Lindstrom's Perspective

No easy answers to address drug shortages

According to the April 2, 2019, FDA drug shortages list, there were 270 current drugs in shortage across 26 therapeutic fields. The ophthalmic drugs in shortage included drugs utilized for both diagnostic and therapeutic indications.

Fluorescein, indocyanine green, proparacaine, atropine and tropicamide caught my attention on the diagnostic side. On the therapeutic side, bacitracin ophthalmic ointment, erythromycin ophthalmic ointment and azithromycin ophthalmic suspension were all on the list, putting a dent in our ability to treat lid margin disease including blepharitis and meibomian gland dysfunction. On the glaucoma front, topical dorzolamide/timolol (generic Cosopt), dorzolamide and latanoprost were all in shortage, as was intravenous acetazolamide. Injectable lidocaine and bupivacaine with and without epinephrine, our mainstays in peribulbar and retrobulbar injections, were also on the list. Other notable drugs mentioned that affect the ophthalmologist included oral prednisone and methotrexate. I myself continue to have trouble accessing the Shingrix vaccine (GSK) for herpes zoster prophylaxis.

These shortages negatively affect our ability to properly treat our patients. While the FDA is motivated to do what it can to avoid drug shortages, the FDA cannot require a pharmaceutical manufacturer to make a drug, make more of a drug or enhance its distribution. Many factors influence drug shortages, including loss of access to the active pharmaceutical agent, quality manufacturing lapses, low manufacturing capacity, increased demand and the like. I believe a major issue is lack of financial incentive to make some generic drugs with extremely low profit margins and no opportunity to generate a return on investment.

While third-party payers, pharmacy benefit managers, pharmacies and some patients have benefited significantly from the transition away from branded pharmaceuticals to primarily generic medication usage in the U.S., most pharmaceutical manufacturers have not. Simply stated, in our system of capitalism, if there is no profit, there will be no product.

The solution is not an easy one. Specialty compounding pharmaceutical manufacturers have filled the void in some cases, providing much needed drugs at a reasonable price. Some manufacturers focused on generic drug manufacture have attempted to raise their prices as they have struggled to make a profit. This has resulted in significant criticism from the stakeholders who pay for and use the products, including federal and state governments, third-party payers and our patients. How do we force a private company to make a drug at a loss, no matter how critical it is to the health of a patient? Hitting closer to home, how do we force a care provider, whether it be a hospital, ASC or physician, to repeatedly provide a unit of care at a loss, no matter how needed? And, if we allow the manufacturers of drugs and devices along with the institutions and providers who oversee their delivery to generate a reasonable profit, how do the payers and the patients afford it?

The answers to those questions are being debated heatedly today as our presidential primaries begin, and for better or worse, the answers will be constructed by our elected representatives. It behooves us all to pay attention to the debate and choose our elected representatives wisely, as we are ripe for a significant change in how health care is reimbursed in the near future, likely catalyzed by the inevitable next recession.

Disclosure: Lindstrom reports he consults for Bausch Health, Harrow Health, ImprimisRx, Johnson & Johnson Vision, Novartis and several startups in the ophthalmic pharmaceutical and device industry.

Editor’s note: Please read more for an update on this commentary.

According to the April 2, 2019, FDA drug shortages list, there were 270 current drugs in shortage across 26 therapeutic fields. The ophthalmic drugs in shortage included drugs utilized for both diagnostic and therapeutic indications.

Fluorescein, indocyanine green, proparacaine, atropine and tropicamide caught my attention on the diagnostic side. On the therapeutic side, bacitracin ophthalmic ointment, erythromycin ophthalmic ointment and azithromycin ophthalmic suspension were all on the list, putting a dent in our ability to treat lid margin disease including blepharitis and meibomian gland dysfunction. On the glaucoma front, topical dorzolamide/timolol (generic Cosopt), dorzolamide and latanoprost were all in shortage, as was intravenous acetazolamide. Injectable lidocaine and bupivacaine with and without epinephrine, our mainstays in peribulbar and retrobulbar injections, were also on the list. Other notable drugs mentioned that affect the ophthalmologist included oral prednisone and methotrexate. I myself continue to have trouble accessing the Shingrix vaccine (GSK) for herpes zoster prophylaxis.

These shortages negatively affect our ability to properly treat our patients. While the FDA is motivated to do what it can to avoid drug shortages, the FDA cannot require a pharmaceutical manufacturer to make a drug, make more of a drug or enhance its distribution. Many factors influence drug shortages, including loss of access to the active pharmaceutical agent, quality manufacturing lapses, low manufacturing capacity, increased demand and the like. I believe a major issue is lack of financial incentive to make some generic drugs with extremely low profit margins and no opportunity to generate a return on investment.

While third-party payers, pharmacy benefit managers, pharmacies and some patients have benefited significantly from the transition away from branded pharmaceuticals to primarily generic medication usage in the U.S., most pharmaceutical manufacturers have not. Simply stated, in our system of capitalism, if there is no profit, there will be no product.

The solution is not an easy one. Specialty compounding pharmaceutical manufacturers have filled the void in some cases, providing much needed drugs at a reasonable price. Some manufacturers focused on generic drug manufacture have attempted to raise their prices as they have struggled to make a profit. This has resulted in significant criticism from the stakeholders who pay for and use the products, including federal and state governments, third-party payers and our patients. How do we force a private company to make a drug at a loss, no matter how critical it is to the health of a patient? Hitting closer to home, how do we force a care provider, whether it be a hospital, ASC or physician, to repeatedly provide a unit of care at a loss, no matter how needed? And, if we allow the manufacturers of drugs and devices along with the institutions and providers who oversee their delivery to generate a reasonable profit, how do the payers and the patients afford it?

The answers to those questions are being debated heatedly today as our presidential primaries begin, and for better or worse, the answers will be constructed by our elected representatives. It behooves us all to pay attention to the debate and choose our elected representatives wisely, as we are ripe for a significant change in how health care is reimbursed in the near future, likely catalyzed by the inevitable next recession.

Disclosure: Lindstrom reports he consults for Bausch Health, Harrow Health, ImprimisRx, Johnson & Johnson Vision, Novartis and several startups in the ophthalmic pharmaceutical and device industry.

Editor’s note: Please read more for an update on this commentary.