Republic of the Philippines

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1 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

2 RATIONALE Mission Report Ms. Nazarita Tacandong - Lanuza,, Philippines Ms. Abida Haq bt syed M. Haq,, Malaysia Authors Objectives: 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 To empower consumers for proper drug usage (awareness of quality and safety) To conduct a pilot study in the Philippines and Malaysia

3 PILOT AREA DAVAO CITY (Southeastern Mindanao)

4 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. I-report mo! Bantay Gamot CONSUMER MEDICATION ALERT Ang gamot ay nagbibigay lunas ngunit kung di-wasto ang paggamit, pinsala ang kapalit Bantay Gamot CONSUMER MEDICATION ALERT Ang gamot ay nagbibigay lunas.ngunit kung di wasto ang paggamit, pinsala ang kapalit I-report mo! 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) Hotline: San Pedro College (Pharmacy Dept.) / St. Dominic Pharmacie Tel. No. (082) loc. 61 (c/o Carmen) DTI-Consumer Desk Tel. No. (082) loc. 421 We value your Life!!! 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 SAMPLE FORM STEP 2 Ibalik ang Bantay Gamot Form sa DOH-BFAD o kahit saang BOTIKA malapit sa iyo. 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 Or any DRUGSTORE near you!!! This project is a collaboration of WHO, DOH-BFAD, SPC (Pharmacy Dept.), DTI-Consumer Network, Drugstores and DSAP Davao

5 STREAMER I-report mo! Bantay Gamot CONSUMER MEDICATION ALERT HOTLINE Ang gamot ay nagbibigay lunas ngunit kung di-wasto ang paggamit, pinsala ang kapalit This project is a collaboration of WHO, DOH-BFAD, SPC (Pharmacy Dept.), DTI-Consumer Network, Drugstores and DSAP Davao NOTICE OF TRIAL REPORT FORM REPORTER DETAILS (IMPORMASYON TUNGKOL NAGREKLAMO) Name / Pangalan: Address / Tirahan: Telephone / Telepono: 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 Lagda: What was the medicine used for / Ano ang sakit na pinag gamitan ng gamot? Signature / 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: Any other information which you think may be useful in our investigations / Iba pang impormasyon na maaring makatulong sa gagawing pagsisiyasat: Date of purchase / Petsa kung kailan binili ang gamot: 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?

6 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. HOTLINE: / FILL UP THE REPORT FORM DROP REPORT ON DROP BOXES: - Participating Drugstores - DTI Office (Davao) - San Pedro College - Pharmacy Dept. - Regional BFAD Office in Davao

7 CONSUMER REPORTS RECEIVED Year % 2% 2%2% 2% 3% 3% Error in dispensing % 14 Illegal business operation practices 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 9% 6 Counterfeit drugs 9% 6 Expired drugs 13 Unlawful dispensing of drugs in the absence of the pharmacist 12 Selling of unregistered drugs 18% 20% 2% - Suspected ADR 65 - total number of consumer reports received on drug related issues Based 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

8 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

9 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

10 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.

11 Reference of the DRA in policy making System of recording patients concern Monitoring of unethical promotions and deceitful advertisements Food supplements Traditional medicines Strengthen the existing surveillance System of the DRA Assurance of product safety, quality and efficacy Unlicensed drug outlets Direct to patient sale Drive to combat Counterfeit Drugs Remote areas not regularly Inspected by the DRA GSP Equipments Facilities Improvement of healthcare Services CONSUMER REPORTING Posed a challenge to medical health providers Consumer awareness on patient s rights Medication errors Monitoring of ADR Communication between the pharmacist and patients Rational Drug Use Drug Safety Information Early detection Of ADR cases Trigger the government to develop new health policies or initiate programs to protect patient s rights

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