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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. Am I the only one who sees that the City is essentially giving away the MSA site AND giving millions to build new buildings on the site when this site would be the perfect place for the Justice Complex? Across from City-County, check; keeping it centrally located, check, etc. It's my understanding that the GM site must be purchased by the City from Motors Liquidation Company. STOP WASTING WHAT WE ALREADY HAVE AND OUR TAX DOLLARS! The Ballard Administration has not been known for it's common sense...never voted for him and never will!

  2. This guy sounds like the classic molester/manipulator.

  3. Louis D. Brandeis was born in 1856. At 9 years of age it would have been 1865. The Brandeis family did not own slaves. My source Louis D. Brandeis: A Life, by Melvin L. Urofsky.

  4. My name is Matthew Lucas Major, I recently went through a jury trial in Bloomington , In. It was the week of Feb 19-21. Although I have been incarcerated since August 5, 2014. The reason I 'am writing to you sir is on the 21 of February the jury came in with a very excessive and wrongful verdict of guilty on 6 child molesting charges against my daughter who was 9 at the time I was accused. I also had 2 other Felonies one of Intimidation and 1 of Sexual Vicarious Gratification. Judge Marc Kellam on the second day of trial gave me a not guilty on those 2 felonies. The jury was sent out during that time and when brought back Judge Kellam told them to not concern themselves with the 2 Felonies that he ruled on them. They were told to not let evidence they had already heard influence there verdicts. I never in my life touched any child sexually and definitely not with my own daughter. When I was arrested Detective Shawn Karr told me I would be convicted guilty just on my daughters word even without evidence. That's just what happened. my public defender did me so wrong he never once proved to the court and jury all the lies the child told, and Jeremy Noel my public defender could of proven the lies easily. The stories in Serenity's depositions and Forensic interview changed and were not consistent as Prosecutor Darcie Fawcett claimed they were. Yet my attorney never mentioned that. The facts that the child accused me of full penetration in her vagina and rectum was proven lies. Doctor Roberta Hibbard of Riley hospital in Indianapolis confirmed Serenity's hymen intact, no scars, no tearing, no signs of rape to her. Yet my attorney didn't use that knowledge . the DNA was all in my favor. I tell you I will spend my entire life in prison going through rape and beatings etc. even Judge Kellam abused his authority by telling the jurors to listen and believe what the prosecutors side in evidence like my daughters testimony. In one interview with the detectives my daughter got flustered with her mom and said on camera " I'm saying what you told me to mom"!! Yet Mr. Noel said nor did anything to even resemble a defense attorney. Judge Kellam allowed edited version of a taped conversation between the child and her mother. Also Judge Kellam allowed the Prosecutor too bring in to my case a knife found under my seat, the knife wasn't part of my case. She was allowed by my attorney and the judge to put a huge picture of it on the screen and huge picture of my naked privates in a full courtroom and open court. Ms. Fawcett says to jury see how easy Mr. Major could reach the knife and cut his Childs throat. Even though I had no weapons charge against these cases. This gave the jurors prejudice thought against me thinking I threatened her with that knife and how scared she would of been knowing i could get it and kill her. On my sentencing court March 19, 2014 my public defender told Judge Kellam he wish to resign from being my attorney and wished for the court to give me outside council to file a error to trial or appeal. We were denied. Now after openly knowing my public defender don't want to represent me he has to. Well when as parents we make our kids clean a room when they really don't wish to, well the child will but don't mean she will do a good job, that's where I'm at with Mr. Noel. please dont ignore mine and my families pleas for your help . we have all the legal proof you could need to prove Im innocent. Please dont make my spend years in prison innocent when you can fix this wrong. Im not saying Im a perfect man or that I was a perfect dad to my 2 children none of us are. Ive made some bad choices in life and I paid for them. But I didnt ever touch or rape my daughter . I love my children with all my heart. And now through needing attention and a ex-wife who told my granny several times she wish she could put me in prison to get me out of their lives. Well my ex finally accomplished her goal. Sad part is she is destroying our daughter with all this horrific lies and things she taught my daughter to say. My daughter will need therapist to ever hope for a chance of a normal life after what she had done to her by her mom and