Conformity assessment of Pharmaceutical Storage on the Rural Public Health Center of West Kalimantan Indonesia
MT Ghozali*, Yeni Mahar Astuti
School of Pharmacy, Faculty of Medicine and Health Sciences, Universitas Muhammadiyah Yogyakarta,
Bantul, 55183, Daerah Istimewa Yogyakarta, Indonesia.
*Corresponding Author E-mail: ghozali@umy.ac.id
ABSTRACT:
The storage condition of pharmaceutical drugs and medical disposables in the primary healthcare providers (e.g., public health centers) should meet the required quality standard to maximize financial profit and avoid loss. In order to ensure this matter, a conformity assessment is required. This study aimed to examine the conformity of the storage condition in the rural public health center of Dalam Kaum village, West Kalimantan, Indonesia, with the Regulation of the Minister of Health of the Republic of Indonesia Number 74 of 2016 and the indicators for the storage of pharmaceutical drugs and medical disposables. This study was a descriptive non-experimental method applying quantitative and qualitative approaches by observation using a checklist and interviews. Overviews of the conditions were compared with guidelines sourced from the Regulation, including storage method, storage stability, flammable and explosive material storage, narcotic and psychotropic drug storage, and storage with risk of contamination. In addition, the indicators included the percentage of damaged or expired drugs, dead stock of drugs, and turnover ratio (TOR). The study's findings reported that the conformity of the storage condition based on the Regulation was 100% for storage method, storagestability,narcotic and psychotropic drug storage, and storage with risk of contamination, while 0% was for flammable and explosive material storage. In terms of the indicators, this study found 10.8% for damaged or expired drugs, 53.4% for dead stock of drugs, and 8.53 times per year for TOR. Based on the findings, it could be concluded that almost all aspects of the public health center of Dalam Kaum village conformed to the Regulation of the Minister of Health of the Republic of Indonesia. Unfortunately, only one aspect showed conformity regarding the indicators for the storage of pharmaceutical drugs and medical disposables.
KEYWORDS: Conformity assessment, Medical disposables, Pharmaceutical drugs, Public health center.
INTRODUCTION:
Storage is one of the vital functions in the management of drugs and pharmaceutical products. In order to carry out the functions, a management system consisting of organizations, human resources, budgets, facilities, and infrastructures should be supported and strengthened1. In third-world countries, the storage condition of pharmaceutical drugs and medical supplies, especially in the primary healthcare provider (.e.g., public health centers), still concerns the government2.
In Indonesia, the conditions for primary healthcare providers have been quite effective in some districts; however, some various problems still need to be improved by the government. The problems vary but may include poor facilities, less representative storage, inconsistent use of drugs and pharmaceutical products, poor drug planning, unstable changes in room temperatures affecting the preparations, delays in reporting empty inventory, and negligence of personnel resulting in damaged and expired products3,4. A similar finding was also found in India and Pakistan, reporting that the country's condition of primary healthcare (rural division) needs improvement. Irrational use of limited resources occurs because of a lack of coordination between activities (e.g., complex procedures and manual system of record maintenance) and the resources (e.g., infrastructures and labor)5,6.
Regulation of the Minister of Health of Republic of Indonesia, Number 74 of 2016 concerning pharmaceutical service standards in public health centers) states that pharmaceutical services in the public health centers are integral to implementing health policies and playing an essential role in improving the quality of health services for the community7,8. They should support three main functions of public health service, including a center for driving health-oriented development, a center for community empowerment, and the first-level health service center, including individual and public health providers. Pusat Kesehatan Masyarakat (public health center in English) is an essential public health service facility in Indonesia. It is a unit that functions as a center for health development, fostering community participation in the healthcare sector, and a first-level health service center that carries out its activities in a comprehensive, integrated, and sustainable manner in the community8,9.
