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I. BACKGROUND

Intestinal helminthiasis or soil transmitted helminthiasis (STH) remains a global public health problem. It affects the most vulnerable sector of our society – the children aged 1 to 12 years old who are in a period of intensive physical and intellectual growth. STH infection have an adverse effect on cognitive development and school attendance and is also associated with nutritional deficiencies particularly iron and vitamin A. Significant improvement in language and memory development have been observed and iron status and vitamin A absorption have improved after treatment or helminthiasis (WHO & UNICEF joint statement).

A nationwide prevalence survey of soil-transmitted helminthiasis among children 12-71 months old revealed that 66% are infected (de Leon, Lumampao, 2004), while 54% among schoolchildren have worms (Belizario et al, 2006). Recent evidence confirms that a significant reduction in the burden of disease due to helminths can be achieved through regular mass deworming directed to all high risk groups (WHO and UNICEF). Recognizing the high burden of worm infection, the DOH established the STH Control Program (STHCP) in 1999 through the issuance of Administrative Order No. 30-F S 1999.

Mass deworming of 1 to 12 years old children are done twice a year or every six months. For preschoolers (1-5 years old), deworming is done during the nationwide Garantisadong Pambata (GP) campaign in April and October. For the schoolchildren, deworming is scheduled every January and July per AO No. 2006-0028.

Currently, albendazole 400mg or mebendazole 500mg are the drugs of choice for mass treatment of intestinal infections. Both drugs are included in the WHO model list of essential medicines for the single-dose treatment of STH. The anthelminthics drugs are cheap so that regular mass treatment are both affordable and sustainable (WHO and UNICEF).

Albendazole and mebendazole have an excellent safety record; adverse reactions are minimal and transient and serious adverse experiences are extremely infrequent. Temporary minor reactions following treatment occur mainly in infected people as a result of the body’s response to the dying worms. The heavily infected people are more likely to experience such reactions. Generally, the number of people reporting adverse reactions is highest at the first round of treatment and tends to decrease during subsequent rounds (WHO).

However, there are cases of reactions to deworming drugs that have not been documented in the past years since the national deworming was implemented. Hence, this guideline on the management of AEFD is develop to prepare field workers in the management of any untoward reaction and to document and report correctly such reactions to the type of deworming drugs given orally to recipients.

II. OBJECTIVES

This Order aims to guide health workers and providers on the following:

1. Administering deworming drugs to different age groups.
2. Management of the adverse events following deworming, and AEFD drug of choice
3. AEFD reporting and recording

III. SCOPE OF THE APPLICATION

This order shall apply to all national, regional and local Offices and stakeholders involved in the deworming program of the DOH.

IV. DEFINITION OF TERMS

1. Adverse drug reaction (ADR) is a noxious and unintended reaction, which occurs at doses normally used in humans for prophylaxis, diagnosis or treatment of disease, or for the modification of physiological function (WHO).

2. Adverse event following deworming (AEFD) is a medical event that happens after ingestion of deworming drugs. While the drugs are safe and effective against helminths, adverse reactions which are usually mild and transient may occur within 8-12 hours after ingestion which is the half life of albendazole.

3. Eligible population is a group of individuals qualified or entitled to receive anthelminthic treatment in preventive chemotherapy interventions (WHO).

4. Mass deworming is the giving of an antihelminthic or deworming drugs to an entire group of people without prior diagnosis of current infection to get rid of intestinal parasites which include hookworm, ascaris, and trichuris

5. Preschool children are all children between the ages of 1 and 5 years who are not yet attending school but may be in the daycare centers (WHO).

6. Preventive chemotherapy is the use of anthelminthic drugs, either alone or in combination, as a public health tool against helminth infections (WHO).

7. School children are all children between the ages of 6 to 12 years old or those children enrolled in Grade 1 to grade 6

8. Serious adverse experience (SAE) is defined as an adverse experience following treatment with a drug that results in any of the following: death, life-threatening condition, in-patient hospitalization or prolonging of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly, cancer or overdose (WHO).

