He Yanling, the chief pharmacist of the Pharmacy Department of Guangzhou Women and Children's Medical Center, has been in the business for more than 30 years and has witnessed the rise and fall of children's medicine in my country.
promotes children's drug clinical trial research, cultivates children's pharmacy talents, and knowledge of popular science drugs. He Yanling has devoted many years to the children's availability and safe use of drugs.
She believes that the role of pediatric pharmacists is very important and is full of expectations for the future industry prospects.
For parents, the most feared thing about raising a baby is that the baby is sick, and even a little cold and fever will make parents feel nervous. The medicine is too bitter. Children don’t want to take it. There is no suitable dosage of medicine for the child. I am afraid of breaking the medicine. I am worried that the doctor will abuse antibiotics....
These problems also bother doctors and pharmacists. Problems such as the shortage of pediatric medicines, the inconsistent dosage forms and specifications, and the obstruction of related clinical trials have emerged one after another, constantly testing the level of pediatricians and pharmacists. How does
get out of the plight of children's medication? This time, the medical community invited He Yanling , director of the Pharmacy Department of Guangzhou Women and Children's Medical Center, to review the development of pediatric medicine over the years and the efforts she and her team have made to break through difficult problems.
There is a large gap in specialty medications, and pharmaceutical companies are not motivated.
Guangzhou Women and Children’s Medical Center, where He Yanling is located, is the largest third-class A-level medical care institution for women and children in South China. The annual outpatient volume exceeds 4 million visits during non-peak hours every day. The number of outpatient visits is approximately 12,000. Under the pressure of huge outpatient volume, the pediatric department of this hospital can basically meet the demand for commonly used drugs.
He Yanling introduced that in recent years, the state has carried out centralized bidding and procurement of medicines. Guangzhou has included children's medicines in the scope of centralized procurement and formulated many preferential policies. At present, medicines for common diseases such as colds, fevers and coughs or Chinese patent medicines have relatively complete dosage forms and specifications, and the packaging and taste can meet the needs.
However, in terms of specialized diseases, the lack of medicine for children is more serious. For example, for some children with heart disease, epilepsy, immunodeficiency, rare diseases, etc., there is a big gap in specialty medication. There are few imported medicines and there are no dosages suitable for children on the instructions, which is particularly difficult for pediatricians.
He Yanling recalled that in clinical practice, children aged 3 and under may be afraid to come to the hospital and will not cooperate with the examination. CT, MR and other examinations require children to be quiet and need to take a drug called chloral hydrate. Due to the preservation problem, the current hospital uses hospital preparations to solve it. However, during use, the drug is bitter and unpalatable, and the child will vomit. If you increase the amount at this time, it will be very dangerous, because part of the drug enters the gastric mucosa and is quickly absorbed, and the amount of spit out is difficult to calculate. If the amount is too large, it may cause adverse reactions. In this regard, He Yanling called for a change in the dosage form, anal administration through suppositories, or the use of embedding technology to improve the chewing taste of the medicine, and to improve the accuracy and compliance of the medicine in children.
In addition, there is an abnormal shortage of varieties and dosage forms suitable for children, and manufacturers often out of stock, which can only be solved by pharmacists dividing medicines and hospital preparations. For example, potassium chloride for the treatment of metabolic diseases, digoxin and other drugs for the treatment of congenital heart disease. "We hope that companies can produce such drugs in designated places, and while considering economic benefits, they can help children with rare diseases in society. "He Yanling said.
Children's clinical drug research increased. Third-party agencies assisted
. Another identity of He Yanling is the director of the Office of Drug Clinical Trial Institution of Guangzhou Women and Children's Medical Center. In 2012, the hospital obtained the qualification to undertake clinical trials of children's drugs.
According to 2010 World Health Organization (WHO) statistics, there are about 7.6 million deaths of children under 5 years old every year, many of which are due to the lack of safe and effective drugs. Therefore, the lack of medicines for children is a problem that urgently needs global joint efforts to solve. Encouraging clinical trials of medicines for children is one of the most critical measures.
In the first few years of her work, He Yanling felt a lot of difficulties. She took fewer than 10 projects each year. The main obstacles came from parents and pharmaceutical companies.
He Yanling observed that many parents do not understand why their children should participate in clinical research. For common diseases such as colds, fever and even pneumonia, parents feel that there are already a lot of related drugs, and there is no need to involve their children. For children with chronic diseases in the Department of Neurology and Hematology, parents have a higher degree of cooperation. Z1z
-related pharmaceutical companies lack policy support and have a small market share of children's drugs, so they are less motivated to participate in clinical research. On the other hand, the test has high requirements on the health of the subjects, and many people drop out in the middle of the test, so the test aborted.