The storage conditions of pharmaceutical drugs and medical disposables in the public health center need to be observed since an efficient condition will determine the success of the public health center’s management10. In addition, they also significantly affect the effectiveness of treatment and safety in terms of clinical practices. As stated in the Regulation of the Minister of Health of the Republic of Indonesia, patient safety should be prioritized in healthcare services. This observational study took place at the public health center of Dalam Kaum village, located in the Sambas Regency, West Kalimantan Province, the second large area in the regency. The public health center had many patients and was multiplying. Regarding the Regulation of the Indonesian Ministry, to make sure that storage conditions of the public health center meet the required quality standard, it is necessary to carry out an observational study. Unfortunately, no research observed this matter; therefore, the storage conditions of the village public health center were still unclear. It is why this study was carried out to examine the conformity of conditions of pharmaceutical drugs and medical disposables in the storage of the public health center of the village with the Regulation of the Minister of Health of the Republic of Indonesia Number 74 of 2016 and the indicators for the storage of pharmaceutical drugs and medical disposables. In terms of novelty, this research is the first observational field study to assess the conformity of storage conditions of pharmaceutical drugs and medical disposables in the public health center of Dalam Kaum village.
MATERIALS AND METHODS:
Materials:
A guideline functioning to compare the aspects was the Regulation of the Minister of Health of the Republic of Indonesia Number 74 of 201611. In addition, the study also utilized indicators for the storage of pharmaceutical drugs and medical disposables12. All the guidelines were applied to assess the conformity of the storage conditions of pharmaceutical drugs and medical disposables in the public health center of Dalam Kaum village where this study occurred. The instruments of this study were as follows:
1. A checklist sourced from the Regulation of the Minister of Health of the Republic of Indonesia Number 74 of 2016. Many specific aspects extracted include storage method, storage stability, flammable and explosive material storage, narcotic and psychotropic drug storage, and storage for materials with contamination risk.
2. Medication use report and request sheet documents from 2019,including aspects of dead stock and turnover ratio (TOR) of pharmaceutical and disposable medical products.
3. A list of damaged or expired drugs, functioning as data in analyzing the indicators for storing pharmaceutical drugs and medical disposables.
Methods:
This observational study occurred at the public health center of Dalam Kaum village, West Kalimantan, Indonesia, in January 2020. Regarding data collection, this study used quantitative and qualitative models to determine the conformity of the storage condition in the rural public health center of Dalam Kaum village, West Kalimantan, Indonesia, with the Regulation of the Minister of Health of the Republic of Indonesia Number 74 of 2016, in addition to the indicators for the storage of pharmaceutical drugs and medical disposables. The study applied a descriptive non-experimental method with a total population sampling model in a quantitative approach. Moreover, the qualitative approach was in the form of a short interview with the personnel, meant to explore more real conditions. The population and sample of this study involved pharmaceutical personnel (one pharmacist and four pharmacy technicians) of the public health center in the village.
Data Analysis:
1. Regulation of the Minister of Health of the Republic of Indonesia Number 74 of 2016:
The obtained data were analyzed by comparing the actual condition of pharmaceutical and disposable medical storage of the public health center and the regulation of the Minister of Health of the Republic of Indonesia Number 74 of 2016 to determine their conformity. According to the regulation, the high lighted aspects include storage method, storage stability, flammable and explosive material storage, narcotic and psychotropic drug storage, and storage for materials with contamination risk. A score of 100 means that the actual condition of the storage showed conformity with the regulation, while 0 did not show conformity.
2. Indicators for the storage of pharmaceutical drugs and medical disposables:
The obtained data of this study were also analyzed using the indicators for storing pharmaceutical drugs and medical disposables to examine the conformity. According to the indicators, three aspects analyzed include dead stock, damaged or expired drugs, and turnover ratio (TOR).
2.1. Percentage of dead stock:
The analysis of the dead stock of this study included the number of different types of drugs for which there had been no transaction for three consecutive months, generally known as damaged or expired drugs, and the total number of different types of drugs. The percentage of comparison between these types will result in the dead stock of drugs. According to the indicators, the ideal percentage is zero (0%). Below is the formula for the percentage of dead stock of drugs implemented in this study.
