Help Your Low Income, Uninsured Patients Get Rx Help

As the price of prescription drugs continues to increase, many Americans do not have adequate insurance coverage for this expense and they need prescription drug help. Actual spending on prescription medicine in the United States rose 17.4% from 2005 to 2006 while the average cost of prescription drugs rose 10.2%. Lower income, uninsured Americans may be forced to choose between paying for essential prescriptions or food. A recent Harris Poll of 1300 adults found that 23% of those surveyed had not filled at least 1 prescription for medicine during the year in order to save money. The problem is even greater in households with lower incomes. In households with incomes less than $25,000, 40% did not fill at least 1 prescription, and 30% took prescription medication less often than prescribed to save money. Along with multiple prescription drugs for hypertension, diabetes, or other systemic illnesses, ophthalmology patients often require long-term prescriptions for the treatment of glaucoma, uveitis, or dry eye. Ophthalmology patients may view expensive sight-saving medicine as nonessential, especially when prioritizing the many systemic prescription medicine they require each month.

There are many ways physicians can help their uninsured, low-income patient obtain their much needed medicine at no cost, directly from the drug companies. Virtually all pharmaceutical manufacturers offer assistance programs for those who have no prescription medicine coverage and whose income falls below certain levels. These programs are not widely publicized, and many ophthalmologists and other healthcare professionals may be unaware of the programs. There are several ways to obtain information regarding these programs. The American Academy of Ophthalmology (San Francisco, CA) publishes the Directory of Ophthalmic Pharmaceutical Assistance Programs for the Medically underserved. This directory was created by the Foundation of the American Academy of Ophthalmology’s Eye Care America program. This guide is free to ophthalmologists and provides an alphabetical list of ophthalmic prescription drugs and the manufacturer of each medication. The manufacturers are subsequently listed with information regarding the assistance programs of each drug manufacturer.

Pharmaceutical Research and Manufacturers of America (PhRMA) (Washington, DC) provides a list of companies providing patient assistance programs free of charge. A review of several drug manufacturer patient assistance programs reveals that these programs are currently being used by many who are aware of the programs. Patients must apply separately to each company for each medication and reapplication is typically required every 3 months. Patients may need to provide proof of income such as a tax return or notarized affidavit of financial need. Drugs are either shipped directly to the patient or to the healthcare provider’s office. Several of the applications require the physicians to fill out applications on behalf of the patient. This paperwork may be burdensome but ultimately, as the patient’s advocate, the healthcare provider may be able to ensure that patients will receive sight-saving medicine and avoid a potential decision between paying for food or paying for prescription medication.

There are several drugs assistance companies that act as an advocate for the patient and provide a valuable service. These companies will complete all the paperwork, coordinate the physician’s portion and appeal any denials, which is common. For patients that have multiple medicine and other healthcare provider in addition to their ophthalmologists these firms provide a very valuable service.

Effect of Physicochemical Properties of Ophthalmic Formulations on Ocular Bioavailability Program

The Food and Drug Administration, otherwise referred to as FDA, is a federal government agency operating within the United States Department of Health and Human Services that is primarily responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs.

The grants and programs of the FDA are all geared towards the achievement of its primary agency mission which is to “protect consumers and enhance public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products.”

In this capacity, the Food and Drug Administration has recently established the Effect of Physicochemical Properties of Ophthalmic Formulations on Ocular Bioavailability Program in an attempt to study the effects of various physicochemical properties of ophthalmic suspensions and emulsions on ocular bioavailability.

To this effect, the program will cover the key physicochemical properties which may impact clearance, distribution, and drug release; specifically globule/particle size distribution, surface change, osmolality, pH, viscosity, and dispersibility.

It is known that there are several kinds of ophthalmic drugs which are available in the market today. The goal of this study is to determine which manufacturing differences may result in physicochemical differences which in turn may affect clearance, distribution, and release of the drug.

Furthermore, it is also noted that suitable bioequivalence methods are lacking for many generic ophthalmic formulations, including suspensions and emulsions. Therefore an investigation of the relationship between various physicochemical properties and their effect on ocular bioavailability will help the FDA in establishing guidelines for the determination of bioequivalence of ophthalmic suspensions and emulsions.

The scope of the program will cover two types of inquiries:

a) In vitro study – Formulations with different physicochemical properties are manufactured using a selected steroid and characterized in vitro. Drug release and stability tests are conducted to understand how differences in physicochemical properties may affect ocular bioavailability.

b) In vivo study – Formulations selected based on the results of the in vitro study are tested in an animal model. A pharmacokinetic study should be conducted by assessing the ocular distribution of the steroid in various eye tissues and organs at various time points.

In order to support these initiatives, the Food and Drug Administration is set to administer funds in the amount of $400,000.

The institutions and organizations who will be deemed eligible to submit an application under this program are the following:

a) Private and Public Non-profit entities

b) State and Local Governments

c) Indian Tribal Governments and Organizations

d) Faith-based Organizations

e) Community-based Organizations

f) Institutions of Higher Education

g) Private and Public Colleges and Universities

h) Independent School Districts

The United States Department of Health and Human Services, the mother agency funding the Effect of Physicochemical Properties of Ophthalmic Formulations on Ocular Bioavailability Program, is country’s premiere agency for protecting the health of all Americans and providing essential human services, especially to those who medically challenged and vulnerable.

What Are Lotemax Eye Drops?

Lotemax and Alrex are two brand names of the ophthalmic solution Loteprednol. The rights of this solution were purchased from Pharmos Corporation by Bausch & Lomb for approximately twenty five million dollars in cash. Lotemax is now the number one prescribed ophthalmic steroid brand in the United States.

Lotemax eye drops are generally prescribed for eye redness and irritation that can occur if one suffers from seasonal allergies, a problem with the eye that results in redness or from inflammation caused from surgery. Lotemax is classified as a corticosteroid and is only available through a prescribing physician. One should use caution with these eye drops especially if allergic to the preservative benzalkonium chloride or if pregnant.

Studies have not been conducted on the effects of the ophthalmic solution on pregnancy but high doses of the drug given orally to animals in test trials have resulted in birth defects. If 0.5% solution is prescribed, the user should not wear soft contact lenses but if 0.2% solution is prescribed and the user has eye redness then the individual should wait a total of ten minutes before reinserting soft contact lenses.

Lotemax dosage is one to two drops in the eye four times a day for a period of two weeks. One should take care and not use Lotemax for a period longer than prescribed or discontinue use prematurely. Prolonged use of this medication may result in optic nerve damage and glaucoma as well as vision problems. Problems associated with this medication are increased interocular pressure or fungal infection.