Republic of the Philippines

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INVOLVING CONSUMERS IN

MEDICINES SURVEILLANCE

(Report of the Pilot Study)

Republic of the Philippines

Cynthia J. Lim

Bureau of Food and Drugs

Department of Health

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RATIONALE

Mission Report

Ms. Ms. Nazarita Tacandong Nazarita Tacandong - - Lanuza, Philippines Lanuza , Philippines

Ms. Ms. Abida Haq bt syed Abida Haq bt syed M. M. Haq, Malaysia Haq , Malaysia

Authors

Objectives:

¾ To expand the existing surveillance system of the DRA and

to include involvement of consumers in reporting quality

defects, ADRs, misleading claims, inappropriate product

labeling, suspected counterfeits / unregistered products

and other drug related problems

¾ To empower consumers for proper drug usage (awareness

of quality and safety)

¾ To conduct a pilot study in the Philippines and Malaysia

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PILOT AREA

DAVAO CITY

(Southeastern Mindanao)

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POSTER

- Displayed in

prominent selling

area of the drug

retailers

- Contains simple

instructions on

how to submit

reports and

contact numbers

of program

coordinators

- Showed sample of

notice of trial

form

Bantay Gamot

CONSUMER MEDICATION ALERT

I-report

mo!

“Ang gamot ay nagbibigay lunas….ngunit kung di wasto ang paggamit, pinsala ang kapalit”

Name: _____________________________________ Date: _______________

Address: _________________________________________________________

Contact No. (Tel.) ____________________ (Cel.) ________________________

Name of Medicine: ________________________________________________

Dosage Form: (Please Check)

Tablet Injectables Capsule Others: (Please Specify)

Syrup/Suspension _________________________________

Where Bought: ___________________________________________________

(Name of Store) Date Bought: ______________________

Complaint: (Please Check)

Drowsiness Itchiness

Headaches Others: (Please Describe)

Rashes __________________________________

_________________________________________________________________

Signature Where to submit?

DOH-BFAD

Tel. No. (082) 305-1902 Hotline: 09184052551 http://www.chd11.doh.gov.ph/

San Pedro College (Pharmacy Dept.) / St. Dominic Pharmacie Tel. No. (082) 221-0257 loc. 61 (c/o Carmen)

DTI-Consumer Desk Tel. No. (082) 224-0511 loc. 421 Or any DRUGSTORE near you!!!

SAMPLE FORM

W We e v va al lu ue e y yo ou ur r L Li if fe e! !! !! !

Aims:

9 To monitor the adverse effects of medicines

9 To encourage the consumers to participate in programs that will improve the quality of drugs

9 To save lives

STEP 1

Kung may

nadama kang

di-kanaisnais

pagkatapos

mong uminom

ng biniling

gamot, isulat

ito sa Bantay

Gamot Form

na kasama sa

ibiniling gamot

galing sa

botika .

This project is a collaboration of WHO, DOH-BFAD, SPC (Pharmacy Dept.), DTI-Consumer Network, Drugstores and DSAP Davao

I-report mo!

Bantay Gamot

CONSUMER MEDICATION ALERT

“Ang gamot ay nagbibigay lunas…ngunit

kung di-wasto ang paggamit,

pinsala ang kapalit”

STEP 2

Ibalik ang

Bantay

Gamot

Form

sa

DOH-BFAD

o kahit

saang

BOTIKA

malapit sa iyo.

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This project is a collaboration of WHO, DOH-BFAD, SPC (Pharmacy Dept.), DTI-Consumer Network, Drugstores and DSAP Davao

Bantay Gamot

I-report mo!

CONSUMER MEDICATION ALERT HOTLINE 09184052551

“Ang gamot ay nagbibigay lunas…ngunit

kung di-wasto ang paggamit,

pinsala ang kapalit”

STREAMER

REPORTER DETAILS

(IMPORMASYON TUNGKOL NAGREKLAMO)

Name / Pangalan:

Address / Tirahan:

Telephone / Telepono: Email:

PATIENT DETAILS / IMPORMASYON TUNGKOL SA PASYENTE Name / Pangalan:

Age / Edad: Sex / Kasarian:

Relationship to reporter / Kaugnayan sa Nagrereklamo:

ABOUT THE MEDICINE BEING COMPLAINED TUNGKOL SA GAMOT NA INIREREKLAMO:

Name of medicine / Pangalan ng gamot :(please use generic name and brand name and include sample if available / Isulat ang generic name at brandname ng gamot na inirereklamo at isumite ang gamot na natitira)

Dosage form / Uri ng gamot: :

Tablet / Tableta □ Capsule / Kapsula □ Syrup / Likido □ Injection / Ineksyon □ Name of Manufacturer / Pangalan ng gumawa: Lot / Batch No:

(please refer to product label) Expiry Date:

NATURE OF THE COMPLAINT / KLASE NG REKLAMO

□ Quality defect like mottling, discoloration and inability to dissolve / suspend powder upon reconstitution / Depekto ng gamot gaya ng hindi pantay pantay na kulay o kupas na tableta, hindi matunaw o namumuong mga pulbos sa likido □ Experienced side effect / Masamang epektong naranasan □ No improvement from previous conditions / Walang epekto ang gamot □ Others / At iba pa

Please give details on the nature of the problem / Isulat ang detalye ng reklamo

___________________

Signature / Lagda:

What was the medicine used for / Ano ang sakit na pinag gamitan ng gamot?

