• Health Policy and Management
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• v.11 no.4
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• pp.88-108
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• 2001

Separation of prescribing and dispensing practice in Korea has changed the service pattern of the pharmacy. The prescription dispensing activities, however, are concentrated excessively on the pharmacies near hospitals or clinics. Thus this study was conducted to estimate the number of optimal dispensing cases for the community pharmacy. Forty-six pharmacies were selected using systematic stratified random sampling method, and ninety-five pharmacists were interviewed on their workload of dispensing and other activities at pharmacies. One hundred and seventy prescriptions were chosen based on the length of drug administration and drug dosage form, and the dispensing time was measured by time-watch method. Also pharmacy benefit claims data were analyzed to identify the characteristics of the pharmacies which performed more than optimal dispensing cases. According to the study results, the average work time per pharmacist per day was found to be 10hours 32minutes and the dispensing activities occupied 7hours 36minutes. It took 5.72minutes on average for each dispensing case. The optimal dispensing case was estimated as 75 cases under the condition of 10hours 32minutes work time and 6% allowance rate. Even though the pharmacies near hospitals or clinics participated dispensing services actively, only pharmacies near clinics dealt with more than optimal dispensing cases. For the pharmacies near hospitals they dealt with less than optimal cases, but drug administration period per prescription was almost 3 times longer than that of pharmacies near clinics. Thus the intensity of dispensing activities such as drug administration period is to be considered to estimate optimal dispensing cases more accurately.

• Korean Journal of Clinical Pharmacy
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• v.21 no.4
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• pp.347-352
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• 2011

Health insurance review & Assessment service (HIRA) has enforced cutting the drug costs when physicians prescribe split extended release drugs, starting from December, 2010. The objective of this study is to analyze extended release and enteric coated drugs on pharmaceutical reimbursement list in Korea, and to investigate the impact and barriers of the health insurance review on splitting extended-release formulation drugs. By using the ingredient code, extended release and enteric coated formulations make up 7.8% of all drugs in April, 2011. The most frequently used drugs are agent affecting circulatory and digestive system. From the extended release and enteric coated formulations (n=112), 34.8% (n=39) were not available in other dosage forms. According to questionnaire survey for 169 pharmacists (response rate: 73.8%), the rate of splitting and crushing of extended release and enteric coated drugs decreased. When pharmacists correct physician's prescription errors, the biggest problem was lack of other dosage forms. So it is necessary to develop variety of other dosage forms, and computerized checking system for splitting extended-release drugs. It is also important to inform physicians and patients in regard to the problems of split prescription of extended release and enteric coated drugs.

• YAKHAK HOEJI
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• v.57 no.2
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• pp.150-159
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• 2013

A study was performed to identify current drug shortages, assess impact of drug shortages on public hospitals and patients, and investigate needs of pharmacists for a drug shortage list. An e-mail survey was sent to the pharmacists of 13 national public hospitals. Total 61.5% of public hospitals has 10 or fewer drugs a year in short supply. Shortages involved mood drugs, anti-tumor drugs, analgesics, antibiotics and etc. in 2012. Among them 75.0% was prescription drugs and the other 25.0% was non-prescription drugs. 79.2% was domestic products and 20.8% was imported drugs. Only 12.5% was injections. Less than 3 pharmacists usually spent within 3 hours managing one drug shortage. Since a single item for a certain medicine may raise risk of drug shortages, it's needed to consider developing manuals, laying up medicine stocks and holding plural medicines for drug shortages in public hospitals. Main information resources of drug shortages are wholesalers or manufacturers. But the information appeared to be not only inadequate but also too late for appropriate activities. A survey of pharmacists revealed that overall 84.6% of respondents were in need of the drug shortage list. They expected it to be conducted to take proper measures for the drug shortage and to improve patient healthcare outcome and convenience. This study will contribute to improving public health by promoting stable supply of drugs and repairing the information delivery system.

