Why is the pharmaceutical company always hurt?

Guidance: On July 29, the Food and Drug Administration of Hainan Province issued the “Report on the Treatment of Adverse Drug Reactions/Events of Progesterone Injection in Hainan and Beijing Reproductive Hospitals”, and the use of corpus luteum on Hainan and Beijing Reproductive Hospital on July 12th. Ketone injection (manufactured by Guangzhou Baiyunshan Mingxing Pharmaceutical Co., Ltd., hereinafter referred to as Mingxing Pharmaceutical) showed detailed reports of local swelling and induration adverse events/events.

Adverse events and adverse reactions cannot be confused

On July 19, Dandelion Wechat commented on the recall of progesterone from the Food and Drug Administration of Hainan Province and used the term “adverse events”. The recall notice of the Food and Drug Administration of Hainan Province used the term “adverse reactions”.

<Administrative Measures for Monitoring Adverse Drug Reactions> The definition of adverse reactions is:

Adverse drug reactions refer to harmful reactions unrelated to the purpose of use of the drug under normal usage and dosage.

Obviously, Hainan's progesterone has emerged as a group of adverse events. Because it is used in excess of instructions, it cannot be called an adverse reaction.

July 29 "Hainan and Beijing Reproductive Hospital using progesterone injection adverse reaction / event handling situation" has identified: The drug used in the prophylaxis dose has exceeded the instruction manual (operating instructions for the 10mg ~ 20mg / day Most of the doses used for assisted pregnancy are 40 mg to 100 mg/day, and the time for use is often more than half a month to 2 months (the longest term for instructions is 10 days).

Why is the pharmaceutical company always hurt?

Hainan progesterone incident, whether it is the media, hospitals, drug administration departments are suspected of having "selective deafness." Just last year, a similar progesterone group event occurred in Zhejiang, the reason is very clear clinical overdosing, over specification and improper clinical use.

The Hainan progesterone incident was very clear from the beginning of the news media, and it also belongs to the clinical overdose and super specifications. However, whether it is the hospital, the drug administration department, or the media, the first question is the quality of the drug. Suspected drug companies.

The same incident occurred twice in a row. I think the relevant party is suspected of having "selective deafness."

Even if it is suspected that there is a problem with the product quality of the pharmaceutical company, before the drug regulatory agency has clarified the cause, whether it has issued a deactivation notice first, and then conducts an in-depth investigation and decides whether or not it needs to be recalled according to the investigation.

The following content is reproduced from Hainan Food and Drug Administration:

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A report on the use of progesterone injections in the treatment of adverse reactions/events in Hainan and Beijing Reproductive Hospital

(Published on 2016-07-29)

The use of progesterone injections in Hainan and Beijing Reproductive Hospital for the treatment of all adverse reactions/events has been basically completed and is hereby notified as follows.

First, the basic situation of the incident and disposal measures

At 10 o'clock in the morning on July 12, the province's Adverse Drug Reaction Monitoring Center (hereinafter referred to as the provincial ADR monitoring center) received reports from Hainan and Beijing Reproductive Hospital, due to the use of progesterone injection (Guangzhou Baiyunshan Mingxing Pharmaceutical Co., Ltd. Production, hereinafter referred to as Mingxing Pharmaceuticals, has localized swelling and induration adverse reactions/events.

The provincial ADR monitoring center conducted an on-site investigation of the incident jointly with the Provincial Bureau of Food and Drug Administration Inspection Bureau and Haikou ADR Monitoring Center on the afternoon of the same day. The progesterone that caused adverse reactions/events was identified as three batches of Mingxing Pharmaceutical: 150909, 160111, and 160206. The hospital found no problems with the storage of the drug. The investigation team sampled the relevant drugs for inspection. The provincial ADR monitoring center immediately searched for the adverse drug reaction report. From January 1, 2014 to July 12, 2016, our province received a total of 24 reports of adverse reactions to progesterone injection, involving 15 parts of Mingxing Pharmaceutical. After the Provincial Food and Drug Supervision Bureau intervened in the investigation, the medical institutions successively made a return visit, and from the 13th to the 28th, 149 other reports were received by Mingxing Pharmaceutical (of which 135 were from Beijing Hospital). After being asked to search for the National Center for Adverse Drug Reaction Monitoring, from January 1, 2015 to July 13, 2016, except for cases reported in Hainan Province, other provinces did not report any drugs involved.

On July 13, the Provincial Food and Drug Administration conducted a survey on the distribution and sales of three batches of drugs involved in the province and confirmed that the drug had been sold to 145 medical institutions in the province, totaling 124,370. To ensure the safety of medication, the Provincial Food and Drug Administration issued a notice on July 14 suspending the sale of 3 batches of related drugs. Drug wholesale companies recalled 13,980 drugs that had not been used before July 16.

On July 16, the Provincial Food and Drug Administration and the Provincial Health Planning Commission chief headed to the hospital involved in a joint investigation. The Provincial Health and Development Commission set up a treatment expert group to provide rehabilitation guidance to hospital patients. At the same time, the “Progesterone Adverse Reaction Treatment Guidelines” was formulated and announced to the public.

The Provincial Institute of Drug Control conducted a full inspection of all three batches of drugs involved, and all the results were in compliance with the regulations.

The Provincial Food and Drug Administration has organized clinical medicine, pharmacy and ADR monitoring experts twice to discuss and evaluate the incident.

Second, the initial judgment of the incident

The drugs used in this incident have been found to meet the requirements after inspection, and the storage links also meet the requirements.

Judging from the nature of the progesterone injection, it is due to the fact that soy oil is the solvent for the liquid. It does have a slow absorption during intramuscular injection. The response may differ from the individual after injection. The usage and dosage, the duration of the drug, and the post-injection treatment In other cases, the appearance of redness and induration can be alleviated by various external application methods after injection.

Progesterone is a natural progesterone. Progesterone injection instructions indicate that the indication is habitual abortion, amenorrhea, irregular menstruation, etc. According to clinical experts, the drug is widely used in reproductive fertility in the past 10 to 20 years. , Has been recognized by the Chinese Medical Association experts in reproductive, perinatal, family planning, etc. The dosage of the drug used in the prophylaxis has exceeded the user's manual (10mg to 20mg/day for use, 40mg to 100mg/day for progestational use), and it is usually half a month to two months in use. Unequal (The maximum length of instructions for use is 10 days). Repeated injections increase the likelihood of local accumulation of drugs in injections, resulting in increased chances of adverse symptoms such as redness; some patients are brought back to their place of residence for injection by local medical institutions or patients, injection techniques and injections. Improper care can also increase the symptoms of adverse reactions.

Third, follow-up measures

Raise public awareness of safe and rational use of drugs so as to understand the side of medicines that can treat and prevent diseases, and some side effects that cannot be completely avoided, and raise the awareness of risk in medical institutions and national drugs, and awareness of adverse reactions.

The first is to increase propaganda, so that the majority of patients understand that qualified drugs will also have adverse reactions under normal usage and dosage. Specific to the drug involved in this case, the patient should be more aware of the expected circumstances that may have occurred, so that patients can better grasp the follow-up care to reduce the occurrence of adverse conditions.

Second, medical institutions should track patient's drug use in a timely manner in clinical use, guide patients to do a good job of care, if found serious adverse reactions should be reported through the monitoring system in a timely manner; patients in the event of discomfort symptoms should also promptly to the medical institutions or The drug administration department responded so that the adverse reactions that emerged could be controlled as early as possible, so as to minimize the damage to the patients.