ILNews

Pharmacy representation grows as practice niche

Back to TopCommentsE-mailPrintBookmark and Share

A central Indiana institutional pharmacy recently had a dilemma. At the height of flu season, it had a surplus of vaccine while other providers in the region were running out.

The pharmacy wanted to do the right thing but didn’t know where to start because of the multiple federal regulations and inventory control issues that would arise.

“It turned out fine,” said Jennifer F. Skeels, an attorney at Hall Render Killian Heath & Lyman P.C., who got the call and helped facilitate the transfer of vaccine. “The pharmacy board was very, very receptive to the call.”

hallrender-15col.jpg Hall Render Killian Heath & Lyman P.C. recently instituted a pharmacy practice section that represents clients including retail and institutional pharmacies. Attorney Jennifer F. Skeels, left, practices in the section led by Hall Render shareholder Susan Bizzell, right.(IL photo/Eric Learned)

The board is frequently receptive, she said, because the firm has developed collaborative relationships among its practitioners who are familiar with pharmacy law and the regulatory framework. Pharmacy service providers frequently call, Skeels explained, and tell attorneys, “We need an answer within an hour or two.”

A group of about 10 attorneys, including Skeels, work in Hall Render’s new pharmacy practice section. The Indianapolis-based health law firm announced the creation of the group in January, and the firm believes it is the first in Indiana with a designated section devoted to pharmacy law.

“I would say it was very organic because we have worked on pharmacy issues for years,” said Hall Render shareholder Susan Bizzell, who leads the practice group. The firm’s client list includes retail and mail-order pharmacies, hospitals and long-term care facilities.

Bizzell said Hall Render plans to bring aboard an attorney with pharmacy credentials, but the practice group has several attorneys with a variety of medical and clinical backgrounds who know the regulatory and administrative terrain.

“There’s definitely an increasing enforcement environment in health care,” Bizzell said. “Pharmacies are feeling it as much as other providers.”

Hall Render helps pharmacies and providers navigate the U.S. Food and Drug Administration, Drug Enforcement Agency and

other federal and state regulations under which they operate, Bizzell said. She advises practitioners that regulators in the current environment are “basically looking for problems.”

“Our goal is to work proactively with clients and make sure good compliance programs are in place,” she said.

 

Larry Sage, executive vice president of the Indiana Pharmacists Alliance, said his members also need the assistance of attorneys who can help in transactional matters. “Most of the time it turns out to be a general business sort of thing – people buying or selling a pharmacy,” he said.

The IPA has used Hall Render in the past, and Sage said its development of a pharmacy practice area is a sign of the times. “There’s business out there, and it’s a very complex, regulated profession and something that’s not going to get any simpler.”

Professor G. Thomas Wilson has taught pharmacy law for most of the past 35 years at the Purdue University College of Pharmacy. For 25 years or so, he’s compiled study guides for pharmacy students for the federal pharmacy law exam that each must pass.

While pharmacists must have knowledge of state and federal law, Wilson said they can’t be expected to keep on top of the myriad regulations that are anything but static. It is no surprise, he said, that firms are developing specialized practices.

“Pharmacists have been sort of invisible in the past in terms of litigation and the like, and we are seeing an increase in that, and it is a specialized business,” Wilson said.

Along with the North American Pharmacist Licensure Exam, nearly all state pharmacy boards require prospective pharmacists to pass the Multistate Pharmacy Jurisprudence Exam that tests a candidate’s knowledge of pharmacy law, according to Butler University pharmacy law professor Erin Albert.

“Pharmacy, overall, is one of the most highly regulated industries out there,” Albert said. Along with federal laws governing the control and dispensation of prescription medication, “there are a lot of bodies of law relative to the state of Indiana for pharmacy practice.”

People who practice pharmacy law also must have a good basis in administrative law to represent clients before the Indiana Board of Pharmacy. “We’re starting to see a lot of trends of pharmacists being disciplined,” Albert said. Pharmacy attorneys said substance abuse and diversion of medication are frequent factors in licensure and discipline cases.

As an active attorney and pharmacy professor, Wilson frequently fields inquiries from pharmacists who are stumped about what they can and cannot do professionally. “I don’t mind answering a few federal law questions,” the Purdue professor said, “but I never pretend to hold myself out as an expert.”

He offered an example that illuminates how complex pharmacy regulation can be.

“Someone asked me by email if they could mail narcotics containing a controlled substance,” Wilson said. “I didn’t know the answer.

“As it turns out, it’s something that was never in pharmacy law,” he continued, “it existed only in the Domestic Mail Manual.” The answer: Such prescriptions may be mailed, but laws through the 1970s didn’t allow it.

Wilson quipped that his services for such advice, without retainer, “should be billed out at anywhere from $300 to $500.”

winders-kate-mug Winders

Kate Winders practices pharmacy law as a partner at the Indianapolis law firm Plews Shadley Racher & Braun LLP, where she is part of the firm’s health care and life sciences group. She began that experience representing pharmacists with professional licensing issues before the pharmacy board, but the practice has evolved to include challenges such as helping pharmacies introduce cutting-edge automated systems for dispensing medication and maintaining electronic health records.

Winders said she’s had the opportunity to make presentations of such systems before the pharmacy board.

“Indiana is well-situated to adapt to innovations that improve pharmaceutical care,” she said of the state’s pharmacy regulation. Compared with other states’ pharmacy boards that lack rule-making authority, “Indiana is a much more favorable environment,” she said, because the pharmacy board is made up of mostly pharmacists who are committed to advances in the profession. “There have been some exciting innovations here.”

