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Drug shortage – emergency in state health sector that needs to be addressed now
View(s):- Chilling disclosures by powerful SLMA Panel of health experts
By Kumudini Hettiarachchi
This was the chilling revelation by a panel of powerful health experts of the Sri Lanka Medical Association (SLMA) on Thursday afternoon.
“Some hospitals may be having limited stocks of these medicines. Of the zero-stock 160 medicines, about 60 medicines are expected to be imported shortly, the Health Ministry has indicated,” said panellist and President of the College of Anaesthesiologists & Intensivists, Dr. Anoma Perera.
She underscored that not only is there a shortage of some essential drugs but there are no stocks at all of others. Some examples are anaesthetics and pain management medicines. Both local and general anaesthetic agents are not available, limiting the options of the doctors.
As Dr. Perera’s college members provide their expertise across the board whether it is a patient in the Intensive Care Unit (ICU), someone who has undergone surgery, an expectant mother who has had a Caesarian section or a victim of an accident, a shortage or lack of medicines would impact them all.
From the left: Dr. Anoma Perera, Prof. Priyadarshani Galappatthy, Dr. Vinya Ariyaratne, Dr. Pramitha Mahanama and Dr. Ananda Wijewickrama. Pic by M.A. Pushpa Kumara
“Whether it is a rural hospital or the National Hospital of Sri Lanka (NHSL), whether it is a state or private hospital, the impact is all over the country. It impacts you and me and if we ignore it anymore, there is a looming dedi asaadya thathvayak (critical situation),” said Dr. Perera, adding it is an avadanam kalayak. In the next few weeks, there would have to be a limitation of all health services, leaving room only for life-saving procedures, if this need is not addressed immediately, right now.
She stressed that the situation can be managed and overcome like Sri Lanka did with the COVID-19 pandemic, “if we act now with the proper use of available resources and strict fiscal discipline”.
Dr. Perera requested people, on their part, to take urgent measures to help overcome this crisis. “Do not throw away any medication prescribed to you but take the full regimen. Control your illnesses, if you are suffering from chronic diseases such as diabetes. Try and prevent accidents whether in your home, on the roads or at your workplace.”
The SLMA Panel told a media briefing on ‘Non-availability of essential medicinal drugs in the health sector’ that the immediate need is to import only essential medicines and halt all imports of non-essential medicines and manage the patients carefully until the country comes out of this major economic crisis which is impacting heavily on health.
The other members of the panel were SLMA President Dr. Vinya Ariyaratne; the Professor of Pharmacology, Faculty of Medicine, University of Colombo, Prof. Priyadarshani Galappatthy; and Consultant Physician, National Institute of Infectious Diseases (NIID), Dr. Ananda Wijewickrama. The discussion was moderated by SLMA Council Member Dr. Pramitha Mahanama.
On a positive note, the panel said that beginning Tuesday, the Health Ministry has set up a committee comprising all stakeholders such as representatives from professional medical colleges, associations and the Government Medical Officers’ Association (GMOA) and health officials to discuss and find solutions to take prompt action with regard to this situation.
The committee, chaired by the Director General (DG) of Health Services, Dr. Asela Gunawardena, is scheduled to meet weekly, with a monthly meeting with the Health Minister also on the cards. In addition to ministry officials, the committee includes those from the National Medicines Regulatory Authority (NMRA), the Medical Supplies Division (MSD) and the State Pharmaceuticals Corporation (SPC).
Dr. Ariyaratne said that the SLMA had predicted a crisis with regard to a shortage of medicines, in a letter to then President Gotabaya Rajapaksa, in April 2022 (last year) and urged “immediate action”.
Now the crisis is upon us, he said, stressing that if there is a further
delay in addressing this critical need, patients would be in grave danger. It is clear that there is an emergency, barapathala thathvayak.
“Like all our experts have pointed out though this is a challenging time, it is also an opportunity to define and introduce a strong drug management system which would be of immense value to the country in the long term,” added Dr. Ariyaratne.
