently compounding sterile products are required to submit an application to obtain the Special Sterile Compounding Permit.

However, the exceptions are for stand-alone Special Parenteral/Enteral pharmacies, Special Parenteral/Enteral Extended Scope pharmacies, pharmacies that only perform non-sterile compounding, and non-resident pharmacies.

How to Apply for the Special Sterile Compounding Permit.

To obtain the new Special Sterile Compounding Permit, an applicant must already hold another pharmacy permit and must submit an application for the new permit. Those applying for this permit will be required to submit information from current policies and procedures which will be reviewed before an inspection is requested from the Florida Board of Pharmacy.

The application is available by clicking here.

Once approved, the Florida Board of Pharmacy will issue a new Special Sterile Compounding Permit. This means pharmacies that compound sterile products will have two pharmacy permits.

New Standards Most Likely Triggered by Tainted Compounded Medications.

These new standards are being implemented about a year after a nationwide outbreak of fungal meningitis linked to contaminated drugs made by a compounding pharmacy in Massachusetts. Click here to read our previous blog. Florida is no stranger to allegations of tainted compounded products. In May 2013, Franck’s pharmacy in Ocala, Florida, was accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog on this.

It’s likely this new permit is a direct result of the recent issues with compounded medications and compounding pharmacies. The aim of the permit is to help authorities, such as the Department of Health (DOH) and U.S. Food and Drug Administration (FDA), track Florida pharmacies compounding sterile products.

New Requirements Released for Physician Medical Records Related to Compounded Medications.

Similarly, on September 5, 2013, the Florida Board of Medicine and the Florida Board of Osteopathic Medicine published new requirements for medical record documentation related to compounded medications administered to patients in an office setting.  These standards became effective on September 9, 2013. The standards are contained in Florida Administrative Code Rules adopted by each board. Click here to read our previous blog on this.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

Had you heard of this new permit? How will this affect pharmacies compounding sterile products? Please leave any thoughtful comments below.

About the Authors: Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the OrlandSeptember 18, 2013o, Florida, area. www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone:  (407) 331-6620.

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.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Drug Quality and Security Act Boosts FDA Regulations Over Compounding Pharmacies

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm

On November 18, 2013, the United States Senate voted to increase federal oversight of compounding pharmacies that produce large volumes of mixed drugs. This bill comes in the wake of last year’s meningitis outbreak stemming from unsanitary conditions at the New England Compounding Center (NECC). Click here to read a previous blog on the meningitis outbreak.

This bill does not give the U.S. Food and Drug Administration (FDA) absolute authority over compounders, but creates significant safeguards.

This particular piece of legislation passed the House of Representatives in September of 2013, passed in the Senate in November 2013, and President Obama signed it into law on November 28, 2013. To read a summary of the Drug Quality and Security Act, click here.

Under Law, Registration with the FDA is Voluntary.

The goal of the Drug Quality and Security Act is to enact greater controls, tracking, and oversight of the compounding pharmacy industry. Presently, the U.S. Food and Drug Administration (FDA) only regulates manufacturers of medications, leaving compounding pharmacies to be regulated by state boards of pharmacy.

However, this two-part regulation left large compounding operations like the NECC in somewhat of a gray area. Large compounding labs like NECC that mass produce products to ship across state lines have come under fire from state boards of pharmacy.

At a recent meeting of the Florida Board of Pharmacy’s Compounding Committee, the panel members expressed concerns over the lack of inspections and oversight of pharmacies shipping drugs into Florida. In general, the Committee supported the efforts to strengthen regulations, whether by the FDA or state boards.

Overview of the Law.

Under the final legislation, compounders that mix sterile drugs without a prescription and ship across state lines can choose to register as outsourcing facilities. The pharmacies that register would then be regulated by the FDA rather than by state boards of pharmacy. The hope is that compounding pharmacists will want to register with the FDA because physicians will prefer using compounding pharmacies that are federally regulated, and therefore considered safer.

The law also creates a national system for tracking prescription drugs from the manufacturer to retail pharmacies, first this is done through serial numbers on bottles and later through electronic codes. Drug makers will be required to add serial numbers to all drug packages within four years, and within 10 years drug makers must implement electronic codes that can be used to track medicine from the factory to the pharmacy.

Issues with Previous Inspections.

As mentioned above, the issue of large-scale compounding and nonresident pharmacies was recently discussed by the Florida Board of Pharmacy.

Florida has more than 700 nonresident pharmacy permits outstanding. According to the Board of Pharmacy, approximately half of those are shipping compounded sterile products into Florida.

Prior to the events at NECC, state boards of pharmacy were under the mistaken assumption that their sister boards were appropriately regulating and inspecting these pharmacies. However, it turns out that many of the inspections were conducted by inadequately trained staff, or the staff was misled as to exactly what was going on at the pharmacy.

Many of the pharmacies wrongly informed the state inspectors that they were registered with the FDA as a manufacturer and did not have to provide prescriptions during inspections. This led to largely unregulated production of compounded sterile medications and eventually the meningitis outbreak of 2012.

Florida Board of Pharmacy to Have More Oversight.

Frustrated with the general lack of oversight and the potential harm to Floridians, the Board is preparing to take additional steps to ensure that compounders are appropriately regulated.

