WHO: 10% of drugs sold in developing world dubious

Two WHO reports released on Tuesday estimated that roughly 10.5% of medicines being sold in Low and Middle Income countries (LMIC) could be substandard or falsified.

Hence, they concluded, the size of the dubious drugs market in these countries at about $30 billion. However experts slammed the basis for these estimates and said they were grossly exaggerated.

While substandard medicines have been a matter of concern in many countries, several member states are expressing concern with the findings, especially the estimation of prevalence of substandard and falsified medical products in Low and Middle Income countries using an “unscientific methodology”, said a statement issued by Third World Network (TWN), a transnational alternative policy group aimed at strengthening cooperation among countries of the Global South.

Of the two reports, one was on the cases reported to the WHO’s Global Surveillance and Monitoring System (GSMS) for dubious drugs launched in July 2013.

The cases reported between 2013 and 2016 were categorised under various heads such as “falsified”, “suspected falsified”, “substandard”, “diverted”, “stolen” and “unlicensed” medical products.

However, after the World Health Assembly decided in 2016 to categorise compromised medicines as “substandard” and “falsified” and adopted working definitions for the same, the Global Surveillance and Monitoring System cases appear to have been automatically categorised as one of these two, said Third World Network.

Source: The Times of India.

FDA approves first digital pill that tracks patients

For the first time, the Food and Drug Administration has approved a digital pill — a medication embedded with a sensor that can tell doctors whether, and when, patients take their medicine.

The approval, announced on Monday, marks a significant advance in the growing field of digital devices designed to monitor medicine-taking and to address the expensive, longstanding problem that millions of patients do not take drugs as prescribed.

Experts estimate that socalled nonadherence or noncompliance to medication costs about $100 billion a year, much of it because patients get sicker and need additional treatment or hospitalisation.

“When patients don’t adhere to lifestyle or medications... there are really substantive consequences that are bad for the patient and very costly,” said Dr William Shrank, chief medical officer of the health plan division at the University of Pittsburgh Medical Center.

Patients who agree to take the digital medication, a version of the antipsychotic Abilify, can sign consent forms allowing their doctors and up to four other people to receive electronic data showing the date and time pills are ingested.

A smartphone app will let them block recipients anytime they change their mind. Although voluntary, the technology is still likely to prompt questions about privacy and whether patients might feel pressure to take medication. A controversial use might be requiring digital medicine as a condition for parole. Abilify is an arguably unusual choice for the first sensor-embedded medicine. It is prescribed to people with schizophrenia and bipolar disorder and, in conjunction with an antidepressant, depressive disorder. Symptoms of schizophrenia and related disorders can include paranoia and delusions, so some doctors and patients wonder how widely digital Abilify will be accepted.

The newly approved pill, called Abilify MyCite, is a collaboration between Abilify’s manufacturer, Otsuka, and Proteus Digital Health, a California company that created the sensor.

The sensor, containing copper, magnesium and silicon (safe ingredients found in foods), generates an electrical signal when splashed by stomach fluid said Andrew Thompson, Proteus’s president and chief executive.Dr Jeffrey Lieberman, chairman of psychiatry at Columbia University and New York-Presbyterian Hospital, said many psychiatrists would likely want to try digital Abilify. But he noted it has only been approved to track doses, and has not yet been shown to improve adherence.

Proteus has spent years bringing its sensor to commercial use, raising about $400 million from investors, including Novartis and Medtronic, Thompson said. Until now, the sensor could not be embedded in pills, but pharmacies could be commissioned to place it in a capsule along with another medication. In 2016, the encapsulated sensor started being used outside of clinical trials, but commercial use is still limited, Thompson said.

Nine health systems in six states have begun prescribing it with medications for conditions including hypertension and hepatitis C, the company said, adding that it has been found to improve adherence in patients with uncontrolled hypertension and others. How patients will view Abilify MyCite is still unclear.
Source: The Times of India