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  • Evaluation Of Pharmaceutical Waste Management Practices and Environmental Risk Perception Among Community Pharmacies

  • Department Of Pharmacy, Dr. D. Y. Patil College Of Pharmacy, Akurdi, Pune, India.

Abstract

The improper disposal of pharmaceutical waste generated by community pharmacies is now a major concern since it poses significant risks for environmental pollution, public health, and antimicrobial resistance (AMR). It refers to expired medications and those no longer required by patients, including their packaging, which should be disposed of appropriately at the community level. In India, there are the Biomedical Waste Management Rules of 2016 (amended in 2018) that can be used for guidance on proper waste management in this area, although implementation rates may vary from region to region. This paper aims to investigate the awareness levels, current practices, attitude towards waste management, training exposure, and problems associated with pharmaceutical waste management by community pharmacists. A cross-sectional study using a structured and validated questionnaire produced 232 respondents for further analysis. Ninety-four percent of the sample was aware of pharmaceutical waste, while 87.5% considered its effect on the environment. Only a few respondents disposed of waste using municipal waste (8.3%) or drainage systems (5.7%). One of the critical problems identified by participants was insufficient awareness about pharmaceutical waste at the community level (80.5%). Although awareness levels are relatively high, some pharmacists failed to follow guidelines.

Keywords

Pharmaceutical waste, community pharmacy, environmental risk, Biomedical Waste Management Rules, expired medicines, waste disposal practices

Introduction

The pharmaceutical waste can be explained as those drugs and other substances which are no longer considered useful for their intended use. This may entail drugs that have passed the expiry date, drugs in surplus, drugs that are in poor quality condition, or contaminated drugs that require proper disposal. In addition to drug products, the WHO includes in the category those pharmaceuticals that have been rendered useless, known as active pharmaceutical ingredient. As opposed to general domestic and commercial wastes, these wastes can be either biologically effective or toxic in nature.

Such kind of pharmaceutical waste may occur during any stage in the life cycle of the pharmaceuticals, right from their manufacturing process, through distribution, hospitals, and even consumer-level uses. However, community pharmacies are identified as one of the major sources due to the high volumes of medicines being handled in them.

Pharmaceutical waste generated in community pharmacies consists of expired medicines, leftover medicines, cytotoxic waste, controlled substances, expired items, and other pharmaceuticals like blisters, bottles, ampoules, vials, and syringes.

Improper disposal of pharmaceutical wastes affects the environment. Flushing medicines down the drain or disposing of them in landfills contaminates soil and water resources with antibiotics, hormones, analgesics, and many more chemicals. These actions pollute and fill landfill sites and are dangerous for humans and animals alike. Leftover medicines ultimately contaminate water resources, and antibiotics even at trace levels in the environment cause antimicrobial resistance.

The main legislation governing the management of pharmaceutical waste in India is the Biomedical Waste Management Rules 2016 (revised in 2018) under the Environment Protection Act of 1986. In addition, there are provisions under the Drugs and Cosmetics Act, 1940 (Schedule M), as well as guidelines by the Central Pollution Control Board and State Pollution Control Boards.

Community pharmacists are the first point of contact to the public for medicines but the official training on handling and disposing of pharmaceutical wastes is not always consistently given. Earlier studies carried out in India and other developing regions have shown that there is a wide range in compliance, infrastructure, and everyday working habits. Keeping these findings in mind, the authors of this paper decided to look into community pharmacists' pharmaceutical waste disposal practices and their perception of the environmental risk.

MATERIALS AND METHODS

STUDY DESIGN AND POPULATION:

The research used a cross-sectional design targeting people who had relations with community pharmacy practice in the study location. The respondents were community pharmacists, pharmacy assistants, and pharmacy students dealing with dispensing work. Convenience sampling was used for data collection, and the data collection tool (questionnaire) was delivered through Google Forms. After checking for consistency, a total of 232 questionnaires were analyzed.

