Lipitor: The first statins non-***

In recent years, more and more pharmaceutical companies have entered the OTC field and will convert more prescription drugs to OTC products. Pfizer announced that it is investing a lot of resources to promote the related plan for the sales of the Lipitor. The clinical trial is expected to be completed by the end of 2014. If successful, Lipitor will become the first non-prescription drug of statins.

Cold fever, buy anti-fever medicine; throat swelling and inflammation, buy anti-inflammatory drugs; blood pressure, blood sugar, blood pressure and hypoglycemic drugs! In recent years, people’s awareness of self-medication has been continuously enhanced and self-purchasing of drugs has become commonplace, which has promoted the development of over-the-counter (OTC) markets. Affected by this, more and more pharmaceutical companies are entering the OTC field, and more prescription drugs will be converted into OTC products.

Recently, Pfizer chief executive Ian Read announced that the company is investing significant resources to promote the counter-sold version of Lipitor, and has conducted over-the-counter (OTC) Lipitor clinical trials on 1,200 patients. test.

The clinical trial is expected to be completed by the end of 2014, and clinical trial results will determine whether Pfizer will apply to the US drug regulatory agency. If Pfizer applies and is successfully approved, Lipitor will become the first non-prescription drug for statins.

It is difficult to convert prescription drugs to non-prescription drugs. There are also many successful cases.

The change from prescription drugs to non-prescription drugs requires the accumulation of long-term clinical data, which proves that the drug will not cause excessive use, improper use, or safety problems due to human differences in the OTC sales model. However, in the United States, the conversion of prescription drugs to over-the-counter drugs is still difficult.

Janet Woodcock, director of the US Food and Drug Administration's Drug Center, said that we have tried to convert statins to over-the-counter drugs in several trials, but these trials have failed because consumers cannot judge their lipid status. In 2008, FDA rejected Merck Pharmaceutical's request for the sale of Lactazone (Lovastatin) as an over-the-counter drug.

However, there are examples of successful conversions. In 2009, Novartis announced that its lansoprazole 24-hour sustained-release capsules for the treatment of gastroesophageal reflux have been approved by the FDA for conversion to OTC, and patients can purchase directly from over-the-counter forms. It is understood that the FDA is currently open to the use of cholesterol-reducing non-prescription drugs, as long as drug companies can prove that they can use the drugs on their own.

Compared with prescription drugs, OTC drugs are relatively safe and have special market attributes. The distribution channels are pharmacies for consumers to purchase and self-treat. Pfizer also said that the launch of the non-prescription drug Lipitor will enable more patients with high blood lipids to receive convenient treatment, save resources for the entire medical system, and reduce patient medical costs.

Over-the-counter drugs are safe and accessible, but licensed pharmacists must follow medication instructions

From this perspective, OTC benefits are many, but there are many doubts. Wang Genyun, deputy director of the Food and Drug Administration of Xianyang City, Shaanxi Province, who is in charge of drug safety supervision, believes that compared with prescription drugs, OTC is often used in the absence of doctors' guidance and supervision, which inevitably magnifies the safety of its use to some extent. risk.

At the same time, monitoring of adverse reactions to OTC was not implemented. Wu Junmin, Food and Drug Administration of Yongzhou, Hunan, pointed out that some grass-roots retail pharmacy sales personnel have lower entry barriers, generally low professional quality and professionalism, coupled with high mobility of personnel, lack of understanding of the basic knowledge of adverse drug reactions, and The reporting process for adverse drug reactions is unfamiliar, and many pharmacies are forced by regulatory agencies to monitor adverse drug reactions and to report transcripts against drug instruction manuals.

Although OTC is relatively safe, under the widely used conditions, there is an increased probability of occurrence of adverse reactions. This is true in our country, and it is also true in foreign countries. According to statistics, over one-third of unreasonable use of non-prescription drugs has been made in China, especially in the elderly population. For OTC, it is especially important to strengthen the guidance of licensed pharmacists.

According to research data from abroad, in 1999, over 170,000 people were hospitalized in the United States due to improper use of OTC, which cost US$750 million. A nationwide survey of drug use and health in the United States in 2008 showed that approximately 3.1 million people aged 12 to 25 years had at least one abuse of OTC cold cough medicine.

Expert advice: OTC drug companies to do adverse reaction monitoring, direct docking with pharmacies
Therefore, Dong Yongli of the Food and Drug Administration of Fuding City, Fujian Province, said that converting prescription drugs to non-prescription drugs is not the end of their safety evaluation, but the beginning of new safety monitoring and evaluation. After the drugs are identified as OTC, the widespread use of more people is an important means to further accumulate their safety data, which is conducive to discovering the safety issues in the widespread use of OTC and taking corresponding risk control measures. Therefore, we must pay more attention to the monitoring of adverse reactions of OTC.

For the development of OTC companies, Guiyang Luo, general manager of Guiyang Dechang Pharmaceutical recommends that non-prescription drugs is a typical brand consumption, so the brand is a top priority, can not be ignored; at the same time, it is necessary to implement refined management, and carry out direct docking with pharmacies; In addition, we must pay attention to the core rights and interests of consumers, that is, to optimize the scientific use of medicines, and to treat the diseases and health care as the core needs and core rights and interests of customers.