Punjab reacts to adverse drugs
LAHORE, July 25: With the bitter experience of the Punjab Institute of Cardiology tragedy which claimed lives of more than 150 patients in mind, the Punjab government is set to launch a ‘patient-safety’ project called Pharmacovigilance (PV) Centre.
It is a World Health Organization (WHO) recommended scheme which has been in practice in many developed and developing countries to prevent adverse drug reactions (ADRs).
The prime function of this initiative is the reporting of suspected adverse reactions of medicines and vaccines besides unregistered and alternate medicines used in herbal, unani and ayurvedic treatments.
Efforts were made in the past to materialise this scheme in Pakistan but it was dropped owing to certain reasons, a senior official of the health department said. He said the ‘unholy alliance’ of the healthcare professionals and the pharma industry delayed implementation of the patient-friendly project as the consultants had feared that they would lose favours they get from the pharma industry.
The Punjab government is the first among the provinces which has established (in the first phase) provincial office of the PV Centre at the Directorate General Health Services, Punjab.
Shortly after the PIC scam, the Punjab government had deliberated on several short-term and long-term strategies and finally opted for establishing the WHO-recommended Pharmacovigilance Centre.
According to documents, a copy of which is available with Dawn, the health department through a notification on April 21 had constituted an eight-member committee headed by the then Allama Iqbal Medical College principal, Prof Dr Javed Akram, to formulate the recommendations.
Other members on the committee were Prof Arif Mahmood Siddiqui of the same institute, Prof Dr Afzal Sheikh of Children’s Hospital, Mayo Hospital MS Dr Zahid Pervez, Dr Nasir Khan of Children’s Hospital, Punjab Institute of Mental Health Deputy Drug Controller Farooq Bashir Butt, Sir Ganga Ram Hospital Deputy Drug Controller Riffat Naz and Punjab Directorate General Health Services Pharmacy Director Ayaz Ali Khan.
The committee formulated the recommendations and submitted them to the health department on June 4. The department established its provincial office at the DGHS on Cooper Road.
The committee proposed establishment of adverse reaction reporting system, drug information and poison control centre and pharmacy services in the state-run hospitals.
Drug Information and Poison Control Centre and PV Centre will be established in each hospital. They will deal with identification and reporting of serious adverse drug reactions and propose appropriate measures to prevent untoward happenings in future.
The committee proposed that there’s a need to involve consumers and patients in PV practices.
Empowering patients by providing information is an opportunity for PV centres to improve their public health role. Reports accepted by provincial PV Centre will be reported to the National PV Centre and WHO adverse drug reactions database at the Uppsala Monitoring Centre, Sweden. The National PV Centre is yet to be established.
The PV centres at tertiary-care hospitals and districts will be linked to the provincial PV centre.
In each hospital a drug information and poison control centre and PV centre will be established in the Pharmacy Department. A PV committee will be established under the chairmanship of dean/principal of the institution, with chief pharmacist as its secretary. In addition, professors of relevant specialties including medicine, surgery, MS, and senior pharmacist will be its members.
Each DHQ/THQ will establish PV committee in their respective hospitals under the chairmanship of MS and chief pharmacist as its secretary. Other members will be from senior-most clinicians from medicine and surgery.
These committees will create awareness for reporting serious ADRs within hospital, meet regularly to discuss and scrutinise each ADR report received and will forward it to the provincial PV Centre, health directorate Lahore for necessary action.
Every ward and OPD department will have ADR forms and on observing even will report immediately to the hospital’s PV committee which on scrutinising the information and events will report to the provincial PV centre in Lahore. The tertiary-care hospitals will report directly and others through the EDO (health).
The PV Centre will also be established in each pharmaceutical firm along with appointment as Qualified Person Pharmacovigilance (QPPV) and they shall be bound to report any adverse event to the provincial PV centre.
In case of any ADR incident, the chief drug controller of the health department will be informed for legal action and samples of the suspected drug(s) will be sent for test analysis for immediate counter test.
The CDC will issue alert to immediately stop the use of medicines etc and immediate notification will be issued to stop public procurement of drugs. In case the drug is available in the market immediate instructions will be issued to the field force/drug inspectors to take action accordingly.
Case will be reported to the provincial quality control board for necessary legal action and recommendations to the federal government accordingly.