Date: 02/12/2024
Details regarding maternal deaths in
districts of Karnataka between 2023-2024 that needs investigation
The recent maternal deaths in Ballari district hospital is
devastating. It is good that the state government is taking some action towards
investigating the matter in other districts as well and has formed an expert
committee for it. Although the issue has received attention now, these incidents
are not limited to just November 2024 and Ballari district alone. Here are a few details of deaths in other
districts earlier this year and previous year (2023) in addition to the recent
unfortunate maternal deaths in Ballari that needs investigation. (collected
by having informal conversations with the health workers in various health
facilities and district drug warehouse)
- Davanagere district Hospital (Chigateri Hospital) - had
5 maternal deaths occurred in Feb 2024 post C-section due to Acute
Kidney Injury (AKI) and reduced urine output and there were conversations
that this was possibly due to substandard ringer lactate (RL) solution.
- A woman (from Davanagere district) died due to AKI in
Davanagere Hospital in Dec 2023 or early January 2024 in Chigateri
Hospital who
otherwise had uneventful pregnancy and good antenatal care - delivered in
Harihara Taluk Hospital (government) through C-section in Nov, 2023 (last year). After multiple referrals
and hospitalisations including Shimoga district hospital, she lost her
life. The family spent around 2.5-3 lakh pushing them to extreme poverty
with them not having enough money to even purchase formula milk for the
newborn.
- A few health workers also
stated that similar deaths were
being recorded in other taluks and districts like Chitradurga during
Feb/March 2024 due to sub-standard RL or fungal contamination of RL.
- A recent newspaper article also
reported regarding the high
maternal deaths over the last 7 months (28 maternal deaths and 135 infant
deaths) in Davangere district hospital - https://hosadigantha.com/135-infants-and-28-pregnant-women-died-in-this-hospital-in-davangere-in-7-months/
- District Drug Warehouse worker in Davangere mentioned
that - quality control issues had occurred (where the quality testing had
shown RL as “not of standard quality”) in March 2024 had prompted the decision to
halt the supply of RL IV fluids. Usage of the affected batch was asked to
be ceased across all centres, and the new batch was still pending in
April. Retrieval of the affected batch from the centres had not yet
occurred in April.
- In the Women and Children Hospital, Davangere - all women were
experiencing drug reaction after tubectomy and had to be stabilised and
observed in the month of March and April, 2024 and the procedure was
paused with cause not known.
The
questions that arise are -
- Since when is this substandard RL/drugs causing deaths
and impact in Karnataka across districts? - transparent investigation is
required at least since last year as some of the above deaths occurred
during Nov 2023 and there would be many more alike in other districts. Deaths need to be audited in all
government facilities across districts since 2023. This includes -
- Maternal deaths across
districts 2023 - until Nov 2024
- Patients admitted to
government hospitals across districts and who died of - Acute Kidney
injury, anaphylaxis/drug reactions, sepsis, septic shock, endocarditis/
cardiac failure etc especially if young / unexpected.
- To evaluate - Outcomes of
patients admitted to government hospitals across districts and who were
given RL in these months
- Why was the drug quality testing done after the issue
occurred and not before distribution of the batches of RL? Is quality testing not part of
the protocol of drug procurement by the KSMSCL? If quality testing and
certification was done beforehand, then how did this batch get through the
process? This is in deep violation of patient safety and accountability.
- As per the details provided on
KSMSCL website, “if two or more
than two batches/products fails in quality testing, then such firms will
be blacklisted”. Although the
company was blacklisted on 22/03/2024, the high court put a stay on this
order on 04/04/2024. This occurred due to lapse in KSMSCL in following the
protocols of blacklisting. Moreover, why was the distribution and usage of
RL manufactured by the same company continued in the system? In fact
if quality testing was done before the distribution, these preventable
deaths could have been prevented!
- Compensation has been spoken
about in the context of women who succumbed to this incident in Ballari in
November, 2024. But compensation
will have to be provided to all the patients who have died due to this
across districts and across the one year timeline.
