Pharmacy board redux

The struggles with the State of Ohio Board of Pharmacy continue. The pharmacy board reopened its comment period for 2 weeks and received many comments from multiple physicians, organizations, and patients who would be adversely affected by the Board’s move to hold physicians’ offices to the same standard as compounding pharmacies. This was the topic of my recent column, in which I pointed out that as a result, “any practitioners who reconstitute any drug in their offices is considered to be a compounding pharmacy, ordered to pay compounding pharmacy registration fees ($112 yearly), and to undergo the same inspections as compounding pharmacies”.

At their last meeting, the pharmacy board members made a few minor changes, but practitioners will still have to throw out their neurotoxins after 1-6 hours (the exact time is still under debate). Incidentally, I have spoken to all three neurotoxin manufacturers, and they have no interest in adding preservative to their products or in bringing out smaller unit dose packaging. These regulations will have broad impact across the house of medicine because many specialties use neurotoxin.

You should know the back story behind all of this, and how the house of medicine came to this sad place.

About 20 years ago, pain control became a cause célèbre in medicine championed by no less than the World Health Organization. Numerous publications, thought leaders, and policy wonks decried the inadequacy of pain control both in and out of the hospital. It was explained loud and long that patients should have their pain controlled and that physicians fell short if they did not do so, never mind that there is no quantifiable way to measure pain. Further, it was explained that patients in severe pain did not become addicted to narcotics. And the Joint Commission heralded pain control as “the fifth vital sign.”

Where are these thought leaders now?

Graded on responsiveness to patients’ pain and the results of patient surveys on pain control, physicians grudgingly opened the narcotic floodgates and large quantities of prescription narcotics hit the streets. Admittedly, some were written by bad doctors running “pill mills,” but other supplies were diverted by producers, pharmacists, pharmacies, and pharmacy technicians. Hundreds of thousands of Americans became addicted to prescription narcotics, but overdoses were infrequent because there was a unit dose on the street.

Then the medical pendulum swung back, and it was decided that there was too much pain medicine on the streets. The narcotic supply spigots were tightened sharply by the Drug Enforcement Administration, medical boards, and legislatures. It became hard for drug-seeking patients to fill multiple prescriptions, pill mills were shut down, doctors were encouraged to prescribe minimum dosages of narcotic pain relievers, and the price of the unit dose shot up on the street. The patterns of abuse and addiction shifted as heroin became cheaper and more readily available, but hard to dose, particularly when Mexican fentanyl was being sold as “heroin.” Unable to judge the dose of illicitly obtained drugs, addicts began overdosing and dying all over America.

Angry, bereaved family members demanded an accounting for the addiction and deaths of their relatives. Heat was applied to politicians, and a “culprit” was found, physicians! Physicians had made these drugs available and caused all of these people to be addicted!

And thus began the political ascendancy of the pharmacy board, whose members claimed clean hands in this affair. Keen to expand their scope of practice, pharmacists have been trying to find a way into clinical medicine for years. The pharmacy board offered their expertise, and politicians angry at doctors were willing to give the pharmacists’ recommendations a try.

Last year in Ohio, the legislature passed a huge budget reconciliation bill with language tucked in it that authorized the pharmacy board to regulate buprenorphine and other dangerous drugs. The obvious reading of this authority would be that pharmacists were supposed to regulate compounding pharmacies, like the one that produced tainted steroid injections that resulted in 64 deaths in 2012.The regulation is so vague, however, that it could be construed that pharmacists were supposed to regulate everyone in the state, especially since the pharmacy board unilaterally moved to define “dangerous” as any prescription drug. This puts all of medicine in play. The board then declared that it would apply U.S. Pharmacopeial Convention standards (those used for compounding pharmacies) to all physician offices and declared that reconstitution of any drug is considered to be compounding.

