FDA Says No Shortage of Essential Drugs

FDA Says No Shortage  of Essential Drugs
FDA Says No Shortage  of Essential Drugs

Local pharmacies are short of an average number of 30 drugs every month, however, they are not essential life-saving medications, says Akbar Abdollahi Asl, planning deputy at the Food and Drug Administration.

“The deficit reflected in the 13-Aban Pharmacy shortage reports pertain to medications that are already being produced locally, although their foreign equivalents are prescribed by doctors,” he was quoted as saying by ILNA.

The FDA does not give import permit to foreign equivalents of domestically produced drugs and the helpline 201490 at the Health Ministry is open to pharmacies and people to report medicinal shortages 24/7.

“Medicine shortage reports are transferred to the market control department and urgent import permits are issued for drugs not available or produced in the country,” Asl stressed.

In Iran, In Iran, the incidence of drug shortages are reflected in the 13-Aban Pharmacy shortage reports. The reports contain important information on the availability of medicines. Drug shortages can frustrate the drug therapy process and increase the probability of medical complications due to the lack of timely supply of medications.

The College of Pharmacy, Tehran University of Medical Sciences, established seven community pharmacies in the 1980s that are the major suppliers of medicine in Tehran. The pharmacies have contracts with all the main Iranian health insurance companies and supply about 3,500 prescriptions per day. Moreover, they play an important role in the management of deficit drugs, whose distribution is usually centralized in the pharmacies to overcome insufficient supplies and ensure equitable supply. Therefore, shortage reports of 13-Aban Pharmacy are an alarm bell for the Health Ministry on the status, strengths and weaknesses of the national drug policy.

The 13-Aban Pharmacy is a community pharmacy and does not dispense all pharmaceuticals such as vaccines for routine immunization, narcotics and antivenins.

Earlier this year, Nasser Riahi, head of the Iranian Pharmaceutical Importers Association had stated that restricting imports could harm the pharmaceutical industry by “reducing competition, encouraging smuggling and threatening the well-being of patients.”

The FDA appears to have focused its policies on reducing pharmaceutical imports while boosting exports in the coming years, he said, quoted by ISNA, referring to FDA head Rasoul Dinarvand’s announcement of plans to reduce pharmaceutical imports to $800 million this year (started March 21) from the current $ 1 billion, as reported by IRNA.

Riahi also pointed to an FDA proposal to boost the level of pharmaceutical exports to $500 million per year, “from the current $150-$160 million, over the next three years.”

 No Checklist

According to a study conducted some years ago, there is no standard or a checklist to determine the frequency of drug shortages. Most healthcare organizations consider the problems of the supply chain system as a major cause of drug shortages. Drug shortage usually does not have a single cause. It can be due to manufacturing, marketing, economic, distribution and regulatory problems. The United Nations (UN) Security Council sometimes bans and replaces drug regulators. Regulation and enforcement problems can be one major reason for fluctuations in the drug market, the study said.

Last year, Dinarvand said more than 30 essential drugs are produced locally. That, however, does not meet the national demand as certain drugs including BCG vaccine which provides immunity or protection against tuberculosis (TB) and is also an effective treatment for some non-invasive bladder cancers, are still lacking.

He said drug shortage had reduced compared to the corresponding period in the previous year, signaling an improvement.

An interview with Dr. Ebrahim Hashemi, managing director of Ferdows Distribution Company, the country’s largest private distribution firm, by the Financial Tribune in August confirmed that the country is experiencing a severe shortage of essential drugs.

Many countries and also the WHO have codified a list of minimum medicines needed for a basic health care system and published them as a list of essential medicines. Essential medicines should be available under all healthcare systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price which the individual and the community can afford.

In Iran, FDA prepares the National Drugs List (instead of the essential drugs list).

Compiling a list of essential medicines will help in the monitoring and management of shortages of essential drugs accurately. It will help the FDA to focus on the shortages that are critical for the healthcare system.