The Beyond-Use Date Perception of Drugs in North Jakarta, Indonesia

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Indonesian Journal of Clinical Pharmacy, September 2021 Available online at:

Vol. 10 Iss. 3, pg 172–179 http://ijcp.or.id


ISSN: 2252–6218, e-ISSN: 2337-5701 DOI: 10.15416/ijcp.2021.10.3.172
Original Research

The Beyond-Use Date Perception of Drugs in North Jakarta, Indonesia


Fonny Cokro, Sherly T. Arrang, Jonathan A. N. Solang, Pangestuning Sekarsari
Department of Pharmacy, School of Medicine and Health Sciences,
Atma Jaya Catholic University of Indonesia, Jakarta, Indonesia

Abstract
Beyond-Use Date (BUD) refers to the unsafe period of drug consumption and is calculated
from the moment of opening the primary package. Meanwhile, Indonesia has no current related
data, in terms of public awareness. Therefore, this research aims to assess the BUD perception
of North Jakarta communities and pharmacists’ roles in providing the relevant information. The
data collection process employed a semi-structural interview across 6 districts in the research
location between September-November 2019, followed by data transcription and thematic
development. Based on 60 informants recruited by purposive sampling, three themes were
obtained, including residual drug storage, pharmacists’ contributions, and BUD awareness.
Furthermore, about 97% of the respondents were completely unaware of the subject matter,
while 100% denied having any form of sensitization from pharmacists. The perception of 50%
were based on the expiration date labelled on the medications. In summary, North Jakarta
community’s views were possibly influenced by very poor BUD knowledge. Therefore, the
role of pharmacists in educating patients and communities appears very essential.

Keywords: Drug-compounding, drug-stabilities, perception, pharmacists

Persepsi mengenai Beyond-Use Date Obat pada Masyarakat


Jakarta Utara, Indonesia
Abstrak
Beyond-Use Date (BUD) merupakan waktu ketika sediaan obat tidak dapat digunakan lagi
dan dihitung berdasarkan waktu pembukaan kemasan primer sediaan. Sampai dengan saat ini,
tidak terdapat data tentang pemahaman masyarakat Indonesia mengenai BUD. Penelitian ini
bertujuan untuk melihat persepsi masyarakat Jakarta Utara mengenai BUD, serta mengetahui
peran apoteker dalam menyediakan informasi BUD. Data mengenai persepsi BUD diperoleh dari
wawancara semi terstruktur yang dilakukan di 6 kecamatan yang terletak di Jakarta Utara pada
September–November 2019, dan diikuti oleh proses transkripsi dan pengembangan tema. Dari
60 informan yang direkrut secara purposive sampling, didapatkan tiga tema yaitu penyimpanan
sisa obat racikan, kontribusi apoteker terkait BUD, dan pengenalan terhadap BUD. Mayoritas
informan (97%) tidak mengetahui tentang BUD, dan semua informan (100%) tidak pernah
menerima informasi BUD dari apoteker. Sebagian dari informan memiliki persepsi bahwa
BUD sama dengan masa kadaluarsa yang ada di kemasan pabrik. Kami menyimpulkan bahwa
persepsi masyakat Jakarta Utara mengenai BUD dapat disebabkan oleh pengetahuan tentang
BUD yang rendah, dan peran apoteker dalam menginformasikan dan mengedukasi pasien dan
masyarakat mengenai BUD sangat diperlukan.

Kata kunci: Apoteker, obat racikan, persepsi, stabilitas obat

Correspondence: apt. Fonny Cokro, M.Farm.Klin., Department of Pharmacy, School of Medicine and Health
Sciences, Atma Jaya Catholic University of Indonesia, Jakarta, Daerah Khusus Ibukota Jakarta 14440, Indonesia,
email: [email protected]
Submitted: 5th August 2020, Accepted: 30th July 2021, Published: 30th September 2021

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Indonesian Journal of Clinical Pharmacy Volume 10, Issue 3, September 2021

