FDA Philippines Signs Policy to create National Pharmacy Information System to Protect Patient Safety

The FDA electronic Drug Safety System (eDSS) mobile app recalls dangerous medicines, fights counterfeits, gathers prescription information, and cuts bureaucracy
For half a century, pharmacists were required by the 1969 Philippine Pharmacy Act to maintain paper logbooks in which they wrote down prescription information word for word. This meant spending less time with patients and more time with paper bureaucracy.

FDA Philippines Signs Policy to create National Pharmacy Information System
FDA Director General Charade G. Puno and mClinica President and CEO Farouk Meralli 

Now, for the first time as a part of the FDA’s modernization efforts, electronic reporting is required. The FDA signed the circular “Guidelines for the Use of the Electronic Drug Safety System (eDSS)” on June 27, 2018 announcing that paper prescription logbooks will be modernized with a new mobile app called the electronic Drug Safety System (eDSS).

The eDSS mobile app, available to pharmacies and the FDA, digitizes the information written on prescriptions. Pharmacists use the eDSS mobile app to snap a photo of each prescription they receive and enter a few fields using their phones, significantly reducing the amount of time needed to comply with old regulations. Most importantly, the data generated from these prescriptions will save lives. By analyzing upticks in specific medicine use, the government can quickly fight outbreaks and understand patterns of treatment for diseases like diabetes or TB.

FDA Philippines Signs Policy to create National Pharmacy Information System
FDA Director Nela Charade Puno and Farouk Meralli CEO of mClinica

The data generated from these prescriptions will also help the government know where medicines are available and how to allocate resources - a great challenge considering there are over 10,000 active pharmacies spread across more than 7,000 islands in the Philippines. When Yolanda hit, many people faced dire medicine shortages in areas without knowing that those same medicines were available in towns nearby. With a national pharmacy information system, however, government and aid agencies can advise people on where to find life-saving medicines in an emergency situation, even if ports and airports are closed.

FDA Director General Nela Charade Puno stated: “Paper logbooks were used for long enough - it’s time to modernize and innovate. That’s exactly what the eDSS does. Not only does it cut bureaucracy, but the eDSS mobile app is going to help millions of Filipino patients each time medicine is purchased. The data generated from the eDSS creates a national pharmacy information system that helps the FDA allocate resources efficiently as well as protect patients. The data will help us find counterfeits and recall dangerous or ineffective medicines instantly.”

Emily Cruz has worked as a practicing pharmacist for 29 years, advising patients and providing medicines at the Parmasyutika Drugstore, a small independent pharmacy located in Manila. She said that keeping a paper logbook was “Really very tedious. It’s impractical, pointless, and irrelevant to the practice.” She said that she preferred the FDA eDSS to paper logbooks and demonstrated the use of the eDSS mobile app, taking a photo with her phone. It took seconds. When asked if she wanted to go back to paper she said, “Oh no, not anymore.”

FDA and mClinica teams

The new requirement will be rolled out in tiers, starting with Manila, Cebu, and Davao in 2018 leading to all cities nationwide by 2020. Exceptions to the requirement will be made for rural areas with limited internet access. The eDSS launch kicks off with an orientation event for FDA inspectors from Visayas and Mindanao in Cebu City on September 25, 2018. All FDA inspectors nationally are expected to be ready to implement the eDSS by the end of October.

The eDSS mobile app was developed by mClinica, a social enterprise, and donated to the FDA to improve public health data at no cost to the taxpayer. It is the latest effort by the FDA to place the Philippines on the map as a country on the cutting edge of healthcare by harnessing the power of mobile technology to generate never-before-seen insights to protect citizens.