Why the Gonak Hypromellose Shortage Matters to Your Practice

The ongoing shortage of Gonak hypromellose ophthalmic solution has created significant challenges for ophthalmologists, optometrists, and their patients nationwide. This critical shortage impacts more than just procurement logistics—it directly affects patient care and diagnostic capabilities. Gonak, containing 2.5% hypromellose (hydroxypropyl methylcellulose), serves as an essential component for gonioscopy examinations, where clear visualization of the eye’s drainage angle is crucial for managing conditions like glaucoma.

For healthcare professionals managing ocular diseases, this shortage represents more than an inconvenience. It threatens your ability to provide timely, accurate diagnoses and appropriate treatment plans. With Akorn Pharmaceuticals’ bankruptcy and manufacturing disruptions in the pharmaceutical supply chain, practices are scrambling to find viable alternatives while maintaining the quality of care their patients expect.

The reality is clear: this shortage affects your bottom line, patient satisfaction, and clinical outcomes. Procedures may be delayed, rescheduled, or performed with suboptimal substitutes. Understanding why this shortage exists and exploring strategic solutions is essential for any ophthalmic practice navigating this challenge.

How Pipeline Medical Addresses the Hypromellose Ophthalmic Solution Crisis

At Pipeline Medical, we understand the complex medical supply challenges facing healthcare providers during drug shortages. Our approach to the Gonak shortage goes beyond simply finding product—we’ve developed a comprehensive strategy to help ophthalmology practices maintain continuity of care.

Strategic Sourcing of Hypromellose 2.5% Alternatives

When standard supply chains fail, our procurement specialists work through our extensive network of FDA-approved suppliers to source alternatives. Unlike traditional distributors who simply report “page not found” or “out of stock,” we proactively search for solutions that meet both regulatory requirements and clinical needs.

We source both branded and generic hypromellose options, ensuring that all products meet stringent quality standards. Our team carefully vets each alternative to confirm they provide the same viscosity and optical clarity needed for successful gonioscopy procedures.

Transparent Pricing During Ophthalmic Solution Shortages

In times of shortage, price gouging often becomes a concern for healthcare facilities. Pipeline Medical maintains transparent pricing structures even during supply constraints. We believe in ethical business practices that support the healthcare community rather than exploiting shortages for profit.

Our approach allows us to offer competitive pricing on available alternatives while maintaining the quality standards necessary for ophthalmic applications. We clearly communicate pricing, availability, and potential allocation limits, allowing practices to budget appropriately during this challenging time.

Supply Chain Intelligence for Healthcare Professionals

Our dedicated team monitors the pharmaceutical manufacturing landscape to provide real-time updates on the Gonak situation. This includes tracking the status of Akorn’s production capabilities, FDA approval of new manufacturers, and anticipated resolution timelines for the shortage.

This intelligence allows your practice to make informed decisions about inventory management, patient scheduling, and potential procedural adjustments. Rather than reacting to shortage surprises, you can proactively plan with the best available information.

What Ophthalmic Professionals Need to Know About Gonak Alternatives

Understanding your options during this shortage is essential for maintaining quality patient care. Here’s what you need to know about alternatives to Gonak hypromellose ophthalmic solution.

Clinical Considerations for Hypromellose Product Substitutions

When selecting an alternative to Gonak, several factors must be considered to ensure optimal diagnostic results:

Concentration matters: The standard 2.5% hypromellose concentration in Gonak provides specific viscosity characteristics. Alternative products should match this concentration for comparable performance.
Preservative content: Some patients may have sensitivities to specific preservatives. Review alternative formulations for benzalkonium chloride or other preservatives that might cause adverse reactions.
Contact lens compatibility: If your patients wear contact lenses, verify whether alternative solutions require different waiting periods before lens reinsertion.
Storage requirements: Some hypromellose formulations have specific temperature or light exposure limitations that differ from Gonak.

Available Hydroxypropyl Methylcellulose Options During Shortage

Several alternatives exist that may help bridge the gap during this shortage:

Compounded hypromellose solutions: Many hospital and specialty pharmacies can compound hypromellose 2.5% solutions to specifications similar to Gonak. These require a prescription but can be tailored to match the needed characteristics.
GenTeal Gel: While primarily marketed for dry eye treatment, the higher viscosity formulations contain compatible hydroxypropyl methylcellulose that some physicians have successfully adapted for gonioscopy in emergency situations.
Imported hypromellose options: We’ve identified several internationally available hypromellose 2.5% solutions that meet FDA import requirements for critical shortages. These undergo additional quality verification before we make them available.
Alternative viscosity agents: In some cases, sodium carboxymethylcellulose or polyethylene glycol solutions can serve as functional substitutes, though they may require technique adjustments.