Introduction and its components, microbe proliferation


potency, container type, the right storage
Extemporaneous drug formulation is a condition needed for the drug, and duration
preparation using traditional compounding of required therapy.8,9
techniques to produce a specific dosage Based on the descriptions above, BUD is
specifically to meet a certain individual’s a crucial way to monitor the excellent quality
needs, which dosage not commercially of drugs, guaranteeing drug efficacy and
available.1–3 Dermatologic products were safety. This research inquired the community
the most frequent extemporaneous drug perception in North Jakarta, Indonesia,
formulations being made.2 In Indonesia, the about BUD, particularly in non-sterile
number of extemporaneous drug formulations extemporaneous preparations.
prescriptions is highly implemented. Andriani According to the United States
et al. found that 13.04% of prescriptions are Pharmacopeia (USP) and Ministry of Health
extemporaneous compounding capsules, Republic of Indonesia Regulations No. 35
and 44.88% of them contained six or more the year 2014 about Pharmaceutical Service
drugs.4 The use of extemporaneous drug Standards, BUD is one of the information
formulations was more common in children. that must be added to the patient drug label.
This phenomenon is caused by some factors, The pharmacist needs to counsel the patient
i.e., the need for drug dosage adjustment about how to use, how they keep and discard
from adult form available in the market, the the drugs, especially regarding BUD, related
child’s refusal to take solid forms, and the to drug storage and drug disposal.8,10 Based
limitation of drug formulation availability on a cross-sectional survey in Indonesia,
in primary health care facilities and rural only about 43.75% of pharmacists practicing
areas.3,5 Mufarrihah et al. found that 99.76% BUD without detailed information about
of pediatric patients received crushed tablets, this practice.11 Therefore, we also want to
and 27.24% of them containing more than assess people’s perception of a pharmacist’s
four drugs.6 contribution in providing BUD information
Meanwhile, Hapsari et al. found that related to extemporaneous drug preparation
97.67% of pediatric patients in Banyumas service.
Regency, Central Java, Indonesia, received
extemporaneous drugs, with the most common Methods
drug formulations were crushed tablet (88.36%)
and suspension (8.06%).7 The disruption of their This study was conducted following the
original packaging’s integrity causes changes Helsinki Declaration of 1975. It had been
in crushed tablet’s stability and sterility and reviewed by the ethical committee of the
any other extemporaneous drug formulations. School of Medicine and Health Sciences,
Therefore, the stability of drug forms that Atma Jaya Catholic University of Indonesia
had been altered or torn from their primary (AJCUI) with ethical clearance approval no.
packaging will not follow the expiration date but 07/05/KEP-FKUAJ/2019.
following Beyond-Use Dates (BUD).8
Beyond-Used Date (BUD) is set based on Study design
the time of the preparations, active ingredient’s Qualitative with phenomenology study
stability, and allowed sterility limits, design, initiated by recorded semi-structural
considering active ingredient properties and interviews, followed by data transcription
its degradation mechanism, drug dosage form and thematic development.

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Indonesian Journal of Clinical Pharmacy Volume 10, Issue 3, September 2021

Research team Interviews


The interviews were conducted by male Authors developed questions framework
and one female pharmacy students. Each from in-depth literature reviews. Informants
of the interviewers had been trained by were given open questions about how they
two professional clinical pharmacists on keep the extemporaneous drug formulations
conducting good interview techniques. The or drugs that have been torn open, the
interviewers had no relationship with each of information they got from the pharmacist
the participants. when they were procuring the drugs, their
knowledge regarding the beyond-use date
Settings and its difference with an expiration date.
Data were collected between September The verification process was done during the
and November 2019. Data was collected in interviews, and the principal researcher took
the public spaces, e.g.: malls or shopping field notes after the interviews.
centers in all districts in North Jakarta,
which are Cilincing, Penjaringan, Kelapa Analysis
Gading, Tanjung Priok, Pademangan, and Interview results were transcribed and then
Koja. All districts were included to be more analyzed thematically by two researchers
representative of North Jakarta. independently, continued by discussions
to overcome discrepancies. In the results
Sampling part, the themes detected from the interview
The sampling technique was done using non- transcripts were marked by adding quotations.
probability sampling, which is purposive The unnecessary conversation was being
sampling. The samples of this study were cut using sign /…/. A square bracket sign
collected based on inclusion criteria until is used to accommodate terms not included
reaching data saturation. There were ten in the parts of the theme for the readers to
informants’ data collected from each district, understand the conversations. The themes
with a total of 60 informants, assuming this were translated from Bahasa to English, not
number is sufficient to achieve data saturation. word for word, but by the true meaning, to
This number of informants was considered increase the conversations’ comprehension.
sufficient to represent the assessed community
since repetitive and similar results were Results
obtained during the interview, indicating data
saturation. The inclusion criteria were people About ten eligible people from each district
who live in North Jakarta and more than 18 (Cilincing, Penjaringan, Kelapa Gading,
years old. Tanjung Priok, Pademangan, and Koja) were
selected as informants, creating a total of 60
Data collection informants whose interview results showed
Samples were obtained following the data saturation. Among the informants,
purposive sampling technique. Each informant there are 48 males and 12 females. Majority
had to fill out a form on demographic details (n=37) of informants came from age group
and signed the consent forms. Samples that of 36 to 55 years. Their demographic data
met all inclusion criteria became informants, are presented in Table 1. Each informant
who were semi-structurally interviewed face- was asked three main questions, and the
to-face using a voice recorder. Data were answer was categorized into three themes as
collected until reaching data saturation. followed:

