pharmacy attorney | The Health Law Firm Blog

New Requirements Released for Physician Medical Records Related to Compounded Medications

By Michael L. Smith, R.R.T., J.D., Board Certified by The Florida Bar in Health Law and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

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 become effective September 9, 2013. The standards are contained in Florida Administrative Code Rules adopted by each board.

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 health care professionals to trace drug reactions and spot tainted batches of medications quickly. The new changes apply to the exact documentation required anytime a compounded medication is administered to a patient.

For the Florida Board of Medicine this is an update to Rule 64B8-9.003, Florida Administrative Code. For the Florida Board of Osteopathic Medicine this is an update to Rule 64B15-15.004, Florida Administrative Code.

New Medical Records Standards.

According to the Florida Board of Medicine and the Florida Board of Osteopathic Medicine, when compounded medications are administered to a patient in the office the medical record documentation must contain, at a minimum:

1. The name and concentration of medication administered;
2. The lot number of the medication administered;
3. The expiration date of the medication administered;
4. The name of the compounding pharmacy or manufacturer;
5. The site of administration on the patient;
6. The amount of medication administered; and
7. The date the medication was administered.

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 these updated requirements are a direct result of the recent issues with compounded medications and compounding pharmacies. In the event a health care professional’s office receives a batch of tainted compounded medicine, these medical record standards will help the health care professional track which patients received the tainted medications. Also, authorities, such as the Department of Health (DOH) and U.S. Food and Drug Administration (FDA), will be able to easily track and send recalls to the offices that receive tainted compounded medications.

Contact Health Law Attorneys Experienced in the Representation of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, pain management doctors, dentists, pharmacists, psychologists 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?

Had you heard of these updates? Do you think these requirements will help officials track tainted medications? Please leave any thoughtful comments below.

About the Authors: Michael L. Smith, R.R.T., J.D., is Board Certified by The Florida Bar in Health Law. He 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, FL 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.

Two More Compounding Pharmacies Recall Drugs

By Carole C. Schriefer, R.N., 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

Two different compounding pharmacies have recently recalled products due to concerns from the Food and Drug Administration (FDA). The New Jersey compounding pharmacy, Med Prep Consulting, and Clinical Specialties Compounding in Georgia, both recalled products between March 17, 2013 and March 20, 2013.

The recalls were issued as the FDA and state agencies step up regulation on compounding pharmacies across the country. These agencies are trying to prevent another widespread outbreak, like the fungal meningitis outbreak in the fall of 2012, which is responsible for 50 deaths.

Recall Upgraded in New Jersey.

Med Prep Consulting first issued a recall on March 17, 2013, for all lots of magnesium sulfate for injections after a hospital reported seeing visible particles in the containers. Three days later, the compounding pharmacy recalled all of its compounded products. Med Prep Consulting has halted production, processing and shipping. The FDA reported products distributed through March 15, 2013, in New Jersey, Pennsylvania, Delaware and Connecticut need to be returned to the company. Click here to see all the recalled products from Med Prep Consulting.

Eye Infections from Georgia Compounding Pharmacy Products.

According to Modern Healthcare, at least five people have acquired serious eye infections associated with the use of the cancer drug Avastin packaged in syringes from Clinical Specialties Compounding. At the company’s facility in Georgia the FDA raised concerns about the lack of sterility assurance. Products covered under the recall were distributed nationwide, between October 19, 2012 and March 19, 2013. Until further notice, healthcare providers are asked to stop using all of these sterile products and return them to the company. Click here to read the press release on the recall from the FDA.

Florida Compounding Pharmacy in Hot Water Due to Fungal Growth.
We have 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 on this.

Harsher Regulations on Compounding Pharmacies.

Since the widespread fungal meningitis outbreak, compounding pharmacies have fallen under heightened scrutiny. The FDA is beefing up their oversight of compounding, and, according to Modern Healthcare, the FDA and state Department of Health (DOH) agencies have been paying surprise visits to compounding pharmacies. Click here to read more from Modern Healthcare.