DATA COLLECTION INSTRUMENT:

The research utilized a structured questionnaire as a means of collecting data. This tool was developed based on a thorough literature review on the issue of pharmaceutical waste management, and the questionnaire had been pre-validated prior to its use. The questionnaire was divided into six parts, focusing on various aspects of the study including demographic information such as age, gender, educational qualifications, and experience in the pharmaceuticals industry; level of awareness about pharmaceutical waste; disposal procedures; and professional attitudes. Other aspects that were examined included the level of training received and sources of information.

STATISTIC ALANALYSIS:

The survey data was collected, compiled, and analyzed using MS Excel and Python. The graphs were created using matplotlib. The analysis was done based on descriptive statistics, which involved looking at frequencies and percentages of single choices. The findings were then reported in tables and supported by basic graphs such as bar and pie charts.

RESULTS AND DISCUSSION

A total of 232 valid responses were received and analysed. Results of each survey domain are presented below.

Demographic Data

The age distribution of the majority of participants was relatively younger, where 55.2% belonged to the <25 age group, whereas 30.6% belonged to the 25–35 age category. The results are similar to that of a group of pharmacy students and newly practicing pharmacists. Around 57.8% of participants were males, while 42.2% belonged to the female gender group. Women pharmacists have gained prominence in recent years in India. Educational qualification of pharmacists showed that B.Pharm degree holders accounted for 75.5% of the total population, followed by D.Pharm graduates with 17.9%, while M.Pharm degree holders accounted for only 3.1%. The duration of professional practice was generally less than five years among most participants, and more than 90% of the participants had work experience of less than five years, with 36.4% having an experience of less than one year.

 

Table 1: Summary of Demographic Characteristics of Respondents (n=232)

Demographic Parameter

Category

n

%

Age Group

Below 25 years

128

55.2

 

25–35 years

71

30.6

 

36–45 years

31

13.4

 

Above 45 years

2

0.9

Gender

Male

134

57.8

 

Female

98

42.2

Qualification

B. Pharm

173

75.5

 

D. Pharm

41

17.9

 

M. Pharm

7

3.1

 

Others

11

3.5

Experience

< 1 year

84

36.4

 

1–5 years

126

54.5

 

6–10 years

15

6.5

 

> 10 years

6

2.6

Pharmacy Type

Independent

108

47.0

 

Hospital-attached

86

37.4

 

Chain Pharmacy

36

15.7

 

Awareness and Knowledge of Pharmaceutical Waste:

On the whole, the survey highlighted a reasonable level of knowledge of pharmaceutical waste among participants. As high as 94.4% were aware of the concept of pharmaceutical waste, indicating comprehensive knowledge of the subject matter. In addition to this, 84.4% were also able to name four types of pharmaceutical waste, including expired, unused, broken, and contaminated medicines. Furthermore, an 87.5% were informed that the improper disposal of pharmaceutical waste could be harmful for the environment and public health.

Knowledge of BMW guidelines among pharmacy staff remained lower, nonetheless. Even though 77.6% knew the BMW rules completely, another 14.7% had only partial knowledge about them while 7.8% did not know them at all. The results point to the fact that many employees at pharmacies are unaware of legal requirements for proper pharmaceutical waste disposal. Indian surveys conducted in the past have also found that community pharmacists have reasonable levels of awareness but little knowledge of the legal issues associated with waste management.

 

Table 2: Awareness and Knowledge of Pharmaceutical Waste among Respondents

Awareness Parameter

Response

n

%

Term 'Pharmaceutical Waste'

Yes

218

94.4

 

No

13

5.6

Waste Categories (comprehensive)

All categories

195

84.4

 

Partial knowledge

36

15.6

Environmental Harm Awareness

Yes

203

87.5

 

No

23

9.9

 

Not sure

6

2.6

BMW Rules Knowledge

Fully aware

180

77.6

 

Partially aware

34

14.7

 

Not aware

18

7.8

Significant Waste Generation

Yes

193

83.2

 

No/Not sure

39

16.8

 

Disposal Practices:

According to the study results, 79.7% of respondents said that their pharmacies disposed of different types of pharmaceutical wastes. Among those who dispose of expired medicines, slightly more than half—53.9%, use incineration facilities provided by the relevant bodies, which is considered a secure and legal way. The other 32.2% returned such expired medicines to the producers and/or distributors.