Among the possible steps to be taken are:

1. Outsourcing nonresident pharmacy inspections to organizations like the National Association of Boards of Pharmacy (NABP);

2. Require personal inspection by a Florida Board-approved inspector prior to issuing or renewing a license (costs of the inspection would be paid by the permittee);

3. Training specialized compounding pharmacy inspectors; and

4. Creating a Verified Pharmacy Program in conjunction with the NABP and other state boards.

Ultimately, the result of the additional regulations will mean more rigorous compliance standards on both in and out-of-state compounding pharmacies.

New Permit Law for Florida Pharmacies that Compound Sterile Products.

The Florida Board of Pharmacy also recently announced a new law which will be required for pharmacies that compound sterile products. Effective September 23, 2013, Rule 64B16-28.100(8), Florida Administrative Code (F.A.C.), requires most pharmacies that engage in the preparation of sterile compounded products in Florida to obtain a Special Sterile Compounding Permit. Pharmacies compounding sterile products under their current pharmacy permit may continue to do so, but must obtain the new Special Sterile Compounding Permit on or before March 21, 2014. To read more, click here.

These new standards will make it easier for authorities to quickly spot where tainted batches of medications were produced. It is important to regularly review the Board of Pharmacy rules and USP guidelines to ensure your facility is compliant.

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.

Comments?

Have you heard of these new possible pharmacy regulations? How will this affect you or your pharmacy? Please leave any thoughtful comments below.

Sources:

Lee, Jaimy. “Bill Boosting FDA Authority Over Compounding Pharmacies Heads to Obama.” Modern Healthcare. (November 18, 2013). From: http://www.modernhealthcare.com/article/20131118/NEWS/311189973/bill-boosting-fda-authority-over-compounding-pharmacies-heads-to?utm_source=frontpage&utm_medium=newsitem309&utm_campaign=carousel-traffic

Perrone, Matthew. “Pharmacy Bill Set for Test Vote in Senate.” Washington Post. (November 11, 2013). From: http://www.washingtonpost.com/politics/pharmacy-bill-set-for-test-vote-in-senate/2013/11/11/a961c958-4b25-11e3-9890-a1e0997fb0c0_story.html

About the Author: Lance O. Leider 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.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Compounding Pharmacies Urged to Sign Up for U.S. Food and Drug Administration Oversight

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm

It is estimated there are 3,000 compounding pharmacies in the United States, 14 of which have signed up to be regulated by the U.S. Food and Drug Administration (FDA) under the Drug Quality and Security Act. On January 8, 2014, the commissioner of the FDA sent thousands of letters to hospitals and other medical providers that may buy medicines from the compounding pharmacies. The letters urged providers to encourage compounding pharmacies to register as producers of sterile drugs in an effort to protect the public. The letters also mentioned last year’s meningitis outbreak stemming from unsanitary conditions at the New England Compounding Center (NECC). To read a previous blog on the meningitis outbreak, click here.

In November 2013, the Drug Quality and Security Act was passed. Under the law, the FDA does not have absolute authority over compounders, but it creates significant safeguards. To read a previous blog on the Drug Quality and Security Act, click here.

Registering with the FDA is Voluntary.

The goal of the Drug Quality and Security Act is to enact greater controls, tracking, and oversight of the compounding pharmacy industry. Previously, the FDA only regulated manufacturers of medications, leaving compounding pharmacies to be regulated by state boards of pharmacy. However, this two-part regulation left large compounding operations like the NECC in somewhat of a gray area. Large compounding labs mass producing products and shipping across state lines have recently come under fire from state boards of pharmacy.

Overview of the Drug Quality and Security Act.

Under the final legislation, compounders that mix sterile drugs without a prescription and ship across state lines can choose to register as outsourcing facilities. The pharmacies that register are regulated by the FDA rather than by state boards of pharmacy. The hope was that compounding pharmacies will register with the FDA because physicians will prefer using facilities that are federally regulated, and therefore considered safer.

The law also creates a national system for tracking prescription drugs from the manufacturer to retail pharmacies, first this is done through serial numbers on bottles and later through electronic codes. Drug makers will be required to add serial numbers to all drug packages within four years, and within 10 years drug makers must implement electronic codes that can be used to track medicine from the factory to the pharmacy. To read a summary of the Drug Quality and Security Act, click here.

What Registered Compounding Pharmacies Must Agree To.

Compounding pharmacies registering with the FDA must agree to routine inspections, and to report adverse events associated with their products. Registered compounding pharmacies must also pay a fee for the privilege. The FDA is listing on its website the companies that have already registered. Click here to see the list.

Ultimately, the result of voluntary federal oversight will mean more rigorous compliance standards for both in and out-of-state compounding pharmacies. However, the purported benefits (more business and a better reputation) may far outweigh the burden.

If your pharmacy is considering FDA registration it would be best to consult with an experienced health attorney to guide you through the process.

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.

Comments?

What do you think about the number of compounding pharmacies that have signed up to be regulated by the FDA? As a provider, would you consider using compounding pharmacies that have not signed up? Please leave any thoughtful comments below.

Sources:

Palmer, Eric. “Compounders Start to Sign Up for FDA Oversight.” FiercePharma. (January 10, 2014). From: http://www.fiercepharma.com/story/compounders-start-sign-fda-oversight/2014-01-10

Associated Press. “States Urged to Register Compounding Pharmacies.” ABC News. (January 10, 2014). From: http://abcnews.go.com/US/wireStory/states-urged-register-compounding-pharmacies-21489538

Burton, Thomas. “FDA Urges Compounding Pharmacies to Register.” Wall Street Journa. (January 10, 2014). From: http://online.wsj.com/news/articles/SB10001424052702303754404579312680341438784

About the Author: Lance O. Leider 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.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

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