Prof. Galappatthy who chairs the SLMA’s Sub-committee on Medicinal Drugs said that as the earlier system could not be followed due to the economic crisis, they saw the need to send recommendations (nirdesha) to minimize the import of non-essential medications. Is Sri Lanka using the Indian Credit Line optimally – for the import of essential medicines versus non-essential medicines?
“Seeing shortcomings, we requested a mechanism to support the Health Ministry because the doctors from all professional colleges are working across the country at all hospitals and dealing with patients on a daily basis. This is why the DG has set up this committee,” she said, pointing out that it would help to focus on critically required medicines, identify whether they can be secured in the form of donations; whether one hospital facing a shortage can borrow any excess stocks another hospital may have; or whether medicines need to be purchased from abroad. The committee discussions would help show the way forward.
Referring to donations, Prof. Galappatthy said that non-essentials can also come into the country this way, while it may be difficult to maintain standards if there was a flood. Importing medicines cannot be equated to importing something like soap.
She reminded how Sri Lanka faced a similar situation during the tsunami and large stocks not only of non-essential medicines but also expired ones had to be destroyed at great cost. There should be no repetition.
| Arbitrary registration waiver for over 270 medicines by NMRA CEO By Kumudini Hettiarachchi Sri Lanka’s drug regulator has arbitrarily authorised the import of over 270 medicines into the country without evaluation and thus without an assessment of quality, safety and efficacy. The Chief Executive Officer (CEO) of the National Medicines Regulatory Authority (NMRA) has approved the import of these medicines, giving a ‘Waiver of Registration’ (WOR), Consultant Physician Dr. Ananda Wijewickrama told a media briefing on Thursday when a Sri Lanka Medical Association (SLMA) Panel revealed this serious breach of protocol. Dr. Wijewickrama said that this serious violation came to light when a document titled ‘Issued WOR approvals for the procurement from the ICL (Indian Credit Line) pathway’ was tabled at the 74th meeting of the NMRA’s Medicines Evaluation Committee (MEC) on January 24. The matter had also been discussed when the Health Ministry summoned a meeting of representatives of medical professional colleges such as the physicians, surgeons and microbiologists and the Government Medical Officers’ Association (GMOA) as well as the NMRA, Medical Supplies Division (MSD) and the State Pharmaceuticals Corporation (SPC). The meeting held on Tuesday chaired by the Director General of Health Services discussed how to overcome the severe shortage of essential medicines in state hospitals. “With this registration waiver given by the NMRA CEO, medical specialists are concerned over whether there is assurance of quality, safety and efficacy,” said Dr. Wijewickrama. Explaining the usual process with regard to registration of new medicines, he said that the NMRA’s MEC checks all the dossiers before granting registration. In instances where the country needs urgent drug imports such as when there is a sudden outbreak of disease, a disaster or life-saving drugs are needed on specific instances, a sub-committee of the MEC fast-tracks the evaluation, before recommending whether a waiver of registration should or should not be granted. The Sunday Times which saw the document granting the registration waiver to the 270-odd drugs noted a column which indicated ‘CEO/NMRA Approval’. These approvals had been given since September last year (2022). When asked whether any of these unevaluated medicines had been brought into the country, Dr. Wijewickrama said he did not know. When the 270-odd list given the waiver was tabled for NMRA Board approval, the members representing the professional medical colleges had insisted on an evaluation and now it has been sent to the MEC’s sub-committee. “The irony is that when the country is hard-hit for valuable dollars, among these 270-odd medicines are also numerous non-essential medicines. There is a standard Formulary for all medicines disbursed to state hospitals, which has been prepared after exhaustive discussions with doctors, pharmacists etc., and is updated from time to time. Some of the 270-odd medicines are not in the Formulary as well,” he said. Stressing that it is shameful to waste money on non-essential medicines when the country is utilsing a loan from India which has to be paid back and while state hospitals are crying for essential medicines of which there is a massive shortfall, he asked: “Who ordered such drugs and why and if some of these drugs are not in the Formulary and are non-essential, why has a registration waiver been granted?” Meanwhile, a Consultant Dermatologist in the audience at the media briefing pointed out that the list even had a hair shampoo. | |
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