MEDICINES CONTROL AGENCY. Guideline for Safe Disposal of Medicines and Related Products

Transcription

1 MEDICINES CONTROL AGENCY Guideline for Safe Disposal of Medicines and Related Products

2 FORWARD The Medicines Control Agency (MCA) established by an Act of Parliament and assented to on 24th December 2014 is mandated to regulate the manufacture, import, wholesale, storage, distribution and supply of medicines and related products, and to ensure that all medicines and related products sold and used in the country conform to the required standards of quality, safety and efficacy throughout the product lifecycle in The Gambia. In pursuance of the Medicines and Related Products Act 2014, Part VIII, MISCELLANEOUS, Section 64 Guidelines herein quoted the Agency may publish guidelines in connection with matters provided for under this Act for the purpose of giving guidance, the MCA deems it very essential to develop written Guidelines and Standard Operating Procedures (SOPs) to guide the implementation of the various regulatory functions of MCA in ensuring the safety, efficacy and quality of medicines and related products available to the population. Page 2 of 12

3 ACKNOWLEDGEMENTS The Medicines Control Agency (MCA) wishes to thank the Ministry of Health and Social Welfare, members of the MCA Board and the various institutions for their support. Special thanks is extended to the Global Fund through Action Aid International The Gambia (AAITG) for their financial support in the development of the Quality Assurance Policy and Plan, some regulatory guidelines and SOPs for use by MCA and its stakeholders.. Special thanks is extended to the Technical Working Group and staff of the Medicines Control Agency for their commitment and technical input in the development of this guideline. Gratitude is extended to key stakeholders including the Directorate of National Pharmaceutical Services, Pharmacy Council, Medical and Dental Association, Pharmaceutical Society of The Gambia, Nurses and Midwives Council, Regional Health Directorates, National Aids and TB Control Programs, National Public Health Laboratory Services and Gambia Standards Bureau for their valuable contributions and participation in the validation of the Quality Assurance Plan, which will ensure that all medicines and related products are of the required quality for their intended use. Page 3 of 12

4 Table of Contents 1. List of Abbreviations and Acronyms 5 2. Introduction 5 3. Purpose and Scope 5 4. Prerequisites for Disposal Steps to be taken Consequences of improper disposal or non-disposal 7 5. Disposal Methods Return to donor or manufacturer High temperature incineration Engineered landfill 9 6. Inappropriate Disposal Methods Open landfill Burning in open containers 9 7. Final Provisions 9 8. References 9 9. Document History Definition of Terms 10 Page 4 of 12

5 1. LIST OF ABBREVIATIONS AND ACRONYMS MCA MoHSW NGO WHO Medicines Control Agency Ministry of Health & Social Welfare Nongovernmental Organisation World Health Organization 2. INTRODUCTION 2.1. Medicines and related products play an important role in treating many conditions and diseases and when they are no longer needed it is important to dispose of them properly to help reduce harm from accidental exposure or intentional misuse Information on disposal of medicines and related products must be carefully handled as it may be politicised and sensationalised, especially when the products were donated. If the public and media are not kept judiciously informed of the efforts to dispose of expired medicines and related products safely, the disposal work may be severely hampered by misinformation propagated by uninformed journalists and politicians. Good public relations including comprehensive dissemination of information to stakeholders is therefore an important element in achieving satisfactory safe disposal The Medicine Control Agency (MCA) is mandated to prescribe standards of quality in respect of medicines and related products This guideline is based on the National Medicines Policy (2007). 3. PURPOSE AND SCOPE 3.1. This guideline provides advice on the safe disposal of unusable medicines and related products, where applicable Methods for safe disposal are described, which involve minimal risks to public health and the environment This guideline does not cover the disposal of other wastes generated by health facilities including for example, infectious waste, photographic chemicals, solvents, wastes with a high content of heavy metals (e.g. mercury and cadmium), laboratory wastes, or radioactive wastespecialized advice for these categories of waste is available from World Health Organization (WHO) This guideline applies to the central medical store and regional medical stores management as well as manufacturer/importers, wholesalers, retailers and health facilities (public, private and NGO) The guideline covers all medicines and related products, where applicable as defined in the Medicines and Related Products Act, In the following text, the term medicine will only be used, but the guidance may also apply to related products. Page 5 of 12

