Juliet:
"What's in a name? That which we call a rose
By any other name would smell as sweet."
Romeo Montague and Juliet Capulet meet and fall in love in Shakespeare's lyrical tale of "star-cross'd" lovers. They are doomed from the start as members of two warring families. Here Juliet tells Romeo that a name is an artificial and meaningless convention, and that she loves the person who is called "Montague", not the Montague name and not the Montague family. Romeo, out of his passion for Juliet, rejects his family name and vows, as Juliet asks, to "deny (his) father" and instead be "new baptized" as Juliet's lover.
But when it comes to medicines, do you say to yourself: What’s in a name? How does it matter if it is a branded drug or a generic? Xalatan or latanoprost hydrochloride?
Many people become concerned because generic drugs are often substantially cheaper than their branded counterparts. The cost difference makes one wonder if the quality and effectiveness have been compromised to make the less expensive products.
Why are generics cheaper than branded drugs?
Actually, generic drugs are cheaper because the manufacturers did not spend for developing and marketing the new drug. When a company brings a new drug onto the market, the firm has already spent substantial money on research, development, marketing and promotion of the drug. A patent is granted that gives the company that developed the drug an exclusive right to sell the drug as long as the patent is in effect. Once the patent expires, other manufacturers can also make and sell generic versions of the drug; and without the startup costs for development of the drug, other companies can afford to make and sell it more cheaply. When multiple companies begin producing and selling a drug, the competition among them can also drive the price down even further.
Is there a difference in the effectiveness or side-effect profile of the generic medications?
The drug authorities of all countries require generic drugs to be equivalent to the original brand name product. Unfortunately the generic drugs do not undergo the same rigorous testing that is undertaken when the original patented product is released, so in some cases doctors may experience dissatisfaction in terms of IOP reduction or slight exacerbation of adverse effects such as increased hyperemia with the generic drug. But one cannot generalize that all branded drugs are better than all generics.
An Indian patient on Xalatan is now switched to generic latanoprost by his doctor as his dispensing pharmacy no longer provides Internationally marketed brands, and he is very apprehensive about the changes in his IOP profile. What needs to be explained to him to reduce his concerns?
Three alternatives should be discussed with the patient.
First, that he can try the generic drug and review its effects with his ophthalmologist, 3- 4 weeks after starting it.
Alternatively, he can pay the additional cost of continuing on the brand name, Xalatan itself, although the cost difference may hurt his pocket.
Lastly, he should be told that there are two other similar products that are available in case the generic does not work and he cannot afford Xalatan. These medications are Lumigan (bimataprost, Made by Allergan, Inc.) and Travatan (travoprost, made by Alcon, Inc.) and he can be switched to these, if need be.
In general, patients who are switched to a generic product should be told that the eye drop size delivered from the bottle and the amount of product in the bottle itself may vary in generic products. Hence, they should keep a note about how long the generic bottle lasts so that a timely refill can be taken.
Back to the key question: What may account for differences between generic and Branded?
Some differences will have a scientific explanation while others will be anecdotal in nature. IOP is a very difficult parameter to assess due to the significant fluctuation over the diurnal and nocturnal periods. When a patient is switched to a new medication or generics, it is often difficult to determine whether the switch or the fluctuation in IOP is the primary reason for a change in IOP relative to the previous visit.
Ocular tolerability, in contrast, is easier to assess as patients will commonly bring side effects to the physician's attention.
Generic- Branded drug scenario across the globe
Even the most developed nation, USA, has one of the highest levels of generic drug use relative to total prescription volume among developed nations. So, it is logical that a similar scenario would exist in developing nations.
In India more than one-third of the population is below the poverty line (earn less than 10 rupees per day) and a 2007 report by the state-run National Commission for Enterprises in the Unorganised Sector (NCEUS) found that 77% of Indians, or 836 million people, lived on less than 20 rupees (approximately US$ 0.50) per day. This fact must be kept in mind and the income of the family noted before prescribing expensive glaucoma medications which are to be taken lifelong.
Generic low cost versions of prostaglandins which are free of BAK preservative are now available in India (eg. Xovatra – Travoprost by Cipla Inc., Latoprost RT- Latanoprost by Sun Pharma, Travo Z – by Micro Vision Inc.) which may be used as cost is a very important issue in developing countries.
How to establish whether a generic is working or not?
When any generic version is used where field trials on efficacy are not published, one must check the percentage drop in IOP (atleast 20%), size of the drop/nozzle of the bottle to ensure only 1 drop comes out with each squeeze of the bottle and the availability of the drug in the native place of the patient to ensure a good compliance.
Well, in a nutshell our challenge as eye care providers is to be cognizant of the unknowns regarding ophthalmic generic medications