Implementation Guide for Practice Managers

For clinic administrators navigating this shortage, follow these steps to minimize disruption:

Audit current supply: Determine exactly how much Gonak remains in inventory and calculate your burn rate based on scheduled procedures.
Prioritize cases: Work with physicians to identify which cases absolutely require hypromellose 2.5% solution versus those that might use alternatives.
Evaluate alternatives: Review the options listed above, considering patient populations, procedure types, and physician preferences.
Order strategically: Rather than panic-ordering excessive quantities, work with Pipeline Medical to develop a sustainable ordering plan that addresses immediate needs while preparing for long-term solutions.
Train staff on alternatives: Ensure all technicians and physicians understand any procedural modifications needed when using alternative products.

The Pharmaceutical Supply Chain Behind the Gonak Shortage

Understanding why shortages happen helps practices better prepare for current and future supply disruptions. The Gonak situation reflects broader vulnerabilities in the pharmaceutical supply chain.

Manufacturing Challenges in Ophthalmic Solution Production

The current shortage stems from multiple factors affecting hypromellose ophthalmic solution production:

Akorn Pharmaceuticals, the primary manufacturer of Gonak, filed for bankruptcy in February 2023, disrupting their manufacturing capacity. This left a significant gap in the market that smaller manufacturers couldn’t immediately fill.

Raw material constraints have affected even alternative manufacturers. Pharmaceutical-grade hydroxypropyl methylcellulose requires specific production standards that limit available suppliers.

Quality control issues at remaining facilities have led to batch rejections, further reducing available inventory. The stringent requirements for ophthalmic solutions mean even minor deviations can cause entire production runs to be discarded.

Regulatory hurdles slow the entry of new manufacturers. Even companies with production capability face months of FDA review before bringing new ophthalmic products to market.

Timeline and Projections for Hypromellose 2.5% Availability

Based on our industry intelligence and supplier communications, we project the following timeline for the Gonak shortage:

Short-term (1-3 months): Continued severe constraints with sporadic availability through specialty distributors like Pipeline Medical who maintain diverse supplier relationships.
Mid-term (3-6 months): Gradual improvement as alternative manufacturers increase production capacity and cleared inventory begins entering the market.
Long-term (6+ months): Return to stable supply as either Akorn resumes production or other manufacturers secure permanent approvals to fill the market gap.

These projections help your practice develop appropriate contingency plans based on the anticipated duration of the shortage.

The Role of FDA and Regulatory Bodies in Drug Shortages

The FDA plays a crucial role in both preventing and mitigating drug shortages:

The agency maintains a drug shortage database that tracks availability issues for critical medications, including Gonak and other ophthalmic solutions.
During critical shortages, the FDA sometimes implements temporary regulatory flexibility, such as allowing controlled importation of equivalent products or expediting review of new manufacturer applications.
Manufacturers are required to notify the FDA of potential production disruptions, though this system doesn’t always provide sufficient lead time for healthcare providers to prepare.

Working with distributors like Pipeline Medical who actively engage with regulatory bodies ensures your practice receives the most current information on shortage status and potential resolutions.

Managing Patient Care During Hypromellose Ophthalmic Solution Shortages

The ultimate goal during any medical supply shortage is maintaining quality patient care. Here’s how to manage patient needs during the Gonak shortage.

Communication Strategies for Patients About Ophthalmic Procedures

Clear patient communication is essential when adapting to product shortages:

Explain to patients that while there’s a shortage of a specific solution used during eye examinations, alternative options exist that provide comparable results.
Reassure patients that their care won’t be compromised, as the practice has implemented strategies to ensure continued access to appropriate diagnostic tools.
For patients with known sensitivities, proactively discuss any preservative differences in alternative products to address potential concerns.
If procedures need to be rescheduled due to supply constraints, provide clear reasoning and realistic timeframes to minimize patient frustration.

Clinical Adaptations for Ophthalmologists During Shortages

Physicians may need to implement temporary procedural adjustments:

Consider modifying gonioscopy techniques when using alternative solutions with slightly different viscosity characteristics.
Schedule complex cases requiring ideal visualization during times when preferred solutions are available.
Implement solution conservation protocols, such as using single-use containers more efficiently without compromising sterility.
Document any clinical variations in visualization quality when using alternatives to track effectiveness across different patient scenarios.

