“SA PANAHON ng krisis, bawal magkasakit.”
This slogan from a popular vitamin commercial speaks aptly of the hard times. Prices of commodities are shooting up like the mercury in a thermometer, while new illnesses are proliferating like mushrooms.
Most Filipinos nowadays live in deplorable conditions where they cannot afford high-priced medicines. With their scanty income, Filipinos need cheaper drugs that are as good as branded drugs made by multinational companies.
But are generic drugs as good as branded ones. Bioavailability tests may provide the answers.
The Bioavailability Unit
Bioavailability is knowing the rate and extent of the absorption of a drug in the body. Through bioavailability, researchers determine bioequivalence, that is if two drugs of different brands act the same way in a person’s body.
The University houses the Bioavailability Unit, a center directed to this kind of research, located at the fourth floor of the Clinical Division of the University of Santo Tomas Hospital (USTH).
In 1994, the Department of Health (DOH) and the Australian Agency for International Development (AusAID) constructed the Unit as part of the Philippine National Drug Policy Cooperation Program. The program aimed to create essential, low-priced, and high-quality drugs for the people.
Patterned after the University of South Australia’s bioavailability unit, it became operational in 1996.
The Unit is fundamentally a medical research center. It is headed by Enrico Lagdameo, who assumed his post as Unit Manager in 1998.
Essentially, the center evaluates drugs that the Bureau of Food and Drugs (BFAD) sends to them. Since this government agency regulates drug products produced by pharmaceutical companies in the country, the products have to be tested for their chemical components and bioavailability.
Lagdameo said that several companies have approached them to perform these tests. Among these companies were Biogenerics, Glaxo-Wellcome, Natrapharm, Novartis Healthcare, Pascual Laboratories, and United Laboratories Inc.
The drugs tested are in the List-B prime drugs in the Philippine National Drug Formulary (PNDF). This list contains all the products manufactured by multinational and local companies.
The tests consist of determining the safety and efficacy of the drugs through comparison. For example, the products made by two local generic drug companies are compared with an equivalent product made by a multinational company. After putting them through various tests, the results would either prove or disprove the companies’ claims that their product exhibits a high quality and degree of therapeutic effect.
Lagdameo said that if these medicines fail to meet the bioavailability standards, the Unit would recommend measures to improve the product. In this way, the Unit helps the local companies to produce better and satisfactory medicines and prevent failure of treatment to the patients.
“We are a service bureau to the pharmaceutical industry. We aid in the production of quality medicines for the people,” Lagdameo stated.
He said they discovered certain local generic drugs like rifampicin, a drug used to treat tuberculosis, is bioequivalent to the branded multinational product. Yet, they also found that other locally-manufactured drugs are not bioequivalent to their branded counterparts.
Lagdameo said these tests determined the concentrations of branded and local products available in the market. These tests involve volunteers, who are vital to conducting these tests, he added. (See related article on “A call for volunteerism”)
Aside from bioavailability determinations on drug products, the center offers other services like clinical trial studies on procedures for drug testing. Other services include biostatistical data in knowing the inference of a drug and analytical laboratory services on quantitative and qualitative chemistry.
Training ground
Lagdameo said that students are welcome to the Unit. In fact, he said that the Unit has trained third and fourth-year Pharmacy students who have completed their internships. Likewise, they assist the students in their thesis when procedures involve drug dissolution processes, drug stability, chemical analyses, and content potency.
Faculty of Medicine and Surgery students consult the Unit when working on clinical pharmacology experiments while Medical Technology interns seek their help to conduct tests on blood extraction, urinalysis, and blood chemistry. The Unit also helps Engineering students on chemical analysis.
The High Performance Liquid Chromatography apparatus (HPLC), which is often used in bioavailability experiments, determines the exact concentration of a certain drug component.
Before using the Unit’s HPLC, one needs to pay P3, 000.
“The fee covers the chemical reagents used and an unlimited number of drug samples can be tested in one session,” Lagdameo said. He added that this fee is very minimal compared to the rates in other laboratories that charge as much as P5, 000.
The Unit’s accessible location in the USTH makes it convenient for medical professionals to research and to provide volunteer medical support during clinical tests. The Unit also provides facilities for Clinical Pharmacologists who study protocols for drug evaluation, pharmacokinetics, and pharmacodynamics.
Plans
One of the Bioavailability Unit’s main objectives is to expand their drug evaluation. This would make their role similar to the United States Food and Drug Administration’s Drug Evaluation and Research Department (US-FDA) that they evaluate drugs available in the market and conduct research regarding these drugs.
Examples of drugs they have already analyzed are anti-tuberculosis drugs like pyrazinamide; antibiotics like cephalexin; and cardiac drugs like diltiazem. Currently, they are testing theophylline, a drug for asthma. In addition, they plan to test drugs that are widely-consumed in the market like the anti-hypertensives and respiratory drugs.
These tests also reduce adverse reactions during medication. Lagdameo said he aims to make the Bioavailability Unit a premier center for drug bioavailability studies and to serve the Filipino masses with their scientific expertise. Bioavailability advocates satisfactory medicines. It plays a significant role in the pharmaceutical industry by providing accurate information for research and development. In turn, bioavailability helps companies produce cheap but satisfactory, safe, and quality medicine.