Number of types of unused drugs
--------------------------------------------- × 100%
Total number of types of drugs
2.2. Percentage of damaged or expired drugs
The second aspect was the damaged or expired drugs, obtained by comparing the number of types of damaged or expired drugs with the total numbers of different types of drugsmultiplied by 100 %. A good percentage of this aspect, similar to the aspect of dead stock, is zero (0%). The formula for the percentage of damaged or expired drugs was as follows:
Number of types of damged or expired drugs
------------------------------------------------------- ×100 %
Total number of types of drugs
2.3. Turn Over Ratio (TOR):
The third aspect of the indicators was the turnover ratio (TOR). Data for calculating TOR were the total number of types of drugs in the public health center of Dalam Kaum village in 2019. According to the indicators, a good turnover ratio implemented in the public health center ranges from 8 to 12 per year. In order to determine the turnover ratio of this study, the following formula was applied:
Number pf types of sold drugs
------------------------------------------ × 100%
Total number of types of drugs
Research Ethics:
This study obtained ethical clearance from the Research Ethic Commission of the Faculty of Medicine and Health Sciences, Universitas Muhammadiyah Yogyakarta, Indonesia (No.018/EC-KEPK/FKIK-UMY/I/2019).
RESULT:
1. Regulation of the Minister of Health of the Republic of Indonesia Number 74 of 2016:
This study found that the storage method conformed 100% with the regulation regarding the conformity of storage conditions of pharmaceutical drugs and medical disposables. Additionally, other two aspects, namely the storage stability and narcotic and psychotropic drug storage, also showed conformity. Unfortunately, one part, the flammable and explosive material storage, did not show it. Table 1 represents the levels of conformity of storage conditions of pharmaceutical drugs and medical disposables in the public health center of Dalam Kaum village with Regulation of the Minister of Health of the Republic of Indonesia Number 74 of 2016.
Table 1: Conformity of storage conditions of pharmaceutical drugs and medical disposables in the public health center of Dalam Kaum village
|
Parameters |
Conformity (%) |
Notes |
|
Storage method |
100 |
Conformed |
|
Storage stability |
100 |
Conformed |
|
Storage for flammable and explosive materials |
0 |
Not conformed |
|
Storage for narcotic and psychotropic drugs |
100 |
Conformed |
|
Storage for materials with contamination risk |
100 |
Conformed |
2. Indicators for the storage of pharmaceutical drugs and medical disposables:
2.1. Percentage of dead stock:
The dead stock explains a condition of drugs that have not been used for three consecutive months. Regarding data collection for dead stock calculation, this study applied medication use reports and request sheet documents as the source to ascertain drug stocks with slow turnover in 2019. The percentage of dead stock was calculated by comparing the number of unused drugs for three consecutive months during 2019 with the total number of drug types in the same year. Table 2 shows a higher-than-average percentage of dead stock. This study's results confirmed that the dead stock rate was 53.4% or greater than zero percent. It explains that the stakeholders did not distribute pharmaceutical drugs and medical disposables evenly in the storage of the public health center of Dalam Kaum village.
Table 2: Percentage of dead stock in the public health center of Dalam Kaum villagein 2019
|
Parameters |
|
Percentage |
|
Number of types of unused drugs |
173 |
53.4% |
|
Total number of types of drugs |
324 |
2.2. Percentage of Damaged or Expired Drugs:
This study determined damaged or expired drugs using a list of expired or damaged ones for three consecutive months. The study found that the percentage of damaged or expired drugs was 10.8%, meaning that it was greater than the standard, or more than 0.2%. Table 3 represents the percentage of damaged or expired drugs in the public health center of Dalam Kaum village, Sambas, West Kalimantan, in 2019.
Table 3: Percentage of damaged or expired drugs in the public health center of Dalam Kaum village in 2019
|
Parameters |
Number |
% |
|
Number of damaged or expired drugs |
35 |
10.8% |
|
Total number of types of drugs |
324 |
2.3. Turn Over Ratio (TOR):
This study showed that the TOR of the public health center of Dalam Kaum village was 8.53. It indicates that the average inventory in the public health center's pharmaceutical and disposable medical storage experienced a turnover of 8.53 times during 2019, meaning that drug supplies in the Dalam Kaum village were standard and distributed within 43 days.
DISCUSSION:
The requirements for pharmaceutical and disposable medical storage conditions are contained in the Regulation of the Minister of Health of the Republic of Indonesia Number 74 of 2016 concerning pharmaceutical service standards in the public health center. The requirements are primarily meant to ensure the safety and quality of the conditions at the public health centers.