Common Deficiencies We See in Pharmacy Inspections.

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), FDA and DOH, have the authority to inspect pharmacies.

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; and

5. Not keeping schedule II inventory and dispensing records separate from schedule III-V records.

Click here to read a recently blog listing more deficiencies and your best defense to protect your pharmacy license and pharmacist license.

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?

What do you think of the harsher regulations compound pharmacies are now facing? Please leave any thoughtful comments below.

Sources:

Meinhardt, Jane. “Compounding Pharmacies Set to Navigate Potential Regulations.” Tampa Bay Business Journal. (January 25, 2013). From: http://www.bizjournals.com/tampabay/print-edition/2013/01/25/compounding-pharmacies-set-to-navigate.html?s=print

Blesch, Gregg. “Georgia Compounding Pharmacy Widens Recall.” Modern Healthcare. (March 22, 2013). From: http://www.modernhealthcare.com/article/20130322/NEWS/303229959/#

Clinical Specialties. “Clinical Specialties Compounding Pharmacy Announces Voluntary Nationwide Recall of All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance.” Food and Drug Administration. (March 20, 2013). From: http://www.fda.gov/Safety/Recalls/ucm344786.htm

About the Authors: 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.

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.

Meningitis Cases in Florida Continue to Rise – Doctors Getting Sued

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

The Florida Department of Health (DOH) confirmed another case of fungal meningitis in Florida on November 19, 2012. A 56-year-old man allegedly received a contaminated steroid injection at Florida Pain Clinic in Marion County, Florida. This brings the state’s total number of fungal meningitis cases up to 24, including three deaths.

To read the entire press release from the Florida DOH, click here.

Meningitis Numbers Around the U.S.

As of November 19, 2012, the Florida DOH reported the number of fungal meningitis cases nationwide is up to 480 with 33 deaths in 19 states.

The meningitis outbreak is reportedly linked to contaminated steroids made at the New England Compounding Center (NECC) in Framingham, Massachusetts, which is now closed. The compounding pharmacy was allegedly not following the requirements of its state license, according to the Massachusetts DOH. Under Massachusetts state law the NECC was only supposed to produce medications for patient-specific prescriptions, but it is believed the compounding pharmacy was preparing drugs in bulk. I previously wrote a blog on the reports related to the compounding pharmacy violating its license. Click here to read that blog.

Victims Sue Physicians.

Victims of the meningitis outbreak are starting to file lawsuits against the physicians and clinics that administered the tainted steroids. In a Business Insurance article released on October 28, 2012, I was quoted as saying liability might be established to the extent that the physicians were aware that the steroids distributed by the NECC violated regulations on compounding prescription medications. To read the entire article from Business Insurance, click here.

Florida and Fungal Outbreaks.

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

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.Jameson. Marni. “Florida Health Officials Confirm State’s 24th Case of Fungal Meningitis.” Orlando Sentinel. (November 19, 2012). From: ttp://www.orlandosentinel.com/news/local/breakingnews/os-florida-fungal-meningitis-20121119,0,3451600.story

Comments?

What do you think of the lawsuits again the physicians and clinics that administered the tainted steroid shots? Please leave any thoughtful comments below.

Sources:

Hiers, Fred. “Man Who Received Injection Locally Confirmed to Have Fungal Meningitis.” Ocala Star Banner. (November 19, 2012). From: http://www.ocala.com/article/20121119/ARTICLES/121119679/1412?Title=Man-who-received-injection-locally-confirmed-to-have-fungal-meningitis

Greenwald, Judy. “Meningitis Lawsuits Target Physicians.” Business Insurance. (October 28, 2012), From: http://www.businessinsurance.com/article/20121028/NEWS07/310289984?tags=|75|303

Hammonds, Jessica. “Florida Department of Health Uncovers Case of Fungal Meningitis.” Florida Department of Healht. (November 19, 2012). From: ttp://newsroom.doh.state.fl.us/wp-content/uploads/newsroom/2012/11/111912MeningitisUpdateonecase.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.