9. Soil-transmitted helminthiasis (STH) is an infection caused by nematodes Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm) or hookworm.

V. GENERAL GUIDELINES

1. Recommended drugs for mass deworming program of DOH

The following drugs which are listed in the Philippine National Drug Formulary, Volume 1, 5^th Edition 2000, are recommended for mass treatment. The same drugs are also recommended by WHO and are being used in all countries which conduct mass treatment in their fight against worms.

• Albendazole 400 mg chewable, flavored tablet

• Mebendazole 500 mg chewable, flavored tablet

Albendazole and mebendazole are benzimidazole derivatives which are very effective against single or mixed infections of intestinal worms. These drugs have the widest range of therapeutic activity and are known to be effective against all worms. They fulfill the criteria for the choice of drug for mass deworming, being safe, economical and simple because they are given as single dosage, thus making the administration easy even for non-health workers.

Albendazole and mebendazole work by interfering with the energy producing processes of worms including impairment of glucose metabolism leading to the worms’ immobility and death.

All persons 1 year old and above who may or may not have intestinal worms such as: roundworm, whipworm, hookworm, pinworm, and other intestinal parasites, regardless of when the last deworming was given to them, can take the deworming drug. Both drugs shall be taken ON FULL STOMACH.

2. Drug dosages and frequency of deworming by target groups

The eligible populations for albendazole or mebendazole are the following:

Preschool (1-5 years old) and school age (6-12 years old) children, women of childbearing age including pregnant women in the 2^nd and 3^rd trimesters and lactating women, high risk adults such as food handlers/operators, farmers, miners, soldiers and Indigenous peoples.

Source: Report of the WHO Informal consultation on the use of praziquantel during pregnancy/lactation and albendazole/mebendazole in children under 24 months.eneva 8-9 April 2002

^*Preschool children and out-of-school youths should be given deworming drugs at the Rural Health Unit or Municipal Health Center.

^**School children are dewormed in schools

^***Pregnant, lactating adults and other special groups are given deworming drugs at the Rural Health Unit or Municipal Health Center.

3. Adverse reactions following deworming (AEFD) and its management

Albendazole has been used in over 80 countries in 10 years to treat intestinal and systemic parasitic infections in man at the recommended dose of 400 mg.

There are no reports of any developmental adverse effects attributable to albendazole and its primary metabolite, sulfoxide. The common adverse effects listed below and which are expected to manifest within the first 10 hours after intake of the drug are mild and transient. Therefore in majority of the cases, treatment is not necessary.

However, supportive drugs may be given in few cases.

Common adverse effects	How to manage*
local sensitivity or allergy	Give antihistamine
mild abdominal pain	Give antispasmodic
diarrhea	Give oral rehydrating solution
erratic worm migration	Pull out the worms from mouth/nose

^*See annex 1 for recommended drugs and dosages

Parents/caregivers are allowed to manage the adverse reactions, but if these reactions persist, a doctor shall be consulted and any of the AEFD team shall be informed (See Section 5B1).

4. Precautionary Measures on Deworming Program Implementation

To ensure smooth and safe implementation of the deworming program, the following measures are recommended:

• The target clients or their caregivers shall be adequately informed of the possible adverse reaction to the drug and how to manage this in case it occurs.
  

• Adverse reactions shall be accurately recorded and proper authorities (AEFD team) shall be informed
  

• Health personnel at the community level shall be informed of the on-going deworming activity. Support drugs shall be available at the nearest health facility.

The following individuals are advised not to take deworming drugs:

• Seriously ill child/individual
  

• Child/individual with abdominal pain
  

• Child/individual with diarrhea
  

• Child/individual who previously suffered hypersensitivity to the drug
  

• Severely malnourished (underweight) child/individual

5. Steps in reporting Adverse Events:

A. When to report AEFD:

Any serious adverse event experienced by the client within 8-10 hours after ingestion of the drug should be reported immediately to the appropriate authority.

