Requirements for Prescribing and Dispensing Opioids SB 226 | P J Klosinski

By: P J Klosinski

What does a statement acknowledging that all people are “endowed by their CREATOR with certain inalienable rights; that among these are life, liberty, and the pursuit of happiness” describe? We have heard these words quoted many times even more so now than ever before yet few of us realize the magnitude to which these words essentially impact our very existence. Life has many phases, one of the most controlling is pain. An individual besieged by pain has a greatly compromised style of Life. The inalienable right to life is a fight for survival on a daily basis. The means to survive must also be the sole possession of the individual and as healthcare choice is paramount it cannot be commandeered by government.

Why can Indiana determine limits on opioid amounts and duration of use?

The Indiana General Assembly has an established system for managing the private healthcare business of the individual. Drugs and health care providers must be approved to be considered legal. Now Indiana has decided that in response to what is termed as an opioid addiction epidemic that patients will come under further control by law for their prescriptions. The doctor-patient relationship considered confidential is being revised. Under the excuse of protecting an individual from the individual Indiana has determined it must further control opioids by inserting “laws” between you and your doctor.

Why does the prevention of opioid addiction require more government? Step one.

Is Indiana intending to prevent opioid addiction by using two well-practiced government methods using two government entities? The General Assembly is proposing to add a new chapter to the law regulating the prescribing and dispensing of opioids.

SB 226 limits an adult who is being prescribed an opioid for the first time mandating an “initial prescription may not exceed a seven (7) day supply” also “If the prescription is for a child who is less than eighteen (18) years of age, the prescription may not exceed a seven (7) day supply.”

Ok so far so good simple law. If you can’t be prescribed more than a 7 day supply you will not become addicted. Is it really that simple? Of course not this is government now enter the exceptions to the limits “for the treatment of specified conditions or circumstances”. The limitations do not apply “under any of the following circumstances: for the treatment or provision of any of the following:” Cancer. Palliative care. Medication-assisted treatment for a substance use disorder”.

When is a rule a law? Step two enter control by an agency.

Now Indiana uses the second method of control rules that are adopted by agencies. This bill provides that “A condition that is adopted by rule by the medical licensing board under IC 25-22.5-13-8 to be necessary to be exempted”. The result, we have an agency determining a rule which has the force and effect of law to be adopted by permission from lawmakers contained in this bill without House or Senate debate or approval. Does it appear this bill leaves significant considerations for exempted conditions by an agency?

Step three back to the General Assembly for exceptions and required documentation.

SB 226 first mandates limits, then provide lawmaker defined exemptions then relinquishes control to an agency to determine more exemptions. Now lawmakers address your physician, “ If, in the professional judgment of a prescribed, a patient requires more than the prescription limitations” and the prescriber determines that no other drug is appropriate the stated exemptions can be used with the requirement that “the prescriber shall document in the patient’s medical record the indication that a drug other than an opiate was not appropriate and that the patient is receiving palliative care or that the prescriber is using the prescriber’s professional judgment for the exemption”. Why should your doctor need to follow limitations in determining your treatment then be told under certain determinations limitations can be exempted?

Step four. Why not grant the patient some power under the law?

Lawmakers have determined to legalize “A prescriber shall, upon the request of the: patient; personal or legal representative of the patient; or guardian of the patient; issue the opioid prescription for a lesser amount than the prescribed initially intended to prescribe, issue the opioid prescription for the lesser amount, and indicate the request and who made the request in the patient’s medical file”. Why would lawmakers believe that a patient must rely on the “law” to tell their physician that they only desire a smaller prescription? Do lawmakers believe that a physician would refuse such a request without being held liable under the law? And of course, the physician must record this request in a confidential file for the legitimate reason of?

SB 226 next addresses the role of the pharmacist including documentation of the partial fill request that the request was made by the person or legal representative or guardian. “ For a partial fill of an opioid prescription, a pharmacist shall dispense, upon request of the: patient; a personal or legal representative of the patient; or guardian of the patient; the lesser amount requested. “ And “ the pharmacist shall do the following: Comply with the partial refill requirements set forth in 21 U.S.C. 829.” The “law” now provides the patient or legal representative or guardian the power to tell the pharmacist to only partially fill the prescription. We need a law to say I only want so much medication?

Who has the authority to adopt rules?

“The medical licensing board of Indiana shall, in consultation with the state department of health, the office of the secretary of family and social services, and representatives of prescriber stakeholders, adopt: emergency rules under IC 4-22-2-37.1 before December 1, 2017; and rules under IC 4-22-2; setting forth the conditions the board considers necessary under IC 25-1-9.7-2(b)(1)(D) to be exempted from the prescribing limitations.” The medical licensing board consists of seven (7) members appointed by the governor with the condition that no more than (4) can be members of the same political party. The state department of health executive board consists of eleven (11) members appointed by the governor. “The Family and Social Services Administration (FSSA) Secretary is appointed by the Governor and is a member of the Governor’s cabinet. Representatives of prescriber stakeholders is a group for which I cannot provide any verification.

What all of the listed members of this consultation have in common is that none are elected legislators acting within the duties of Article 4. yet they have been charged by the General Assembly with the ability to consult and determine rules which are not required to be submitted and subject to input, debate, and resolution by either the people or the elected Representatives and Senators of Indiana or requiring the signature of the Governor to be placed in effect.

What does this bill accomplish?

SB 226 seeks to limit to first time and under 18 year old patients to receiving no more than a 7 day supply of medication determined by their physician to be necessary that is unless they fall under the exemptions listed in the bill or under the specific rules yet to be determined by the assigned medical licensing board or further rules adopted after consultation by members listed in the bill.

What is the “or else” control or punishment provided for violations under this bill? Are they yet to be determined; are there no consequences for not following a law? Who will determine the consequences, unelected agency members or Representatives and Senators elected to be the voice of the people when determining the laws under which government can require the people to live? Is this proposed law written in words and phrases which can be taken in their plain, ordinary usual sense? Can the average individual understand how this law will impact them in a given medical situation?

Where is the authority to determine the who, what and why of law?

Rights can only be possessed if individuals exercise them, once given compromise rights become a privilege to be determined by those who have been given the power to administer the rule of law we all are expected to live under.

The Hierarchy of Law controlling Indiana is the U.S and Indiana Constitutions and all statutes of the general assembly of the state in force, and not inconsistent with such constitutions. This law governing the state applies to all under the jurisdiction of the state including elected officials. The solemn Oath in the Indiana Constitution Article 15 Section 4 which elected officials are required to take binds them as our representatives to abide by the same rule of law governing all. If elected officials are charged by law with specific duties why should the people expect there can be exceptions for any reason?

“The Legislative authority of the State shall be vested in a General Assembly, which shall consist of a Senate and a House of Representatives. The style of every law shall be: “Be it enacted by the General Assembly of the State of Indiana”; and no law shall be enacted, except by bill.” Indiana Constitution Article 4.

Is there any specified authority in the Indiana Constitution providing for the passage of this law? Is there specified authority allowing the General Assembly to abdicate authority to pass rules to non-elected individuals appointed to administrative agencies? Does forming agencies to provide the administration of laws also grant the power to adopt rules with the force and effect of laws? Is there specified authority to be able to control what and the amount of any substance you can take to relieve your debilitating medical condition? Does this law provide for the punishment of an offense committed against an individual causing harm? What are the qualifications for the authority for this law?

In determining our way of life and how to control our demons each individual has their own distinct path. When government believes it can control the path of an individual because of the choices of another what authority exists or has been granted to do so? Life is an individual possession and the decisions for the care of that life are also individual decisions with individual responsibilities and consequences.




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