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Indonesian Journal of Clinical Pharmacy Volume 10, Issue 3, September 2021

Tabel 1 Demographic Data


Residence (% (n))
Kelapa Tanjung
Cilincing Penjaringan Pademangan Koja
Gading Priok
(n=10) (n=10) (n=10) (n=10)
(n=10) (n=10)
Gender
Male 70 (7) 90 (9) 90 (9) 60 (6) 90 (9) 80 (8)
Female 30 (3) 10 (1) 10 (1) 40 (4) 10 (1) 20 (2)
Age Category (Years)
Young adult (18–35) 50 (5) 30 (3) 40 (4) 30 (3) 40 (4) 40 (4)
Middle-aged adult (36–55) 50 (5) 70 (7) 60 (6) 70 (7) 60 (6) 60 (6)
Older adult (>55) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)

Theme 1: Storage of remaining drugs “I usually keep them for three months the
During the interviews, the informants were longest. Longer than that, I will not take them
asked about how they kept the remaining again because I’m afraid they are not effective
drugs (when the primary packaging have anymore. I keep them [the remaining drugs].
been torn) after they got fully recovered from /…/ Yes, sometimes I have a relapse that
sickness. The answers were ranging from requires me to continue taking the drugs,
not keeping the remaining drugs to keeping but if this is not the case, I won’t take them
them without time limit. Most respondents anymore.”
only used one drug storage technique for all
types of drug forms, be it a crushed tablet, • Keeping the remaining drugs for not
syrup, or cream/ointment. Thus indicating more than six months
that informants had low knowledge about the “Usually, I keep them for six months, and
right storage for drugs. I won’t take the drugs that have been kept
for longer than that. I’m afraid, well, they
• Not keeping the remaining drugs won’t be effective anymore, how do I know
“Well, if I am fully recovered, I will throw that. If it is still far from the limit time, I will
away the remaining drugs.” take them again, but if it is too close to the
limit time, I won’t dare [taking the remaining
• Keeping the remaining drugs for not drugs]. I keep them so they can still be used,
more than two weeks just in case my family or brother or sister or
“Two weeks is the longest. After that, I my uncle needs them. Yes [for the family],
will throw them away.” for example, I got a cough, and I took
effective drugs for it from public health care,
• Keeping the remaining drugs for not or whatever, I can recommend those drugs,
more than one month let them take those drugs.”
“For me, usually we take them [drugs]
many times daily. If the drugs not finished, • Keeping the remaining drugs up to drug’s
we will keep them for at least a month. Yes expiration date
[keeping the drugs], just in case we still need “Depends on the expiration date. Yes, I
them.” would take them [the remaining drugs] again,
[but] if they are not effective, then I would go
• Keeping the remaining drugs for not to the doctor again.”
more than three months “Check the expiration date. If it’s still far

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Indonesian Journal of Clinical Pharmacy Volume 10, Issue 3, September 2021

from it, then I’ll take them [the remaining about how to store capsule drugs.”
drugs] again for the same disease.” “Sometimes they [pharmacists] do, but
sometimes not. Usually, [they inform me]
• Finishing the drugs, no remaining drugs about where to keep the drugs, in the room
“Not long until they are finished. I would temperature.”
throw them away [if there were remaining
drugs]” Theme 3: Familiarity with BUD
The informants were asked about their
• Keeping them without time limit familiarity with BUD. Overall 97% did not
“Until they are finished. I would keep know about BUD. About 50% thought that
them [the remaining drugs] just in case the the expiration date was the same as BUD.
cough relapse.”
• No idea about BUD
• According to what the doctor said “Well, I don’t know. Usually, I only look
“Well, I’ll follow what the doctor says.” at the expiration date.”
“Depends on what the doctors say in the “I only know about the expiration date. I
[following] consultation. Sometimes the doctor don’t know if it [the maximum time of drug
might say the time limit.” storage] could be invalid.”