Long-term Solutions for Ophthalmic Practice Resilience

Beyond addressing the immediate Gonak shortage, practices should implement strategies to reduce vulnerability to future supply disruptions:

Develop relationships with multiple suppliers, including specialty distributors like Pipeline Medical who have diverse sourcing capabilities.
Consider maintaining a modest reserve of critical supplies, balanced against expiration dates and storage constraints.
Regularly review procedure protocols to identify potential alternative products or techniques that could serve as backups.
Join industry organizations that provide early alerts about potential shortages, allowing for proactive planning rather than reactive scrambling.

The Impact of Hypromellose Shortages on Ocular Disease Management

The Gonak shortage has specific implications for managing various eye conditions that require careful angle assessment.

Glaucoma Monitoring During Hypromellose Product Constraints

Glaucoma patients represent a population particularly affected by the hypromellose shortage:

Regular gonioscopy is essential for monitoring disease progression and treatment effectiveness in glaucoma patients.
Delayed examinations due to product shortages may result in missed opportunities to adjust treatment plans.
Alternative solutions may provide adequate visualization for routine monitoring but might present challenges for subtle angle changes.
Practices should prioritize high-risk glaucoma patients for procedures when preferred solutions are available.

Dry Eye Complications and Hypromellose Alternatives

The dual use of hypromellose for both diagnostic and therapeutic purposes creates additional challenges:

Many patients rely on hypromellose-based solutions for dry eye symptom management.
The shortage affects both diagnostic procedures and treatment options, potentially requiring separate solutions for each purpose.
Patients may need guidance on preservative differences when transitioning between products.
Alternative dry eye treatments may need to be explored for patients previously managed with hypromellose solutions.

Educational Resources for Healthcare Providers

Staying informed about best practices during the shortage is essential:

Professional organizations like the American Academy of Ophthalmology offer guidance on alternative techniques and products during shortages.
Peer-reviewed literature provides evidence-based approaches to adaptation when preferred products are unavailable.
Manufacturer-neutral training on alternative product use helps ensure staff competency regardless of which solution is available.
Pipeline Medical provides regular updates on availability and clinical considerations specific to ophthalmic supply shortages.

Essential Procurement Strategies During Ophthalmic Solution Shortages

Strategic procurement approaches can help mitigate the impact of the Gonak shortage on your practice.

Building Resilient Medical Supply Chains

A diversified procurement approach helps weather shortages more effectively:

Work with distributors like Pipeline Medical who maintain relationships with multiple manufacturers rather than relying on single-source suppliers.
Consider joining group purchasing organizations that may have preferential access to limited supplies during shortages.
Develop contingency plans for critical supplies, identifying second and third-choice alternatives before shortages occur.
Implement inventory management systems that provide early warnings when supply levels approach critical thresholds.

Price Considerations for Hypromellose 2.5% During Shortages

Financial management becomes particularly important during shortages:

Budget for potential premium pricing on available stock, as market forces typically drive prices upward during scarcity.
Calculate the true cost of alternatives, including not just product price but also any procedural adjustments or additional staff time required.
Consider the financial impact of rescheduled procedures or alternative diagnostic approaches when evaluating procurement options.
Work with payers to ensure appropriate reimbursement when using alternative products that may have different billing codes.

Ethical Considerations in Ophthalmic Supply Allocation

When supplies are limited, allocation decisions require careful ethical consideration:

Develop transparent criteria for prioritizing use of limited supplies, such as clinical urgency or specific diagnostic requirements.
Avoid stockpiling beyond reasonable needs, as this can exacerbate shortages for other practices and patients.
Share resources with neighboring practices when possible, creating community solutions to regional shortages.
Document allocation decisions to ensure consistency and defensibility if questions arise.

The Future of Pharmaceutical Manufacturing for Ophthalmic Solutions

Looking beyond the current shortage, understanding industry trends helps practices prepare for future supply chain resilience.

Technological Advancements in Hypromellose Production

Emerging technologies may help prevent future shortages:

Continuous manufacturing processes are replacing batch production at some facilities, potentially reducing disruption risks.
Advanced analytics help manufacturers predict and prevent quality issues that could lead to production stoppages.
New formulation approaches may eventually create longer-shelf-life alternatives that allow for more effective stockpiling.
3D printing of pharmaceutical components is reducing dependency on single suppliers for certain production elements.

Regulatory Changes Affecting Ophthalmic Medical Supplies

The regulatory landscape continues to evolve in response to ongoing shortages:

The FDA has implemented more stringent reporting requirements for manufacturers planning production changes that could affect supply.
New incentives encourage redundant manufacturing capabilities for critical medications, including ophthalmic solutions.
Streamlined approval pathways for shortage-related alternatives help bring substitutes to market more quickly.
International harmonization efforts are making it easier to source equivalent products from global suppliers during domestic shortages.