1. Regulation of the Minister of Health of the Republic of Indonesia Number 74 of 2016:
This observational study confirmed that the storage method of the public health center in the Dalam Kaum village was managed by storing drugs following their dosage form and alphabetic type, First In First Out (FIFO) and First Expired First Out (FEFO) model. Meanwhile, vaccines, suppositories, and serums were stored in the refrigerator.
Another study finding reported that the pharmaceutical and disposable medical storage conditions based on stability were appropriately managed by the pharmaceutical personnel (4 pharmaceutical technicians) examined by the pharmacist of the public health centers. The pharmaceutical personnel carried out this activity once a month and then submitted the annual reports to the local health office to get an assessment. Technically, lighting was set by installing curtains on the windows to support the storage stability, so incoming light was not too bright. The storage was also equipped with air conditioning to maintain the room's humidity to keep it stable. It performs by monitoring the temperature in the room and keeping the relative humidity at not more than 60%. Water evaporation will occur quickly when the temperature is high while relative humidity is low. In contrast, evaporation will occur more slowly when the temperature is low, and the relative humidity is high. Mold and spoilage may occur when the relative humidity is close to 100%.
Ideally, in terms of the storage conditions following the Regulation of the Minister of Health of the Republic of Indonesia Number 74 of 2016, explosive and flammable materials should be stored in a fireproof room and marked with a particular hazardous material label. In addition, other dosage forms, namely medical gases, should be stored in a standing position, tied, and marked to avoid human errors. However, the Dalam Kaum village public health center had not yet applied the method. It was reported that flammable materials were marked with a particular sign for hazardous materials but only stored in the pharmaceutical and disposable medical storage. This finding describes that this aspect did not show the conformity of the regulation. Inadequate facilities and infrastructure are why the pharmaceutical personnel stored all materials in the storage13,14. For better pharmaceutical service in the future, as stated by the Minister of Health of the Republic of Indonesia in their regulation, it is recommended to add or build special storage for these materials.
This study also found that the storage of narcotic and psychotropic drugs at the public health center in Dalam Kaum village used remarkable cabinets with double doors and locks. The cabinet was made of sturdy wood and not easily moved to another place. However, the pharmaceutical personnel stored psychotropic and narcotic drugs together in a cupboard. Previous studies suggested that an ideal condition for storing narcotics should separate the psychotropics due to different toxic effects; thus, their marking should also be different.
Theoretically, contamination of other products stored in the same room can cause a decrease in the quality of pharmaceutical and disposable medical products. At the public health center of Dalam Kaum village, this study reported that the conformity of the storage conditions of pharmaceutical drugs and medical disposables with a risk of contamination was 100%. This finding describes that the storage conditions meet the regulation of the Minister of Health of the Republic of Indonesia. The storage has a sound ventilation system, adequate lighting, and a constantly monitored temperature. Regarding damaged and expired drugs, they should be separated and immediately disposed of. They should also be stored properly, and the storage area should not be used to store other items as this may lead to contamination. Pharmacy installations must ensure that drugs are appropriately kept and inspected periodically.
2. Indicators of pharmaceutical and disposable medical storage:
2.1. Percentage of dead stock:
This study found that the percentage of dead stock in the public health center of Dalam Kaum village was more significant than the average (53.4%). It means that over half of the total types of drugs had been held by the pharmacy installation of the public health center for a long time and are unlikely to distribute to the patients15. It was because Dalam Kaum village is an outpatient public health center, and the number of patients who need to take drugs was relatively low. Theoretically, many factors, such as prescriptions that do not refer to the formulary standardized by the government, a change in prescription patterns, or disease prevalence, can cause the dead stock{Citation}. In addition, slow-moving drugs may affect the supply of drugs in pharmaceutical storage. To address dead stock and make it easier to collect data, pharmaceutical personnel should label unsold pharmaceutical drugs and medical disposables with “dead stock”. Another way is by actively communicating to doctors to prescribe dead stock products. Suppose a doctor can no longer use a dead stock product until the expiration date arrives. The product can be stored in a particular room for further destruction or returned to the suppliers.
