Hospital Pharmacy Service Guideline (2015) was formulated in order to provide access to health services for all in an effective manner by providing accessible and quality service to patients and clients through the operation of its own pharmacy service. The 2015 guideline was repealed in 2021 and a new guideline was issued in line with Section 64 of Public Health Service Act (2018). The new Guideline was endorsed on January 31, 2022.
The new guideline lacks major content dealing with hospital pharmacy. It is worse than the 2015 guideline and may require further intervention from the policy level to make it more resourceful and accommodative. It was a matter of pride to say that the previous Hospital Pharmacy Service Guideline (2015) was a piece of remarkable evidence guiding many pharmacists oriented to clinical services. The new guideline sets a decrement in the benchmark previously set.
The 2015 guideline should have been studied well before taking the decision to amend it. Here, I try to compare the differences between these two guidelines and explain why the current one has so many problems.
Comparison between the guidelines
Both guidelines explain the establishment of the Drug and Therapeutic Committee (DTC) (Rule 3) which is responsible for carrying out efficient services related to pharmaceuticals and allied substances in hospitals. The DTC is responsible for carrying out the functions mentioned within Rule 4 by both guidelines. However, there are changes in the recent one with the addition of sub-rules discussing standard treatment protocol, selling of drugs on Maximum Retail Price (MRP), and Hospital Pharmacy Operation Committee. However, the previous one discussed these issues more descriptively as a separate rule. The 2015 guideline had a separate rule for the Hospital Pharmacy Operation Committee where it explained what members are to be within the committee and who are responsible for running the pharmacy in an organized manner.
Rule 8 of the 2015 guideline, which spoke on the procurement procedure of medicine and medicinal substance and material as per the Public Procurement Act (2007) and Public Procurement Rules (2008), has been removed in the new guideline. This sparks controversy on how procurement is to be regulated. Rule 9 which spoke on the major issue of the selling price of medicinal products which would be no more than 20 percent of the cost price has been totally removed. This rule was significant as this covered the idea of basic concepts like affordability and availability. This gives hospitals the right to sell medicines at the MRP price and would lead to a conundrum regarding tender procured medicines.
Though Rule 8 of the new guideline provides access to pharmacists in hospitals ranging from 5 bedded to 100 and more, it specifically doesn’t speak on what professional degree pharmacists are to be within the hospital setting for the clinical management of patients. The previous guideline provided a specification for clinical pharmacists and their role in hospitals with 51-100 and more than 100 beds.
Formulary is one of the essential parts of guiding evidence-based medicine and helps to know the basic information about drugs ranging from indications, dose, and strength to contraindication. Despite the new guideline having a sub-rule for the preparation of formulary it specifically doesn’t speak on what contents are to be added. This was very well explained by the 2015 guideline in Rule 19.
With all this, the major drawback in the recent guideline is the removal of Rule 20 of the previous guideline regarding ‘Special Arrangement for Private Hospital.’ It explained how private, co-operative, community, teaching as well as non-governmental sector hospitals also must run their own pharmacy service with approval from the Government of Nepal. This excuses private hospitals for not accepting hospital pharmacies within their proximity. The removal of this rule may make medicines within the private, co-operative, community, teaching as well as non-governmental sector hospitals unaffordable for the patients. The exclusion of rules 15 (Financial Management) and 16 (Accounting of Income and Expenditure) makes the current guideline even weaker. Separate bank account for deposition of transaction of money or money received from the Ministry, daily sales, local body and the use of account for expenses is explained within Rule 15, while Rule 16 explains on the management of accounting of income and expenditure of the pharmacy along with the role of auditing of the hospital pharmacy which would be conducted by the Office of the Auditor General. The fact that these topics are not covered in the new guidelines raises questions about the transparency of financial works.
Though the new guideline lacks many points there is one thing good about it. It explains the establishment of standard operating procedures to be followed in compliance with good pharmacy practice and standard treatment protocol. These are positive points. Yet, the Hospital Pharmacy Service Guideline (2021) is much weaker than the previous one and it needs to be amended.
Nabin Pathak is a registered pharmacist currently pursuing Masters in Pharmaceutical Sciences, Clinical Pharmacy at the School of Health and Allied Sciences, Pokhara University.