To consider physician’s offices as compounding pharmacies is absurd and will degrade patient care by increasing expense and denying access to treatments. Physicians have made and applied individual customized medications to their patients since Galen. It is an integral part of the practice of medicine and has not suddenly become the practice of pharmacy. Using this logic, pharmacists, who have recently won the right to administer vaccinations, should obtain special licenses from the state medical board, since injecting medications is clearly in the purview of medical practice. Physicians have not been killing patients by running dirty compounding pharmacies, pharmacists have. Good, clean up the compounding pharmacies! But applying these compounding rules to physicians’ offices will not save any lives.

This battle has just been joined. The American Medical Association recently passed a resolution declaring that physician compounding should be regulated by state medical boards. This action is most helpful, and another reason for you to join and support the AMA. If you practice in Ohio, you should join the Ohio State Medical Association post haste. They are a big dog in the Ohio legislature, and your membership will influence their efforts.

I hope the Ohio governor’s Common Sense Initiative Office will convene a joint meeting that allows physicians, especially dermatologists, to demonstrate the absurdity of these rules, and their potentially destructive effects on patient care. However, I do not expect the pharmacy board to readily give up this power. Ultimately, the language in the legislative code must add two words after the word “compounding.” The words to be added are “by pharmacists.”

These rules may have to be stayed by a legal injunction. If the legislation is not clarified, a lawsuit against the pharmacy board based on restraint of trade should be successful.

Be vigilant, and watch your state legislatures. Just recently, the pharmacy board of North Dakota has made the same power grab. Stay tuned, as this struggle has national implications.

Dr. Coldiron is past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Write to him at dermnews@frontlinemedcom.com.

The struggles with the State of Ohio Board of Pharmacy continue. The pharmacy board reopened its comment period for 2 weeks and received many comments from multiple physicians, organizations, and patients who would be adversely affected by the Board’s move to hold physicians’ offices to the same standard as compounding pharmacies. This was the topic of my recent column, in which I pointed out that as a result, “any practitioners who reconstitute any drug in their offices is considered to be a compounding pharmacy, ordered to pay compounding pharmacy registration fees ($112 yearly), and to undergo the same inspections as compounding pharmacies”.

At their last meeting, the pharmacy board members made a few minor changes, but practitioners will still have to throw out their neurotoxins after 1-6 hours (the exact time is still under debate). Incidentally, I have spoken to all three neurotoxin manufacturers, and they have no interest in adding preservative to their products or in bringing out smaller unit dose packaging. These regulations will have broad impact across the house of medicine because many specialties use neurotoxin.

You should know the back story behind all of this, and how the house of medicine came to this sad place.

About 20 years ago, pain control became a cause célèbre in medicine championed by no less than the World Health Organization. Numerous publications, thought leaders, and policy wonks decried the inadequacy of pain control both in and out of the hospital. It was explained loud and long that patients should have their pain controlled and that physicians fell short if they did not do so, never mind that there is no quantifiable way to measure pain. Further, it was explained that patients in severe pain did not become addicted to narcotics. And the Joint Commission heralded pain control as “the fifth vital sign.”

Where are these thought leaders now?

Graded on responsiveness to patients’ pain and the results of patient surveys on pain control, physicians grudgingly opened the narcotic floodgates and large quantities of prescription narcotics hit the streets. Admittedly, some were written by bad doctors running “pill mills,” but other supplies were diverted by producers, pharmacists, pharmacies, and pharmacy technicians. Hundreds of thousands of Americans became addicted to prescription narcotics, but overdoses were infrequent because there was a unit dose on the street.

Then the medical pendulum swung back, and it was decided that there was too much pain medicine on the streets. The narcotic supply spigots were tightened sharply by the Drug Enforcement Administration, medical boards, and legislatures. It became hard for drug-seeking patients to fill multiple prescriptions, pill mills were shut down, doctors were encouraged to prescribe minimum dosages of narcotic pain relievers, and the price of the unit dose shot up on the street. The patterns of abuse and addiction shifted as heroin became cheaper and more readily available, but hard to dose, particularly when Mexican fentanyl was being sold as “heroin.” Unable to judge the dose of illicitly obtained drugs, addicts began overdosing and dying all over America.

Angry, bereaved family members demanded an accounting for the addiction and deaths of their relatives. Heat was applied to politicians, and a “culprit” was found, physicians! Physicians had made these drugs available and caused all of these people to be addicted!

