Standard Operating Procedures Hospital 5s273m

DR. TOMAS L. NOLASCO SR. HOSPITAL Centro Sur, Gattaran, Cagayan DTLNHS Pharmacy STANDARD OPERATING PROCEDURES (SOPs) DTLNHS Pharmacy premise reflects the professional character of pharmacy and facilitate delivery of quality and comprehensive pharmaceutical services by the pharmacist without compromising his or professional judgment. This premise was designed and maintained to meet the patien rights and needs. Moreover, Pharmacist shall be responsible for the purchasing, receiving, storage, distribution and disposal of drugs in Parmacy. I.

the her the the

Pharmacy istration a.

The Pharmacist or the person designated in writing as responsible for the pharmacy is able to the Chief or the executive officer, for properly storing and dispensing drugs, record keeping, and maintaining a pharmacy policy an procedures manual, including complaint privacy and security provisions, and ensuring limited access into the pharmacy during and after hours. b. The Pharmacist or the person in charge of the pharmacy shall acquire, store, compound, and dispense medications according to applicable Pharmacy Law and observe the highest standards of professional practice and established pharmaceutical procedures to ensure the best possible in patient safety and/or patient medication safety practices. The Pharmacist or the person in charge of the pharmacy shall ensure adequate current pharmacy references, hardbound and/or online access. II.

Prescriptions a. Prescriptions written by Medical/ Dental Practitioners shall be filled and If the medicines prescribed are not available at the pharmacy,the patient may have the prescription filled outside of the hospital. b. Prescriptions shall be personalized. If more than one member of a family is prescribed the same drug, a separate prescription blank must be used for each member. c. Pharmacy staff shall write the filled prescription details such as manufacturer's name, lot number, and expiration date in the record book.

III.

Dispensing a.

The pharmacy shall serve as the source of supply of required pharmaceuticals and related supplies. In addition, the pharmacy dispenses required, authorized preparations directly to patients. b. Except for OTC program items, the pharmacy shall dispense all stocked items only on receiving a properly written, verified prescription. If pharmacy staff receive an illegible prescription or question its authenticity, dosage, compatibility, or directions to the patient, staff shall obtain clarification from the prescriber before dispensing the medication(s).

c. This hospital shall have a system (computerized, written, etc.) in place to ensure they can obtain prescriptions in case of a product recall. d. This hospital shall submit all pertinent patient adverse reactions or product quality problems to FDA DOH CHD CV. e. When dispensing medication, the dispenser shall identify the patient and ensure his or her eligibility. f. In the event of a MEDICATION ERROR (i.e. an error discovered after a prescription has been dispensed to the patient), a Medication Error Report including pertinent information relevant to the error (name of discoverer, date of discovery and a brief statement describing error) shall be completed. IV.

Labeling a.

b.

c. d. e.

V.

A label will be prepared for each prescription dispensed to individuals and will be securely affixed to the container prior to dispensing. The label or appropriate auxiliary labeling will show as a minimum: 1. Name of Pharmacy, including the pharmacy address and number. 2. Prescribers name. 3. Definite, concise directions to the patient. 4. Drug name and strength, unless prescriber directs otherwise. 5. Amount dispensed 6. Patient’s first and last name. 7. Initials of person writing the prescription label. 8. Date prescription filled. 9. Indication of refills. 10. Expiration date 11. Necessary supplemental or auxiliary labels. If prescription contents are for external use only or require further preparation(s) for use (shaking, dilution, temperature adjustment, or other manipulation or process) include the appropriate directions on the label or affix an additional label to the container. If liquid preparations for external use are poisonous, affix a "poison" label to the container. If medicines prescribed for internal use are poisonous, use sound judgment whether to label them "poison" based on the finished preparation’s potency in each case. Medicinal preparations compounded or packaged in the pharmacy for subsequent issue will be identified and labeled with the full generic name, except that trade or brand names may be used provided trade or brand name product actually is in the container. The manufacturer’s name, lot number, and expiration date, if any, will be shown on the label.

Procurement a. Only those items that have been licensed and approved by the Food and Drug istration (with the exception of vitamins with an established RDA) are authorized for sale in the Pharmacy. b. Drugs and other Pharmaceutical products shall be procured from FDA licensed drug distributors and manufacturers. c. The procurement process of all medicines should be handled and supervised by a pharmacist. d. All purchases should be done through formal Order book, /LPOs signed off by the pharmacist.

e. All purchases should be received by formal delivery notes clearly detailing; the product generic name, Brand name, quantity, batch Number, expiry date and other technical specifications like strength, dosage form etc. All documents used per procurement should be properly dated, filled, signed, stamped with the pharmacist’s stamp bearing the name and registration number and filed in a box file.

