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Adverse drug reaction reporting. Philippine experience.

For almost 20 years, the Philippine Medical Association, and specifically its Committee on Foods, Drugs and Cosmetics, has not been able to successfully gather information on adverse drug reactions (ADRs). The reporting of ADRs began in 1967, using a very comprehensive reporting form, at a time when news items of anaphylactic shock and deaths allegedly from intramuscular injections of penicillin, and subsequent litigation, were appearing. Up until 1973, when there were new initiatives, a few ADR reports were obtained mainly from hospitals who employed Philippine Medical Association committee members. Despite the issuing of directives for co-operation from hospitals, reports were not forthcoming. Involvement of hospital pharmacists and officers of specialist societies subsequent to the arrival of a World Health Organization (WHO) consultant in 1981 resulted in a simplified reporting form. Initial enthusiasm generated some ADR reports, but information was often inadequate and requests for further details were ignored. A new form entitled 'Drug Experience Reporting'--based on the USA FDA example--was introduced in 1984, when the Philippine Pediatric Society on ADR reporting also designed a project for use in hospitals. A change in doctor and patient attitudes is necessary before progress can be made, and a new strategy based on the education of doctors and medical students has been implemented. An important requirement is a mechanism to review and assess ADRs that will satisfy health authorities and maintain confidentiality.

Drug-Related Side Effects and Adverse Reactions↗

Periodic abstinence in the Philippines: new findings from a national survey.

This paper presents the main survey findings from a nationally representative sample of 607 users of periodic abstinence methods in the Philippines in 1984. The survey was conducted because of the widespread popularity of periodic abstinence in the Philippines and a lack of detailed knowledge about how the method is understood and practiced in the Philippines. Findings are presented on the prevalence of the different types of periodic abstinence methods, the nature of their use, knowledge about the various periodic abstinence methods, instruction received, perceived advantages and disadvantages, the husband's role, and the use-effectiveness of periodic abstinence both with and without backup methods. The implications of these findings for program management and for future research are also discussed.

Family Planning Services↗

Study of lung flukes from Philippines: --a preliminary report.

In this paper taxonomic study on paragonimus including their metacercariae obtained from the crabs collected from Sorsogon, Luzon, Philippines and adult worms and ova obtained through animal feeding, with light microscopy and scanning electron microscopy revealed that there may exist two or more species of lung flukes in Philippines. The occurrence of Semisulcospira libertina in addition to Antemelania dactylus (Lea) as an additional snail host is mentioned for the first time. The chromosome Karyotyping of the adult worms revealed that they belong to the diploid pattern. Electronic scanning showed that the cuticular spines of the Paragonimus from Sorsogon look like "pineapple ears" both in distribution and in appearance, a new finding that has not been recorded before. In the lungs of a white rat killed 290 days after infection, two adult worms were obtained within the solitary cyst. These 2 adult worms measured 4.5 x 2.5 mm and 4.5 x 3.0 mm respectively. Their unusually small size and somewhat round shape suggest that they may be of a different species from those hitherto reported in the Philippines. Clearcut evidence is presented for the first time, demonstrating the occurrence of the phenomenon of cross fertilization (allogamy) of lung flukes.

Animals↗

Studies on the fresh water cercariae in Leyte Island, Philippines. I. Collection of snails.

During the past two years of 1975 and 1976, approximately sixteen thousand specimens of fresh water snails were examined for the presence of cercariae in Leyte Island, Philippines. These snails comprised about 14 species belonging to 7 families, and ultimately 43 species of cercariae were found, namely, 6 species from Oncomelania quadrasi, 13 species from Thiaridae, 9 species from Viviparidae and Pilidae, 8 species from Planorbidae, and 7 species from Lymnaeidae and Bulinidae. As a total, out of 15,925 snails examined, 761 or 4.78% were found infected with cercariae. Up to the present, 22 species of cercariae had been reported from the Philippines, and almost all of them are from Luzon Island only. Therefor, except for the cercaria of Schistosoma japonicum, all of the cercariae in the present study are new discoveries, and most of them are considered as new species. In this paper, the historical review on the cercarial study in the Philippines was made first, then dates and localities of snail collection in the present study were shown in details with some map and table, and general method of cercarial observation was described for the benefit of succeeding reports of this series.

