SPECIAL REPORT: PUBLIC SAFETY AND SUBSTANDARD DRUGS
Substandard
Drugs Are Killing Poor Filipinos
Deaths
and injury caused by substandard drugs in Philippine hospitals are raising alarm. But no one, let alone the authorities, seems to be doing anything about
the problem.
(First of Three Parts)
By
MIKE AC-AC and RACHEL ANNE CALABIA
In the afternoon of June 5 last year, Prescilla Galao, a teacher in a community daycare center, bled to death a few hours after a normal and spontaneous delivery of a baby boy inside a public tertiary hospital in Tagbilaran City, Bohol.
Clinical records from the Gov. Celestino Gallares Memorial Hospital (GCGMH) indicate that Galao succumbed to “postpartum uterine atony,” a condition characterized by profuse bleeding after delivery of baby and placenta. She was 41.
In the Philippines, where one mother dies for every 1,033 live births, Galao’s case would seem appallingly ordinary. Her case could have been just another statistic, until an unexpected twist came two months later.
Substandard
Drug Victim?
On August 10, the 16 resident doctors, consultants and specialists from the ob-gyne department of the GCGMH signed a two-page confidential letter to hospital administrators. The letter raised concerns about a particular drug in the hospital pharmacy, apparently for its questionable potency and efficacy.
The drug was methylergometrin maleate, an injectable solution used to stimulate uterine contraction after delivery. Doctors noted an unusual increase in uterine atony among patients with the use of a particular batch of the drug supplied to the hospital by a local company, the Pasig City-based generics importer Phil Pharmawealth Inc.
The same batch of drug was administered to Galao and four other patients, all admitted at the hospital from early June to late July. The drug proved ineffective even in high doses so that the five patients had to undergo emergency hysterectomy (surgical removal of the uterus) to prevent further blood loss.
The operation failed to save Galao, who passed away barely five hours after delivery. The four mothers who survived were confined for more than a week. One patient, 38-year-old Trifena Lanzaderas, who had normal delivery but spent nine days recuperating from the hysterectomy operation, had hospital bills running to more than P12,000. Her husband Diego, a corn farmer, was able to raise the money through loans and earnings from an entire harvest season.
“Five successive uterine atony cases in just two months is definitely unusual and alarming,” a GCGMH source told Ibon Features in a recent interview. “A patient in confinement is constantly monitored…so nothing like this should happen.”
Previously, one case in a year was enough to cause concern in the ob-gyne department, which delivers an average of 10 babies daily. The only tertiary hospital in the province, the GCGMH caters to poor Boholańos from Tagbilaran City to as far as Alicia town, which is some 103 kilometers away.
In the same letter, the doctors requested that a branded drug with good track record be stocked at the pharmacy to prevent further harm to patients. But the request was denied by the administration for still unclear reasons.
Eventually, the hospital did phase out the drug late last year, but this was about a month after the ob-gyne resident doctors decided among themselves not to prescribe it.
Instead, the doctors made the patients (or their companions) choose between the generic drug available at the hospital and its branded counterpart that is double the price but with a reliable clinical record. As expected, patients opted to spend more than risk their life with the unreliable generic. The doctors themselves carry with them three to four ampules at their own expense whenever they are on duty for cases where indigent patients cannot afford the branded drug.
To this day, the case of the five Bohol mothers remains unsolved. The doctors were never updated on the investigation -- that is, if any serious effort was ever carried out by health authorities.
The letter of the 16 doctors was forwarded in September to the Bureau of Food and Drugs (BFAD) office in Manila, which sent a staff member to Bohol to gather more details on the five cases.
But when the case was brought up late last year in a meeting of Department of Health (DOH) officials that included then secretary Alberto Romualdez, the latter reportedly refused to touch the issue.
Ibon Features also visited the GCGMH administration in Tagbilaran City for an update, but hospital chief Dr.Nenita Po declined to comment, saying she had “more important matters” to attend to.
Health Secretary Manuel Dayrit, who had replaced Romualdez after the People Power II uprising, claimed in an interview with Ibon Features that his office has not received any written complaints from government doctors about substandard drugs or reports of adverse reactions.
Dayrit did admit to hearing stories about questionable drugs in the regions and government doctors “who have actually signed petitions.” But he was quick to point out that in many of these cases, the drugs in question were discovered to be counterfeit.
The methylergometrin maleate in the Bohol case was not counterfeit. The drugs were imported from Mercury Laboratories Ltd. in India and repackaged for local distribution by Phil Pharmawealth. The latter is one of around 70 generic drug manufacturers and distributors authorized by DOH to sell medicines on the market and bid for government contracts.
A sales invoice issued in April last year from the GCGMH pharmacy showed the hospital had procured from Phil Pharmawealth 500 ampules of methylergometrin maleate under batch number MIE-909.
The drug was bought at only P12 per ampule. Clearly a bargain, since the same ampule costs P85 at a commercial drugstore located just outside the hospital. On the other hand, a branded drug of the same kind manufactured by a foreign company costs around P156. The hospital thus saved some P73 to P144 per ampule, or anywhere between P36,500 to P72,000 for 500 ampules.
In the last two years, the DOH has taken pride in its campaign to lower domestic drug prices by encouraging imports from countries where drugs are manufactured cheaper. But at what cost?