Boca Raton Compounding Pharmacy Shuts Its Doors After Receiving an Emergency Suspension Order

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.

Rodent Feces, Dead Bugs and a Sink Full of Dirty Water all Found at 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.

All Compounding Pharmacies Are Now Under Pressure.

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.

Another Florida Compounding Pharmacy in Trouble Due to Fungal Growth.

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.

New England Compounding Pharmacy Linked to Meningitis Outbreak Suspected of Violated License

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

The compounding pharmacy behind the meningitis outbreak was allegedly not following the requirements of its state license, according to the Massachusetts Department of Health (DOH) in a released statement on October 10, 2012.

To read the entire statement from the Massachusetts DOH, click here.

The New England Compounding Center (NECC) shipped more than 17,000 vials of a steroid to pain clinics in 23 states, including Florida. The Centers for Disease Control and Prevention (CDC) is now reporting 214 cases of meningitis and 15 deaths associated with the fungal infection. NECC has surrendered its license and has recalled all medications. To see a blog I previously wrote about the recall and compounding facility shutting down, click here.

Under Law NECC Was Only Suppose to Produce Medication for Patient-Specific Prescriptions.

The Massachusetts DOH representative said under state law the NECC was only supposed to produce medications for patient-specific prescriptions. It is believed the company violated state law governing those pharmacies.

Apparently the DOH has had issues with the NECC prior to the outbreak. According to the statement, in 2006 the NECC received a warning letter from the Massachusetts DOH. The letter stated the company was operating more like a drug manufacturing firm than a compounding pharmacy.

All Compounding Pharmacies Now Under the Microscope.

On October 10, 2012, the Board of Pharmacy sent out an alert to all compounding pharmacies in Massachusetts to reinforce the state rules. The Board also issued an order requiring that all compounding pharmacies in the state sign an affidavit attesting compliance with all laws and regulations. The Massachusetts DOH officials do not believe any other pharmacies are operating outside of the rules, but said the alert was a precautionary measure.

Click here to see the alert from the Board of Pharmacy.

Compounding Pharmacy in Florida Faced Fungal Outbreak.

Florida has seen its share of fungal outbreaks. 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.

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?

What do you think of this story? Please leave any thoughtful comments below.

Sources:

Smith, Michael. “Meningitis: Pharmacy in Outbreak Violated License.” MedPage Today. (October 11, 2012). From: http://www.medpagetoday.com/Neurology/GeneralNeurology/35276?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news

Biondolillo, Madeleine Dr. “Statement of Dr. Madeleine Biondolillo Director of the Bureau for Health Care Safety and Quality.” Department of Public Health Massachusetts (October 10. 2012). From: http://www.mass.gov/eohhs/docs/dph/quality/boards/pharmacy-necc-biondolillo-statement.doc

Associated Press. “CDC: US Meningitis Outbreak Growing, 14 Dead.” Florida Today. (October 11, 2012). From: http://www.floridatoday.com/viewart/20121011/HEALTH/121011041/CDC-US-meningitis-outbreak-growing-14-dead?odyssey=tab%7Ctopnews%7Ctext%7CLocal%20News

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.

Out-of-State Compounding Pharmacies May Need a Permit To Do Business in Florida

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

Beginning on October 1, 2014, out-of-state compounding pharmacies may be required to hold a compounded sterile product permit. That’s because the Regulated Industries Committee of the Florida Senate voted on March 13, 2014, to approve a bill increasing the restrictions on out-of-state compounding pharmacies that ship medications into Florida. These increased regulations would apply to around 300 compounding pharmacies shipping medicine to Florida.

The bill was introduced to increase standards for compounding pharmacies that create medications that are tailored to the needs of individual patients. Currently the bill is out for reference review. Considering that this is a hot issue in Florida and nationally, we expect the bill to pass.