Animals↗

Rate of digesta passage in the philippine flying lemur, Cynocephalus volans.

The rate of digesta passage was measured in five captive Philippine flying lemurs (Cynocephalus volans). These animals were force fed capsules containing known quantities of either particulate or soluble markers. The volumes of the gastrointestinal tracts of three flying lemurs were determined based on the wet weight of the contents of each section of the gut. The mean rate of digesta passage was 14.37 +/- 3.31 h when determined using the particulate marker and 21.9 +/- 0.03 h when determined using the soluble marker. The values based on the particulate marker are between 2% and 10% of similar values for other arboreal folivores. The morphology of the gastrointestinal system of the Philippine flying lemur is similar to that of other hindgut fermenters. Flying lemurs have a simple stomach and a large caecum. The total gut capacity of the Philippine flying lemur is similar to that of other herbivores, but is slightly smaller than that of either the koala (Phascolarctos cinereus), a hindgut fermenter, or the three-toed sloth (Bradypus variegatus), a foregut fermenter. These data suggest that flying lemurs deal with the problems of a folivorous diet very differently than some other arboreal mammals. Phascolarctos cinereus and Bradypus variegatus may represent one extreme with Cynocephalus volans representing the other extreme along a continuum of foraging strategies that are compatible with the arboreal folivore lifestyle.

Animals↗

Stakeholder attitudes toward the risks and benefits of agricultural biotechnology in developing countries: a comparison between Mexico and the Philippines.

Public perceptions and political debates regarding the risks and benefits of agricultural biotechnology are well documented in industrialized countries. Yet, hardly any surveys have been conducted in developing countries. The following study aims to contribute to a better understanding of stakeholder attitudes toward agricultural biotechnology in developing countries. For this purpose, stakeholder representatives in the public debates in Mexico and the Philippines were asked to complete two nearly identical questionnaires on the risks and benefits of agricultural biotechnology. A comparison of stakeholder attitudes in the Philippines and Mexico is interesting because it shows how the different political systems, cultural and ecological backgrounds, and the regional context of food and agriculture influence perceptions. In general, the results of the surveys indicate that the participants in both countries consider genetic engineering to be an important tool to address agricultural, nutritional, and environmental problems, and they do not regard transgenic foods as risky for consumers. However, they are concerned about the potential impact of such transgenic crops on their countries' rich biological diversity and do not believe that national biosafety guidelines will be implemented properly. Although the surveys show that stakeholder attitudes in the Philippines and Mexico are quite similar, they also highlight significant differences in perception often related to cultural and political aspects.

Journal Article↗

Laboratory diagnosis and susceptibility profile of Helicobacter pylori infection in the Philippines.

BACKGROUND: Helicobacter pylori diagnosis and susceptibility profile directs the applicability of recommended treatment regimens in our setting. To our knowledge, there is no published data on the culture and local susceptibility pattern of Helicobacter pylori in the Philippines. METHODS: 52 dyspeptic adult patients undergoing endoscopy from the Outpatient Gastroenterology clinic of the University of the Philippines-Philippine General Hospital underwent multiple gastric biopsy and specimens were submitted for gram stain, culture, antimicrobial sensitivity testing, rapid urease test and histology. Antimicrobial susceptibility testing was done by Epsilometer testing (Etest) method against metronidazole, clarithromycin, amoxicillin, and tetracycline. RESULTS: Sixty percent (60%) of the study population was positive for H. pylori infection (mean age of 44 years +/- 13), 70% were males. H. pylori culture showed a sensitivity of 45% (95% CI [29.5-62.1]), specificity of 98% (95%CI [81.5-100%]), positive likelihood ratio of 19.93 (95% CI [1.254-317.04]) and a negative likelihood ratio of 0.56 (95% CI [0.406-0.772]). All H. pylori strains isolated were sensitive to metronidazole, clarithromycin, amoxicillin and tetracycline. CONCLUSION: Knowledge of the antibiotic susceptibility patterns in our setting allows us to be more cautious in the choice of first-line agents. Information on antibiotic susceptibility profile plays an important role in empiric antibiotic treatment and management of refractive cases.