Date when problem occurred / Petsa kung kalian

napansing nag umpisa ang masamang epekto ng gamot: Date when medicine was used / Petsa unang ginamit ang gamot:

Name & Address where medicine was bought / Pangalan at lugar kung saan nabili ang gamot:

Proof of purchase / Resibo ng biniling gamot:

Date of purchase / Petsa kung kailan binili ang gamot:

Any other information which you think may be useful in our investigations / Iba pang impormasyon na maaring makatulong sa gagawing pagsisiyasat:

Do you agree to us contacting you if we require further information / Ikaw ba ay pumapayag na aming tawagan kung kinakailangan pa ang karagdagang impormasyon?

REPORT FORM

NOTICE OF TRIAL

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PROCESS FLOW FOR CONSUMER REPORTING

CONSUMER PROCUREMENT OF

MEDICINES IS ACCOMPANIED WITH

NOTICE OF TRIAL FORM

CONSUMER WILL RETURN

ACCOMPLISHED NOTICE OF TRIAL FORM

TO PARTICIPATING RETAIL OUTLETS.

DROP REPORT ON DROP BOXES:

- Participating Drugstores

- DTI Office (Davao)

- San Pedro College - Pharmacy Dept.

- Regional BFAD Office in Davao

FILL UP

THE “REPORT FORM”

HOTLINE:

0928-4821045/0905-8100210

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21%

20%

18%

9%

3% 3%

2% 2%2%

2%

CONSUMER REPORTS RECEIVED

Illegal business

operation practices

Unlawful dispensing

of drugs in the

absence of the

pharmacist

Selling of

unregistered

drugs

6 Expired

drugs

6 Counterfeit

drugs

6 Error in

dispensing

14

13

12

2

2 1 1 1 1

3% - Common side effects

3% - Pharmacist is connected to

two establishments

2% - Lack of drug efficacy

2% - False claim for food

supplement

2% - Product formulation

2% - Suspected ADR

Year 2007 – 2008

¾ 65 - total number of

consumer reports

received on drug related

issues

¾ Based on the number of

reports with complete

result of investigation,

68% of the reports

received were found

accurate.

¾Issued 33 Cease and Desist Orders for confirmed unregistered drugs

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CASE No. 1

Steven Johnson Syndrome

Details:

A report from a son was

received regarding the critical

condition of his father in the

hospital due to appearance of

rashes after taking

Lamotrigine 50 mg Tab.

Action:

A Food and Drug Regulation

Officer was sent to investigate

and found out that patient

was admitted for Steven

Johnson Syndrome.

A revision of drug

label was made to include

an additional Warning “ To

stop the use of drug at the

first appearance of a

rash due to possible life

threatening condition eg. SJS

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Case 2.

Stupor, Weakness, Nausea and Vomiting

Details:

An 11 year old girl - epileptic patient suffered stupor,

weakness, nausea and vomiting after taking Carbamazepine

Suspension 100mg / 5mL

Action:

Analysis showed very high content of the active

ingredient, almost three times of declared label claim.

The Bureau of Food and Drugs issued an advisory for the

immediate recall of the batch

The result of investigation showed GMP related problem on

the part of the manufacturer to compound the suspension.

Company stopped local production

Case 2.

Stupor, Weakness, Nausea and Vomiting

Details:

An 11 year old girl

An 11 year old girl - - epileptic patient suffered stupor, epileptic patient suffered stupor,

weakness, nausea and vomiting after taking

weakness, nausea and vomiting after taking Carbamazepine Carbamazepine

Suspension 100mg / 5mL

Action:

Analysis showed very high content of the active

ingredient, almost three times of declared label claim.

The Bureau of Food and Drugs issued an advisory for the

immediate recall of the batch

The result of investigation showed GMP related problem on

the part of the manufacturer to compound the suspension.

Company stopped local production

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EVALUATION

OF THE PILOT STUDY

¾ The study proves that direct involvement of

consumers in reporting drug related problems is an

effective means to strengthen the Drug Regulatory

Authority’s (DRA) existing surveillance system.

¾ Responses to reporters / complainants are

important to gain public trust however care should

be taken when giving statements in order to avoid

issues of litigation and unnecessary alarm to the

public.

¾ Commitment and support of drug retailers and

pharmacist play a vital role in the success of the

program.

¾ The budget for advocacy materials and constraints

in manpower posed additional challenges for the

DRA.

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System of

recording

patients

concern

Drive to combat

Counterfeit Drugs

Improvement

of healthcare

Services

Posed a

challenge to

medical health

providers

Consumer

awareness

on patient’s

rights

Communication

between the

pharmacist and

patients

Strengthen

the existing

surveillance

System of the

DRA

Monitoring

of unethical

promotions

and deceitful

CONSUMER

REPORTING

Rational Drug Use

Drug Safety

Information

Trigger the government

to develop new health

policies or initiate

programs to protect

patient’s rights

Early

detection

Of ADR cases

Medication errors

Monitoring of ADR

GSP

Equipments

Facilities

Unlicensed

drug outlets

Direct to

patient sale

Remote areas

not regularly

Inspected by the DRA

Reference of the DRA

in policy making

Food supplements

Traditional medicines

Assurance of

product safety,

quality and

efficacy

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