However, there were examples of the improper handling of medicine waste. About 8.3% of respondents disposed of expired medications along with other solid municipal waste. An additional 5.7% disposed of medicines in toilets and sinks. These two practices are responsible for nearly 14% of total disposal of medicine waste. There is a precedent for the mentioned figures, which has already been established in researches by Bhandari and Bhosle and by Bound and Voulvoulis.

When it comes to waste segregation, the majority of respondents—or about two thirds—of respondents segregate waste, separating pharmaceutical from general waste. On the contrary, about 29.3% of respondents segregate waste occasionally while 3.9% do not segregate waste at all. This means that around one third of pharmacies did not comply with the existing guidelines on biomedical waste management.The findings also revealed that 92.6% of pharmacies used dedicated waste containers, and 90.4% maintained records related to waste disposal activities.

 

Table 3: Pharmaceutical Waste Disposal Practices of Respondents

Disposal Parameter

Response

n

%

Disposal Method – Expired Medicines

Incineration (authorised agency)

124

53.9

 

Return to distributor/company

74

32.2

 

Municipal garbage

19

8.3

 

Flush into drain/toilet

13

5.7

Segregation Frequency

Always

155

66.8

 

Sometimes

68

29.3

 

Never

9

3.9

Separate Containers Used

Yes

214

92.6

 

No

17

7.4

Disposal Records Maintained

Yes

208

90.4

 

No

22

9.6

 

Professional Attitudes:

Generally, most respondents exhibited professional attitudes when handling pharmaceutical waste disposal. For instance, 95.6% of respondents were aware that proper disposal of pharmaceutical waste was a professional responsibility. 76.6% strongly agreed with this notion, while 19.0% agreed. The attitudes toward medicine take-back programs among pharmacists were relatively positive, too. More precisely, 84.0% were willing to engage in such programs, whereas 92.2% expressed their willingness to do so or had a chance of doing so. Besides, 89.6% of respondents felt that proper training would enhance their attitudes regarding proper waste disposal. It can be seen that pharmacists were willing to be motivated toward improved pharmaceutical waste management

Training Exposure and Information Sources:

In general, it is clear from the study that almost 85% of respondents have undergone training on some aspects of pharmaceutical waste management. However, about 15% of respondents had no experience of being trained in this regard. In addition, government guidelines became the major source of information for nearly half (45.7%) of respondents. Another quarter (26.3%) gained their awareness through the sensitization process in their academic studies. Only 19.4% obtained information from continuing professional education programs. About 8.6% learned about pharmaceutical waste management through self-study.

Challenges and Regulatory Perceptions:

Without any doubt, the absence of knowledge became the leading barrier among all others for all respondents in the study, which accounted for 80.5%. In addition, other barriers were associated with inadequate facilities for waste disposal (10.4%), weak regulation and support from authorities (5.2%), and financial constraints (3.9%). Almost 92.2% of respondents recommended increased regulation of waste disposal in community pharmacies.

 

Table 4: Attitudes, Training Exposure, and Challenges Among Respondents

Parameter

Response

n

%

Professional Responsibility

Strongly Agree

177

76.6

 

Agree

44

19.0

 

Neutral

10

4.3

Willingness – Take-Back Programmes

Yes

194

84.0

 

Maybe

19

8.2

 

No

18

7.8

Training Impact Belief

Yes

206

89.6

 

Not sure

15

6.5

 

No

9

3.9

Formal Training Received

Yes

196

84.8

 

No

35

15.2

Primary Challenge

Lack of awareness

186

80.5

 

Lack of facilities

24

10.4

 

Lack of regulatory support

12

5.2

 

Cost issues

9

3.9

Need for Stricter Regulations

Yes

213

92.2

 

No / Not sure

18

7.8

 

CONCLUSION

The cross-sectional design was employed to analyze the handling of pharmaceutical waste by community pharmacists and their perception of environmental hazards. The results reveal that while there is moderate awareness regarding pharmaceutical waste and its environmental impact, proper segregation of pharmaceutical waste does not always reflect that awareness level.