Click here to read the entire bill.

Requirements Under the New Bill.

The bill requires out-of-state compounding pharmacies to hold a compounded sterile product permit to ship medications into Florida. Applications for the permit would be provided by the Board of Pharmacy. The bill also requires pharmacies to meet or exceed Florida’s sterile compounding standards. Under the bill, the Florida Department of Health (DOH) is responsible for inspecting out-of-state compounding pharmacies for compliance. The DOH would hold the authority to punish or revoke an out-of-state compounding pharmacy’s license for noncompliance. The pharmacy would be responsible for reimbursing the cost of the inspection.

If the bill passes, compounding pharmacies already shipping compounded sterile products into Florida may continue to do so, as long as the pharmacy receives a permit before January 31, 2015.

Permit Law for Florida Pharmacies that Compound Sterile Products.

Similarly, the Florida Board of Pharmacy promulgated a rule requiring a permit for pharmacies that compound sterile products in Florida. 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.

Click here to read more on this permit.

New Standards Most Likely Triggered by Tainted Compounded Medications.

These new standards are being implemented after a nationwide outbreak of fungal meningitis linked to contaminated drugs made by a compounding pharmacy in Massachusetts. Florida is no stranger to allegations of tainted compounded products. In May 2012, 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.

It’s likely these new permits are a direct result of the recent issues with compounded medications and compounding pharmacies. The goal of these permits is to help authorities, such as the DOH and U.S. Food and Drug Administration (FDA), track pharmacies compounding sterile products.

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?

What do you think of the bill to increase restrictions on out-of-state compounding pharmacies that ship medications into Florida? Please leave any thoughtful comments below.

Sources:

The News Service of Florida. “Pharmacy Bill, FL Budge Taking Shape.” WUSF News. (March 14, 2014). From: http://wusfnews.wusf.usf.edu/post/pharmacy-bill-fl-budget-taking-shape

Palombo, Jessica. “After Federal Compounding Pharmacy Crackdown, Fla. Panel Passes Extra Restrictions.” WFSU News. (February 12, 2014). From: http://news.wfsu.org/post/after-federal-compounding-pharmacy-crackdown-fla-panel-passes-extra-restrictions

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.

Drug Enforcement Administration (DEA) Agents May Surprise You at Florida Board of Pharmacy Meeting

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

At several recent Florida Board meetings, after hearings at which disciplinary cases were considered by the Board, Drug Enforcement Administration (DEA) agents approached the health professional. Even in instances where the pharmacist was represented by an attorney and the attorney was there, the DEA agents confronted the professional involved.

What Were the DEA Agents Trying to Do?

In the cases where The Health Law Firm’s attorneys were there representing clients, the professional received some type of discipline on his or her license. Some of these were Settlement Agreements. The DEA Agent approached the professional and urged the professional to sign a voluntary relinquishment of DEA registration.

It seems that this is happening to professionals where there is some type of serious or long-term discipline is being taken against their licenses, such as long-term probation, suspension or revocation. Also, if the charges against the health professional involved, drugs, over-prescribing, abuse of narcotics, operation of a “pill mill,” selling or illegally dispensing or prescribing narcotics, drug diversion or abuse, being impaired from use of drugs, and other similar misconduct. These are often grounds for the revocation, suspension or revocation of the DEA number.

This action by DEA agents has occurred at Board of Medicine meetings and hearings, Board of Osteopathic Medicine meetings and hearings, Board of Dentistry meetings and hearing and Board of Pharmacy meetings and hearings. If you are a professional who has a DEA registration and number, you are, apparently, fair game.

Don’t Be Surprised; Be Prepared and Don’t Make a Rash Decision.

