Indian Public Health Standards 2012 and the diabetes pharmacopoeia.

As India grapples with an unprecedented epidemic of non-communicable diseases, the healthcare system faces more demands and newer challenges. Earlier geared towards infectious diseases, maternal and child health problems, public health issues and now includes in its ambit ‘modern’ or non-communicable disease diabetes mellitus. The growing concern of disease burden as per global and national statistics is well-known and needs no repetition in this journal.

The Indian Public Health Standards (IPHS), revised in 2012,[12345] are an attempt to set operating standards for government health institutions, ranging from sub-centers and primary health centers to sub-district/sub-divisional and district hospitals. The IPHS provide exhaustive coverage of the physical and human resources necessary to run health institutions, duties and responsibilities of staff, and the processes and procedures by which these are to be achieved. Included in the IPHS are lists of drug to be made available at health facilities of various levels. To some extent, but not completely, the drug lists of the IPHS demonstrate concordance with the National List of Essential Medicines (NLEM).[6] The NLEM, last revised in 2011, is a governmental list of drugs, which are essential at primary, secondary, and tertiary levels of healthcare system.

The strong presence of endocrine pharmacopoeia in the Indian NLEM has already been discussed.[7] This underscores the heightened importance given to endocrine and metabolic disease at the policy-maker level. Equally important, it also demonstrates the responsibility felt by the endocrine community towards fulfilling its mandate of better patient care at not only the individual, but also the public health level.

This editorial discusses the diabetes drugs listed in the IPHS, and suggests simple changes which maybe implemented to improve care for people with diabetes, irrespective of which healthcare facility they choose to visit.

The Indian public health system comprises of sub-centers, primary healthcare centers, community health centers, sub-district and sub-divisional hospitals (31 to 100 beds), and district hospitals (101 to 500 beds). Each level of healthcare performs different duties and fulfils unique responsibilities. This is achieved with a pre-specified set of physical equipments and drug lists.

COMMUNITY HEALTH CENTERS

The community health center drug list includes regular insulin, intermediate insulin, metformin tablets (500 mg strength), and Daonil (glibenclamide) (5 mg strength). This list represents the basic minimum required drugs for diabetes care. In a community health setting, however, the emphasis is on convenience, safety, and tolerability. One can, therefore, argue for addition of premixed insulin to the IPHS for community health centers. Availability of premixed insulin will obviate the need to educate medical and paramedical staff, as well as patients, about the technique for mixing insulins. Thereby inclusion of premix insulin not only will save time but, will also reduce potential errors in drug administration. It will also allow doctors the flexibility of prescribing once- or twice- daily insulin regimes,[89] based on recent Indian and global evidence instead of having to prescribe, and monitor, basal-bolus regimes.

Addition of safer sulfonylureas, such as glipizide, gliclazide, or glimepiride, which are associated with a lower risk of hyperglycemia, will also make diabetes care much safe and better tolerated options at the community health center. A metformin and sulfonylurea combination is an inexpensive and effective method of achieving glycemic control in many people with diabetes,[10] and a case can be made for including such fixed dose combinations (FDCs) in the IPHS.

SUB-DISTRICT AND DISTRICT HOSPITALS

The IPHS suggest a more exhaustive list of anti-diabetes drugs at the sub-district/sub-divisional hospital and district hospital levels. Lists for these two categories of hospitals are similar as far as diabetes-related drugs are concerned. They still contain secretagogues, which are no longer in use, such as chlorpropamide and tolbutamide. Glibenclamide is mentioned by generic name, while the term “biguanide” is used, presumably as a synonym for metformin. The strengths of glibenclamide and biguanide are not specified.

As for Community Health Centers, addition of FDCs to the drug menu will help improve diabetes care for patient in sub-district and district hospitals.

All types of insulin, viz, short-acting, intermediate-acting, and premixed, are listed in the IPHS for hospitals, though the terminology is at variance from what is used in contemporary endocrinology. Insulin rapid and “cry insulin” (crystalline insulin) are mentioned separately. This clearly indicates the need for both rapid-acting analogues (aspart, lispro) and regular insulin at sub-district and district hospital. On the other hand, it is possible that these terms are used interchangeably for regular short-acting insulin. Insulin lente is included in the drug list, through it is no longer in production.

What is important though is that, the need of rapid-acting insulin and basal insulin is understood by policy makers to strengthen the healthcare systems at primary, secondary, and tertiary healthcare levels. The only insulin for which there is no ambiguity in the IPHS is Mixtard, which is mentioned by trade name, and followed by the word (desirable), in brackets. This not only shows the understanding on treatment compliance and better outcomes but also endorses that how inevitable the role of premixed insulin is, to these healthcare levels in Indian setting along with, realization of the benefits of originator viz. a viz. generic copies.[11]

RATIONALIZATION

In general, the list of anti-diabetic drugs in the IPHS is similar to that of NLEM, though an update is required with deletion obsolete drugs from the former.

It is appreciated that writing the IPHS must have been a Herculean (or to be more culturally appropriate, Bhima-esque) task for the authors. It is also understood that the IPHS writing committee may not include specialist endocrinologists. Professional bodies such as the Endocrine Society of India can take a proactive step by approaching IPHS with a suggested addendum of endocrine and diabetes drug lists. Such an addendum will highlight the already existing endocrine pharmacopeia in IPHS, such as thyroxine, prednisolone, testosterone depot 50 mg and testosterone plain 25 mg, while requesting for addition of other essential drugs such as hydrocortisone, fludrocortisone, carbimazole, and vitamin D.[7] Similar action by professional organizations representing other specialties and sub-specialties will contribute towards making the IPHS drug list more relevant and responsive to the patient's needs.

The IPHS 2012 is a well-conceived and well-written document of seminal importance in rationalizing the lists of drugs in the IPHS with special perspective that will help and enhance its prestige in improving its utility for all stake-holders, including both clinical, as well as public health professionals.

CONCLUSION

A rational, exhaustive list of drugs with acceptable quality standards and ensured availability of all in adequate quantity will certainly improve healthcare for the millions of Indians living with diabetes, and help them achieve better glycemic control. The IPHS drug list should be based on patient safety, tolerability, and efficacy while taking convenience of use into account. Biologic molecules should be mentioned by trade name to prevent interchangeability and errors in dispensing. Not to be forgotten are the devices necessary for insulin administration. Insulin syringes (in appropriate concentration, 40 IU/ml, and 100 IU/ml) must be included separately in the IPHS (as well as NLEM) lists, as must insulin technique guidelines,[12] glucose monitoring meters, and strips.

Through its pages, the Indian Journal of Endocrinology and Metabolism supports the move to empower and equip health centers and smaller hospitals with the facilities required to fight the diabetes epidemic.