Journal Article↗

Quantitative parasitologic findings in rabbits infected with Japanese and Philippine strains of Schistosoma japonicum.

Sixty-seven rabbits were killed 8-66 weeks after infection with a Japanese strain of Schistosoma japonicum and 22 were killed 12-55 weeks after infection with a Philippine strain. Worm numbers decreased moderately over the course of infection and the number of eggs laid by each worm pair also decreased, as evidenced by decreasing numbers of mature (viable) eggs per worm pair in the tissues and, for the Japanese strain, by decreasing numbers of eggs per worm pair passed in the feces. Many eggs calcified in the tissues and the number of eggs per worm pair found in the tissues increased with time in a nearly linear fashion. For both schistosome strains, the total number of eggs in the tissues was proportional to the number of worms present at any given time. The number of eggs passed in the feces correlated well with the number of worm pairs present in rabbits infected with the Japanese strain, but in rabbits infected with the Philippine strain the few eggs passed in the feces correlated poorly with the intensity of infection. Worms of the Japanese strain were located primarily in venules of the proximal jejunum and those of the Philippine strain primarily in venules of the colon.

Animals↗

Extrahepatic pathology in rabbits infected with Japanese and Philippine strains of Schistosoma japonicum, and the relation of intestinal lesions to passage of eggs in the feces.

A Japanese strain of Schistosoma japonicum produced segmental circumferential lesions 15-40 cm in length in the proximal jejuum of infected rabbits, while a Philippine strain of the parasite produced small numbers of focal nodular lesions (bilharziomas) in the colon. Sequestration of large numbers of schistosome eggs in these latter lesions apparently accounted for the small and erratic number of S. japonicum eggs passed in the feces of rabbits infected with the Philippine strain. These focal masses also illustrate dramatically the gregarious nature of schistosome worm pairs, all of which concentrated in two or three focal lesions, leaving essentially normal bowel elsewhere. Sandy patches were frequently seen in the bowel in sites of heavy egg deposition, and calcified eggs were evident radiologically. The fibrotic response to schistosome egg deposition was marked in the liver. In contrast, the collagen content of the intestine was nearly normal in animals infected with the Philippine strain and only moderately increased in rabbits infected with the Japanese strain. Numerous eggs and granulomas were present in the lungs, but fibrosis of pulmonary granulomas was minimal.

Animals↗

Estimating sensitivity and specificity of a faecal examination method for Schistosoma japonicum infection in cats, dogs, water buffaloes, pigs, and rats in Western Samar and Sorsogon Provinces, The Philippines.

Schistosoma japonicum causes a chronic parasitic disease, which persists as a major public health concern in The Philippines, the People's Republic of China and Indonesia. This infection is unique among helminthic zoonoses because it can infect humans and more than 40 other mammals. The objective of this study was to estimate the sensitivity and specificity of the Danish Bilharziasis Laboratory technique in cats, dogs, pigs, water buffaloes and rats in the Philippines. Faecal samples from each animal were collected on up to five occasions on five consecutive days in four villages of Sorsogon and Western Samar Provinces between January and July 2003. The faecal samples were analysed with the filtration and sedimentation Danish Bilharziasis Laboratory technique. Sensitivity and specificity of one, two, three, four, and five faecal samples were estimated using a Bayesian latent class approach. A total of 59, 43, 74, and 80% of the censored cats, dogs, pigs, and water buffaloes in the four villages were sampled, respectively. For all species, the sensitivity estimates when using the results of only 1 day of sampling were less than 80%. However, the sensitivity improved to at least 96% in all species when three or more faecal samples were collected on three separate days. The specificity was estimated to be above 92% across all species, even if just a single sample is used. The prevalences and 95% credible intervals of S. japonicum, adjusted for imperfect sensitivity and specificity, in cats, dogs, pigs, rats, and water buffaloes were 11.9% (6.8-18.3%), 19.9% (15.1-25.2%), 2.9% (1.1-5.2%), 31.3% (18.3-45.6%) and 6.3% (2.1-12.6%), respectively. Our results suggest that the Danish Bilharziasis Laboratory technique is valid for the detection of infection with S. japonicum in animals, and that sensitivity estimates are excellent when faecal samples are collected on at least three different days. Monitoring S. japonicum infection in animal reservoirs with a valid test could contribute to more effective public health control programmes.