It is unusual to see federal agents of this type “cruising” state professional board meetings like we have seen lately. But, it seems to make sense, from the DEA’s point of view. If you can take several minutes and convince, surprise or intimidate a health professional into relinquishing his or her DEA registration voluntarily, then you may save the government hundreds of hours of time and thousands of dollars in expenses in having to investigate and have a separate administrative hearing (which the health professional may win), if he or she voluntarily relinquishes the DEA registration.

Immediately consult with an experienced health law attorney who has dealt with the DEA before.

Remember Your Rights; Yes, You Have Rights!

Yes, you do have rights, Constitutional rights. Use them! That is what they are there for.

You have the right to consult with counsel before making a decision. Don’t believe it if a DEA agents tells you that you don’t.

You have the right not to sign any forms or make any statements. Don’t sign anything. Don’t make any statements except for getting the agent’s card and telling them you will have your attorney contact them.

You have the right to take time to consider the matter and consult with others. You do not have to make a decision right away.

The Consequences of Voluntary Relinquishment are Serious and Long-Lasting.

Your voluntary relinquishment are serious and long lasting. It will be treated the same as a revocation of your DEA number. We have consulted with physicians and pharmacists who have never been able to get it back after they relinquished it.

You will probably be terminated from any health insurance panels you are on if this happens.

You will probably have action taken against your clinical privileges if you have clinical privileges at any hospital, nursing home or ambulatory surgical center (ASC).

You may be terminated from the Medicare or Medicaid Program.

There are many other consequences that may result.

Therefore, you and your attorney should be aware that this may happen and you and your attorney should be prepared if it does happen.

For more tips on how to prepare, click here to read my prior blog.

Don’t Wait Too Late; Consult with an Experienced Health Law Attorney Early.

Do not wait until action has been taken against you to consult with an experienced attorney in these matters. Few cases are won on appeal. It is much easier to win your case when there is proper time to prepare and you have requested a formal hearing so that you may actually dispute the facts being alleged against you.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing pharmacists, pharmacies and pharmacy technicians in investigations and at Board of Pharmacy hearings. Call now or visit our website 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.

Keywords: Administrative hearing attorney, representation for administrative hearings, administrative complaint defense attorney, Board of Pharmacy representation, Board of Pharmacy attorney, Board of Pharmacy defense attorney, representation for Board of Pharmacy investigations, representation for Board of Pharmacy complaints, DEA hearing defense attoreny, DEA investigation attorney, DEA hearing representation, DEA investigation representation, pharmacist attorney, health care professional defense attorney, representation for health care professionals, professional licensure defense attorney, professional licensure representation, licensure defense attorney, representation for licensure issues, representation for pharmacists, representation for pharmacies, pharmacy attorney, review of The Health Law Firm, The Health Law Firm attorney reviews

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2018 The Health Law Firm. All rights reserved.

By The Health Law Firm|2018-02-07T02:39:35-05:00May 15, 2018|Categories: Pharmacy Law Blog|Tags: administrative complaint defense attorney, administrative hearing attorney, board of pharmacy attorney, Board of Pharmacy defense attorney, Board of Pharmacy representation, DEA hearing defense attoreny, DEA hearing representation, DEA investigation attorney, DEA investigation representation, health care professional defense attorney, licensure defense attorney, pharmacist attorney, pharmacy attorney, professional licensure defense attorney, professional licensure representation, representation for administrative hearings, representation for Board of Pharmacy complaints, representation for Board of Pharmacy investigations, representation for health care professionals, representation for licensure issues, representation for pharmacies, representation for pharmacists, review of The Health Law Firm, The Health Law Firm attorney reviews|0 Comments

Pharmacies May be Liable for Filling Valid Prescriptions

By 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.

Negligence Will Determine the Success or Failure of the Meningitis Lawsuits Against Doctors and Clinics

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

The victims and survivors of the meningitis outbreak are now filing lawsuits against the physicians and clinics that administered the tainted steroids. According to an article in The Tennessean, on January 29, 2013, a husband who lost his wife to fungal meningitis filed the first lawsuit against a Nashville outpatient clinic. It’s believed hundreds of people were injected at the same clinic with the tainted steroids. The man is now seeking $12.5 million in damages.