Pressed by Ibon Features whether these imported drugs go through the government’s screening process before distribution to the local market, Dayrit admitted that only some do. But he clarified that this procedure was legal under current international laws on trade and product standards.
With the advent of liberalization, tariffs have been lowered and production quality standards “globalized” to facilitate smoother trade between countries, including medicines and drug products.
The government’s program of decentralization, on the other hand, dispersed several functions (including drug procurement) from the DOH central office to the regions and local governments. Procurement officers at the regional and local level or at the hospitals themselves deal directly with accredited drug distributors, and are subjected to all kinds of pressure and offered favors.
Local governments and hospital pharmacies in the regions have reportedly become a haven for substandard drugs since regulations there are not too strict. Competition is so fierce in the provinces that drug companies undercut each other just to win a contract — sometimes with very huge discrepancies that already defy logic.
Companies also allegedly undercut on active ingredients of the drug to save on expenses. This enables them to bid a lower price for these products, an insider told Ibon Features.
The latter is very possible since under current BFAD regulations, product testing for quality is done only after the winning bidder has already distributed the drugs to government hospitals. The result sometimes takes too long that by the time it is released, some of the drugs may have already been used.
A drug is considered substandard if it is found lacking in potency and efficacy, does not meet labeling specifications, or shows signs of impurity upon visual inspection.
The use of substandard drugs in the health system is not a new issue to the medical community, especially to clinical doctors who have had direct experience with them. But it was only very recently that government doctors began documenting cases of adverse effects to patients.
“The problem is that many doctors are afraid to speak out because the drug industry holds many by the neck,” said Dr. Reynaldo Lesaca, a clinical psychiatrist and former member of the National Drug Committee under the Philippine National Drug Policy Program of the DOH.
The Bohol incident is not the first documented case involving drugs of questionable quality. In the last two years, BFAD has received substandard-drug complaints from its regional offices and public hospitals, particularly in the Visayas and Mindanao. These are backed by physical inspection reports indicating contamination or defect, as well as actual clinical findings of lack of effectiveness.
A report dated January 22 this year from the Davao Medical Center (DMC) in Davao City was also telling. The cover letter was signed by the hospital’s chief of clinics Dr. Jean Tay and addressed to BFAD deputy director Dr. Kenneth Hartigan-Go.
The report documented seven ob-gyne cases of adverse reactions to generic oxytocin between February to September last year. Oxytocin is also an injectable uterine stimulant like methylergometrin maleate. The seven patients also developed uterine atony and had hysterectomy operation. Incidentally, the drugs involved were Indian imports of the same company, Phil Pharmawealth.
The DMC report also included a complaint from the pediatrics department regarding another Phil Pharmawealth product, Diazepam, an anticonvulsant. The drug was administered to an 18-month-old baby admitted due to poor suck and spasms, but the drug proved ineffective even in high doses.
This particular drug, it turned out, had been the subject of a similar complaint by the hospital last year. “This is made in follow up of the previous complaint submitted last August 2000 regarding the ineffectiveness of the generic diazepam which is available in our pharmacy with the same manufacturer,” the report said.
As in the Bohol case, the BFAD has yet to come up with definitive findings on the reports filed by the DMC doctors.
Ibon Features also obtained a report dated December 1999 from the Dr. Jose C. Locsin Memorial Hospital in Silay City, Negros Occidental. It cited two drugs found unacceptable by doctors upon physical inspection prior to use.
One drug was metronidazole with lot number 8002, manufactured by Eupharma Laboratories in Bombay, India, and distributed locally by PNF Pharmaceuticals Inc. The other was hydrocortisone sodium succinate with batch numbers SP91 and SP92, manufactured by Samarth Pharma in Bombay, India, and also distributed locally by Phil Pharmawealth Inc.
Still, there is another substandard drug report from neighboring Cauayan District Hospital in Isio, Cauayan town, also in Negros Occidental. It identified hydrocortisone sodium succinate from one batch (SP91) as those issued to its Silay City counterpart. Doctors there also rejected the drug after it failed physical inspection prior to administration to patient.
“When doubt is raised on the quality of a particular drug, an investigation should be conducted immediately and the batch of drugs recalled as a safety precaution,” according to Dr. Romy Quijano, an associate professor at the pharmacology department of the University of the Philippines. He is also president of the nongovernment Pesticide Action Network-Philippines.
Quijano is seconded by Dr. Kenneth Hartigan-Go, BFAD’s deputy director. “Medicines are no ordinary products… These are regulated by the government and people’s lives depend on it.”
Hartigan-Go, who assumed the BFAD’s second highest post in 1999, was tasked in January last year to track down reports of alleged substandard drugs in the market. For the first half of the year, medicine samples for testing were collected at random from hospitals and drug outlets nationwide. Government doctors were also encouraged to submit clinical reports of their experiences, if any, with violative drugs.
Initial reports trickled in. But by August, mounting evidence strongly indicated that the problem of substandard drugs is serious and widespread, as admitted by Hartigan-Go himself. “I was alarmed by the findings. There are substandard drugs being reported from the regions, but the BFAD was not doing anything,” he said.
(Part Two:
Substandard Drugs Are Undermining Generics Law)