Preparing Your Practice for Future Ophthalmic Solution Challenges

Proactive planning can reduce the impact of future shortages:

Regularly review and update your practice’s contingency plans for critical supplies.
Train staff on alternative products and procedures before shortages occur.
Build relationships with specialized medical suppliers like Pipeline Medical who provide not just products but also shortage intelligence.
Participate in professional organizations that advocate for supply chain improvements in ophthalmic healthcare.

Frequently Asked Questions About the Gonak Shortage

What exactly is Gonak used for in ophthalmology?

Gonak is a 2.5% hypromellose (hydroxypropyl methylcellulose) ophthalmic solution primarily used during gonioscopy examinations. It creates a coupling interface between the goniolens and the cornea, eliminating the air-cornea interface and allowing clear visualization of the eye’s drainage angle. This visualization is crucial for diagnosing and monitoring conditions like glaucoma and assessing the eye’s drainage system.

Why is there a shortage of Gonak hypromellose ophthalmic solution?

The primary manufacturer, Akorn Pharmaceuticals, filed for bankruptcy and ceased operations, significantly disrupting the supply chain. Additional factors include raw material constraints, quality control issues at alternative manufacturing facilities, and regulatory hurdles that slow new manufacturers from entering the market. These combined factors created a perfect storm affecting hypromellose 2.5% availability.

How long is the Gonak shortage expected to last?

Based on current industry intelligence, severe constraints are expected to continue for 1-3 months, with gradual improvement over the following 3-6 months. Full resolution may take 6+ months as either the original manufacturer resumes production or alternative manufacturers secure permanent approvals to fill the gap. Pipeline Medical continuously monitors these timelines and provides updates as new information becomes available.

What are the best alternatives to Gonak during the shortage?

Several alternatives exist, including compounded hypromellose solutions from specialty pharmacies (requiring prescription), higher-viscosity GenTeal gel formulations (adapted for emergency use), FDA-approved imported hypromellose 2.5% solutions, and in some cases, alternative viscosity agents like sodium carboxymethylcellulose. The best choice depends on your specific procedural requirements, patient population, and physician preferences.

Will insurance cover alternative products during the shortage?

Most insurance plans will cover medically necessary alternatives when the primary product is unavailable due to shortage. However, coverage may vary by specific plan and alternative chosen. Some alternatives may require different billing codes or additional documentation of medical necessity. Pipeline Medical can provide guidance on typical reimbursement patterns for various alternatives based on our experience with multiple practices.

How can I ensure my practice maintains access to hypromellose products?

Working with specialized medical suppliers like Pipeline Medical who maintain diverse sourcing relationships provides the best opportunity for accessing available inventory. Developing a strategic procurement plan, rather than panic-ordering, helps ensure fair allocation. Additionally, exploring compounding options with local specialty pharmacies provides a backup solution when commercial products are unavailable.

Ensuring Ophthalmic Care Continuity During Hypromellose Shortages

The Gonak shortage presents real challenges for ophthalmic practices, but with strategic planning and the right partnerships, these challenges can be effectively managed. Understanding the underlying causes, available alternatives, and best practices for adaptation allows practices to maintain quality patient care even during supply constraints.

Pipeline Medical remains committed to supporting healthcare professionals through this and other medical supply challenges. Our approach combines product sourcing expertise with educational resources and supply chain intelligence to provide comprehensive solutions, not just stopgap measures.

By implementing the strategies outlined in this guide, your practice can navigate the current shortage while building resilience against future supply disruptions. The key lies in proactive planning, transparent communication, and partnership with suppliers who understand the unique needs of ophthalmic healthcare.

Contact Pipeline Medical today to discuss your specific needs regarding hypromellose ophthalmic solutions and develop a customized plan to ensure continued access to the supplies your practice needs. Our procurement specialists understand the critical nature of these products and will work tirelessly to support your practice’s requirements during this challenging time.

Conclusion

At Pipeline Medical, we believe that every healthcare provider deserves a procurement partner who understands what’s at stake when critical supplies like Gonak become unavailable. Your patients rely on your expertise, and you should be able to rely on your medical supplier. We stand ready with FDA-approved alternatives, transparent pricing, and industry expertise to keep your practice running smoothly through this shortage.

Don’t let supply chain disruptions compromise patient care. Partner with Pipeline Medical today and discover how our strategic sourcing solutions can transform your practice’s resilience against shortages while reducing costs. Your success is our mission.

This article is for informational purposes only and does not constitute medical advice. Please consult with a healthcare professional before making any changes to your surgical protocols, selecting medical products, or incorporating new supplies into your practice.

Shortage of Gonak: Managing Hypromellose 2.5% Ophthalmic Solution Alternatives for Patient Care