VI.

Storage a. In storage, separate external use medications from internal use medications and ophthalmic and otic preparations b. Store flammable drugs according to accepted fire safety regulations.

VII.

Pharmacy and Therapeutics Committee a. The committee is an advisory group on all matters relating to the acquisition and use of medications. Its recommendations are subject to the approval of the Chief of Hospital or the Executive Officer. b. The committee is composed of but not limited to atleast one physician, one dentist, pharmacist and representative from medical istration.

VIII.

Disposal of materials and equipment a.

Approved Expiry and Near Expiry stickers should be available and used in the manner stated under standards for storage area. b. There should be segregated waste bins for biohazard waste, hazardous waste and nonhazardous labelled in three colors red, yellow and black respectively. For sharps (bio-hazardous waste), a sharps container should be available. c. Records should be maintained for disposal of bio-hazardous and hazardous waste and never destroyed. d. This Pharmacy shall establish a mechanism of informing clients to return expired drugs, unused medicines, used drug receptacles (bottles, vials, boxes etc) to the pharmacy premises. e. Pharmaceutical waste should be clearly identified and separated from usable stock. f. The pharmacist should ensure that all the existing legal and professional requirements with respect to the disposal of pharmaceutical waste are met. g. The pharmacist should ensure that the relevant documentation is completed and complies with legal and professional requirements. IX.

Products Complaint Handling a. The responsibilities defined in the standards SHOULD be complied with at all times. b. The Hospital Pharmacy complaints policy which should be reviewed from time to time. All complaints-oral or written- must be immediately addressed by the pharmacist, and suitable action be taken to amend the situation. c. The complaint, its nature, the erring person’s name and the action taken must be documented in a complaint .

d. The event should be reviewed and evaluated to find the underlying cause(s). Appropriate steps should be taken to amend the operating procedures or other guidelines so as to prevent the recurrence of the same or similar events. X.

Drug Recall a. The Pharmacist should have a well-documented recall policy. b. The pharmacy should proactively participate in any state wide or nationwide recall process for any substandard drug. All such records should be initiated upon receiving authentic information and alarms to do so. The initiation, progress and completion of recall should be well documented. c. Adequate vigilance must be maintained to look out for recall alarms from regulatory sources as well as from pharmaceutical companies. d. In case of any suspicion, the pharmacist should take immediate steps to stop the sale of drug and notify the relevant parties. e. If the pharmacist has a suspicion or a reason to believe that short comings have occurred in the process of delivery of medicines from the pharmacy, immediate effective measures should be initiated to minimise the risk of damage or danger to the patient(s).

XI.

Cold Chain Management a. The Pharmacist and Pharmacy staff shall ensure that the vaccines they dispense have been correctly stored. b. The refrigerator for storage of biologicals should be specifically designed for this purpose and should have a lock. c. Vaccines are sensitive biological products; protection of vaccine potency and

stability is important. The recommended temperature for vaccine storage is, at all times, +2ºC to +8ºC. d. All biological products freeze at temperatures below 0°C; products that have been exposed to temperatures below 0°C should not be used. e. A temperature monitoring system shall be placed in the refrigerator and calibrated from time to time. f. A cool pack/ box must be used in transporting biologicals. g. All acquired biologicals shall be recorded properly by the Pharmacist or the Pharmacy staff.

XII.

Adverse Drug Reaction a. The Pharmacist shall outline a step by step approach for employing the spontaneous reporting of adverse drug reactions in monitoring medicines safety for use. b. In case of ADRs reported by patients, the Pharmacist shall fill out the reporting form and submit it to FDA.

c. The reporting form should be simple and easy to complete. The reporting form should not request too much information, particularly information that is difficult to find and record, or information that is unlikely to be used. d. The reporting form should have sufficient space in which to describe the suspected reaction(s). The form should carry a statement reassuring confidentiality of information given

e. The reports should be stored securely to maintain privacy. f. ADR Report shall include essential data elements, details of medicines, reaction details, reporter details, advise to reporter and report follow up.

Approved by: ___________________________

Date: ____________________________