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Currently, clinical pharmacists are playing an increasingly important role in the access of innovative drugs.

"At this stage, the transfer of drugs in and out of the hospital's drug catalog, the allocation of national negotiations and centralized procurement varieties, as well as the selection and access of innovative drugs and post-marketing evaluation, all fall within the scope of the pharmacy department's work." A person in charge of the pharmacy department of a provincial tertiary hospital in China told the First Financial reporter that in the past, helping innovative drugs achieve the "last mile" required pharmacists to have sufficient pharmaceutical economic research capabilities and collaborate with multiple departments, "which also puts higher demands on pharmacists."

In recent years, the provisions on pharmaceutical talents in documents such as "Opinions on Strengthening the High-quality Development of Pharmaceutical Services" and "Opinions on Strengthening Pharmaceutical Management in Medical Institutions to Promote Rational Use of Medicines" are mostly aimed at ensuring the supply of medicines and strengthening the standardized use of medicines, and the ultimate beneficiaries are patients. In the context of deepening medical and health reform, especially in the access of innovative drugs, how can pharmaceutical talents play a more critical role?

Conducting “pharmacoeconomic evaluation”

Data shows that, taking national negotiated varieties as an example, the total number of drugs in the new version of the medical insurance drug list in 2023 reached 3,088 drugs, of which 126 drugs were newly added that year and 1 drug was transferred out; taking centralized procurement varieties as an example, the National Healthcare Security Administration previously stated that in 2024, it is expected that the total number of national and provincial centralized procurement drugs will reach at least 500.

How to support the continuous iteration and updating of drugs to achieve "emptying the cage and replacing the bird"? The role played by the pharmacy department is crucial. The reporter learned that usually, when a drug is introduced into the hospital, pharmacists will refer to the "Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs (Trial 2021 Edition)" issued by the health department to conduct a comprehensive evaluation from six dimensions (effectiveness, safety, economy, suitability, feasibility and innovation) and complete the selection.

However, a senior hospital pharmacist said that the hospital mostly uses minimum cost analysis (i.e. comparing different drugs to see which one has the lowest cost), but the selection of innovative drugs requires more precise evaluation models, as well as post-market re-evaluation.

"Pharmacoeconomics should be incorporated into the research and practice of hospital pharmacy and become an essential skill for hospital pharmacists. This will not only assist pharmacists in making decisions such as drug selection and treatment plan optimization, but also enable certain cost control of drug expenditures or provide clinical medication recommendations." Liu Guoqiang, deputy director of the Pharmacoeconomics Committee of the Chinese Society of Research Hospitals and director of the Department of Clinical Pharmacy of the Third Hospital of Hebei Medical University, said that in addition, pharmacists will also use pharmacoeconomic evaluation methods when evaluating innovative drugs after they are launched on the market.

Liu Guoqiang gave an example to reporters. For example, in drug selection, when choosing a drug to treat a certain disease, if two drugs have similar efficacy but one drug has a lower treatment cost, pharmacists can give priority to introducing that drug to save drug expenses for the hospital. For another example, in treatment plan optimization, chronic disease patients have a variety of therapeutic drug combinations to choose from, and pharmacists choose the most economical and effective treatment plan based on the results of pharmacoeconomic research and combined with the severity of their disease, comorbidities, etc.

In terms of providing medication recommendations, Liu Guoqiang said that this requires collaboration with clinical departments to develop personalized medication plans for patients. "For example, when developing anti-tumor treatment plans for patients, it is sometimes necessary to consider the patient's financial affordability. Then pharmacists can recommend cost-effective chemotherapy drug combinations based on the results of pharmacoeconomic evaluation."

Shen Aizong, deputy director of the Pharmacoeconomics Committee of the Chinese Society of Research Hospitals and academic director of the Department of Pharmacy of the First Affiliated Hospital of University of Science and Technology of China, also told reporters that on the one hand, as the "secretariat department" of the hospital's pharmacy council, the pharmacy department needs to collect and organize data on the access of innovative drugs, including their pharmacological effects and whether the dosage form is suitable; on the other hand, the pharmacy department also needs to optimize the hospital's drug catalog through pharmacoeconomic evaluation, control the drug ratio within a certain range, and monitor the clinical response of drugs.

