Revised Guidelines on Mass Drug Administration and Management of Adverse Events Following Deworming and Serious Adverse Events

December 22, 2015

DOH ADMINISTRATIVE ORDER NO. 2015-0054

 

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 and special populations/groups such as pregnant & lactating women, women of child bearing age, farmers, food handlers and others. STH infection has an adverse effect on cognitive development and school attendance and is also associated with nutritional deficiencies particularly iron and vitamin A. Significant improvements in language, memory developments and iron status have been observed and vitamin A absorption after treatment of helminthiasis (WHO & UNICEF joint statement).

A nationwide prevalence survey of soil-transmitted helminthiasis among children 12-71 months old revealed that 66% were infected (de Leon, Lumampao, 2004), while 54% among schoolchildren have worms (Belizario et al, 2006). Recent evidence confirmed the 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. In 2006, the program was renamed as Integrated Helminth Control Program, IHCP (Administrative Order No. 2006-0028).

Mass deworming of 1 to 12 years old children is done twice a year or every six months. For pre-school children aged 1-4 years old, deworming is done during the nationwide Garantisadong Pambata (GP) campaign during the months of April and October. Further, it is also important to note that deworming drugs are also available in all health centers nationwide. For the enrolled school-aged children (5-12 years old or kindergarten to Grade VI), school deworming is scheduled every July (Round 1) and January (Round 2) per AO No. 2006-0028. Unenrolled school-aged children are dewormed at the health centers. CAIHTE

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 anti-helminthic drugs are cost-effective 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, since the implementation of national deworming program, there are cases of reactions to deworming drugs that have not been documented. Hence, this guideline on the management of AEFD was developed and updated to prepare field workers in the management of any untoward reaction. Further, this will serve as a guide to document AEFD through reporting and recording from and to relevant offices.

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.

3. AEFD reporting and recording at different levels.

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) or non-serious adverse event (NSAE) 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 to 12 hours after ingestion.

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

4. Mass deworming is the giving of anti-helminthic drugs or deworming drugs to the entire eligible population without prior diagnosis of current infection to get rid of intestinal parasites which include hookworm, ascaris, and trichuris.

5. Mass Drug Administration Provider (MDAP) — a person who administers the deworming drugs. This can be any teacher supervised by a health worker from the Department of Health, Department of Education, Local Government Units, or volunteer groups (with prior approval from the DOH Regional Office) who have the capacity and background in health, administration of deworming drugs, and management of adverse events.

6. Pre-school aged children (Pre-SAC) are all children between the ages of 1 and 4 years who are not yet attending school but may be in the daycare centers.

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

8. School-aged children (SAC) are all children between the ages of 5 to 12 years old, enrolled or not enrolled, which falls between kindergarten to Grade VI in the Philippine curriculum context.

9. Serious Adverse Events (SAE) is an adverse events following treatment with a drug that results in life-threatening condition.

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

11. Severely malnourished children are those children whose weight or height is below the — 3SD when compared with WHO Child Growth Standards (CGS) using indicators of weight for height (severely wasted).

V. General Guidelines

1. The following drugs which are listed in Philippine National Drug Formulary (PNDF) and are recommended by World Health Organization shall be used for Mass Drug Administration (MDA):

a. Albendazole 400 mg chewable, flavored tablet

b. Mebendazole 500 mg chewable, flavored tablet

2. The target population for MDA shall be composed of pre-school aged children (1-4 years old) and school aged children (5-12 years old). Special population (such as Women of childbearing age including pregnant women in the 2nd and 3rd trimesters and lactating women, high risk adults such as food handlers/operators, farmers, miners, soldiers and indigenous people) shall also receive deworming drugs thru selective treatment.