Click here to read the entire article from The Tennessean.

This lawsuit is just one in what is expected to be a series of lawsuits, in not just Tennessee, but across the country.

Compounding Pharmacy Allegedly Behind the Meningitis Outbreak is Out of Business.

The meningitis outbreak was at a peak in the fall of 2012. Contaminated steroid injections were allegedly made at the New England Compounding Center (NECC) in Framingham, Massachusetts. NECC is accused of shipping thousands of vials of tainted drugs across the country. There are allegedly 45 deaths nationwide from the steroids. The company shut down in October 2012, and filed for bankruptcy in December, according to an article in American Medical News.

Tennessee Complaint Alleges Outpatient Clinic Put Money Before Patients.

The man suing the Nashville outpatient clinic believes, among other things, that officials at the clinic put the company’s bottom line before patient care. The lawsuit specifically alleges:

1. The outpatient clinic ignored important information when it chose NECC to purchase thousands of vials of steroids,
2. That clinic officials failed to properly notify the victim that she had been injected with a potentially contaminated steroid,
3. That clinic officials failed to recommend the victim should receive treatment,
4. The clinic chose to purchase drugs from NECC because it was a cheaper than the safer alternatives.

Click here to read the entire complaint.

The Responsibility of Doctors and Clinics.

Negligence is the most common claim used against doctors in cases of defective medication. The assumption is that the physician breached the standard of care because he or she knew or should have known that NECC was not meeting applicable standards in compounding the medications. Another legal theory is that the physician should have known that certain medications should not have been compounded, but rather obtained directly from a manufacturer. I believe the liability of physicians and clinics might be established to the extent that the physicians were aware that the steroids distributed by NECC violated regulations on compounding prescription medications.

It’s imperative physicians and clinics are sure of the credentials of all vendors and suppliers.

I was recently quoted in an American Medical News article about physicians and clinics that are entangled in tainted drugs lawsuits. To read the entire article, click here.

Florida Compounding Pharmacy No Stranger to Fungal Outbreaks.

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

Pharmacists Need to Obtain Good Professional Liability Insurance.

Many pharmacists, especially those who work for state agencies, large hospitals, pharmacy chains or other large institutions, scrimp on their purchase of professional liability insurance. Many mistakenly believe their employer will cover any legal defense expenses. This is not true and is often found out too late.

A pharmacist should always carry his/her own professional negligence insurance. It is inexpensive and can cover many types of legal actions other than just civil negligence cases. Always, always, always be sure your insurance includes at least $25,000 in professional license defense coverage. Get this in writing!

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?

What do you think about the lawsuits against these doctors and clinics? Who do you think should be help responsible: the compounding pharmacy that shipped the contaminated steroids, or the doctors and clinics that administered the steroid shots? Please leave any thoughtful comments below.

Sources:

Roche Jr., Walter. “Meningitis Outbreak: Victim’s Husband Sues Saint Thomas Clinic.” The Tennessean. (January 31, 2013). From: http://www.tennessean.com/apps/pbcs.dll/article?AID=2013301300211&nclick_check=1

Wayne A. Reed v. Saint Thomas Outpatient Neurosurgical Center. Case Number 13C-417. Complaint. (January 29, 2013). From: http://www.thehealthlawfirm.com/uploads/Reed%20v.%20St.%20Thomas%20Outpatient.pdf

Gallegos, Alicia. “Physicians Entangled in Tainted Drugs Lawsuits.” American Medical News. (February 11, 2013). From: http://www.thehealthlawfirm.com/uploads/AMN_PhysicianLawsuits.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.

Selling Tobacco Can Get You Penalized By Insurance Panels

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

Beware: selling cigarettes could burn a hole in your pocket.

