VACCINE FRAUD - Strengthen Supervision System

A recent disclosure about the distribution of fake vaccines serves as an important lesson on the need to strengthen the vaccine supervision system. Verification of vaccine suppliers must become a mandatory procedure that must not be overlooked, particularly when hospitals or other health facilities procure vaccines.

So far, aside from using an electronic catalogue, private clinics and hospitals can procure medicines and vaccines on their own. Their desire to get inexpensive medicines or vaccines provides opportunities for the suppliers of fake vaccines. "Possibly, the producers are said to be overseas, but the distributors are domestic players. It is the verification of vaccine suppliers that must be strengthened," said Tri Yunis Miko Wahyono, a lecturer with the School of Public Health at the University of Indonesia in Jakarta on Thursday (30/6/2016).

The Food and Drug Supervision Agency's director of therapeutic products distribution supervision, Arustyono, said there are already requirements for how medicines and vaccines must be procured. However, the economic motives of the suppliers who want to achieve high sales and of the health facilities that want to get inexpensive products make it possible for fake vaccines to get into those facilities.

"In the field, suppliers with no licenses can supply vaccines to health facilities. In fact, vaccine suppliers must be certified on how to carry out good drug distribution," he said.

Hampered by regulation

BPOM acting head Tengku Bahdar Johan Hamid said the supervision of vaccines from production through to distribution to pharmaceutical dealers is under the authority of the BPOM. Meanwhile, the supervision of pharmaceutical services at hospitals, drugstores and community health centers (Puskesmas) is in the hand of the Health Ministry and the local administration. "So, there are too many institutions that supervise drugs," he said.

Health Ministerial Regulation No. 58/2014 on standard pharmaceutical services at hospitals and Health Ministerial Regulation No. 35/2014 on pharmaceutical services at drugstores regulate the pharmacy services. "If the supervision runs well and the regulations are followed, there would be no fake vaccines," he added.

So far, BPOM supervision over drugstores is minimum. Regulation No. 35/2014 stipulates that the guidance and supervision of drugstores is performed only by the health minister and the head of the health offices in the province and municipality or regency. "After the issuance of the regulation, if a health facility refuses to show a receipt of the vaccine purchase, we can do nothing," Arustyono said.

BPOM secretary Reri Indriani said the small number of food and pharmacy supervisors at the BPOM has led to weak supervision. Ideally, for the Indonesian population of about 250 million there should be 10,618 food and pharmacy supervisors. Yet, there are only 1,634, about 15 percent of the ideal.

Aside from that, BPOM law and public relations bureau head Riati Anggriani said other issues concerning fake vaccines are related to the improper management of medical waste. Medical waste, including expired vaccines, must be destroyed.

Strengthen the supervision

"The elimination of fake vaccines and the control of vaccine distribution must be improved for the future of Indonesian people," Bio Farma director Iskandar said recently in Bandung, West Java. The producer of nearly 3.2 billion doses of vaccine per year acknowledged that his company's serum products, such as BIOSAT (anti-tetanus serum), BIOSAVE (anti-snake poison serum) and Tuberculin PPD, had been counterfeited. Early prevention is important to give the public a sense of safety. The producers and distributors of vaccines, as well as health workers, must check the labels, expire dates, codes of production and the origins of the vaccines before giving them to the public.

In several regions, such as Yogyakarta, Jayapura (Papua) and Bogor (West Java), the local food and drug supervision agencies (BBPOM) keep monitoring the local health facilities to check the authenticity of the vaccines. The inspections are performed at public hospitals, mother and child hospitals, clinics, drugstores and distributors.

Meanwhile, 10 babies and toddlers below 5 years old have shown indication of having received fake vaccines from a midwife in Ciracas, East Jakarta. Those babies and toddlers will undergo observations by a medical team to determine the impact of the fake vaccines. Health Minister Nila F. Moeloek and National Police Crime and Investigation Division head Comr. Gen. Ari Dono Sukamto checked their condition recently.

National Police chief Gen. Badrodin Haiti said the police have checked on the raw materials of the fake vaccines and sought comments from experts regarding their impacts on the human body. Police have named 17 suspects in the case.

 

Source Kompas, Friday, July 1, 2016