their side of the family. My daughter told everyone even on stand she had a dream months before i supposedly molested her in this dream I was molesting her and when I finally did it matched her dream perfectly. She admitted to watching movies about little girls being molested and watching U-Tube videos about child molesting all before it happened supposedly to her. Doesn't that sound very unusual that a non molested 9 yr old would need to know so much about being molested? The only reason I could think a 9 year old would need so much information is to be prepared to know what to say and be able to say how it felt what took place etc.. So when questioned by authorities she would be prepared. And there again sir if a parent is pre grooming a 9 year old child she would need intimate details . Like telling her daughter about a couple moles on my private area. The child admitted to sneaking my cell and looking many many times at nudes of me and my girlfriend even one where my penis was entering my girlfriends vagina. In that picture my moles are obvious. Yet when prosecutor showed everyone in court my privates and pictures of the moles she said the only way the child would know about them is if she saw them for herself. My attorney once again said nothing about the pictures my child saw. Or could a ex-wife be able to describe my moles to help her case against getting rid of me? I beg you help me. This is my very existence. Ive lost everything , a good job, a wonderful girlfriend, my freedom, but worse thing Ive lost is my children. They were my reason to get up every morning and strive to be better. The wonderful bond I had with my Serenity is gone. After this I would be afraid to even hug her for fear of what next can they do to me. I'm not afraid to tell you I sit here in this cell and try to hold back my tears. Everyone knows you cant show weakness in prison. My life has already been threatened here at Wabash Valley Prison. After only 3 days of arrival. I was tricked into signing a waiver now Im in G Block General Population with 6 child molesting felony charges. Mrs. Hart as a 18 year old I almost died hooked to machines in hospital almost 1 month and now I know that fear was childish compared to this . I cant help but put emotions in this, after all Mrs. Hart Im human and God help Me I never been more afraid in my life. I didnt hurt my little girl I didnt touch her sexually. As much as it shreds me and fills my mind what Im facing I worry more about my mom and granny because of their great love for me mam they are suffering so deeply. I aint done this things but my loved ones suffering right along beside me and If you take my case you will be in essence freeing them also. I sent momma this letter and asked her to email it to you. I'm scared I have been done so unjustly by our legal system and I need you to fix this and give me freedom. I ask you please don't just ignore my pleas. Here in America its nice to be able to trust our legal justice system, well they destroyed my and my loved ones trust in our justice system . And I'm trusting in You !!! My entire family is suffering this nightmare with me. My 77 year old granny had a stroke and isn't doing so well. My single mother that raised 3 kids alone is dying from Lupus and since my arrest has stayed so sick and weary. Our lives torn to peices by a government I was taught I could trust in. my momma has tried so many innocent project and wrongfully accused and cant get anywhere. please please help me. A quote from the late Nelson Mandela: To be free is not merely to cast off ones chains, But to live in a way that respects and enhances The Freedom Of Others. I have Faith in you and your clinic to cast my chains off and give me freedom I do deserve as a wrongfully accused Man, son, brother, father, friend. Matthew Major DOC# 246179 Cause # : 53c02-1308-FA-000779 God Bless you. Please contact me with your decision so I know you made a life changing decision for me , just please at least write me so I know you care enough about your citizens to respond to cries for your help. You can speak openly with my mother Charlotte Spain (828) 476-0406: 71 Lakeview Dr. Canton, NC 28716 Thank You Matthew Major I know yall get thousands of request and inmates claiming innocence, and each person who are innocent deserve to have organizations like yours willing to fight for them and I give yall so much Thanks and I thank God everyday yall are out there caring enough to help free the innocents. Since discovering firsthand how easily lives and families can be destroyed by Poor Defense attorneys not doing their job . And Prosecutors allowed to do as they please in court

  5. Frankly, it is tragic that you are even considering going to an expensive, unaccredited "law school." It is extremely difficult to get a job with a degree from a real school. If you are going to make the investment of time, money, and tears into law school, it should not be to a place that won't actually enable you to practice law when you graduate.

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