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Pharmacy representation grows as practice niche

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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.”•
 

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  1. I have been on this program while on parole from 2011-2013. No person should be forced mentally to share private details of their personal life with total strangers. Also giving permission for a mental therapist to report to your parole agent that your not participating in group therapy because you don't have the financial mean to be in the group therapy. I was personally singled out and sent back three times for not having money and also sent back within the six month when you aren't to be sent according to state law. I will work to het this INSOMM's removed from this state. I also had twelve or thirteen parole agents with a fifteen month period. Thanks for your time.

  2. Our nation produces very few jurists of the caliber of Justice DOUGLAS and his peers these days. Here is that great civil libertarian, who recognized government as both a blessing and, when corrupted by ideological interests, a curse: "Once the investigator has only the conscience of government as a guide, the conscience can become ‘ravenous,’ as Cromwell, bent on destroying Thomas More, said in Bolt, A Man For All Seasons (1960), p. 120. The First Amendment mirrors many episodes where men, harried and harassed by government, sought refuge in their conscience, as these lines of Thomas More show: ‘MORE: And when we stand before God, and you are sent to Paradise for doing according to your conscience, *575 and I am damned for not doing according to mine, will you come with me, for fellowship? ‘CRANMER: So those of us whose names are there are damned, Sir Thomas? ‘MORE: I don't know, Your Grace. I have no window to look into another man's conscience. I condemn no one. ‘CRANMER: Then the matter is capable of question? ‘MORE: Certainly. ‘CRANMER: But that you owe obedience to your King is not capable of question. So weigh a doubt against a certainty—and sign. ‘MORE: Some men think the Earth is round, others think it flat; it is a matter capable of question. But if it is flat, will the King's command make it round? And if it is round, will the King's command flatten it? No, I will not sign.’ Id., pp. 132—133. DOUGLAS THEN WROTE: Where government is the Big Brother,11 privacy gives way to surveillance. **909 But our commitment is otherwise. *576 By the First Amendment we have staked our security on freedom to promote a multiplicity of ideas, to associate at will with kindred spirits, and to defy governmental intrusion into these precincts" Gibson v. Florida Legislative Investigation Comm., 372 U.S. 539, 574-76, 83 S. Ct. 889, 908-09, 9 L. Ed. 2d 929 (1963) Mr. Justice DOUGLAS, concurring. I write: Happy Memorial Day to all -- God please bless our fallen who lived and died to preserve constitutional governance in our wonderful series of Republics. And God open the eyes of those government officials who denounce the constitutions of these Republics by arbitrary actions arising out capricious motives.

  3. From back in the day before secularism got a stranglehold on Hoosier jurists comes this great excerpt via Indiana federal court judge Allan Sharp, dedicated to those many Indiana government attorneys (with whom I have dealt) who count the law as a mere tool, an optional tool that is not to be used when political correctness compels a more acceptable result than merely following the path that the law directs: ALLEN SHARP, District Judge. I. In a scene following a visit by Henry VIII to the home of Sir Thomas More, playwriter Robert Bolt puts the following words into the mouths of his characters: Margaret: Father, that man's bad. MORE: There is no law against that. ROPER: There is! God's law! MORE: Then God can arrest him. ROPER: Sophistication upon sophistication! MORE: No, sheer simplicity. The law, Roper, the law. I know what's legal not what's right. And I'll stick to what's legal. ROPER: Then you set man's law above God's! MORE: No, far below; but let me draw your attention to a fact I'm not God. The currents and eddies of right and wrong, which you find such plain sailing, I can't navigate. I'm no voyager. But in the thickets of law, oh, there I'm a forester. I doubt if there's a man alive who could follow me there, thank God... ALICE: (Exasperated, pointing after Rich) While you talk, he's gone! MORE: And go he should, if he was the Devil himself, until he broke the law! ROPER: So now you'd give the Devil benefit of law! MORE: Yes. What would you do? Cut a great road through the law to get after the Devil? ROPER: I'd cut down every law in England to do that! MORE: (Roused and excited) Oh? (Advances on Roper) And when the last law was down, and the Devil turned round on you where would you hide, Roper, the laws being flat? (He leaves *1257 him) This country's planted thick with laws from coast to coast man's laws, not God's and if you cut them down and you're just the man to do it d'you really think you would stand upright in the winds that would blow then? (Quietly) Yes, I'd give the Devil benefit of law, for my own safety's sake. ROPER: I have long suspected this; this is the golden calf; the law's your god. MORE: (Wearily) Oh, Roper, you're a fool, God's my god... (Rather bitterly) But I find him rather too (Very bitterly) subtle... I don't know where he is nor what he wants. ROPER: My God wants service, to the end and unremitting; nothing else! MORE: (Dryly) Are you sure that's God! He sounds like Moloch. But indeed it may be God And whoever hunts for me, Roper, God or Devil, will find me hiding in the thickets of the law! And I'll hide my daughter with me! Not hoist her up the mainmast of your seagoing principles! They put about too nimbly! (Exit More. They all look after him). Pgs. 65-67, A MAN FOR ALL SEASONS A Play in Two Acts, Robert Bolt, Random House, New York, 1960. Linley E. Pearson, Atty. Gen. of Indiana, Indianapolis, for defendants. Childs v. Duckworth, 509 F. Supp. 1254, 1256 (N.D. Ind. 1981) aff'd, 705 F.2d 915 (7th Cir. 1983)

  4. "Meanwhile small- and mid-size firms are getting squeezed and likely will not survive unless they become a boutique firm." I've been a business attorney in small, and now mid-size firm for over 30 years, and for over 30 years legal consultants have been preaching this exact same mantra of impending doom for small and mid-sized firms -- verbatim. This claim apparently helps them gin up merger opportunities from smaller firms who become convinced that they need to become larger overnight. The claim that large corporations are interested in cost-saving and efficiency has likewise been preached for decades, and is likewise bunk. If large corporations had any real interest in saving money they wouldn't use large law firms whose rates are substantially higher than those of high-quality mid-sized firms.

  5. The family is the foundation of all human government. That is the Grand Design. Modern governments throw off this Design and make bureaucratic war against the family, as does Hollywood and cultural elitists such as third wave feminists. Since WWII we have been on a ship of fools that way, with both the elite and government and their social engineering hacks relentlessly attacking the very foundation of social order. And their success? See it in the streets of Fergusson, on the food stamp doles (mostly broken families)and in the above article. Reject the Grand Design for true social function, enter the Glorious State to manage social dysfunction. Our Brave New World will be a prison camp, and we will welcome it as the only way to manage given the anarchy without it.

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