Animals↗

HISTOPLASMIN SENSITIVITY OF YOUNG MEN IN ALASKA, HAWAII, THE PHILIPPINES AND PUERTO RICO.

The author describes results of a continuing study of skin sensitivity to histoplasmin among United States Navy recruits from Alaska, Hawaii, the Philippine Islands and Puerto Rico. For comparison, material is also included for several groups of recruits from different states of mainland United States.The evidence is interpreted as indicating that the frequent large reactions in Puerto Rican and Filipino recruits represent specific infection with Histoplasma, whereas the small reactions in recruits from Hawaii and the Philippines represent cross-reactions due to sensitization with a presently unknown agent or agents.

Alaska↗

Surgery in the Philippines.

The Philippines is an archipelago of about 7000 islands, with an area about the size of England, situated just above the equator in Southeast Asia. It has a population of 70 million. The Philippines has had extensive commercial and social contact with Asian neighbors, specifically the Chinese, even before the 377 years of Spanish colonization from 1521 to 1898 and the 48 years of American rule from 1898 to 1946. More than 80% of Filipinos are Catholics; the rest are Muslims and Protestants of various denominations, including those who belong to Filipino church groups. Infectious diseases such as tuberculosis, amoebiasis, typhoid fever, and malaria are still prevalent, and arteriosclerosis, cancer, and stroke are common and on the rise.

Curriculum↗

Hepatitis B virus profile of hepatocellular carcinoma in the Philippines.

The hepatitis B virus (HBV) profile was investigated in 104 age-grouped hepatocellular carcinoma (HCC) patients and 84 controls from the Philippines. The HCC-control percent positivities of the HBV parameters are: HBsAg: 70-18; anti-HBs: 25-37; anti-HBs: 25-37; anti-HBc: 94-35; HBeAg: 5-2; anti-HBe: 60-30; HBV exposure rate: 97-57; current infection: 80-31. Male HCC anti-HBs positivity is significantly lower than in controls. Female HCC patients' anti-HBs are also lower than controls, but this difference is not statistically significant. Simultaneous presence of HBsAg and anti-HBs was found only in male HCC patients. The mean anti-HBc titer of anti-HBs-positive HCC is higher than that of controls. That of HCC patients negative for both HBsAg and anti-HBs is also higher than the corresponding controls. Anti-HBe positivities of infected and noninfected but previously exposed HCC patients are not significantly different, in contrast to noninfected previously exposed controls whose anti-HBe is lower than those with current infection. The exposure rate prevalence of current infection, and the antibody responses to HBV of HCC patients suggested a close relationship between the two conditions in the Philippines.

Adolescent↗

Maternal vitamin B-6 and folate status and risk of oral cleft birth defects in the Philippines.