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According to research statistics, as of June 2016, China has 62 pediatric clinical trial institutions that have passed qualification accreditation or review inspections, including 12 specialized hospitals for children. At present, the number of visits to pediatric diseases in China accounts for about all diseases. However, there is a lack of information on pediatric clinical drug use, and there are still many blank clinical trials of children’s drugs.
In 2016, things took a turn for the better.
In March of that year, the China Food and Drug Administration (CFDA) issued the "Pediatric Population Drug Clinical Trials" Technical Guiding Principles. This is China’s first guiding recommendation specifically for children’s drug clinical trials. It provides basic principles and operating guidelines for companies and drug clinical trial institutions, and is useful for standardizing children’s drug clinical trials design and improving trial quality It is of great significance. A series of preferential policies of
bring hope to clinical trials of children's drugs. He Yanling clearly feels that clinical research has developed by leaps and bounds in recent years, and many people call to inquire about related matters. At the same time, some third-party institutions for new drug research have emerged, which has greatly reduced the pressure on researchers. "In normal times, researchers in hospitals are very busy and need someone to assist in completing transactional work. These third-party organizations play a big role. They do what they can between the patient and the researcher team to make the trial more smooth and standardized. "Z1z
hospital pharmacists are indispensable, and patient education needs to be popularized.
Before 2017, medicines had to go through many intermediate links from the manufacturer to the sales terminal. After entering the sales terminal hospital, the state allowed medical institutions to sell them to patients at an additional 15%. In 2017, After that, the state cancelled the "zero markup" policy for price increase drugs, forcing public hospitals to "self-help", which also brought a great impact to the pharmacist group, and many pharmacists left the hospital and went to society.
In He Yanling's view, The pharmacist profession is indispensable, and the transition requirements after the zero markup policy are more urgent. She has participated in a number of irrational drug use studies.
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In 2015, He Yanling's hospital outpatient western pharmacy from July 2012 to July 2013 at 1589 Zhang children’s prescription medication list found that irrational drug prescriptions accounted for 5.03%, mainly due to irrational clinical drug selection, irrational usage and dosage, irrational combination medication, irrational choice of solvents, and irrational medication intervals.
In 2016, they retrospectively analyzed the off-label use of drugs in the pediatric outpatient clinic of their hospital in 2014, and found that out of 2366 prescriptions, 1835 were off-label drugs, accounting for 77.56%. The problem of unreasonable medication of
requires pharmacists to participate in improvement. He Yanling clearly feels that the talent team of her pharmacist team has changed significantly. In the past ten years, pharmacists with master's and doctoral degrees have continued to join the team. Currently, there are full-time clinical pharmacists serving inpatients. The daily work is to carry out clinical rounds, provide pharmaceutical services to patients, and guide doctors in the rational use of drugs. At the same time, a series of clinical pharmacy work such as prescription review, special treatment of antibacterial drugs, and rational drug use intervention will be carried out.
At the same time, the state has issued relevant policies, hoping that hospital pharmacists can provide high-level pharmaceutical services.
In He Yanling's view, patient education is an important part of providing high-level pharmaceutical services.
In December 2017, He Yanling and the team organized a mission for parents. Using the children's drug poisoning cases received by our hospital, we led everyone out of many misunderstandings in the safe use of drugs for children, explained the correct use of different drug formulations for parents, and shared tips for feeding babies. Parents Understand the main points on the drug insert, and remind everyone of the details that need to be paid attention to when storing drugs.
"We are now going to spread science through various channels and pass on the knowledge of safe medication to the public." He Yanling said.
Expert profile
He Yanling GuangDirector pharmacist of the City Women and Children Medical Center
, Deputy Director of the Department of Pharmacy, Director of the Clinical Pharmacist Training Base of the National Health and Family Planning Commission, Director of the Office of Drug Clinical Trial Institutions. American Pharmacists Association (APhA) Medication Management (MTM) certified pharmacist.
Member of the Pediatric Medicine Expert Committee of the National Health Commission
Deputy Chairman of the Pharmaceutical Professional Committee of the Futang Children's Medical Development Research Center
Deputy Leader of the Pediatric Pharmacy Professional Group of the Hospital Pharmacy Professional Committee of the Chinese Pharmaceutical Association
Deputy of the Pharmaceutical Management Professional Committee of the Chinese Maternal and Child Health Association Chairman
Guangdong Maternity and Child Health Association Pharmacy Committee Vice Chairman
Guangdong Provincial Hospital Association Hospital Pharmacy Management Committee Vice Chairman
Guangdong Pharmaceutical Association Hospital Pharmacy Committee Vice Chairman
Guangdong Pharmaceutical Association Pediatric Clinical Rational Use Chairman of the Professional Committee
Editorial Board Member of "Journal of Pediatric Pharmacy", "Chinese Journal of Clinical Pharmacy", "China Pharmaceuticals", "Chinese Medicinal Materials" and "Pharmacy Today"
