Current Status of the Dorzolamide Shortage
As of late 2024 and heading into 2025, yes, there is an ongoing shortage of certain presentations of dorzolamide ophthalmic solution. The American Society of Health-System Pharmacists (ASHP) monitors and reports these issues, confirming that at least one key manufacturer, Leading Pharma, has had its 2% dorzolamide 10 mL bottles listed as unavailable. This particular unavailability is not expected to be resolved until at least September 2025. This is not an isolated incident; similar supply disruptions occurred in 2024 and in previous years, reminding both patients and healthcare providers of the vulnerability of the generic drug supply chain.
While some manufacturers are affected, others may still have supply. Reports from ASHP and other sources indicate that manufacturers such as Bausch Health, Micro Labs, and Sandoz have had dorzolamide ophthalmic solution available during various shortage periods. This inconsistency means that a patient's access to the medication can depend on which supplier their pharmacy sources from, creating significant variability and uncertainty.
The Fragile Nature of the Generic Drug Supply Chain
This isn't the first time dorzolamide has been hard to find. Shortages have plagued the availability of this and other generic glaucoma medications for years. The root causes are often complex and systemic within the pharmaceutical industry.
Causes of Supply Issues
- Manufacturing Problems: A significant portion of drug shortages are caused by manufacturing and quality control issues. These can range from problems with equipment in production facilities to contamination concerns, and can force a company to halt production voluntarily or at the direction of regulatory agencies. The FDA has previously cited "manufacturing issues" in relation to dorzolamide shortages.
- Low Profit Margins: Generic drugs, including dorzolamide, are often low-cost, leading to narrow profit margins for manufacturers. This provides little incentive for companies to invest heavily in upgrading equipment or maintaining robust production capacity. If a more profitable drug can be manufactured on the same production line, a company may shift its resources, leading to a shortage of the less profitable medication.
- Consolidation of Manufacturing: As competition drives down prices, some manufacturers may exit the market. This can lead to a situation where only a few companies are producing a generic drug. If one of those manufacturers encounters a problem, there may not be enough remaining capacity to meet demand, triggering a widespread shortage.
Impact on Patients and Healthcare Providers
For patients with glaucoma, a chronic and vision-threatening disease, a medication shortage can be highly stressful and potentially dangerous. Regular treatment is critical to manage intraocular pressure and prevent irreversible vision loss. Disruptions in therapy can lead to anxiety, confusion, and adverse health outcomes.
- Vision Loss Risk: In the past, ophthalmologists have reported seeing patients experience severe vision loss after being unable to fill their dorzolamide-containing prescriptions. This underscores the seriousness of such shortages.
- Administrative Burden: When shortages occur, clinics face a higher volume of patient inquiries and require more administrative work to find alternative treatments or arrange for refills from a different supplier.
- Financial Strain: Generic medications are often the most affordable option. When forced to switch to a more expensive branded alternative, patients can face significant financial hardship, with some reporting co-pays of over $200 for alternatives.
Potential Alternatives and Management Strategies
For patients affected by a dorzolamide shortage, it's crucial to consult with their ophthalmologist or another healthcare provider to discuss alternative treatments. Options can vary depending on the patient's specific condition, overall health, and other medications.
- Switching Manufacturers: The simplest solution is to see if the patient's pharmacy can source dorzolamide from a manufacturer that is not currently experiencing a shortage.
- Alternative Medications: Several other medications can lower intraocular pressure. For example, brinzolamide (brand name Azopt) is another carbonic anhydrase inhibitor that is a logical substitution, though cost and insurance coverage may vary. Brimonidine (brand name Alphagan P) is another alternative often used.
- Fixed-Combination Drops: For patients on the combination of dorzolamide-timolol (generic for Cosopt), shortages can also occur. A suitable alternative might be a combination of brimonidine and timolol (brand name Combigan), provided there is no allergy to brimonidine. It is important to note that fixed-combination products containing dorzolamide have also faced their own manufacturing issues.
- Compounding Pharmacies: In some cases, specialized compounding pharmacies may be able to prepare preservative-free dorzolamide formulations, as was done during a previous shortage. This is a more specialized option and should be discussed with a doctor.
Comparison of Glaucoma Medications
| Feature | Dorzolamide (Generic Trusopt) | Brinzolamide (Azopt) | Brimonidine (Alphagan P) | Prostaglandin Analogues (e.g., Latanoprost) |
|---|---|---|---|---|
| Drug Class | Carbonic Anhydrase Inhibitor | Carbonic Anhydrase Inhibitor | Alpha-2 Adrenergic Agonist | Prostaglandin Agonist |
| Mechanism | Reduces aqueous humor production | Reduces aqueous humor production | Reduces aqueous humor production, increases outflow | Increases uveoscleral outflow of aqueous humor |
| Typical Dosing | 1 drop in affected eye(s) 3 times per day | 1 drop in affected eye(s) 2 or 3 times per day | 1 drop in affected eye(s) 2 or 3 times per day | 1 drop in affected eye(s) once daily |
| Common Side Effects | Stinging, burning, bitter taste | Blurred vision, bitter taste | Burning, stinging, redness | Changes in eye color, eyelash growth |
| Sulfa Allergy | Should be used with caution | Low risk of systemic side effects | Not a sulfa drug | Not a sulfa drug |
Conclusion: Navigating the Dorzolamide Shortage
While an ongoing shortage for some dorzolamide presentations does exist, it does not mean patients are without options. The generic drug market's instability is a known factor that necessitates proactive management by both patients and their doctors. Patients should contact their ophthalmologist immediately upon learning their prescription cannot be filled. By working closely with their doctor and pharmacist, patients can explore alternatives, switch manufacturers, or investigate other strategies to ensure their intraocular pressure remains safely controlled.
This situation also highlights the broader issue of pharmaceutical supply chain resilience. Continued drug shortages, especially for essential medications, put a spotlight on the need for more robust and transparent manufacturing and distribution systems to protect patient health.
For more detailed, up-to-date information on specific manufacturers and estimated resupply dates, patients and clinicians can consult resources like the ASHP website: https://www.ashp.org/drug-shortages.
