[e-drug] For cheaper drug options, send SMS (3)

e-drug
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E-DRUG: For cheaper drug options, send SMS (3)
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[Some practical difficulties of implementing this scheme in India are addressed. However, providing patients with price information can be a very powerful tool leading to patient pressure on prescribers and dispensers for cheaper options. Let's hope they will have means of assessing whether the measure has any effect once implemented. DB]

Dear colleagues

I am afraid this SMS idea is impractical and even illegal for the following reasons;

(1) Under Indian laws applicable to retail pharmacies, substitution of one prescribed brand by another brand, even if cheaper or more expensive, is not permitted. Hence even if the patient is informed about a cheaper brand, the pharmacy will not dispense the same.

(2) The trade discount on drugs is in percentage terms usually 16 to 20% of the retail price. The pharmacy will make less profit on a cheaper brand; hence it will not dispense.

(3) There are over 60,000 brands of medicines produced by just over 8,500 pharmaceutical manufacturers in India. Most brands are sold in certain areas only. Hence even if a cheaper brand is suggested to a patient, the same is most unlikely to be available in the local pharmacy.

(4) Even if brands of large manufacturers (except MNCs) are suggested as alternatives, the price difference is not much. Hence the whole exercise may not be worth the trouble.

(5) Major benefit is if unbranded drugs are suggested because they are far cheaper. The problem is that (a) multi-ingredient products (about 47% of all medicines sold in India) can not be sold without brand name for obvious reasons and (b) the power of prescription will merely shift from prescribers to pharmacies.

(6) The responsibility for the treatment of patients lies with doctors. If a brand is substituted and the patients does not benefit, the doctor (who is obliged to the drug companies due to incentives and freebies) will wash his hand off and hold patients for consuming the 'wrong' medicines.

(7) There are many critical medicines such as anti-epilepsy drug phenytoin sodium where brand substitution is not permitted due to lack of bio-equivalence. In such cases patients can be harmed.

(9) Generic drugs, produced domestically, are not very expensive in India. The major problem lies with patented monopoly drugs which are beyond the reach of 90% or more Indians. There are no cheaper alternatives to such medicines.

All in all the whole idea [should be shelved - part of message missing; moderator] at the least and a well thought out diversion to distract attention from the popular demand to put a cap on all drug prices in India. Under the influence of the drug industry lobby, the Government of India has been dragging its feet in implementing a Supreme Court directive to bring all essential drugs under price control.

Dr. Pankaj Talwar, MD.
Consultant Physician.

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E-DRUG: For cheaper drug options, send SMS (4)
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Dear E-Druggers

I agree that retail pharmacists cannot substitute the brand name written by a doctor in India. This program is not for pharmacists to do substitution but for providing information to consumers.

I have done many surveys on medicine prices and availability in different states of India using a standard methodology developed by WHO and HAI. A recent survey was carried out in National Capital, Delhi in 2011. The data for private sector is collected from retail pharmacies situated in all eight districts of Delhi. I have also done the medicine price components study whereby finding the actual mark up (profit) for wholesalers and retailers for few medicines for their three popular brands and for three not so-popular brand (branded generic).

I would like to make the following points in connection to the on-going discussion of providing prices of a medicine for its different trade names:

Every pack of medicines in India is printed with MRP (maximum retail price). Except for medicines whose price is controlled by NPPA (national pharmaceutical pricing authority), under Ministry of Chemicals and Fertilizers the MRP is fixed by the manufacturer.

The Government or NPPA fixes price for only 74 medicines and it includes only 38 essential medicines, the rest are not commonly used. For all other medicines (except the 74) the manufacturer decides the mark up for wholesaler and retailers. There is no transparency for in fixing the MRP.

For each medicine (INN pharmacological moiety) there are dozens of trade names available in India; Popular trade names are called branded medicines as they are pushed by the manufacturer via doctors and not so popular trade names are called branded generic and are pushed in the market by the retailer.

I do not agree that on medicines with inexpensive or comparatively cheaper MRP (maximum retail price) printed have less percentage of margins for retailers. Retailers have higher margins than the established 16-20% on most of the medicines.