- Further, RL is a fluid given
not only for pregnant women during C-section, but is a commonly used fluid
for patients undergoing other types of procedures/surgeries, for patients
needing hydration etc. Hence are
there other deaths other than maternal deaths that have occurred in
various districts among people who accessed government facilities between
Nov 2023- Nov 2024 due to this fluid? This has to be thoroughly
investigated.
Further at
this juncture, we would like to highlight overall glaring gaps and dereliction
of duty in general by KSMSCL -
● Last annual indenting and tendering
process was done in 2021 and has not happened after.
● Due to this - despite a significant
increase in drug consumption post-COVID, the state has not been able to meet
this demand
● Although 733 medicines (as per list)
are promised by KSMSCL to procure and make available in public health
institutions which is being promised to be expanded to 1000, over several
years, KSMSCL has repeatedly fallen short and procures only around 300-500
drugs and even among them severe shortages are a ground reality in most public
institutions leaving large sections of population having to spend OOP for
medications even in public hospitals. A rapid survey conducted by SAA-K found that on an
average a patient spends ₹ 433 per visit for medications after a visit to a
government hospital.
● As per the quality control measures
described by KSMSCL, random samples of a batch of drug are sent for testing in
empanelled laboratories but simultaneously the batch is “eligible to issue to
health institutions” while these reports are pending. Only when the report
returns as NSQ “Not of standard quality”, the drugs are frozen and withdrawn
from use. This protocol itself lacks patient safety as the drug by then would
have been used for thousands of people across the state and put them at danger
of substandard drugs.
● Further increasing reports of
corruption by KSMSCL have been reported over the years - purchasing without
approvals, favouring blacklisted companies, diverting supplies, and
malpractices at every stage of procurement. [1],[2],[3]
● The indenting system in the
peripheral health institutions through the e-Aushada software is done in such a
manner that the peripheral institutions can only indent what is available as
opposed to what is actually required, thus hiding the actual deficits in supply
faced by the institutions.
● All processes of tender,
procurement, quality testing, pricing, blacklisting, are done in an opaque
manner with the public being uninformed. The entire process should be made
transparent by KSMSCL and all details have to be provided on the website.
● Consumer groups have been advocating
to do drug procurement as done by Tamil Nadu Medical Services Corporation, even
the Chief Minister recently said so but these have remained only empty
statements.
● There is an urgent need to
streamline KSMSCL by forming a committee headed by the Chief Minister with all
bureaucrats concerned and civil society representatives.
Thus, the above issue of maternal deaths is embedded in this
systemic failure and dereliction of duty by KSMSCL and legal action against
KSMSCL and the pharmaceutical company needs to be taken. Further measures to
streamline the process of drug procurement and quality control by KSMSCL and
making it transparent needs to be brought in place at the earliest.
❖ Drug Action Forum – Karnataka (DAF-K https://daf-k.blogspot.com/) is an independent, registered,
not-for-profit organization campaigning for Rational Policy & Use of
Medicines and has been active since the year 2003. DAF-K is part of All India
Drug Action Network (AIDAN https://aidanindia.wordpress.com/) and has been working for revamping
of KSMSCL since the year 2008. It has examined in detail the model at Tamil
Nadu (https://tnmsc.tn.gov.in/), Rajasthan and Kerala model of drug
procurement. DAF-K member was part of Karnataka State Gnana Ayog (Knowledge
Commission) on “Access to Free Medicines.” DAF-K has worked as a member of
Planning Commission on access to medicines.
❖ Given this experience in the domain
of access to medicines, we suggest that DAF-K be included in the committee that
is being formed.
We demand the committee to identify all the families who
have suffered through this over several months to be adequately compensated
across districts.
Yours
sincerely,
Dr Gopal Dabade
Dr Swathi SB
Karibasappa M
Dr Shivanand Pawar
DAF-K (Drug
Action Forum - Karnataka)
[1] https://www.newindianexpress.com/states/karnataka/2024/Oct/20/ksmscl-officials-diverting-medical-supplies-elsewhere