6 4. PREREQUISITES FOR DISPOSAL 4.1 Steps to be taken A series of steps need to be taken when disposing of unwanted medicines, and these are briefly summarized below. Decision: The authorised person of the respective facility (central medical store and regional medical stores management as well as manufacturer/importers, wholesalers, retailers and health facilities (public, private and NGO)) decides when action needs to be initiated Medicines that should never be used and should always be considered as medicines waste are: all expired medicines; all unsealed syrups or eye drops (expired or unexpired); all cold chain damaged unexpired medicines that should have been stored in a cold chain but were not (for example: insulin, polypeptide hormones, gamma globulins and vaccines); all bulk or loose tablets and capsules. If unexpired these should only be used when the container is still sealed, properly labelled or still within the original unbroken blister packs; all unsealed tubes of creams, ointments, etc. (expired or unexpired). Approval: Approval of disposal of medicines must be sought from the MCA, who will provide an approval letter for confirmation. Planning: Planning in terms of funding, necessary expertise, human resources, professional time, space, equipment, material and available disposal options will be required. This is essential before practical steps can be taken to start disposal To obtain a rough estimate of the volume of materials to be disposed of, it is recommended that measurements are made using a tape measure, and conversion from volume of material to weight is made using a density figure of 0.2 metric tons/cubic metre The costs of safe disposal in the public sector are covered by the Ministry of Health & Social Welfare (MoHSW); in the private sector/ngos the costs are to be covered by their management. Forming work teams: In the public sector work should be conducted by teams identified by the Directorate of Pharmaceutical Services. The size of each team and the ratio of experts to workers will be determined by the volume and composition of the stockpiles and working conditions at the sites. In the private sector/ngo a pharmacist or appropriate pharmaceutical personnel should conduct the disposal of medicines. Page 6 of 12

7 Preparation: Unusable medicines should be removed from the shelves, packed in boxes, sealed and labelled Expired Products or Unusable Products and stored at a separate location within the warehouse. Appropriate storage and transportation requirements apply also to unusable medicines (see MCA Guideline for Storage and Distribution of Medicines and Related Products) Health and safety of work teams: All workers should wear appropriate protective equipment including overalls and boots at all times, and gloves, masks and caps when appropriate. Masks should be worn when tablets or capsules are being crushed as part of the disposal technique and when there is a risk of powders being liberated. Particular care is required when handling antineoplastics (cytotoxic-anti-cancer medicines). Disposal: Medicines are ideally disposed of by high temperature (i.e. above 1,200ºC) incineration. Other disposal methods can be used when incineration is not feasible The disposal procedure must be witnessed by MCA Secondary packaging should be disposed of as non-medicine, nonchemical materials. Security: Controlled substances (e.g. narcotics and psychotropics) require tight security and control (see MCA Guideline for Storage and Distribution of Medicines and Related Products) Scavenging of material from landfills is a frequent problem, and disposed medicines may be recovered and sold by the scavengers. Measures are therefore necessary to prevent diversion during preparation for disposal, and pilfering of medicines from landfills. 4.2 Consequences of improper disposal or non-disposal In general, expired medicines do not represent a serious threat to public health or to the environment Improper disposal may be hazardous if it leads to contamination of water supplies or local sources used by nearby communities or wildlife Expired products may come into the hands of scavengers and children if a landfill is insecure Pilfering from a stockpile of waste medicines or during preparation may result in expired products being diverted to the market for resale and misuse. Most medicines past their expiry date become less efficacious and a few may develop a different adverse drug reaction profile There are some categories of expired medicines or defective disposal practices that carry a public health risk. The main health risks are summarized below. Page 7 of 12

8 Contamination of drinking water must be avoided. Landfills must be sited and constructed in a way that minimizes the possibility of leachate entering an aquifer, surface water or drinking water system. Non-biodegradable antibiotics, antineoplastics and disinfectants should not be disposed of into the sewage system as they may kill bacteria necessary for the treatment of sewage. Antineoplastics should not be flushed into watercourses as they may damage aquatic life or contaminate drinking water. Similarly, disinfectants should not be discharged into a sewerage system or watercourse. Burning medicines at low temperatures or in open containers results in release of toxic pollutants into the air and should be avoided. Inefficient and insecure disposal of these unusable medicines may cause scavengers to have access to these products and be diverted for resale to the general public. In the absence of suitable disposal sites and qualified personnel to supervise disposal, unwanted medicines should be securely stored in dry conditions. If stored in their original packing there is a risk of diversion and to avoid this they are best stored in sealed containers until safe disposal is feasible. 5. DISPOSAL METHODS Large stockpiles do not usually accumulate, and waste medicines are best disposed of on a routine basis, small quantities at a time. The disposal methods are briefly described here. 5.1 Return to donor or manufacturer Wherever practical the possibility of returning unusable medicines for safe disposal by the manufacturer should be explored; particularly medicines which present disposal problems, such as antineoplastics. For unwanted, unrequested donations, especially those that arrive past or unreasonably near their expiry date it may be possible to return them to the donor for disposal Expired or spoiled medicines are categorised as wastes to be controlled and may be considered as hazardous waste. As such, if transferred across frontiers, they become subject to the Basel Convention on the Transfrontier Shipment of Hazardous Wastes. This involves prescribed procedures to obtain permission to cross international borders along the transit route prior to actual transport, which can take several months to complete. 5.2 High temperature incineration High temperature technology have furnaces that operate at temperatures well in excess of 850 C, have long combustion retention times and disperse exhaust gases via tall chimneys to high altitudes In The Gambia the high temperature incinerators are the property of the MoHSW located at Kotu and in the Regional Health Directorates. Page 8 of 12

