On September 8, 1994, the Bureau of Food and Drugs (now the Food and Drug Administration) had issued Memorandum Circular No. 22 (Subject: Inventory, Proper Disposal and/or Destruction of Used Vials or Bottles) requesting the "conduct of a periodic inventory, proper disposal or destruction of used vials or bottles" by all concerned entities due to the "proliferation of adulterated, misbranded or counterfeit drugs" in the Philippines.
This was one of the measures taken by the Bureau to address the reports which reveal "that some unscrupulous persons are recycling used vials or bottles and fill it up with substances totally different in strength, quality, purity or potency from that previously contained in it."
On July 6, 1999, the Bureau of Food and Drugs amended BFAD Memorandum Circular No. 22 series of 1994 by the issuance of Bureau Circular No. 16 which defined "the responsibility of the Chief Pharmacists of government and private hospitals to conduct at least, a semestral inventory of the proper disposal and destruction of used vials or bottles, and to submit same to the Bureau within five (5) days fromt the date of inventory." The circular also directed the nurse administering the drugs to "be under strict instructions to return all empty vials to the hospital pharmacy for destruction on a quarterly basis" and that "all inventories and/or destruction shall be done under the supervision of a duly authorized representative of BFAD."
One of the accreditation standards of PhilHealth for health provider organizations (i.e. code 6.5.1.x.1) requires "the handling, collection, and disposal of waste [that] conform to relevant statutory requirements and codes of practice" and states the "presence of license/permits/clearances from pertinent regulatory agencies implementing among others the following: RA 9003, RA 6969, RA 9275, PD 1586, DOH Hospital waste management manual, RA 8749 (Clean Air Act)", as its core indicator.
This standard is consistent with the provision of the Joint DENR-DOH Administrative Order No. 02 series of 2005 (Subject: Policies and Guidelines on effective and proper handling, collection, transport, treatment, storage and disposal of health care wastes) which was also communicated, among others, to the president of the Philippine Health Insurance Corporation and directors of Bureaus under the Department of Health through the issuance of DOH Memorandum Circular No. 2005-0070.
The joint administrative order stipulates that the Department of Environment and Natural Resources-Environmental Management Bureau (DENR-EMB) "shall be the primary government agency responsible for implementing pertinent rules and regulations on the management of health care waste in the Philippines, particulary concerning the issuance of necessary permits and clearances for th Transport, Treatment, Storage, and Disposal of such wastes, as governed by RA 6969, RA 9275, RA 9003 and PD 1585." It also specifies that the "handling, collection, storage and transport of health care wastes shall be in accordance with the provisions of RA 8749, RA 6969, and RA 9003, and the DOH Health Care Waste Management Manual (Chapter 5)."
According to the DOH Health Care Waste Management Manual (2004), pharmaceutical waste "includes expired, unused, spilt, and contaminated pharmaceutical products, drugs, vaccines, and sera that are no longer required and need to be disposed of appropriately. This category also includes discarded items used in handling of pharmaceuticals such as bottles or boxes with residues, gloves, masks, connecting tubing and drug vials."
In this context, Chapter 5 of the Manual specifies that only "large quantities of obsolete or expired pharmaceuticals stored in hospital wards or departments should be returned to the pharmacy for disposal. Other pharmaceutical waste generated at this level, such as expired drugs or packaging containing drug residues should not be returned because of the risk of contaminating the pharmacy. It should be deposited in the specified container at the point of generation." It also states that "health care waste collection practices should be designed to achieve an efficient movement of waste from points of generation to storage or treatment while minimizing the risk to personnel."
Further, DENR Administrative Order No. 36 series of 2004, now requires waste generators to comply with the Waste Transport Record or Manifest System which include the declaration of the class, subclassification, and quantity of each hazardous waste, before it is allowed to store, recycle, reprocess, treat or dispose of hazardous waste at a facility outside its premises by contracting a DENR-accredited waste transporter and treater.
Therefore, policies and procedures on handling, collection, storage, transport and disposal of used pharmaceutical vials or bottles has to be aligned with the current regulatory and accreditation requirements. Ther repealing clause of the Joint DENR-DOH Administrative Order No. 02 series of 2005 which states that "all other issuances whose provisions of DENR and DOH Administrative Order, Memorandum Circulars or other issuances inconsistent [with it] are... repealed or modified accordingly", should also be considered.
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