a. The Pharmacy Services Programme under the Ministry of Health Malaysia (Ministry) is responsible in ensuring that public gets access to safe, efficacious and quality pharmaceutical products. It also protects their interest by means of enforcing relevant legislations and ensuring appropriate usage on medicines by both healthcare providers and patients. The Pharmaceutical Services Division [Bahagian Perkhidmatan Farmasi (BPF)] is attached at various level namely the Ministry, State Health Departments [Jabatan Kesihatan Negeri (JKN)], State Pharmacy Logistic Affairs Branches [Cawangan Farmasi Logistik Negeri (CFLN)], District Health Offices [Pejabat Kesihatan Daerah (PKD)], hospitals and health clinics [Klinik Kesihatan (KK)]. BPF is responsible for carrying out functions of managing stores and handling technical aspects including specifications as well as product evaluation in contract preparation. This is to ensure the procurement is being managed economically and properly without compromising the quality of medication and nonmedication substances; in line with financial and Government procurement procedures. In addition, adequate stock levels are always made available and customers‟ needs are fulfilled. The procurement of medicines is carried out through an Approved Price Product List (APPL) concession agreement and 54 contracts by the Ministry. Moreover, the procurement within JKN/CFLN/PKD levels were also being made either through an open tender, quotations or direct purchase in accordance with its limit of authority. Every procurement arrangement such as invitations, appointment of suppliers and issuance of Letter of Acceptance (LoA) were carried out by the procurement division/unit in their respective Responsibility Centres [Pusat Tanggungjawab (PTJ)]. Meanwhile, the specification preparation and suppliers evaluation were conducted together with BPF/CFLN. Such pharmaceutical services between KK type 1 to 4 compared with KK type 5 and 6 were provided differently. All types of KK provide basic services such as dispensing, counseling and store management. Whereas, additional services provided by KK type 1 to 4 are Medication Adherence Clinic Therapy (MTAC), Value Added Services (VAC), Medication Safety (MER) and Adverse Drug Reaction (ADR).
b. Audit conducted between August to November 2015 revealed that the management of medicine supplies in KK was generally satisfactory and it has also achieved its objectives in which medicine supplies were orderly and efficiently distributed. The allocation for the supply of medicines was spent accordingly and the KPI achievement of stockholding was good in all CFLN/PKD visited. The organisation structure at headquarters, states, districts and KKs have clearly defined its segregation of duties and responsibilities in the 55 management of medicines. On top of that, the Ministry had also enacted several laws and regulations in order to manage a systematic procurement and supply of medicines. A small percentage of vacant post in CFLN/PKD/KK will not affect its whole operation management. However, there were some weaknesses that need to be addressed as follows:
i. 5 (11.1%) out of 45 medicine procurement contracts which were made through tender/quotations worth RM1.56 million was not bound by a formal contract but instead was only guided by LoA. In addition, 31 (68.9%) LoAs for procurement contracts audited at JKN, PKD and CFLN were signed after contract commencement date between 6 to 34 days;
ii. penalty claims due to medicines‟ late delivery under APPL and the Ministry‟s procurement contract were still pending and there was no penalty clauses provided in the event of a late delivery on medicine supplies made through direct purchases;
iii. acceptance of medicines in 6 locations were not verified at 100% capacity and the medicines‟ stock layout in CFLN/PKD/KK‟s pharmacy store did not comply with the stipulated procedures;
iv. the store‟s security conditions were less satisfactory as medicine stocks were kept in an unlocked room adding with an unlatched back-door as well as stock level below 50cm from the ceiling limit was not observed. In addition, there were a few stores in which their ceiling was cracked/broken/torn off, 56 leakages in the air conditioning system, unavailable and expired fire extinguishers as well as empty boxes placed outside the store‟s back door; and v. 15 (15.2%) out of 99 payment vouchers worth RM0.49 million in PKD Johor Bahru and 67 (15.3%) out of 115 payment vouchers worth RM1.55 million in PKD Seberang Perai Utara were incomplete whereby Delivery Order and Goods Received Notes [ePerolehan (eP)] have not been attached to the respective payment vouchers.