3. The Mass Drug Administration Providers (MDAP) shall observe the following drug dosages and frequency of deworming by target groups: DETACa

Target groups	Drug Dosage	Frequency
12-23 months	Albendazole: 200 mg or 1/2 tablet	Every 6 months
	Mebendazole: 500 mg tablet
2 years old and	Albendazole: 400mg or 1 tablet	Every 6 months
above	Mebendazole: 500 mg tablet

4. The following management shall be done to children experiencing common Adverse Events Following Deworming (AEFD):

*Common Adverse Effects	**How to Manage
Local sensitivity or allergy	Give antihistamine
Mild abdominal pain	Give antispasmodic
Diarrhea	Give oral rehydration solution plus Zinc
Erratic worm migration	Pull out the worms from mouth/nose and
	dispose worm properly (see Annex 1,
	section on proper disposal)
* The common adverse effects listed above and which are expected to manifest within the first 10 hours after intake of either of the drugs are mild and transient. Therefore in majority of the cases, treatment is not necessary.
** Refer to Annex I 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 B.1).

5. MDA shall be given IN CAUTION to the following individuals:

Category	Response
Seriously ill child	Manage existing condition prior
Children experiencing abdominal pain	to administration of deworming
Children with diarrhea	drug
Children who previously suffered
hypersensitivity to the drug
Severely malnourished children	Assess for presence or absence of
	medical complication and edema of both
	feet. If present, manage medical
	complications before deworming.
	(Source: Community-based Management
	of Acute Malnutrition)
	For uncomplicated
	severe malnutrition, with no medical
	complication and edema, children may be
	dewormed

VI. Specific Guidelines

1. The target clients, their caregivers and school teachers shall be adequately informed of the possible adverse reactions to the drug and its proper management.

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

3. Adverse reactions shall be accurately recorded and reported to proper authorities which is the AEFD team.

4. The following measures shall be undertaken in reporting SAE:

A. When to report SAE:

A.1 Any serious adverse event experienced by the client within 8-10 hours after ingestion of the drug should be reported immediately to the AEFD Team.

A.2 Any AEFD or non-serious adverse event shall also be recorded for reference.

A.3 Any AEFD or non-serious adverse event reported after 10 hours since the administration of the drug should be investigated and managed appropriately.

B. Whom to report SAE:

Serious adverse reactions shall be reported to the AEFD Team.

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

City/Municipal Level

a. City/Municipal Health Officer

b. City/Municipal Epidemiology Surveillance Officer (if available)

c. IHCP Coordinator

d. DOH representative

e. School Health Coordinator (for school based deworming)

Provincial Level

a. Provincial Health Officer

b. Provincial Epidemiology Surveillance Officer (if available)

c. IHCP Coordinator

d. DOH representative

e. School Health Coordinator (for school based deworming)

Regional Level

a. Regional IHCP Coordinator

b. Regional Epidemiology Surveillance Officer

c. Food and Drug Administration Officer aDSIHc

d. School Health Coordinator (for school based deworming)

National Level

a. Disease Prevention and Control Bureau

b. Epidemiology Bureau

c. Food and Drug Administration

d. Department of Education (for school based deworming)

These teams shall investigate the case at their level and assess if it is truly 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.

B.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 has been developed to describe pertinent information related to the onset of the adverse events. This form should be filled up by the health worker, parent, or teacher (see Annex 2) as necessary. The form should then be forwarded to the relevant offices involved in the investigation of the AEFD. A flowchart is provided to serve as guide on how to go about the reporting of AEFD cases (see Annex 3).

D. Support to DOH Regional Offices for AEFD:

The Integrated Helminth Control Program shall sub-allot the amount of Fifty Thousand Pesos (PhP50,000) to each DOH Regional Office 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 IHCP activities.

VII. Roles and Responsibilities

A. Disease Prevention and Control Bureau (DPCB)

1. Establish 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.

2. Develop and update policies and guidelines on the management of AEFD for schools, RHUs and hospitals and other government agencies involved in mass deworming campaign.

3. Allocate fund for the management of AEFD.

B. Epidemiology Bureau

1. Conduct an in-depth investigation of any serious adverse experience which may be life-threatening or requires hospitalization.