In my opinion it is good to provide information to patients or consumers about the price of different 'brands' available with the name of manufacturer. Consumers should know the price difference and the range available. Maybe next time when she/he visits a doctor she/he can ask for prescribing a medicine with an inexpensive [lower] price. This program should be taken as creating awareness about the medicine prices and this is one of the important factors that can bring down medicine prices.

In India, almost all reputed companies make two versions of the same medicines, with difference in price structures, one is their 'branded' product or popular product and other branded generic (for details see Singal G, Nanda A, Kotwani A. A comparative evaluation of price and quality of some branded versus branded-generic medicines of the same manufacturer in India. Indian Journal of Pharmacology 2011; 43: 131-136.)

The recent survey conducted in Delhi has clearly shown that there is huge price variation in a few medicines which were available in retail pharmacies and some of these medicines are ofloxacin, doxycycline, diclofenac, ciprofloxacin, amoxicillin+clavulanic acid, amlodipine, amitriptyline, cefuroxime, cefixime.

BUT we should know who is responsible for providing this information on SMS. The company or the organization should not have any dealings with any pharmaceutical company(ies). The name of the organization, its members with their declaration of conflict of interest should be identified and should be available on the website and appear in the newspapers. We need transparency in the system and we require good governance and commitment.

Best,
Anita Kotwani

Dr. Anita Kotwani
Associate Professor
Department of Pharmacology
Vallabhbhai Patel Chest Institute
University of Delhi
Delhi 110007
India

[Message edited by moderator for clarity. DB]

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E-DRUG: For cheaper drug options, send SMS (5)
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Dear E-Druggers,

I fully agree with all the points made by Dr Anita Kotwani except however
her definition of 'branded medicines'* versus* 'branded generics' on the
basis of 'popularity' of the product. This may add to the confusion
surrounding these terminologies that otherwise generally prevail.

To keep it simple, the term 'brand' is to be reserved for referring to the
name given by the innovator company who holds the patent, before they
market the researched product. 'Generic medicines' are marketed either
under a non-proprietary name (INN), for example diazepam when they are
called the 'true generics'. Occasionally generic medicines are marketed
under another proprietary or brand name - the 'branded generics'. Thus the
'branded generics' signifies generic equivalent of the originator brand,
marketed by a company other than the innovator company, and
*usually* marketed after expiry of the patent. Therefore,
for each INN medicinal product, there is only one originator brand, there
may be many true generics and many many (no one really knows how many)
branded generics.

In India we have innumerable branded generics - no one really knows how
many. And they do differ greatly in prices. Although the prescribers
have a general belief that the lower the cost the more inferior the quality, there is no hard evidence that the relatively inexpensive branded generics are of poor quality. Rather evidence to the contrary is available. Dr Kotwani's Group in their recent study had shown this (Singal G, Nanda A, Kotwani A. A comparative evaluation of price and quality of some branded versus branded-generic medicines of the same manufacturer in India. Indian Journal of Pharmacology 2011; 43: 131-136).

Best wishes.

Dr Santanu K Tripathi
Professor of Clinical Pharmacology
Calcutta School of Tropical Medicine
Kolkata 700073

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E-DRUG: For cheaper drug options, send SMS (7)
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Dear All,

The definition mentioned by Dr. Tripathi for originator (innovator) brand and generics are correct.
However, in India the situation is different.
Until 2005, the Indian regulatory system used a system of process patents that encouraged the growth of India’s generics industry. In real sense we have only generic versions for all medicines that are manufactured in India. Medicines in India are known as “branded” and “branded-generics” but both describe generic medicines. Because all companies want to generate name recognition for their product, all products carry a brand (trade) name. So called branded medicines are manufactured by a multinational or a reputed Indian manufacturer. The manufacturer’s medical representatives to prescribers, often by means of incentives, market them. Branded medicines are more popular and are the most-sold medicines in India.
“Branded-generics” more closely resemble what are globally referred to as ‘generics’. Though not truly generics as they have a trade name and the cost is not significantly lower than the branded product. Branded-generic medicines have less name recognition, and it falls on the retail pharmacy to promote the medicine.