And thus began the political ascendancy of the pharmacy board, whose members claimed clean hands in this affair. Keen to expand their scope of practice, pharmacists have been trying to find a way into clinical medicine for years. The pharmacy board offered their expertise, and politicians angry at doctors were willing to give the pharmacists’ recommendations a try.

Last year in Ohio, the legislature passed a huge budget reconciliation bill with language tucked in it that authorized the pharmacy board to regulate buprenorphine and other dangerous drugs. The obvious reading of this authority would be that pharmacists were supposed to regulate compounding pharmacies, like the one that produced tainted steroid injections that resulted in 64 deaths in 2012.The regulation is so vague, however, that it could be construed that pharmacists were supposed to regulate everyone in the state, especially since the pharmacy board unilaterally moved to define “dangerous” as any prescription drug. This puts all of medicine in play. The board then declared that it would apply U.S. Pharmacopeial Convention standards (those used for compounding pharmacies) to all physician offices and declared that reconstitution of any drug is considered to be compounding.

To consider physician’s offices as compounding pharmacies is absurd and will degrade patient care by increasing expense and denying access to treatments. Physicians have made and applied individual customized medications to their patients since Galen. It is an integral part of the practice of medicine and has not suddenly become the practice of pharmacy. Using this logic, pharmacists, who have recently won the right to administer vaccinations, should obtain special licenses from the state medical board, since injecting medications is clearly in the purview of medical practice. Physicians have not been killing patients by running dirty compounding pharmacies, pharmacists have. Good, clean up the compounding pharmacies! But applying these compounding rules to physicians’ offices will not save any lives.

This battle has just been joined. The American Medical Association recently passed a resolution declaring that physician compounding should be regulated by state medical boards. This action is most helpful, and another reason for you to join and support the AMA. If you practice in Ohio, you should join the Ohio State Medical Association post haste. They are a big dog in the Ohio legislature, and your membership will influence their efforts.

I hope the Ohio governor’s Common Sense Initiative Office will convene a joint meeting that allows physicians, especially dermatologists, to demonstrate the absurdity of these rules, and their potentially destructive effects on patient care. However, I do not expect the pharmacy board to readily give up this power. Ultimately, the language in the legislative code must add two words after the word “compounding.” The words to be added are “by pharmacists.”

These rules may have to be stayed by a legal injunction. If the legislation is not clarified, a lawsuit against the pharmacy board based on restraint of trade should be successful.

Be vigilant, and watch your state legislatures. Just recently, the pharmacy board of North Dakota has made the same power grab. Stay tuned, as this struggle has national implications.

Dr. Coldiron is past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Write to him at dermnews@frontlinemedcom.com.

The struggles with the State of Ohio Board of Pharmacy continue. The pharmacy board reopened its comment period for 2 weeks and received many comments from multiple physicians, organizations, and patients who would be adversely affected by the Board’s move to hold physicians’ offices to the same standard as compounding pharmacies. This was the topic of my recent column, in which I pointed out that as a result, “any practitioners who reconstitute any drug in their offices is considered to be a compounding pharmacy, ordered to pay compounding pharmacy registration fees ($112 yearly), and to undergo the same inspections as compounding pharmacies”.

At their last meeting, the pharmacy board members made a few minor changes, but practitioners will still have to throw out their neurotoxins after 1-6 hours (the exact time is still under debate). Incidentally, I have spoken to all three neurotoxin manufacturers, and they have no interest in adding preservative to their products or in bringing out smaller unit dose packaging. These regulations will have broad impact across the house of medicine because many specialties use neurotoxin.

You should know the back story behind all of this, and how the house of medicine came to this sad place.

About 20 years ago, pain control became a cause célèbre in medicine championed by no less than the World Health Organization. Numerous publications, thought leaders, and policy wonks decried the inadequacy of pain control both in and out of the hospital. It was explained loud and long that patients should have their pain controlled and that physicians fell short if they did not do so, never mind that there is no quantifiable way to measure pain. Further, it was explained that patients in severe pain did not become addicted to narcotics. And the Joint Commission heralded pain control as “the fifth vital sign.”