2. Establish and maintain a database in coordination with DPCB.

3. Analyze data provided by RESU.

4. Recommend appropriate action if necessary.

5. Provide feedback to concerned offices/LGUs or schools as necessary.

C. DOH Regional Offices/Regional Epidemiology Surveillance Unit (RESU)

1. Confirm reported occurrence of AEFD.

2. Conduct investigation in collaboration with LGUs.

3. Analyze data gathered and recommends appropriate action.

4. Allocate fund to augment national funds in the management of AEFD.

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

1. Oversee the implementation of mass deworming.

2. Conduct initial investigation and confirms reported AEFD through the PESU/MESU.

3. Recommend appropriate action if necessary.

4. Augment fund for the management of AEFD.

5. Report to DOH Regional Office or refers to next higher level if further investigation is required.

E. Food and Drug Administration

1. Perform an independent analysis of the implicated deworming drug and if necessary, shall collaborate with RITM and other accredited reference laboratories in this effort.

2. Provide feedback to DPCB on safety, quality and efficacy of implicated deworming drug. ETHIDa

3. To issue cease and desist orders motu proprio or upon verified complaint for health products, whether or not registered with the FDA: Provided, That for registered health products, the cease and desist order is valid for thirty (30) days and may be extended for sixty (60) days only after due process has been observed (RA 9711).

F. Department of Interior and Local Government

1. Disseminate guidelines on AEFD and SAE for information of LGUs.

2. Promote development of legislations/resolutions to provide technical and financial support to augment resources of CHDs in the occurrence of SAEs.

G. Government Hospitals

1. Ensure treatment of any referrals related to mass deworming AEFD.

2. Report cases of SAEs to MESU/PESU/RESU.

H. Parents/Health workers/Teachers

1. Report cases of SAEs to proper authority, e.g., PESU/MESU.

2. Report cases of SAEs to nearest health facility or proper authority e.g., MHO/PHN/PESU/MESU.

VIII. Repealing Clause

The Administrative Order No. 2010-0023 and other related issuances that are found inconsistent with this Order are hereby repealed or rescinded.

IX. Effectivity

This Order shall take effect after fifteen (15) days following the completion of its publication in two (2) newspapers of general circulation.

(SGD.) JANETTE P. LORETO-GARIN, MD, MBA-HSecretary of Health

ANNEX I

Recommended drugs for the management of Adverse Events Following Deworming (AEFD)

		Drug		Dose
	•	For local and hypersensitivity and allergy:
Diphenhydramine	For oral dosage forms: Syrup 12.5mg/5ml
			•	Children younger than 6 years of age:
				1/2 tsp to 1 tsp every 6-8 hours until
				symptoms subside
			•	Children 6 to 12 years of age: 1 tsp to 2
				tsp every 6-8 hours until symptoms
				subside
	•	For abdominal pain
Dicycloverine	GI spasm:
			For oral dosage forms:
			Syrup 10mg/5ml
			•	Children 6 months-2 years old: 1/2 tsp to
				1 tsp every 6-8 hours
			•	Children 2 to 12 years of age: 1 tsp
				every 6-8 hours
				*Dicycloverine: May be taken with or
				without food. (May be taken before or after meals)
Hyoscine N-butylbromide	Acute attacks of colicky pain:
			For oral dosage forms:
			Syrup 5mg/5ml or tablet 10mg
			•	Children > 6 years: 1 tablet every 6-8
				hours or 2 tsp every 6-8 hours
	•	For diarrhea
Reformulated Oral	To prevent dehydration: give after each
Rehydration Salt	loose stool
			•	50-100 ml (1/4 to 1/2 cup) ORS for
				children under 2 years old
			•	100-200 ml (1/2 cup to 2 cups) ORS for
				children 2-10 years old
Zinc supplementation	Children 6 months to < yrs old: 1 tablet once
			a day for 14 days

 

Erratic worm migration

Pull out worms if it comes out of the nose or mouth, and dispense of properly (flush in toilet or burn/incinerate)

ANNEX II

Integrated Helminth Control Program

Reporting Form

ANNEX III

Flow of SAE Report and Investigation