10 January 2017, Puchong, Selangor – The Malaysian Pharmaceutical Society (MPS) commends the MOH, NPRA and Hovid Berhad on their transparent, efficient and responsible handling of the recent recall of Ternolol 50; and the subsequent cancellation of the manufacturing license of Hovid Berhad by the authorities
MPS President, Tn Haji Amrahi, “All parties acted fast in getting the information to the public. However, our main concern is the safety of the product user and we hope that all the medication in circulation is returned to Hovid Berhad soon”.
“To ensure the recall information was shared widely, MPS and its members helped viral the message on social media with other pharmacists”, he explained.
When asked how such an error could have occurred. Tn Haji Amarahi said MPS would not speculate on the root cause as the investigation is still ongoing by all the parties concerned.
He further stated that the public lack awareness of the regulatory process in Malaysia and are not well informed on how to check for registered products. Further, many members of the public are unclear about recall procedures. Due to the lack of understanding, many incorrect assumptions are made and shared on social media in an irresponsible manner.
Speaking to reporters, he said, “The NPRA has the task of ensuring that therapeutic substances approved for the local market are SAFE, EFFICACIOUS and of QUALITY via product registration, licensing (manufacture, import, wholesale) , monitoring of adverse drug reactions and market surveillance”
He added that the NPRA only approves a drug registration after it has undergone a stringent screening and approval process that takes anywhere between 6 months to 18 months depending on the product classification. Once a drug has been approved, regular post market surveillance is done to ensure registration compliance.
Amrahi also urged the public to use the tools provided by the NPRA to check for registered products.
When asked how this could be done, he explained that the NPRA has conducted many campaigns via their Kenali Ubat Anda mechanism and have also equipped community pharmacists with a tool called the MediTag Decoder to check for counterfeits using a hologram security label.
“Malaysia is the first country in the world to implement the use of a single security hologram label for all pharmaceutical products sold in the country,” he told reporters.
With reference to the current recall for Ternolol 50, the NPRA issued a directive to recall as there was a potential risk to the user of the product.
Elaborating on the recall process by NPRA, he said, “The NPRA is extremely efficient. The manufacturer or product license holder will be instructed to inform all its clients that the product has been recalled, after which they must set in place a mechanism of collection and destruction of the recalled product. Finally an investigation will be conducted to discover the root cause of the error and corrective actions will be put into place to prevent further such occurrences.”
The NPRA has the authority, he said, to revoke licenses or impose fines if they find compliance issues with the product.
The Malaysian Pharmaceutical Society Brief
The Malaysian Pharmaceutical Society (MPS) is the national association for pharmacists formed in 1967 to promote and maintain the honor and interests of the profession of pharmacy in the country. The Society plays an important role to further the development of pharmacy and pharmaceutical education and to foster intra-professional relationship among members. It strives to improve the Science of Pharmacy for the general welfare of the public by fostering the publication of scientific and professional information relating to the practice of pharmacy and aid in the development and stimulation of discovery, invention and research.
The Society also represents the interests of its members and also the general public by having representatives at the Pharmacy Board and the Poisons Board of the Ministry of Health, and other consumer-related interest groups. The Society also confers Honorary membership, Fellowship and Awards to deserving pharmacists. For students, the MPS presents the annual MPS Gold Medallist Award to deserving graduating students from local pharmacy institutions.
Membership is opened to all registered pharmacists in Malaysia.
There is also a category for student membership. Through this channel students can focus their activities through various interest groups (NoGAPS, IPSF, Student Chapter). Special consideration is also given to students to attend MPS-organised activities either through complimentary invitation, or at special student rates.
The Society is actively engaging pharmacists in Continuing Professional Development activities. Throughout the year courses and seminars are being organized to facilitate pharmacists participation. It is also pursuing accreditation of pharmacies for standardization of practice.