"Among these, the biggest challenge for the pharmacy department is the transfer in and out of the drugs in the catalogue. In recent years, the proportion of drugs transferred out has been relatively low and concentrated in." Shen Aizong said that in fact, innovative drugs are constantly being launched on the market and putting forward access requirements, which requires each hospital to introduce truly efficient and high-quality drugs fairly, openly and impartially to meet clinical demands; at the same time, in a market-oriented context, once encountering drug price increases and supply shortages, how hospitals respond to ensure supply also requires more exploration of more refined pharmaceutical management models.

In addition, when talking about the "post-marketing evaluation" directly related to innovative drugs, Liu Guoqiang said that this involves establishing a monitoring system, conducting clinical research, participating in drug bans and regular evaluation and summary.

"For example, the pharmacy department can cooperate with clinical departments to carry out prospective, retrospective or real-world studies on innovative drugs to provide a scientific basis for the re-evaluation of the drug. Regular post-marketing re-evaluation summaries can also provide decision-making support for the adjustment of the next stage of the use strategy of innovative drugs."

How to build a team of pharmaceutical talents

In 2023, an article entitled "Expert Consensus on the Core Competency Framework of Chinese Clinical Pharmacists (2023)" published by the Pharmacy Department of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences in the "Journal of Peking Union Medical College" proposed that in the critical stage of clinical pharmacy transformation, how to standardize and homogenize the competence of clinical pharmacists has become an urgent problem to be solved. The article also announced 6 first-level indicators (including professional quality, knowledge and skills, patient care, communication and cooperation, teaching ability and lifelong learning) and 22 second-level indicators.

Among them, knowledge and skills, and patient care both mentioned "mastering the basic skills of clinical pharmacy, including prescription adjustment (prescription review), prescription comments, therapeutic drug monitoring and individualized medication guidance, drug selection (comprehensive evaluation) and other basic practical skills of clinical pharmacy" and "providing appropriate drug treatment plan recommendations through comprehensive evaluation and comprehensive review of the drug's effectiveness, safety and economy".

Shen Aizong said that the patient's condition will continue to change. Therefore, for pharmacists in hospitals, they need to cope with various patient medication situations through lifelong learning. This is the key. Secondly, it is to truly serve patients with the knowledge they have learned. Pharmacists not only need to prescribe the right medicine and review the prescription, but also need to study and analyze the rationality behind the prescription. At the same time, pharmacists must also make timely judgments on the rational use of drugs and the interaction between drugs.

Regarding the construction of pharmaceutical talent team, Liu Guoqiang also suggested that, first, training and education should be strengthened; this includes: regularly organizing pharmaceutical talents to participate in training and academic exchange activities related to innovative drugs, updating knowledge and improving professional level. The training content can include the research and development progress, clinical application, pharmacoeconomic evaluation, and pharmacovigilance of innovative drugs. Pharmaceutical talents are encouraged to participate in in-service education, pursue master's and doctoral degrees, and improve their academic qualifications and professional capabilities.

Second, we need to establish a talent training mechanism, which includes: formulating a talent training plan for pharmacy, clarifying training objectives and training paths, formulating personalized training programs based on the different levels and professional needs of pharmacy talents, and providing guidance for their career development.

Third, we need to improve the incentive mechanism, which includes establishing a scientific and reasonable performance appraisal system to objectively evaluate the work performance of pharmaceutical talents. The appraisal content can include work quality, work efficiency, innovation ability, teamwork, etc., and the appraisal results will be linked to remuneration, professional title promotion, etc., to encourage pharmaceutical talents to work actively. At the same time, we will establish an innovation reward system to reward pharmaceutical talents who have made outstanding contributions in the research and development, evaluation, and management of innovative drugs.

"In fact, at this stage, there are relatively few in-hospital medical service items that can reflect the value of in-hospital pharmacists (such as concentration testing, genetic testing, etc.), and the income of in-hospital pharmacists cannot truly reflect their abilities and contributions. With the cancellation of drug markups and medical consumables markups, how to fully reflect the value of pharmacists in the above-mentioned difficult and highly professional pharmacoeconomic evaluation tasks in the medical service income part is worthy of further exploration." A senior pharmacist told reporters.