Professional attitude was optimistic among most survey respondents, who were willing to take part in activities such as drug disposal campaigns and training on drug management. This willingness is reflected in their responses. However, some undesirable behaviors still occurred. For example, some respondents admitted that they dispose of drugs in municipal garbage (8.3%) or drainage channels (5.7%). In addition, most participants reported lacking any professional training in pharmaceutical waste management.

A majority of the respondents favored stiffer policies and were willing to adapt more effective waste management practices. Therefore, it can be inferred that such a strategy might be appreciated by the pharmacy industry. Some strategies that could work include continuous professional training for pharmacists, drug take-back program in pharmacies, regulation and proper documentation. Such efforts when implemented together would definitely help in improving the situation.

REFERENCES

  1. Azad MAK, Alam MS, Hossain S, et al. Awareness and practices of pharmaceutical waste disposal among community pharmacists in Pakistan: a cross-sectional survey. J Pharm Pract Community Med. 2020; 6(3): 45-51.
  2. Bhandari VN, Bhosle DK. Assessment of pharmaceutical waste disposal practices in a metropolitan community: implications for public health. Indian J Environ Health. 2018; 60(1): 78-85.
  3. Bound JP, Voulvoulis N. Household disposal of pharmaceuticals as a pathway for aquatic contamination in the United Kingdom. Environ Health Perspect. 2005; 113(12): 1705-1711.
  4. Central Pollution Control Board (CPCB). Annual Report on Biomedical Waste Generation and Management. Ministry of Environment, Forest and Climate Change, Government of India; 2019.
  5. Coma Redon A, Figueras A, Vallano A, et al. Pharmaceutical waste collection and disposal practices in community pharmacies: the SIGRE experience in Spain. Pharm Pract. 2009; 7(4): 175-181.
  6. Daughton CG, Ternes TA. Pharmaceuticals and personal care products in the environment: agents of subtle change? Environ Health Perspect. 1999; 107(Suppl 6): 907-938.
  7. Dhaneria V, Shende VS, Mathur A, Patidar A. A study of antibiotic prescribing pattern and wastage in a tertiary care hospital in Rajasthan, India. J Clin Diagn Res. 2016; 10(4): FC01-FC04.
  8. Government of India. Biomedical Waste Management Rules, 2016 (as amended 2018). Ministry of Environment, Forest and Climate Change; 2016.
  9. Government of India. Drugs and Cosmetics Act, 1940, and Rules thereunder (Schedule M). Central Drugs Standard Control Organisation, Ministry of Health and Family Welfare; 2005.
  10. Kotchen M, Kallaos J, Wheeler K, et al. Pharmaceuticals in wastewater: behavior, effects, and treatment. Environ Sci Technol. 2009; 43(4): 955-960.