• Korea Journal of Hospital Management
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• v.7 no.4
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• pp.102-122
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• 2002

It has been 2 years since the implementation of the separation policy of drug prescription and dispensing. This study analyzes the changes in community pharmacy operation after the implementation of the policy. The main purposes of the analysis are to determine whether the changes in community pharmacy operation have occurred and to evaluate that the changes are consistent with the intention of the policy, if the changes actually have occurred. For the study a survey on 961 pharmacies chosen by stratified sampling method has been performed. Of the 961 sample pharmacies, 438 pharmacies were responded resulting 45.6% response rate. The sample pharmacies are classified by the location that the pharmacy are operating: the pharmacies around large size hospitals, the pharmacies around clinics or medium to small size hospitals and the pharmacies with no hospitals or clinics around. Based on the classification, the number of pharmacies, number of prescriptions processed, the personnel structure, the changes in facility, and other operational characteristics are compared. The results showed that the pharmacies were tended to concentrate around hospitals and clinic since the implementation of the policy. The number of pharmacists per pharmacy was increased, the size of pharmacy was increased and the facilities were improved to accomodate the requirements of the policy. The work hours a pharmacist spent on dispensing drug have increased almost twice, however, there was no corresponding increase in the time spent on patient education and medication history management, indicating a problem in the provision of quality pharmaceutical services. Based on the results, suggestions to minimize the negative effects of the policy are provided.

• Korean Journal of Clinical Pharmacy
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• v.21 no.2
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• pp.106-114
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• 2011

While multiple medication is an important global medication safety issue, ununified concomitant medication by multiple prescriptions may cause more severe problems by the fact that those are neither intended nor watched. This could cause therapy duplication and severe drug interaction and etc. Korean Government made region wide scale programs twice to detect such problems and give warnings to pharmacists and doctors through the internet system in 2009-2010, which are called Drug Use Review Services Pilot Project. This study is an analysis and comparison of the results of the two DUR pilot projects. There were 5.0 and 4.2 cases of severe drug interaction by the concomitant medication of multiple doctors' prescriptions per 10 thousand prescriptions, while only 0.37 and 0 cases by the medication of same doctor's prescription(s). There were 426 and 381 cases of drug duplication by the concomitant medication of multiple doctors' prescriptions per 10 thousand cases, while only 197 and 23 cases by medication of same doctors' prescription(s). Doctors' participation to those projects improved at Jejudo the later one compared to Goyangsi the former, which means the efforts of them to make less prescription problems succeeded to decrease the number of cases caused from same doctor's prescription. But they could not decrease the number of problem cases caused from concomitant medication by multiple doctors prescriptions enough. The findings support the issue of strengthening and widening the project nation wide and the issue of recommending the patients to designate their own pharmacy, which can provide them counseling for unified and safety controlled medication.

• The Korean Society of Law and Medicine
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• v.24 no.3
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• pp.3-26
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• 2023

This paper reviewed the Pharmaceutical Affairs Act issues in case of self-administration of medicines by medical personnel without going through the general process (prescription, dispensing, distribution, administration). If a medical personnel self-medicates, the medicine supplier or medical personnel may be subject to criminal punishment under the Pharmaceutical Affairs Act. The core reprehensibility of the punishment lies in undermining the order in distribution of medicines stipulated in the Pharmaceutical Affairs Act. First, the sale of medicines by a medicine supplier to medical personnel may be the violation of Article 47 of the Pharmaceutical Affairs Act. However, if it was distributed for the case where medical personnels can dispense it directly under the Pharmaceutical Affairs Act, it can be justified under the general provision of the Criminal Act (justifiable act, the exclusion of illegality). If medicine suppliers distribute medicines knowing that the medical personnel acquires medicines for selfadministration, they can be punished as the violation of Article 47 of Pharmaceutical Act. Second, when a medical personnel acquires a medicine for the purpose of self-administration, the medicine supplier distributes the medicine under the false pretense that the medical personnel acquires the medicine for the case in which the medical personnel can directly dispense the medicine according to the Pharmaceutical Affairs Act. At this time, even if the medicine supplier has received all the payment for the medicines, the distribution of the medicines by deceit can constitute the fraud under the Criminal Act. Third, self-administration by medical personnel is a the violation of Article 23 of the Pharmaceutical Affairs Act. It is not a justifiable act under the general provision of the Criminal Act. This is because it is the abuse of the special status granted to medical personnel in the Pharmaceutical Affairs Act, which undermines the order in distribution of medicines.

• Korean Journal of Clinical Pharmacy
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• v.25 no.3
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• pp.138-144
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• 2015

