Doctors treat victims of traffic accidents at the Chợ Rẫy Hospital, HCM City. Specially-controlled drugs like morphine are indispensable in these emergency cases, but for the moment, many hospitals are suffering a serious shortage due to a legal hitch.

Habit-forming drugs, psychedelic drugs, “pre-substances,” and radioactive drugs - falling under the particular group of medicines that requires enhanced management - are caught in the transitional period between old and new provisions of the Pharmacy Law, which takes effect starting from 2017.

In Việt Nam, even after a law takes effect, official instructions are issued before concerned agencies start implementing it.

Since the guidance instructions have not yet been issued for the new law, many drug suppliers have had no choice but to temporarily halt the sale of the special drugs, leaving hospitals scrambling to obtain them, from each other, if possible. 

The Chợ Rẫy Hospital in HCM City, a special centrally-run hospital, receives some 330 patients to its Emergency Room each day, almost half of them traffic accident victims. Besides 130-150 patients are operated on each day for various conditions.

However, the hospital’s pharmacology department has scant supplies of specially-controlled drugs, including anesthetics and painkillers like Ketamine and Midazolam – particularly needed in traffic accident emergencies. The stock of drugs like diazepam and morphine sulfate is set to run out in a few days at most.

The Analgesia Department under the hospital’s Oncology Centre has proposed many alternative drugs to the hospital management, but just one has been deemed acceptable.

Meanwhile, Chợ Rẫy has petitioned the Ministry of Health for instructions on the supply of the special drugs, but has yet to receive a response.

Category V drugs that are of irreplaceable importance in treating patients, especially in emergencies, like Diazepam or Morphine (both as tablets and injections), Ketamine, Midazolam and Tramadol, are still proving very hard to obtain.

According to the hospital, in order to ensure an adequate supply for the upcoming Tết (Lunar New Year) holiday and afterwards, the hospital has placed orders for the special drugs with contracted pharmacy companies as per a backup plan approved by the HCM City’s Department of Health, but to no avail.

Written approval

Both Central Pharmaceutical JSC No.1 (CPC1) and Central Pharmaceutical No.2 (Codupha) said they are currently not allowed to sell these drugs due to the amended Law on Pharmacy’s Clause 1, Article 34, which provides that only companies that have received approval in written form from the State management agencies can sell these drugs.

The 30/4 Hospital under the Ministry of Public Security shares Chợ Rẫy’s plight.

Nguyễn Văn Khôi, Deputy Director of the 30/4 Hospital, said that at the beginning of the month, the hospital received a notice from Central Pharmaceutical No.1 announcing a temporary halt to the sale of specially-controlled drugs since the company is yet to get written approval.

Khôi said that since his hospital does not have the capacity to store large volumes, it has been suffering from a serious shortage of these drugs and the pharmacy department has had to negotiate and “borrow” from other hospitals. However, since other hospitals are not faring any better, their generosity is running thin and all sources are running dry.

“In desperate cases, we have to resort to using alternatives, the effectiveness and the safety of which remain a concern. And we can’t tell patients that they are being administered alternative drugs,” Khôi said.

At the HCM City Medical University Hospital, stocks are likely to run out after a few weeks. The hospital is preparing a dispatch to send to the Ministry of Health regarding this issue.

According to the Health Ministry, only five pharmaceutical companies are qualified to import and sell the special-category drugs: Codupha, CPC1, Central Pharmaceutical No.3, Saigon Pharmaceutical Company (Sapharco), and HCM City Medical Import Export JSC (Yteco). These big five are allowed to supply said drugs to hospitals across the nation.

Bùi Hữu Hiền, Deputy General Director of Codupha, said that without express written permission from the Health Ministry, their hands are tied even though “we are not short of the specially-controlled drugs…but they have to remain in storage.”

Hiền said many hospitals are demanding the drugs, but he can’t do anything, so he redirects them to the Agency of Drug Administration (under Health Ministry) to air their grievances.

Only after Tết

A representative from the Agency of Drug Administration said that the instruction decree will be issued, but only after the Tết holiday.

“The decree on implementation of the amended Law on Pharmacy is still being reviewed by the government and is expected to be promulgated after Tết,” he said.

But for some hospitals, this might be too late, because they cannot keep up their normal operations without these special drugs and may be forced to break the law.

The Tuổi Trẻ newspaper (Youth) has reported that a pharmaceutical company has dispatched urgent emails to hospitals in HCM City and other regions, including private clinics, saying the interruption in supply of specially-controlled drugs this month was due to an unexpected lapse in the implementation of State legislations.

Curiously, the emails also advised hospitals how to exploit a "loophole".

Basically, for the time being, the hospitals can still purchase the drugs they need, and the company will date the invoice  December 2016 - prior to enactment of the amended Law on Pharmacy, making the purchase/selling supposedly legal.

Hospitals in dire need of the special drugs have said they might have to circumvent the law this way. 

Hospitals under the management of HCM City’s Department of Health, anticipating problems in the transitional period between the old and the new law, have stocked up and managed to avoid the paucity of specially-controlled drugs that their counterparts under the management of Ministry of Health are suffering from. 

VNS