The CVS Health Corporation (CVS), the nation’s second-largest drug store, is currently in the midst of launching a tobacco-free prescription-drug network. The company announced in October 2014, that it will begin offering a tobacco-free pharmacy plan to employers, unions, and insurance companies for which its Caremark arm manages prescription benefits. CVS is slapping patients with an extra co-payment “penalty” if they purchase their medications from pharmacies that sell tobacco products, regardless of whether the patient is a tobacco user.

According to US News, by adding a variable co-payment of up to $15, CVS hopes that this new strategy, comparable to a narrow network insurance design, will perpetuate the company’s health-and-wellness based initiatives.

The new network will start in 2015. Customers will receive a list of participating pharmacies before any network change will take place.

Click here to read more from US News.

The Tobacco-Free Retail Trend.

Target and CVS have become the poster children for tobacco-free retailers. In 1996, Target spearheaded the fight against tobacco by eliminating all sales of the toxic substance. In September 2014, the CVS Corporation followed suit and completed its tobacco-free overhaul by removing all tobacco products from store shelves across the nation.

The tobacco-free pharmacy networks would include CVS and Target nationally, as well as local or regional pharmacies such as independent pharmacies that abstain from tobacco sales. Walgreens and Walmart pharmacies, two large-scale rival drug chains that sell tobacco, as well as any other grocery or community pharmacy, should expect patient penalties and negative impacts on prescription-drug revenue.

Those Participating in the Tobacco-Free Network.

According to Yahoo! Finance, CVS representatives said the network was created in a response to pharmacy benefit management (PBM) clients that indicated interest in tobacco-free pharmacies. The tobacco-free network will only be used by the PBM customers that voluntarily participate.

The first employer to sign on is the city of Philadelphia, as it promotes a tobacco-free workforce. Philadelphia officials estimate that between 150 and 200 CVS pharmacies will participate in the Philadelphia network.

To read more on this topic from Yahoo! Finance, click here.

Sincere Motives or a Monopoly in the Making?

There are a myriad of arguments regarding CVS’ genuine motive behind the tobacco-free network. Health benefit analysts argue that the network is a disguised anti-competition scheme. With the announcement of the new network plan, CVS opens itself up to criticism for appearing to steer patients to CVS pharmacies, or strong arm the competition into giving up lucrative tobacco revenue. Although the corporation denies these claims of ulterior motives, Dave Balto, a former policy director at the U.S. Federal Trade Commission argued that “…It’s really another effort to limit the ability of their rivals to effectively compete.”

Independent pharmacies are also questioning the industry benefits of such a plan. Small, local pharmacies that have not carried tobacco products for years may be overlooked by the consumers knowingly aware of CVS as a tobacco-free drug store. These mom-and-pop pharmacies will be forced to spend a pretty penny on increased marketing to stand on their own two feet against these mass retail chains.

The Narrow Network Comparison.

Many critics argue that the new CVS plan could be considered a narrow network strategy. A narrow network applies to any health insurance plan that places constraints on doctors and hospitals that are available to their beneficiaries. Typically plans will not cover medical services received out-of-network or they will increase co-payments.

These designs are becoming more common for insurance companies and pharmacy benefit managers. By limiting the choices, insurers say they can better focus on the quality of medical care that is delivered to plan customers.

Comments?

What is your opinion of the new CVS tobacco-free network plan? Do you think it will be beneficial for overall community health or more detrimental to the livelihood of small pharmacies? 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 or (850) 439-1001 and visit our website at http://www.TheHealthLawFirm.com.

Sources:

Silverman, Ed and Ziobro, Paul. “CVS Plays Hardball with Rival Drug Chains.” (October 20, 2014). From: http://finance.yahoo.com/news/cvs-plays-hardball-rival-drug-231400764.html

Murphy, Tom. “CVS Health Stretches Anti-tobacco Push to New Prescription Drug Network.” (October 21, 2014). From: http://www.usnews.com/news/business/articles/2014/10/21/cvs-develops-tobacco-free-prescription-network

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.