Originators brands

(OBs) in India are also pooled with branded medicines and as such do not have any additional recognition as originator brand. Many-a-times OBs are not available but the same molecules are manufactured by other companies with different trade names and are popular trade name and are recognized as
branded product.
The papers cited
in the previous messages and the report on medicines prices and availability in NCT, Delhi on HAI website will make the subject more clear.
Cheers,
Anita

Dr. Anita Kotwani
Associate Professor
Department of Pharmacology
Vallabhbhai Patel Chest Institute
University of Delhi
Delhi 110007
India
anitakotwani@yahoo.com

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E-DRUG: For cheaper drug options, send SMS (8)
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Dear Colleagues:

Further to this e mail thread, I quote from Dr. Tripathi's message (SMS (5)): " ... . Although the prescribers have a general belief that the lower the cost the more inferior the quality, there is no hard evidence that the relatively inexpensive branded generics are of poor quality."

I wish to bring to your attention an interesting paper by Bate et al. (PDF should be available at http://www.nber.org/papers/w16854), entitled "Does Price Reveal Poor-Quality Drugs? Evidence from 17 Countries" which essentially supports the statement quoted above.

regards

Warren Kaplan
wak@bu.edu

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E-DRUG: For cheaper drug options, send SMS (9)
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Dear colleagues,

This is very impressive feedback from colleagues in India, and goes to paint just how complex the pharma sector has become. The whole issue of presicriber's legal responsibility for what he/she prescribes cannot be overlooked. Further, the expectation that the pharmacist can or should change the prescribed product to another form should not be taken for granted (consider legal implications in doing so; also consider the impact on pharmacists, the prescriber and more so on the patient if a product with a narrow therapeutic index is prescribed but then substituted with the same named product but from a different manufacturer, but the patient experience no treatment result or worse a fatality occurs because of that interchange). To a great extent, therefore, it is not about prescribers sticking to a preferred product in order to support a 'freebee' lifestyle (of course, there are some medical people who support the habit that way, particularly where legal, professional oversight systems are weak); I think it is about these technical / legal responsibilities that are based on processes of trial, evidence, etc.

This interplay between the legal rights of the prescriber to prescribed a product that they have experience with, which has shown results in their patients, and the requirements to cut the cost of healthcare by supplying cheaper (read: quality assured, bioequivelance products or 'true generics') is a matter that needs to be handled in a considered manner. I do not believe that we can only focus on the retail price alone. I believe that public health institutions of government must take all these factors into account and ensure that the government provide a cost- effective health service. That process will include dialogue with pharma industry- the originators and manufacturers of generics, since one is dependant on the other (I also believe that originators would want to see a true generic product made by others, that extends the originator legacy), the prescribers, the pharmacists, the regulators and the public.

I agree with the moderator that indeed providing the general public with information on retail prices for any medicine is a service that will also help inform the decision- making process, even if this sort of service would be clearly complicated in a country the size of India, with thousands of generic products (branded or not), thousands of retail outlets. This is where technology can be of use, in helping inform the public. I am also reminded that the need for providing such information to the general public was the basis for global initiative such as the Medicines Transparency Alliance (MeTA), difficult and challenging as the process is. However, if information can be made to the public on what constitutes a retail price in an environment where there is no retail price controls, the public can make informed choices; further, that sort of transparency could help address the artificially high retail prices that can be found in some outlets.

Regards,

Bonnie

Bonface Fundafunda PhD., MBA., B.Pharm
Manager and Technical Adviser,
Drug Supply Budget Line
Ministry of Health,
P.O. Box 30205,
Ndeke House,
Lusaka,
Zambia
Tel: +260 211 25 41 83
Fax: +260 211 25 33 44
Mobile: + 260 979 25 29 00
Email: bcfunda@hotmail.com

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E-DRUG: For cheaper drug options, send SMS (11)
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[E-druggers have had interesting debates after the first SMS message. However, let us focus on the value of SMS services and mHealth in our essential drugs work in this thread.
Other topics such as new books and discussions on generic substitution are important, but please start new subjects for those. Thanks, WB]

dear E-druggers,

I recommend folks read David Healy's freshly thought-out new book, PHARMAGEDDON. He explains why things would be better if far fewer drugs required a prescription, including some of the issues/problems mentioned here below.

Best,

Don Light
Donald W. Light
Cell: 609-216-0071
Professor, UDMNJ-SOM
Visiting Researcher, Center for Migration & Development, Princeton University
Network Fellow, Edmond J. Safra Center for Ethics, Harvard University
Senior Fellow, Center for Bioethics, University of Pennsylvania
dlight@Princeton.EDU