2.2. Percentage of damaged or expired drugs:
The percentage of damaged or expired drugs reflects the distribution system and planning in addition to quality control and observation of the drug supply in the pharmaceutical storage. At the public health center in Dalam Kaum village, this study confirmed that the percentage was more significant than the average, and the number of damaged or expired drugs was considered high16. Based on pharmaceutical and disposable medical storage indicators, a proper and good distribution and planning system among health care providers were under 0.2 percent. The high number of damaged or expired drugs will lead to financial losses for the public health center. In order to keep the number of damaged or expired drugs relatively low, pharmacists and doctors in the public health center need to improve their communication regarding prescription patterns. As an example, a pharmacist could recommend nearly expired drugs to a doctor when prescribing17. In addition, it is also better to improve communication with suppliers related to nearly expired products. Some suppliers have a policy that the public health centers could replace or refund nearly-expired products by returning the products at least 3 – 6 months before the expiry date18. It depends on the agreement between the health care providers and suppliers. Another recommendation is that the management of public health centers should carry out the procurement process directly. Hence, they receive the products in small quantities and not be piled up in storage19.
2.3. Turn Over Ratio:
Drug supply management at the public health center mainly aims to achieve efficiency—i.e., availability of drugs that do not add financial burden. The efficiency of the management can be measured by turnover ratio or TOR20. It is an indicator to determine how many times the inventory turns over in a year, calculated by comparing the purchase of drugs in a year with the average inventory at the end of the year. In order to achieve cash through sales, a good inventory turnover is required21. The findings of this study indicated that the drug supplies in this public health center of the village were distributed within 43 days and were considered efficient. It explains that the drug supply management of the public health center ran well. Theoretically, the lower the TOR, the longer the items stay in storage. In contrast, the higher the TOR, the more efficient the inventory is. According to previous studies, a good turnover ratio applied in the health care providers, including hospitals and public health centers, ranges from 8 to 12 per year22.
Policy implications of the study:
The practical implications of this study include that the actual findings could be a basis for local governments to focus more on developing facilities and infrastructure (for example, storage with proper facilities). In addition, other implications include improvement of job performance and communication among personnel (doctors, pharmacists, and other health professionals) in terms of pharmaceutical services (e.g., prescription pattern), as well as improvement of the drug supply management of the public health center (e.g., agreement with suppliers regarding procurement process).
Limitation of the study:
This study employed a combination of descriptive quantitative and qualitative approaches. Data were obtained by field observation, document review, and interviews with pharmaceutical personnel of the public health centers of Dalam Kaum village, Kalimantan. However, there were many limitations of this study. First, the public health center only provides a general description of drug storage management through variables available in the storage. Therefore, it could not represent the overall aspects of drug storage in the public health center. The second limitation is that this study only applied data obtained through observation, document review, and interviews with pharmaceutical personnel. This study lacks information from the top management of the public health center.
CONCLUSION:
This study reported that almost all aspects of the public health center of Dalam Kaum village conformed to the Regulation of the Minister of Health of the Republic of Indonesia. However, it was only an aspect of flammable and explosive materials that did not show conformity. Adding or building special storage for these materials is recommended for better future service. Regarding pharmaceutical and disposable medical storage indicators, this study found that two aspects (i.e., dead stock and damaged or expired drugs) did not show conformity. Fortunately, the aspect of Turnover Ratio (TOR) was considered adequate. In order to address the aspect of dead stock, actively communicating to doctors regarding the prescription of dead stock products is a good deal. In addition, pharmaceutical personnel can store pharmaceutical drugs and medical disposables in a particular room for further destruction or return to the suppliers. They can carry it out if the doctor can no longer prescribe the products until their expiration date passes. Meanwhile, to minimize the number of damaged or expired drugs, improving the communication among pharmacists and doctors regarding prescription patterns and suppliers in terms of product return policies is highly recommended. In addition, the management of the public health center should carry out the procurement process directly so the products would be received in small quantities and not be piled up in storage.
CONFLICT OF INTEREST:
There is no conflict of interest in writing this research.
ACKNOWLEDGMENTS:
The authors would are grateful to thank the Department of Pharmaceutical Management, School of Pharmacy, Faculty of Medicine and Health Sciences, Universitas Muhammadiyah Yogyakarta, and also to the editors of the journal,as well as the reviewers of the manuscript.
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Received on 04.08.2022 Modified on 05.12.2022
Accepted on 15.03.2023 © RJPT All right reserved
Research J. Pharm. and Tech 2023; 16(9):4155-4160.
DOI: 10.52711/0974-360X.2023.00681