B. Whom to report AEFD:

Adverse reactions must be reported to the AEFD Team.

1. The AEFD team shall be composed of the following personnel at each level: 

Municipal Level
a. Municipal Health Officer
b. Municipal Epidemiology Surveillance Office (if available)
c. STH Coordinator
d. DOH representative

Provincial Level
a. Provincial Health Officer
b. Provincial Epidemiology Surveillance Officer (if available)
c. STH Coordinator
d. DOH representative

Regional Level
a. Regional STH Coordinator
b. Regional Epidemiology Surveillance Officer
c. DOH representative 

These personnel shall investigate the case at their level and assess if it was really AEFD. The investigation form shall be accomplished by the AEFD Teams when assessing AEFD (see Annex 2). If the event is considered secondary to the deworming drug, the AEFD team shall recommend appropriate action when necessary. If further investigation is required, the team shall refer the case to next higher level.

2. If hospitalization is needed, the AEFD team shall facilitate the admission to a government hospital.

C. How to report AEFD:

An AEFD reporting form was developed and contains pertinent informations related to the onset of the adverse events to be filled up by the health worker, parent, or teacher (see Annex 2*). This form is then forwarded to the relevant offices involved in the investigation of the AEFD. The flow chart will serve as a guide on how to go about reporting of AEFD cases (see Annex 3*).

D. Support to CHDs for AEFD:

The Integrated Helminth Control Program shall sub-allot the amount of Fifty Thousand Pesos (PhP 50,000) to each CHD annually to help defray the expenses incurred related to the occurrence of AEFD during the conduct of deworming activity. If no such incident occurs, then the funds can be used for other STH activities.

VI. ROLES AND RESPONSIBILITIES IN THE MANAGEMENT AND RECORDING/REPORTING OF AEFD

a. National Center for Disease Prevention and Control (NCDPC)

• Establishes a pool of experts or designates collaborating centers which shall provide experts at the national level to provide technical assistance in the management of severe adverse drug reactions
  

• Develops and updates policies and guidelines on the management of AEFD for RHUs and hospitals and other government agencies involved in mass deworming campaign
  

• Allocates fund for the management of AEFD

b. National Epidemiology Center (NEC)

• Conducts an in-depth investigation of any serious adverse experience which may be life-threatening or requires hospitalization
  

• Establishes and maintains a database in coordination with NCDPC
  

• Analyzes data provided by RESU
  

• Recommends appropriate action if necessary
  

• Provides feedback to concerned offices/LGUs as necessary

c. Centers for Health Development (CHD)/Regional Epidemiology Surveillance Unit (RESU)

• Confirms reported occurrence of AEFD
  

• Conducts investigation in collaboration with LGUs
  

• Analyzes data gathered and recommends appropriate action
  

• Allocates fund to augment national funds in the conduct of AEFD

d. Municipal/Provincial/City Health Offices (MHO/CHO/PHO)

• Oversee the implementation of the Program
  

• Conducts initial investigation on reported AEFD through the PESU/MESU
  

• Recommends appropriate action if necessary
  

• Augments fund for the conduct of AEFD
  

• Reports to CHD or refers to next higher level if further investigation is required

e. Government Hospitals

• Ensure treatment of any referrals related to AEFD
  

• Report cases of EFD to MESU/PESU/RESU

f. Parents/Health workers/Teachers

• Report cases of AEFD to proper authority, e.g. PESU/MESU
  

• Report cases to nearest health facility or proper authority e.g. MHO/ PHN PESU/MESU

VII. REPEALING CLAUSE

Some provisions of AO 2006-0028 and AO 176 s. 04 and other issuances that are found inconsistent with this Order are hereby repealed or rescinded.

VIII. EFFECTIVITY

This Order shall take effect immediately.

  (SGD.) ENRIQUE T. ONA, MD, FPCS, FACS
  Secretary of Health