Where are these thought leaders now?

Graded on responsiveness to patients’ pain and the results of patient surveys on pain control, physicians grudgingly opened the narcotic floodgates and large quantities of prescription narcotics hit the streets. Admittedly, some were written by bad doctors running “pill mills,” but other supplies were diverted by producers, pharmacists, pharmacies, and pharmacy technicians. Hundreds of thousands of Americans became addicted to prescription narcotics, but overdoses were infrequent because there was a unit dose on the street.

Then the medical pendulum swung back, and it was decided that there was too much pain medicine on the streets. The narcotic supply spigots were tightened sharply by the Drug Enforcement Administration, medical boards, and legislatures. It became hard for drug-seeking patients to fill multiple prescriptions, pill mills were shut down, doctors were encouraged to prescribe minimum dosages of narcotic pain relievers, and the price of the unit dose shot up on the street. The patterns of abuse and addiction shifted as heroin became cheaper and more readily available, but hard to dose, particularly when Mexican fentanyl was being sold as “heroin.” Unable to judge the dose of illicitly obtained drugs, addicts began overdosing and dying all over America.

Angry, bereaved family members demanded an accounting for the addiction and deaths of their relatives. Heat was applied to politicians, and a “culprit” was found, physicians! Physicians had made these drugs available and caused all of these people to be addicted!

And thus began the political ascendancy of the pharmacy board, whose members claimed clean hands in this affair. Keen to expand their scope of practice, pharmacists have been trying to find a way into clinical medicine for years. The pharmacy board offered their expertise, and politicians angry at doctors were willing to give the pharmacists’ recommendations a try.

Last year in Ohio, the legislature passed a huge budget reconciliation bill with language tucked in it that authorized the pharmacy board to regulate buprenorphine and other dangerous drugs. The obvious reading of this authority would be that pharmacists were supposed to regulate compounding pharmacies, like the one that produced tainted steroid injections that resulted in 64 deaths in 2012.The regulation is so vague, however, that it could be construed that pharmacists were supposed to regulate everyone in the state, especially since the pharmacy board unilaterally moved to define “dangerous” as any prescription drug. This puts all of medicine in play. The board then declared that it would apply U.S. Pharmacopeial Convention standards (those used for compounding pharmacies) to all physician offices and declared that reconstitution of any drug is considered to be compounding.

To consider physician’s offices as compounding pharmacies is absurd and will degrade patient care by increasing expense and denying access to treatments. Physicians have made and applied individual customized medications to their patients since Galen. It is an integral part of the practice of medicine and has not suddenly become the practice of pharmacy. Using this logic, pharmacists, who have recently won the right to administer vaccinations, should obtain special licenses from the state medical board, since injecting medications is clearly in the purview of medical practice. Physicians have not been killing patients by running dirty compounding pharmacies, pharmacists have. Good, clean up the compounding pharmacies! But applying these compounding rules to physicians’ offices will not save any lives.

This battle has just been joined. The American Medical Association recently passed a resolution declaring that physician compounding should be regulated by state medical boards. This action is most helpful, and another reason for you to join and support the AMA. If you practice in Ohio, you should join the Ohio State Medical Association post haste. They are a big dog in the Ohio legislature, and your membership will influence their efforts.

I hope the Ohio governor’s Common Sense Initiative Office will convene a joint meeting that allows physicians, especially dermatologists, to demonstrate the absurdity of these rules, and their potentially destructive effects on patient care. However, I do not expect the pharmacy board to readily give up this power. Ultimately, the language in the legislative code must add two words after the word “compounding.” The words to be added are “by pharmacists.”

These rules may have to be stayed by a legal injunction. If the legislation is not clarified, a lawsuit against the pharmacy board based on restraint of trade should be successful.

Be vigilant, and watch your state legislatures. Just recently, the pharmacy board of North Dakota has made the same power grab. Stay tuned, as this struggle has national implications.

Dr. Coldiron is past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Write to him at dermnews@frontlinemedcom.com.