Objective: It is to evaluate the drug interaction monitoring program as a pilot project to develop a pharmaceutical care model in a medical intensive care unit and to analyze the influencing factors of drug interactions. Method: Electronic medical records were retrospectively investigated for 116 patients who had been hospitalized in a medical intensive care unit from October to December in 2014. The prevalence of adverse reaction with risk rating higher than 'D' was investigated by Lexi-$Comp^{(R)}$ Online database. The factors related with potential drug interaction and with treatment outcomes were analyzed. Results: The number of patients with a potential interaction of drug combination was 92 (79.3%). Average ages, the length of stay in the intensive care unit and the numbers of prescription drugs showed significant differences between drug interaction group and non-drug interaction group. Opioids (14.4%), antibiotics (7.2%), and diuretics (7.2%) were most responsible drug classes for drug interactions and the individual medications included furosemide (6.4%), tramadol (4.9%), and remifentanil (4.5%). There were 950 cases with a risk rating of 'C' (84.6%), 142 cases with a risk rating of 'D' (12.6%), and 31 cases with a risk rating of 'X' (avoid combination) (2.8%). The factors affecting drug interactions were the number of drugs prescribed (p < 0.0001) and the length of stay at intensive care unit (p < 0.01). The patients in intensive care unit showed a high incidence of adverse reactions related to potential drug interaction. Therefore, drug interaction monitoring program as a one of pharmaceutical care services was successfully piloted and it showed to prevent adverse reaction and to improve therapeutic outcomes. Conclusion: Active participation of a pharmacist in the drug management at the intensive care unit should be considered.

• Korean Journal of Clinical Pharmacy
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• v.24 no.3
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• pp.193-198
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• 2014

Objective: This study was conducted to compare the adherence, clinical and economical utility of fixed-dose combination tablets of sitagliptin/metformin with concomitant administration of sitagliptin and metformin in patients with type 2 diabetes mellitus. Methods: Adherence was measured as the medication possession ratio (MPR) of ${\geq}80%$, and MPR was calculated as the number of total prescription days divided by the total treatment period. Hemoglobin $A_{1C}$ ($HbA_{1c}$) differences between baseline and predetermined periods were analyzed. Proportions of patients who achieved $HbA_{1c}$ less than 6.5% for three or more consecutive times were compared. To evaluate cost-effectiveness, prices of sitagliptin, metformin and sitagliptin/metformin tablets were investigated. Results: More than 90% of patients showed adherence in both groups (92.0% in fixed-dose combination group vs 95.9% in concomitant administration group), and there was no statistically significant difference (P = 0.113). Proportion of patients with HbA1c less than 6.5% for three or more consecutive times tended to be somewhat higher in fixed dose combination group than in concomitant administration group without a statistically significant difference (32.6% vs. 28.0%, P = 0.344). Total price of metformin and sitagliptin was cheaper up to 222 KRW in the case of fixed-dose combination tablets compared to the case of concomitant administration. Conclusion: The sitagliptin/metformin fixed-dose combination tablet had a similar patient adherence and was not significantly different in efficacy to the concomitant administration of each component. In terms of drug prices, fixed-dose combination tablets were cheaper than concomitant administration of each tablet.

• KSBB Journal
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• v.25 no.1
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• pp.91-96
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• 2010

This study is an endeavor to evaluate the safety of medicines from heavy metals, prescribed on the basis of herbal medicinal system and oriental medical prescription which are circulated much recently. For that, six globular types, six granular types and seven liquid types of herbal medicines were bought to compare and analyze the content of heavy metals, such as As, Pb, Cd and Hg, which are harmful to human body. The concentration of As was 0.219 mg/kg to 1.243 mg/kg, Cd was 0.0282 mg/kg to 0.8481 mg/kg, Pb was 0.9582 mg/kg to 5.233 mg/kg and Hg was 0.001 mg/kg to 0.01 mg/kg in globular and granular types. Otherwise, in the liquid types, As was 0.0123 mg/kg to 0.5024 mg/kg, Cd was 0.0128 mg/kg to 0.0568 mg/kg, Pb was 0.1755 mg/kg to 0.712 mg/kg, and Hg was 0.001 mg/kg to 0.002 mg/kg. It was found that the concentration of heavy metals in liquid types herbal medicines was relatively lower than globular and granular types. It is required to treat, manufacture and manage herbal medicines for safety.

• Journal of Pharmaceutical Investigation
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• v.34 no.3
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• pp.223-228
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• 2004

A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to the drug products which are proven to be bioequivalent to the reference listed drugs. To expand the list of bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drug are the hot issues in Korea. Also, the KFDA has a plan to revise the pharmaceutical affairs law that bioequivalence reports of all the generic prescription drug products should be submitted to the KFDA for drug approval after July in 2004. Therefore, it is increasing the necessity to develop the bioequivalence-demonstrating methods for specific drug substances and preparations which require to conduct food-effect bioavailability or bioequivalence study. There are some differences between US and Japanese guidances of food-effect bioavailability and bioequivalence studies. In this paper, we examined the recently published US guidance about food-effect study and it will be a reference to make our own guidance about food-effect bioavailability and bioequivalence guidances in Korea.