  11. Kümmerer K. Antibiotics in the aquatic environment — a review — Part I. Chemosphere. 2009; 75(4): 417-434.
  12. Mweshi BJ, Ngandu A, Mukosha M, et al. Healthcare worker awareness and practices in pharmaceutical waste management in community-level facilities: a Zambian perspective. Health Policy Plan. 2021; 36(7): 1124-1132.
  13. Patel DK, Shah AN. Evaluation of pharmaceutical waste management practices among community pharmacies in Gujarat, India. Int J Res Pharm Sci. 2022; 13(2): 1145-1153.
  14. Ruhoy IS, Daughton CG. Beyond the medicine cabinet: an analysis of where and why medications accumulate. Environ Int. 2008; 34(8): 1157-1169.
  15. Sharma N, Tyagi S, Bhardwaj A. Compliance of community pharmacies with biomedical waste management rules in Delhi, India. Indian J Pharm Pract. 2019; 12(3): 172-178.
  16. Singh PK, Nair PP. Pharmaceutical waste management practices in hospital pharmacies: evidence from southern India. Asian J Pharm Clin Res. 2020; 13(5): 88-93.
  17. Tong AYC, Peake BM, Braund R. Disposal practices for unused medications around the world. Environ Int. 2011; 37(1): 292-298.
  18. World Health Organization. Safe Management of Wastes from Health-Care Activities. 2nd ed. Geneva: WHO Press; 2014.
  19. World Health Organization. Guidelines on Pharmaceutical Waste Management. WHO Technical Report Series No. 937. Geneva; 2007.
  20. World Health Organization. Pharmaceuticals in Drinking-Water. WHO/HSE/WSH/11.05. Geneva; 2011.
  21. Auta A, Banwat SB, Sariem CN, et al. Knowledge and disposal behaviour related to unused medicines among healthcare students in a developing setting. J Appl Pharm Sci. 2019; 9(3): 093-098.
  22. Kusturica MP, Sabo A, Tomic Z, et al. Storage and disposal patterns of unused medications among households: a systematic overview. Waste Manag. 2017; 60: 58-71.
  23. Alnahas F, Yeboah P, Fliedel L, et al. Expired medication management practices in community pharmacies: regulatory gaps and environmental concerns. Res Social Adm Pharm. 2020; 16(8): 1097-1103.
  24. Boxall ABA. Environmental exposure to pharmaceuticals: global challenges and future perspectives. Chemosphere. 2004; 56(11): 1133-1144.
  25. Fent K, Weston AA, Caminada D. Ecotoxicological impact of pharmaceuticals in aquatic organisms: a critical review. Aquat Toxicol. 2006; 76(2): 122-159.
  26. aus der Beek T, Weber FA, Bergmann A, et al. Occurrence and fate of pharmaceuticals in the environment: a global review. Environ Toxicol Chem. 2016; 35(4): 823-835.
  27. OECD. Pharmaceutical Residues in Freshwater: Hazards and Policy Responses. Paris: OECD; 2019.
  28. Larsson DGJ. Pollution from drug manufacturing: review of environmental risks and regulatory needs. Philos Trans R Soc Lond B Biol Sci. 2014; 369(1656): 20130571.

