Breathing Assistance
PhilVent may be a good alternative in helping icu patients to breathe in the absence of ventilators
By Isabelle Yujuico, Contributing Writer
For most of us, breathing comes so effortlessly. But for newborns with respiratory problems like respiratory-distress syndrome and hyaline-membrane disease, being hooked up to a ventilator may spell the difference between life and death. Problem is, there is an acute lack of ventilators in the nurseries of many Philippine hospitals.
At the ninth National Institutes of Health Foundation Week, Dr. Enrique Ostrea Jr., professor of pediatrics at Wayne State University, spoke about the Philippine Ventilator (PhilVent)-a prototype, low-cost, pressure-limited, time-cycled ventilator-and how it could address the lack of ventilators in nurseries.
The prototype is here
The dearth of ventilators is attributed to their high cost and the limited budgets of hospitals, especially in the case of government hospitals. To address the problem, the options offered are either to rent a ventilator or use manual ventilation. Since the former is expensive and may exceed the financial capacity of the family, what often occurs is manual hand bagging of the infant by a family member or hospital staff using an Ambu bag.
However, this has serious shortcomings. The required volume and pressure may not be reached and they are not uniformly delivered. When the hand bagger gets tired, stopping ventilation may also spell the tragic end of a life.
PhilVent was developed as an alternative way to provide the ventilatory needs of neonatal-intensive-care units in the Philippines. Although it is intended for commercial use and is protected by a patent, Ostrea stressed that it is not meant to "supplant … more highly advanced commercial ventilators, but to provide simple effective ventilator in areas where ventilators are sparse."
Animal and human trials
Both animal and human clinical studies were conducted to test PhilVent against Sechrist, a standard commercial ventilator. The animal study was conducted at the University of the Philippines department of physiology. Newborn piglets were premedicated with atropine, anaesthetized with ketamine, intubated, hooked up to the Sechrist ventilator, monitored, and given IV solution. After stabilization, Sechrist and PhilVent were used alternately with similar settings.
At the end of the animal study, the researchers found that the efficacy and safety of Philvent were equal to those of Sechrist. There were no significant differences in blood-gas parameters including pH, oxygen, bicarbonate, and carbon dioxide at different pressures and rate settings.
Next came the randomized controlled trial that took place at the the Philippine General Hospital NICU involving premature infants suffering from respiratory insufficiency. Forty-five infants were assigned to PhilVent, and the same number to Sechrist. The study ran for three days and infants on PhilVent were switched to Sechrist (if available) at the end of the study.
For the ventilator settings, oxygen concentration was 62 percent for PhilVent v. 64 percent for Sechrist, while the rates used for Philvent was 44/45 and for Sechrist, 46. The pressures used were 19 mm Hg for PhilVent and 20 mm Hg for Sechrist.
For the blood gases, the means were significantly different but not clinically relevant. In terms of deaths, there was hardly any difference between PhilVent (six deaths) and Sechrist (seven). Heart rate and systolic and diastolic blood pressure were different but not clinically significant.
PhilVent was found to be similar to Sechrist in terms of safety and efficacy. Since the study was limited to newborns one kg and above, PhilVent cannot be recommended for those with lower birth weights. Nonetheless, the PhilVent looks to be a promising alternative in nurseries across the Philippines. In the words of neonatologist Alexander Tuazon, a reactor to the presentation: "Finally, we have one (ventilator) that is sturdily built, well tested, and I hope that more studies will come from this and more uses will come."
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Essentially Lacking
Do Filipinos have access to drugs considered essential?
By Isabelle Yujuico, Contributing Writer
The upward trend in drug prices has been a major concern over the years. In a 1999 Department of Health (DOH) and Department of Trade and Industry (DTI) study, five out of nine drugs were found to be more expensive in the Philippines than in Malaysia or Indonesia. Drug prices were higher by 40 to 70 percent than those of other Southeast Asian countries.
Compounding this, the manufacturing and distribution of drugs are controlled by a limited number of companies. Ocampo (2002) showed that the Philippine drug market is worth about PhP55 billion, half of which is concentrated in the Metro Manila area, 25 percent in Luzon, and the remaining 25 percent in Visayas and Mindanao. And although the Philippines was ahead of its time when it promulgated the Generics Act of 1988 (Republic Act 6675), and its effort to initiate parallel importation was commendable, access to drugs remains a serious problem.
During the ninth Foundation Week and fifth University Science and Technology Week of the University of the Philippines Manila-National Institutes of Health, Drs. Fely Marilyn Lorenzo and Yolanda Robles shared the results of their assessment study on drug security in the Philippines.
"Drug security"
A study on "drug security" must first de-fine the term. The authors met with various stakeholders from the pharmaceutical industry, the government, and nongovernment organizations, and came up with this definition: "the state at which a country, region, city or town has attained stability in terms of drug accessibility and quality of the common drugs rationally used for the 25 highest-burden diseases, especially those of the vulnerable groups at any given time and the accessibility of specific drugs for emerging diseases."
The researchers further assessed drug security in terms of the following factors: accessibility (availability and affordability), quality, rational drug use, and policy mechanisms and management. They also identified the top 25 diseases in the country, using epidemiological records and the
DOH's priority diseases in the 2005-2010 National Objectives for Health. These diseases are "a mixture of communicable and lifestyle diseases."
Based on these conditions, the researchers proposed a basket of 60 drugs that would be needed in attaining drug security. Seventeen were antimicrobials, 15 for heart disease, five for tuberculosis, four for diabetes, two for pregnant women, four vaccines, three for chronic obstructive pulmonary disease and asthma, and three each for supplements, antivirals, and analgesics. Robles explained: "The concept here is to come up with a very minimum critical list of drugs that government will have to ensure at all levels. The rest that are not listed here will have to be ... procured by the patients themselves or by [their private] health insurance."
Insecure?
Unfortunately, the Philippines doesn't appear to be particularly "drug-secure." Out of the 11,355 drugs registered with the Bureau of Food and Drug (BFAD), only a handful could be considered essential. Robles added that in the Philippine National Drug Formulary (PNDF), "the bible for government procurement when it comes to drugs," 609 drugs are considered essential but 58 of them are not available in the Philippines. She added that of these 609, only a third are being manufactured generically by local companies, and local-government procuring entities don't appear to be following the
PNDF list.
As far as the Philippine pharmaceutical industry is concerned, the local companies focus on generic drugs but multinationals still control the market for patented drugs. Furthermore, consumers need grater awareness regarding generic drugs. Drugs are also distributed unevenly with most found in major cities. As for quality, reports of counterfeit drugs being sold in legitimate outlets have been received and the field monitoring leaves something to be desired.
The researchers recommended several policy options. For the
DOH and BFAD, suggestions included having a quality seal for generic drugs, allowing
BFAD to increase fees to generate more resources for monitoring and quality assurance, and decentralizing monitoring and licensing. Allowing the early registration of generic versions of drugs whose patents are about to expire is also something to be considered.
As for the Philippine Health Insurance Corporation (Philhealth), Robles said, "The challenge for
Philhealth is … to reduce out-of-pocket spending on drugs while ensuring quality and rational use." This could be done by allowing the reimbursement of the full course of certain drugs, especially antibiotics.
Other possibilities include making the availability of essential drugs a part of the requirements for the accreditation of health facilities, making clinical-practice guidelines useful for costing, and exploring the controversial drug-voucher system, among others.
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