Among the innovations are dispensing systems and software programs for nursing and long-term care facilities. “Instead of a common 30-day supply, we send a much shorter supply of seven days or less,” said Rick Rondinelli, president of In Touch Pharmaceuticals Inc. in Valparaiso.

“So, one, we have a shorter supply, and two, we have an order of date and time of administration” that helps nurses more efficiently deliver medication, Rondinelli said.

Winders represents In Touch, which provides medication and pharmacy supplies to facilities in Indiana and Michigan.

Along with paving the way for approval of new ways of dispensing and managing prescriptions, Rondinelli said Winders’ representation was crucial in getting the pharmacy board to interpret a regulation aimed at retail pharmacies that was being applied inappropriately to institutional pharmacies. “We had a very favorable outcome,” he said. “It was again through Kate’s ability and knowing the right people on the board that got our situation to the point where we could plead our case.”•
 

ADVERTISEMENT

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in Indiana Lawyer editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
ADVERTISEMENT
Subscribe to Indiana Lawyer
  1. Falk said “At this point, at this minute, we’ll savor this particular victory.” “It certainly is a historic week on this front,” Cockrum said. “What a delight ... “Happy Independence Day to the women of the state of Indiana,” WOW. So we broke with England for the right to "off" our preborn progeny at will, and allow the processing plant doing the dirty deeds (dirt cheap) to profit on the marketing of those "products of conception." I was completely maleducated on our nation's founding, it would seem. (But I know the ACLU is hard at work to remedy that, too.)

  2. congratulations on such balanced journalism; I also love how fetus disposal affects women's health protection, as covered by Roe...

  3. It truly sickens me every time a case is compared to mine. The Indiana Supreme Court upheld my convictions based on a finding of “hidden threats.” The term “hidden threat” never appeared until the opinion in Brewington so I had no way of knowing I was on trial for making hidden threats because Dearborn County Prosecutor F Aaron Negangard argued the First Amendment didn't protect lies. Negangard convened a grand jury to investigate me for making “over the top” and “unsubstantiated” statements about court officials, not hidden threats of violence. My indictments and convictions were so vague, the Indiana Court of Appeals made no mention of hidden threats when they upheld my convictions. Despite my public defender’s closing arguments stating he was unsure of exactly what conduct the prosecution deemed to be unlawful, Rush found that my lawyer’s trial strategy waived my right to the fundamental error of being tried for criminal defamation because my lawyer employed a strategy that attempted to take advantage of Negangard's unconstitutional criminal defamation prosecution against me. Rush’s opinion stated the prosecution argued two grounds for conviction one constitutional and one not, however the constitutional true threat “argument” consistently of only a blanket reading of subsection 1 of the intimidation statute during closing arguments, making it impossible to build any kind of defense. Of course intent was impossible for my attorney to argue because my attorney, Rush County Chief Public Defender Bryan Barrett refused to meet with me prior to trial. The record is littered with examples of where I made my concerns known to the trial judge that I didn’t know the charges against me, I did not have access to evidence, all while my public defender refused to meet with me. Special Judge Brian Hill, from Rush Superior Court, refused to address the issue with my public defender and marched me to trial without access to evidence or an understanding of the indictments against me. Just recently the Indiana Public Access Counselor found that four over four years Judge Hill has erroneously denied access to the grand jury audio from my case, the most likely reason being the transcription of the grand jury proceedings omitted portions of the official audio record. The bottom line is any intimidation case involves an action or statement that is debatably a threat of physical violence. There were no such statements in my case. The Indiana Supreme Court took partial statements I made over a period of 41 months and literally connected them with dots… to give the appearance that the statements were made within the same timeframe and then claimed a person similarly situated would find the statements intimidating while intentionally leaving out surrounding contextual factors. Even holding the similarly situated test was to be used in my case, the prosecution argued that the only intent of my public writings was to subject the “victims” to ridicule and hatred so a similarly situated jury instruction wouldn't even have applied in my case. Chief Justice Rush wrote the opinion while Rush continued to sit on a committee with one of the alleged victims in my trial and one of the judges in my divorce, just as she'd done for the previous 7+ years. All of this information, including the recent PAC opinion against the Dearborn Superior Court II can be found on my blog www.danbrewington.blogspot.com.

  4. On a related note, I offered the ICLU my cases against the BLE repeatedly, and sought their amici aid repeatedly as well. Crickets. Usually not even a response. I am guessing they do not do allegations of anti-Christian bias? No matter how glaring? I have posted on other links the amicus brief that did get filed (search this ezine, e.g., Kansas attorney), read the Thomas More Society brief to note what the ACLU ran from like vampires from garlic. An Examiner pledged to advance diversity and inclusion came right out on the record and demanded that I choose Man's law or God's law. I wonder, had I been asked to swear off Allah ... what result then, ICLU? Had I been found of bad character and fitness for advocating sexual deviance, what result then ICLU? Had I been lifetime banned for posting left of center statements denigrating the US Constitution, what result ICLU? Hey, we all know don't we? Rather Biased.

  5. It was mentioned in the article that there have been numerous CLE events to train attorneys on e-filing. I would like someone to provide a list of those events, because I have not seen any such events in east central Indiana, and since Hamilton County is one of the counties where e-filing is mandatory, one would expect some instruction in this area. Come on, people, give some instruction, not just applause!

ADVERTISEMENT