INVOLVING CONSUMERS INMEDICINES SURVEILLANCE

(Report of the Pilot Study)

Republic of the Philippines

Cynthia J. LimCynthia J. LimBureau of Food and Drugs

Department of Health

RATIONALE

Mission ReportMs.Ms. Nazarita TacandongNazarita Tacandong -- LanuzaLanuza, Philippines, Philippines

Ms.Ms. Abida Haq bt syedAbida Haq bt syed M.M. HaqHaq, Malaysia, MalaysiaAuthors

Objectives:To expand the existing surveillance system of the DRA and to include involvement of consumers in reporting quality defects, ADRs, misleading claims, inappropriate productlabeling, suspected counterfeits / unregistered products and other drug related problemsTo empower consumers for proper drug usage (awareness of quality and safety)To conduct a pilot study in the Philippines and Malaysia

PILOT AREA

DAVAO CITY(Southeastern Mindanao)

POSTER

- Displayed in prominent selling area of the drug retailers

- Contains simple instructions onhow to submit reports and contact numbers of programcoordinators

- Showed sample ofnotice 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

WWee vvaalluuee yyoouurr LLiiffee!!!!!! Aims:

To monitor the adverse effects of medicines To encourage the consumers to participate in programs that will improve the quality of drugs 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.

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”

STREAMERREPORTER 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 FORMNOTICE OF TRIAL

PROCESS FLOW FOR CONSUMER REPORTINGCONSUMER PROCUREMENT OF

MEDICINES IS ACCOMPANIED WITH NOTICE OF TRIAL FORM

CONSUMER WILL RETURNACCOMPLISHED 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 UPTHE “REPORT FORM”

HOTLINE:0928-4821045/0905-8100210

21%

20%

18%

9%

9%

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

6Expireddrugs

6Counterfeitdrugs

6Error 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

65 - total number of consumer reports received on drug related issuesBased on the number of reports with complete result of investigation, 68% of the reports received were found accurate.

Issued 33 Cease and Desist Orders for confirmed unregistered drugs

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 investigateand found out that patient was admitted for Steven Johnson Syndrome.A revision of druglabel 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

Case 2.Stupor, Weakness, Nausea and Vomiting

Details:An 11 year old girl - epileptic patient suffered stupor, weakness, nausea and vomiting after taking CarbamazepineSuspension 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 VomitingStupor, Weakness, Nausea and Vomiting

Details:Details:An 11 year old girl An 11 year old girl -- epileptic patient suffered stupor, epileptic patient suffered stupor, weakness, nausea and vomiting after takingweakness, nausea and vomiting after taking CarbamazepineCarbamazepineSuspension 100mg / 5mLSuspension 100mg / 5mL

Action:Action:Analysis showed very high content of the active Analysis showed very high content of the active ingredient, almost three times of declared label claim.ingredient, almost three times of declared label claim.The Bureau of Food and Drugs issued an advisory for the The Bureau of Food and Drugs issued an advisory for the immediate recall of the batch immediate recall of the batch The result of investigation showed GMP related problem on The result of investigation showed GMP related problem on the part of the manufacturer to compound the suspension. the part of the manufacturer to compound the suspension. Company stopped local productionCompany stopped local production

EVALUATION OF THE PILOT STUDY

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. 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. Commitment and support of drug retailers and pharmacist play a vital role in the success of the program.The budget for advocacy materials and constraints in manpower posed additional challenges for the DRA.

System of recordingpatientsconcern

Drive to combat Counterfeit Drugs

Improvement of healthcare

Services Posed a challenge to

medical healthproviders

Consumerawareness on patient’s

rights

Communicationbetween the

pharmacist andpatients

Strengthen the existingsurveillance

System of the DRA

Monitoring of unethical promotions

and deceitful advertisements

CONSUMERREPORTING

Rational Drug Use

Drug Safety Information

Trigger the governmentto develop new healthpolicies or initiate programs to protect patient’s rights

Early detectionOf ADR cases

Medication errors

Monitoring of ADR

GSPEquipmentsFacilities

Unlicensed drug outlets

Direct to patient sale

Remote areas not regularlyInspected by the DRA

Reference of the DRA in policy making

Food supplementsTraditional medicines

Assurance of product safety,quality and efficacy