BACKGROUND: Vitamin deficiencies induce oral clefts in animal experiments, but the role of specific nutrients in human oral clefts is uncertain. METHODS: Associations between maternal vitamin B-6 and folate status and risk of nonsyndromic cleft lip, with or without cleft palate (CL/P), were examined in case-control studies at two sites in the Philippines--Negros Occidental and Davao. Cases were mothers of affected children and control mothers were those who had no children with oral clefts. RESULTS: The risk of having a CL/P-affected child increased with increasing tertile of vitamin B-6 deficiency in both Negros Occidental and Davao (odds ratios [ORs] and 95% confidence intervals [CIs] for sites combined = 1.0 [reference], OR, 2.94; 95% CI, 1.51-5.73; OR, 4.98; 95% CI, 2.56-9.67). Poor B-6 status had a stronger association with CL/P among mothers with lower versus higher plasma folate levels. Increasing tertiles of plasma folate were marginally associated with an increased risk of clefts in both sites combined (1.0 [reference]; OR, 1.58; 95% CI, 0.93-2.68; OR, 1.59; 95% CI, 0.94-2.70). Increasing tertiles of erythrocyte folate were associated with a decreased risk of CL/P in Negros Occidental (1.0 [reference]; OR, 0.34; 95% CI, 0.13-0.90; OR, 0.46; 95% CI, 0.20-1.09) and an increased risk in Davao (1.0 [reference]; OR, 1.23; 95% CI, 0.54-2.81; OR, 4.85; 95% CI, 2.24-10.50). The inconsistent associations between folate status and CL/P risk appeared to be a result of statistical interaction between folate, vitamin B-6, and case-control status that produced different results in study areas of higher versus lower prevalence of vitamin B-6 deficiency. CONCLUSIONS: Poor maternal vitamin B-6 status was consistently associated with an increased risk of CL/P at two sites in the Philippines. Folate-CL/P associations were inconsistent and may be related to the vitamin B-6 status or other characteristics of the populations under study.

Case-Control Studies↗

Outcome of screening by clinical examination of the breast in a trial in the Philippines.

The value of screening by Clinical Examination of the Breast (CBE) as a means of reducing mortality from breast cancer (BC) is not established. The issue is relevant, as CBE may be a suitable option for countries in economic transition, where incidence rates are on the increase but limited resources do not permit screening by mammography. Our aims were to assess whether mass screening by CBE carried out by trained para-medical personnel is feasible in an urban population of a low-income country, and its efficacy in reducing BC mortality. Our study was designed as a randomised controlled trial of the effect on BC mortality of 5 annual CBE carried out by trained nurses. The target population was women aged 35-64 years, resident in 12 municipalities of the National Capital Region of Manila, Philippines. The units of randomization were the 202 health centres (HC) within the selected municipalities. During 1995 nurses and midwives were recruited and trained in performing CBE. The first round of screening took place in 1996-1997. The intervention however showed a refractory attitude of the population with respect to clinical follow-up and was discontinued after the completion of the first screening round. Cases of breast cancer occurring in the study population during 1996-1999 were identified by the 2 local population-based registries. In the single screening round 151,168 women were interviewed and offered CBE, 92% accepted (138,392), 3,479 were detected positive for a lump and referred for diagnosis. Of these only 1220 women (35%) completed diagnostic follow-up, whereas 42.4% actively refused further investigation even with home visits, and 22.5% were not traced. Of 53 cases that occurred among screen-positive women in the 2 years after CBE only 34 were diagnosed through the intervention. Eighty cases occurred among screen-negative women. The test sensitivity for CBE repeated annually was 53.2%. The actual sensitivity of the programme was 25.6% and positive predictive value 1%. Screen-detected cases were non-significantly less advanced than the others. Previous studies have shown that most breast cancer cases in the Philippines present at advanced stages and have an unfavourable outcome. Although CBE undertaken by health workers seems to offer a cost-effective approach to reducing mortality, the sensitivity of the screening programme in the real context was low. Moreover, in this relatively well-educated population, cultural and logistic barriers to seeking diagnosis and treatment persist and need to be addressed before any screening programme is introduced.

Adult↗

Patterns of familial transmission of HBV and the risk of developing liver cancer: a case-control study in the Philippines.