9 It may be necessary to remove packaging and/or to grind the medicines to avoid clogging and blockage of the fuel feed mechanisms. 5.3 Engineered landfill To landfill means to place waste directly into a land disposal site. Landfill is the oldest and the most widely practiced method of disposing of solid waste An appropriate (engineered) landfill consists of an evacuated pit isolated from watercourses and above the water table An engineered landfill has some features to protect from loss of chemicals into the aquifer. Properly constructed and operated landfill sites offer a relatively safe disposal route. 6. INAPPROPRIATE DISPOSAL METHODS Note: Disposal by inappropriate methods can be hazardous and may lead to prosecution. 6.1 Open landfill Untreated waste discharged into an uncontrolled, non-engineered open dump does not protect the local environment and should not be used. Discarding of untreated waste medicines into such a site is not recommended Discarding medicines in open, uncontrolled dumps with insufficient isolation from the aquifer or other watercourses can lead to pollution, with the risk of drinking water contamination in the worst cases. 6.2 Burning in open containers Medicines should not be destroyed by burning at low temperature in open containers, as toxic pollutants may be released into the air. 7. FINAL PROVISIONS 7.1. This guideline is the first version published by the MCA This guideline will become effective on 01 January The guideline will be reviewed before 2 years after becoming effective. 8. REFERENCES Medicines and Related Products Act, 2014 The Gambia National Medicines Policy, 2007 MCA Guideline for Storage and Distribution of Medicines and Related Products, 2017 MCA Guideline for Dispensing of Medicines, 2017 WHO Good Distribution Practices for Pharmaceutical Products, Annex 5, WHO Technical Report Series 957, 2010 WHO Guide to Good Storage Practices for Pharmaceuticals Annex 9, WHO Technical Report Series, No. 908, 2003 Page 9 of 12

10 Secretariat of the Basel Convention No. 97/012. Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal, 1998 and Decisions Adopted by the First (1992), Second (1994) and Third (1995) Meetings of the Conferences of the Parties (September 1997). 9. DOCUMENT HISTORY Version No Issue Date Reasons for Change Dec 17 New document 10. DEFINITION OF TERMS The definitions provided below apply to the words and phrases used in the MCA guidelines. Although an effort has been made to use standard definitions as far as possible, minor alterations have been made in some cases. Adverse drug reaction: A noxious and unintended response to a medicine Bulk product: Any product which has completed all processing stages up to, but not including, final packaging Container The material employed in the packaging of a medicine; containers include primary, secondary and transportation containers Distribution The holding, storing, selling, supplying, importing, exporting, or movement of medicines or related products, with the exception of the dispensing or providing medicines directly to a patient or his/her caregiver Expiry Date: The date given on the individual container (usually on the label) of the medicine or related product up to and including the date on which the product is expected to remain within specifications, if stored correctly; it is established for each batch by adding the shelf life to the date of manufacture and is determined by using stability studies Good Distribution Practice (GDP): A code of standard practices ensuring that the quality of a medicine or related product is maintained throughout the distribution network so that authorised medicines or related products are distributed to retail pharmacies and others selling medicines to the general public without any alteration of their properties Page 10 of 12

11 Good Storage Practice (GSP): A code of standard practices that ensures that the quality of medicines and related products is maintained by means of adequate control throughout the storage thereof Guideline: A document providing guidance on the scientific or regulatory aspects of medicines; MCA expects that justification is provided for any deviations and is approved by MCA Importation: The act of bringing or causing any goods to be brought into a customs territory (national territory, excluding any free zone) Labelling: Information on the primary or secondary packaging of a medicine Manufacture: Includes the operations involved in the production, preparation, processing, refining, transformation, packaging, re-packaging and labelling of medicines or related products Manufacturer: A company or entity that carries out operations such as production, packaging, repackaging, labelling and relabelling of medicines or related products Medicine: A substance or mixture of substances prepared, sold or represented for use in the diagnosis, treatment, mitigation or prevention of disease, disorder of abnormal physical state or the symptoms of it, in man or animal, restoring, correcting or modifying organic functions in man or animal, including nutritional supplements or herbal medicines Packaging (or Packing): All operations, including filling and labelling, which a bulk product has to undergo in order to become a finished product Pharmacist: A pharmacist registered under the Pharmacy Council Act 2014, holding a current certificate of registration Primary container/packaging (or Immediate packaging): Container that is in direct contact with the product Product: Refers to a medicine and/or a related product Professional: The person responsible for supervising the dispensing, preparation, sale or supply of medicines and related products in approved pharmacy premises Page 11 of 12

12 Related product: An article other than medicine which includes cosmetics, homeopathic medicines, medical device, instrument or apparatus including, components, parts and accessories of it, manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptom of it in man or animal Secondary container/packaging (or Outer packaging): Container that is not in direct contact with the medicine Storage: The storing of medicines and related products from manufacturing up to their point of use Page 12 of 12