May 8 was World Thalassemia Day. India is the world’s
thalassemia capital with 40 million carriers and 1,000,000 patients who
are on regular blood transfusion. Every year 10,000 babies with
thalassemia major are born in India. Roughly 100,000 rupees are spent
annually on therapy by each patient, 95% of which is out-of-pocket
spending.
Many countries have experimented with various
strategies to reduce the disease load. In Pakistan, carrier testing for
relatives of patients with thalassemia was made compulsory in February
2017. UAE and Saudi Arabia already have similar laws. Iran has a
National Program for the prevention of thalassemia based on carrier
detection and counseling, which has shown very encouraging results. The
Thalassemia Prevention Program in Sri Lanka has introduced an
interesting concept of "safe marriage." School leavers are screened for
thalassemia carrier status. People with a mean corpuscular volume (MCV)
>80 fL and mean corpuscular hemoglobin (MCH) <27 pg are given a green
card. Persons with an MCV < 80 fL or MCH < 27 pg are treated with iron
for three months. If MCV or MCH do not rise, they are tested for
thalassemia carrier status and given a pink card if confirmed as a
thalassemia carrier. Marriage between persons, at least one of whom
holds a green card is called a safe marriage. If both persons have a
pink card, it is considered an unsafe marriage.
Just providing blood transfusions, chelation therapy
and bone marrow transplant options without a strong prevention program
seems a lopsided way of handling a mammoth problem. (The Hindu 7 May
2017)
Lawyers Plan to Sue UK Government for
Pollution-related Asthma
In UK, lawyers are planning an unprecedented class
action against the Government for failing to control dangerous levels of
air pollution. Since 2010, the levels of nitrogen dioxide are at illegal
levels in 90% of urban areas, and are considered to be the culprit for
most of the premature deaths. Since there is enough class I evidence
that air pollution causes reduced lung growth, ill health and premature
deaths, people are agitated that despite 7 years of warning to the
government, safe levels of air quality have not been achieved. (The
Gaurdian 4 May 2017)
Prescribing Generics
The Medical Council of India has released new
guidelines stating that "every physician should as far as possible
prescribe drugs with generic names and ensure a rational prescription
and use of drugs." Close on its heels, a nationwide survey by a social
networking platform for doctors ‘Curofy’, found that 73% of doctors
oppose it.
What are the key issues? It is paradoxical that India
is the fourth largest pharmaceutical producer and supplies around 20% of
global requirement of generic medicines. Yet out-of-pocket spending by
patients in India is a whopping 65.5%. Buying medicines in
non-hospitalized patients accounted for 72% (rural) and 68% (urban)
health costs according to data from the 71st National Sample Survey. The
government is struggling to handle this. One attempt was to introduce
Jan Aushadhi stores – pharmacies where only generic medicines would be
sold. However, as against some 800,000 retail pharmacies in the country,
Jan Aushadhi stores number a little below 3000 – clearly inadequate.
In May 2016, the Drug Technical Advisory Board (DTAB)
considered amending Rule 65(11A) of the Drug and Cosmetics Act 1940, so
that pharmacists could dispense generic name medicines or equivalent
brands of prescribed medicines. But the idea was rejected in view of
bioavailability issues.
Two states which have managed to successfully use
generic medicines are Tamil Nadu and Rajasthan. With excellent quality
assurance systems in place, the public health system in these two states
has managed to procure and distribute free generic medicines to the
people.
Prescribing in generic name or in other words
"International Nonproprietary Name (INN)’ is permitted in two-thirds of
OECD countries like the US, and is mandatory in others, such as, France,
Spain, Portugal and Estonia. Similarly, pharmacists can legally
substitute brand-name drugs with generic equivalents in most OECD
countries, while such substitution has been mandatory in Denmark,
Finland, Spain, Sweden and Italy. In some countries, pharmacists have
also the obligation to inform patients about the availability of a
cheaper alternative.
A valid concern of prescribing generic medicines is
that it shifts decision-making from the doctor to the chemist who may
not understand the scientific rationale behind all prescriptions. The
understanding that doctors have developed by close observation of
patients, of what works and what does not, will also be lost at the
chemist level. Another issue is that half the market is flooded with
combination drugs, and writing generic names of all the constituents is
going to be a big challenge for doctors.
However the Union Health Ministry is already busy in
drafting out a detailed regulatory framework to give precedence to
generics. It is already mandated that the print size of the generic name
will be larger than the brand name for single drug medicines. In India
with 90% of the domestic pharmaceutical industry of Rs 100,000 crore
comprising of branded medicines, and half of them fixed drug
combination, the government has a formidable task ahead.
(Economic & Political Weekly 29 April 2017, The Indian Express 21
April 2017, The Hindu 18 April 2017)