The present case-control study was carried out in the Philippines to determine the risk of developing hepatocellular carcinoma (HCC) in relation to different HBV serological profiles of parents and sibs of HCC cases and controls. The HBV serological profiles of parents and sibs of 33 patients with HCC were compared with those of 2 types of community control: 33 general population controls matched for sex and age (C1 controls) and 33 asymptomatic HBsAg carriers also matched for sex and age (C2 controls). When cases were compared with C1 controls, increased risks were associated with the fact of having an HBsAg-positive mother (RR = 2.5, 95% C1 = 0.4-26.3) and older sibs positive for HBsAg (RR = 2.0, 95% C1 = 0.5-9.1), but the increased risk was not statistically significant. However, a significantly increased risk was associated with the fact of having a mother (95% C1 = 3.5-infinity) or father (RR = 11, 95% C1 = 1.6-473) who had been exposed to HBV. On the other hand, when cases were compared with C2 controls, a non-significant 2-fold increase was associated with the fact of having an HBsAg-positive mother, but no differences were observed in the HBV serological profiles of their fathers and older sibs. These results suggest that, in the Philippines, the fact of having a mother or father who has been infected in the past with HBV increases the risk of developing HCC but that the contribution of the mother to this increase in risk is not as important as hitherto believed.

Female↗

Apheresis in the Philippines.

This is a retrospective study of 131 patients who underwent 479 therapeutic apheresis (TA) procedures at St. Luke's Medical Center, in the Philippines, from 1994 to 2003. Diseases were classified according to indication categories using the American Society for Apheresis (ASFA) guidelines. Seventy-eight percent of the patients belonged to ASFA Category I, 14% to Category II, 8% to Category III, and none in Category IV. The most common indication was for neurological disorders (62%), mainly acute inflammatory demyelinating polyneuropathy (49%) and myasthenia gravis (40%). The remaining disease groups were hematologic (25%), renal and metabolic (8%), and autoimmune and rheumatic diseases (5%). Oral corticosteroids are the preference of many for the treatment of CIDP, being much less expensive than IVIG infusion or TA. Favorable response is noted in the use of the latter to prevent kidney transplant rejection through antibody removal among pre-sensitized patients before transplantation. Complete recovery was seen in 2 of 4 patients with acute hepatic failure. The negative outcome of controlled studies in the literature has limited our utilization of TA for the treatment of systemic lupus erythematosus. Immunoadsorption for idiopathic thrombocytopenic purpura has not been performed locally due to the unavailability and prohibitive cost of affinity columns. Factors affecting the practice of TA in our country are cited. Organization of a multicenter study group and an apheresis national registry may lead to a better future of TA in the Philippines.

Blood Component Removal↗

Case report: rapid ante-mortem diagnosis of a human case of rabies imported into the UK from the Philippines.

The United Kingdom is free from rabies, with the last human death from indigenous rabies recorded in 1902. However, between 1946 and 2000, 20 deaths were reported in the United Kingdom in people who were bitten and infected while abroad in rabies endemic areas. The rapid diagnosis of suspected human rabies cases influences the use of anti-rabies post-exposure prophylaxis for potential contacts with the victim. In addition, the occurrence of a human rabies case requires urgent investigation to support patient management policies. In May 2001, a case of human rabies imported into the United Kingdom from the Philippines was identified. A 55-year-old man was admitted to University College Hospital, London, with clinical symptoms and a history consistent with exposure to rabies. Saliva, cerebrospinal fluid), and skin biopsies (from the wound site and nape of the neck) were submitted for conventional ante-mortem diagnostic techniques. Established diagnostic techniques, including the fluorescent antibody test (FAT), mouse inoculation test, (MIT) and the rabies tissue culture inoculation test (RTCIT), failed to detect the virus. In contrast, hemi-nested reverse transcription-polymerase chain reaction (RT-PCR), followed by automated sequencing confirmed the presence of classical rabies virus (genotype 1) in both the saliva and skin specimens within 36 hr of sample submission. Subsequent phylogenetic analysis demonstrated that this isolate was closely related to that of canine variants currently circulating in the Philippines.

Animals↗