Theme 2: Pharmacist’s contributions • Not sure about BUD


The informants were asked about what did “Sometimes, the risk of color change is
the pharmacist say about storing medication. written [on the drug brochure], but sometimes
All informants said pharmacists did not. So, instead of becoming sick from taking
not give any BUD information when the drugs, we should just throw them away.”
they were purchasing the drugs. Most of “I have seen it on the drug’s label. I knew
informations received was about the dosage it from somewhere when my family or I got
and frequency of taking medication per day. sick, and the packaging has been opened, the
drug will expire soon.”
• The pharmacist did not tell anything
about the drugs storage • BUD is the same as expiration date stated
“Never [tell me anything], just about how in the drug packaging
to use them, how many times a day I have to “Well, just follow what’s written in the
take them, but [I have] never been told about packaging.”
how long the drug should be stored.” “Just check the expiration date first before
“Nope [never been told by the pharmacist], taking it [a drug]. Please don’t take it right
just follow the instructions on the box.” away.”
“Never [tell me anything]. When I bought
the drugs, I just bought them. After that, • Obtaining BUD information from doctor
that’s it.” or relatives
“I’ve heard it from the doctor or my co-
• The pharmacist only informed about worker. Usually a week [the BUD]”
where to keep the drugs
“In the pharmacy, yes, they [the pharmacists] • Obtaining BUD information from the
told me, [syrup] should be shaken first, then pharmacist’ drug label
put in the fridge. I don’t think they told me “Usually, there is. I knew it from the

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Indonesian Journal of Clinical Pharmacy Volume 10, Issue 3, September 2021

pharmacist’s writing on the drug’s label. It 14 days. Meanwhile, topical or dermal and
could be three weeks to a month.” liquid or semisolid mucosal preparations with
water content have BUD not more than 30
Discussion days since preparations.8,15
Nevertheless, the informants’ statements
Based on the answers to main question 1, the emphasize that the pharmacist role should be
interesting part is that some informants stated more increased, since the informants are more
that they would keep the remaining drugs familiar with doctor’s role. A pharmacist
not just for themselves but also for their has the responsibility to inform BUD to the
relatives (friends/family). People may think customer, and the informants’ statements
that the drugs should be the same for the indicate the lack of a pharmacist’s role in
same indication regardless of each condition. this area. Alfian et al. found that consumers
This behavior is not relevant to the Patient- need more drug information and more time to
Centered Care concept, highlighting the consult pharmacists.16 Beyond that, according
importance of health care professionals and to Hermansyah et al., 60% of community
patients working together for the best patient pharmacists in Indonesia only work about 30
outcome achievement.12,13 Another interesting hours per week, which means 4.3 hours per
perception is that some of the informants day. Therefore the Indonesian community
would like to use the remaining drugs again. pharmacists not meeting ideal professional
Despite going to health care facilities, some working hours, leading to the less visible role
people prefer using the remaining drugs for of the Indonesian community pharmacists and
the same condition, although different kinds the unawareness of pharmacist existence.17
of drugs might be needed for a better outcome. Another perception is that BUD information
Two other informants suggest that they might could be seen from the pharmacist’s drug
follow the doctor’s instructions about BUD. label. From this informant interview, the
Regarding this issue, the pharmacist role pharmacist only wrote BUD on the drug label
might not be anticipated by the patients. but not informing the patient about BUD.
According to Puspitasari et al., Indonesian Direct information about BUD is also needed
pharmacists lacked involvement due to low to prevent misinterpreting label instructions.
expectations from the patients and doctors, Misinterpreting drug label instructions is
especially in managing non-communicable a common cause of medication error and
diseases.14 affecting patients’ health outcomes.18,19 For
General answers from main question 1 extemporaneous preparations or products that
show that informants’ knowledge regarding have been torn, the labeling is not regulated
drug storage was low. This statement can be and not standardized.1 Therefore, patient
seen by how most informants generalized misunderstanding of drug label instructions
all types of drug dosage form: crushed should be prevented.
tablet, syrup, cream/ointment, into one way of Generally, most informants had no idea
keeping the drug safe. Based on the United about BUD, and half of them believed that
States Pharmacopeia (USP) Convention, BUD and expiration date were the same
non-sterile formulation without water content thing. Some informants had no concern
has BUD not more than six months since its about their medicines, probably due to a
preparation time or following the expiration lack of knowledge about the importance of
date, which one is earlier. Oral formulation drug safety. Those statements emphasize
with water content has BUD not more than the importance of community education or

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Indonesian Journal of Clinical Pharmacy Volume 10, Issue 3, September 2021

information about drug storage. Meanwhile, and publication of this article.


pharmacists’ willingness to give information
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