Reference

  1. Azad MAK, Alam MS, Hossain S, et al. Awareness and practices of pharmaceutical waste disposal among community pharmacists in Pakistan: a cross-sectional survey. J Pharm Pract Community Med. 2020; 6(3): 45-51.
  2. Bhandari VN, Bhosle DK. Assessment of pharmaceutical waste disposal practices in a metropolitan community: implications for public health. Indian J Environ Health. 2018; 60(1): 78-85.
  3. Bound JP, Voulvoulis N. Household disposal of pharmaceuticals as a pathway for aquatic contamination in the United Kingdom. Environ Health Perspect. 2005; 113(12): 1705-1711.
  4. Central Pollution Control Board (CPCB). Annual Report on Biomedical Waste Generation and Management. Ministry of Environment, Forest and Climate Change, Government of India; 2019.
  5. Coma Redon A, Figueras A, Vallano A, et al. Pharmaceutical waste collection and disposal practices in community pharmacies: the SIGRE experience in Spain. Pharm Pract. 2009; 7(4): 175-181.
  6. Daughton CG, Ternes TA. Pharmaceuticals and personal care products in the environment: agents of subtle change? Environ Health Perspect. 1999; 107(Suppl 6): 907-938.
  7. Dhaneria V, Shende VS, Mathur A, Patidar A. A study of antibiotic prescribing pattern and wastage in a tertiary care hospital in Rajasthan, India. J Clin Diagn Res. 2016; 10(4): FC01-FC04.
  8. Government of India. Biomedical Waste Management Rules, 2016 (as amended 2018). Ministry of Environment, Forest and Climate Change; 2016.
  9. Government of India. Drugs and Cosmetics Act, 1940, and Rules thereunder (Schedule M). Central Drugs Standard Control Organisation, Ministry of Health and Family Welfare; 2005.
  10. Kotchen M, Kallaos J, Wheeler K, et al. Pharmaceuticals in wastewater: behavior, effects, and treatment. Environ Sci Technol. 2009; 43(4): 955-960.
  11. Kümmerer K. Antibiotics in the aquatic environment — a review — Part I. Chemosphere. 2009; 75(4): 417-434.
  12. Mweshi BJ, Ngandu A, Mukosha M, et al. Healthcare worker awareness and practices in pharmaceutical waste management in community-level facilities: a Zambian perspective. Health Policy Plan. 2021; 36(7): 1124-1132.
  13. Patel DK, Shah AN. Evaluation of pharmaceutical waste management practices among community pharmacies in Gujarat, India. Int J Res Pharm Sci. 2022; 13(2): 1145-1153.
  14. Ruhoy IS, Daughton CG. Beyond the medicine cabinet: an analysis of where and why medications accumulate. Environ Int. 2008; 34(8): 1157-1169.
  15. Sharma N, Tyagi S, Bhardwaj A. Compliance of community pharmacies with biomedical waste management rules in Delhi, India. Indian J Pharm Pract. 2019; 12(3): 172-178.
  16. Singh PK, Nair PP. Pharmaceutical waste management practices in hospital pharmacies: evidence from southern India. Asian J Pharm Clin Res. 2020; 13(5): 88-93.
  17. Tong AYC, Peake BM, Braund R. Disposal practices for unused medications around the world. Environ Int. 2011; 37(1): 292-298.
  18. World Health Organization. Safe Management of Wastes from Health-Care Activities. 2nd ed. Geneva: WHO Press; 2014.
  19. World Health Organization. Guidelines on Pharmaceutical Waste Management. WHO Technical Report Series No. 937. Geneva; 2007.
  20. World Health Organization. Pharmaceuticals in Drinking-Water. WHO/HSE/WSH/11.05. Geneva; 2011.
  21. Auta A, Banwat SB, Sariem CN, et al. Knowledge and disposal behaviour related to unused medicines among healthcare students in a developing setting. J Appl Pharm Sci. 2019; 9(3): 093-098.
  22. Kusturica MP, Sabo A, Tomic Z, et al. Storage and disposal patterns of unused medications among households: a systematic overview. Waste Manag. 2017; 60: 58-71.
  23. Alnahas F, Yeboah P, Fliedel L, et al. Expired medication management practices in community pharmacies: regulatory gaps and environmental concerns. Res Social Adm Pharm. 2020; 16(8): 1097-1103.
  24. Boxall ABA. Environmental exposure to pharmaceuticals: global challenges and future perspectives. Chemosphere. 2004; 56(11): 1133-1144.
  25. Fent K, Weston AA, Caminada D. Ecotoxicological impact of pharmaceuticals in aquatic organisms: a critical review. Aquat Toxicol. 2006; 76(2): 122-159.
  26. aus der Beek T, Weber FA, Bergmann A, et al. Occurrence and fate of pharmaceuticals in the environment: a global review. Environ Toxicol Chem. 2016; 35(4): 823-835.
  27. OECD. Pharmaceutical Residues in Freshwater: Hazards and Policy Responses. Paris: OECD; 2019.
  28. Larsson DGJ. Pollution from drug manufacturing: review of environmental risks and regulatory needs. Philos Trans R Soc Lond B Biol Sci. 2014; 369(1656): 20130571.

Photo
S. Morey
Corresponding author

Department Of Pharmacy, Dr. D. Y. Patil College Of Pharmacy, Akurdi, Pune, India

Photo
P. Mulay
Co-author

Department Of Pharmacy, Dr. D. Y. Patil College Of Pharmacy, Akurdi, Pune, India

S. Morey, P. Mulay, Evaluation Of Pharmaceutical Waste Management Practices and Environmental Risk Perception Among Community Pharmacies, Int. J. of Pharm. Sci., 2026, Vol 4, Issue 5, 540-547, https://doi.org/10.5281/zenodo.20021176

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